Pfizer
Nervous system symptom reports
Female, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2020-12-31 | pain in extremity |
No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, ache...
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No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, aches, neck lymph node soreness/slight swelling, fatigue
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| 40 | 2020-12-31 | tremor, tingling |
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC...
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CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
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| 40 | 2021-01-01 | feeling hot |
Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved...
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Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved on their own. employee is 14 weeks pregnant.
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| 40 | 2021-01-01 | pain in extremity |
Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Sev...
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Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Severe headache starting again on day 4 lasting through day 5. Unable to focus, eat because of headache. Sore arm for 24 hrs post vaccine.
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| 40 | 2021-01-03 | numbness, tingling |
Reports paresthesias and subjective sense of "numbess" of R lateral neck, face, R ear and temporal a...
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Reports paresthesias and subjective sense of "numbess" of R lateral neck, face, R ear and temporal area of scalp within 30 min of vaccine that persisted x 90 min. Also reported transient "numbness" of R anterior thigh that resolved spontaneously after 30 min. No pruritic, urticaria, rash. No mucus membrane symptoms - no conjunctivitis, rhinitis or oral/perioral symptoms. No mucosal swelling or sense of swelling. No respiratory symptoms. No presyncopal symptoms. Vitals: BP 134/87, Pulse 103, sats 100%.
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| 40 | 2021-01-03 | pain in extremity, numbness |
Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. ...
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Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. Whole top of foot and toe was really swollen and a lot bigger than the other couldnt walk or put pressure on my foot. Have been home unable to work since december 30th
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| 40 | 2021-01-03 | pain in extremity |
Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted...
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Patient immediate burning in her shoulder. Puncture site found to be too high for deltoid. Contacted Pfizer and IM/ID physician. Will re vaccinate in 5 days. Arm very painful, lump under acromion process. Feels like bursitis.
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| 40 | 2021-01-03 | seizure, tremor, weakness |
I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shak...
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I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.
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| 40 | 2021-01-03 | sensory loss, numbness |
On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of d...
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On Dec 29th, I developed bilateral loss of sensation in my thumb and first 3 fingers, with loss of dexterity. It improved somewhat over the next 45 minutes, but I continue to have loss of sensation in all 10 fingertips, worse in both thumb and 5th digits.
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| 40 | 2021-01-03 | sensory loss, muscle spasms, unresponsive to stimuli |
Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as thoug...
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Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.
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| 40 | 2021-01-04 | weakness, migraine |
One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in s...
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One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.
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| 40 | 2021-01-04 | flushing, feeling hot |
About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense...
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About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.
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| 40 | 2021-01-04 | numbness, tingling |
numbness and tingling in all four extremities; numbness and tingling in all four extremities; interm...
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numbness and tingling in all four extremities; numbness and tingling in all four extremities; intermittent weakness in my hands, arms and legs; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0140), via an unspecified route of administration on the left arm on 18Dec2020 12:30 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history reported as none and the patient had no known allergies. The patient's concomitant medications were not reported. It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 13:30, the patient was experiencing numbness and tingling in all four extremities after the first dose of the vaccine. The patient also experienced intermittent weakness in hands, arms and legs. It was also mentioned that the patient had numbness and tingling in all four extremities for the past 10 days. The patient did not receive any treatment for the events. Outcome of the events were unknown.
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| 40 | 2021-01-04 | numbness | She describes joint pain and gradual numbness on her arms. |
| 40 | 2021-01-04 | numbness |
Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then ...
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Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.
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| 40 | 2021-01-04 | tingling, numbness |
Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left h...
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Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in my left hand/fingers and the left side on my lip; This is a spontaneous report from a contactable Nurse (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231) on 23Dec2020 07:15 PM via unknown route of administration (vaccine location: Left arm), at single dose (first dose) for COVID-19 immunization. Medical history was reported none. Concomitant medications included ibuprofen. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not use other vaccine in four weeks. Patient experienced Numbness and tingling (similar to a pins and needles sensation when a limb fall asleep) in her left hand/fingers and the left side on her lip on 25Dec2020. Patient did not receive any treatment. The outcome of the events was not recovered. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
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| 40 | 2021-01-04 | sensory loss, numbness, tingling |
About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek...
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About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek were numb). I also had some numbness on the top of my thigh. I sat for monitoring for a couple hours and was sent home. The tingling moved to the back of my head for a little while last night and seemed to had resolved before I went to bed around 10p. The tingling seems very minimal this morning...on a scale of 1-10, 10 being the most noticeable, yesterday was a 10. Today seems to be a 1 or 2. Only noticeable if I am sitting still and be more along my ear and not my head or shoulder. There is still the weird feeling (similar to numbness) in my face and my thigh. My face is getting better.
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| 40 | 2021-01-05 | weakness, tingling | Lightheadedness, dizziness - "felt like the room is spinning," weakness and tingling all extremities |
| 40 | 2021-01-05 | weakness |
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ...
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Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
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| 40 | 2021-01-05 | depressed level of consciousness |
anaphylaxis; ALOC/decreased level of consciousness; This is a spontaneous report from a contactable ...
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anaphylaxis; ALOC/decreased level of consciousness; This is a spontaneous report from a contactable Pharmacist (patient). a 40-year-old female patient (no pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140) via intramuscular at Left arm on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history included known allergies to egg, seafood, azithromycin, orange and seasonal allergies. The concomitant was reported as cetirizine hydrochloride (ALLERTEC) and PRN 1371. The patient with no known past medical history brought in by CODE Team to RUH ED with concern for ALOC after getting the COVID vaccination 30-40 minutes PTA. Patient was a nurse and experienced decreased level of consciousness following her COVID vaccination. Patient reports h/o anaphylaxis. She was given epinephrine PTA. Denies SOB, oral swelling, CP. Blood glucose (BGL) within normal limits. Patient denies any other complaints or symptoms at this time. Adverse event start date: 23Dec2020. Treatment was unknown for decreased level of consciousness. The outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis /decreased level of consciousness cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-05 | difficulty speaking |
Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. R...
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Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.
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| 40 | 2021-01-05 | feeling cold |
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times t...
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Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
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| 40 | 2021-01-05 | feeling hot |
Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I ea...
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Warmth at injection site Warm all over body Itchy tingling on my lips. Same feeling I have when I eat shrimp.
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| 40 | 2021-01-05 | flushing |
Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tach...
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Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tachycardia. Brought patient away from public area, gave cool pack, oxygen and called EMS. EMS monitored patient and issue resolved within 20 minutes.
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| 40 | 2021-01-05 | flushing |
dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; diz...
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dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.
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| 40 | 2021-01-05 | pain in extremity, feeling hot |
left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable ...
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left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the left arm, on 19Dec2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she took the vaccine on 19Dec2020. On an unspecified date, patient stated that she had no side effects only her arm was hurting. She stated that her whole body is hot. Stated that she has no temperature and is a little nauseous. Stated that whererever she lays down at one can feel the heat. She stated that it was Pfizer BioNTech Covid 19 vaccine EUA is concerned. She stated that she went to the ER and they thought it was because she was taking a medication for urinary tract infection (UTI) and that she was having a reaction. She stated that her doctor told her that the second day she would have had side effects to UTI medicine. She stated that the doctor is stating that it is due to the vaccine. She wanted to know if she should go back to the ER. She stated that her doctor told her to call the place where the vaccine was received for them to monitor her. She stated that she went through her job off site and that this was her first shot. She clarified that she received the shot in her left arm and it was hurting. Outcome of the events was unknown. Information on lot/batch number has been requested.
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| 40 | 2021-01-05 | pain in extremity | Arm soreness, mild fatigue but she is overall okay |
| 40 | 2021-01-05 | pain in extremity |
Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day o...
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Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day one. Headache. Arm pain out of proportion to previous IM vaccinations.
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| 40 | 2021-01-05 | pain in extremity |
Symptoms - ? approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the ...
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Symptoms - ? approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was placed ?too high.? Patient reports she spoke with RN?s on her unit and showed location of vaccination and was educated it was placed too high. Patient reports sore arm after 1st dose but reports, ?this feels so much worse. I can barely lift my arm.? Recommendation? Patient educated to rotate Tylenol and motrin according to the medical directive for prescription medication and to apply ice to injection site. Patient educated to call vaccine support line for worsening symptoms, patient verbalized back understanding and denied further questions at this time.
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| 40 | 2021-01-05 | pain in extremity |
Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and de...
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Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and developed a fever of 101.
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| 40 | 2021-01-05 | pain in extremity | Fevers started 12 hours post vaccine. Severe arm pain. Out of proportion to previous IM vaccines. |
| 40 | 2021-01-05 | pain in extremity |
Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and starte...
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Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.
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| 40 | 2021-01-05 | pain in extremity |
Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep wa...
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Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep was very sore. I have regular yearly flu shots with no issues.
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| 40 | 2021-01-05 | pain in extremity |
a red area at the injection site /growing red spot at injection site; raised area at the injection s...
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a red area at the injection site /growing red spot at injection site; raised area at the injection site/It was raised; irritated area at the injection site/really irritated; sore arm/arm it would wake her up with pain; itching /painful itchy growing red spot at injection site; normal pain at the injection site; there was an induration there; This is a spontaneous report from a contactable physician reporting for herself. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Caller was a ER Physician who received her COVID 19 vaccine last Monday 21Dec2020, and was reporting adverse event at injection site. She reported a red, raised, irritated area at the injection site, stated "thought I got bit by something" and didn't link it to the vaccination, originally. She took Benadryl, treated it like cellulitis by using a heating pad, and applied cortisone. She stated it was persistently getting worse, even seemed worse last night. She had been taking pictures of the skin reaction and wanted to know if there was a way to submit those for follow-up/monitoring. It was also reported painful itchy growing red spot at injection site was reported as worsened. Caller had the vaccine 10 days ago, which was last Monday. She didn't notice at first. She had the normal pain at the injection site. She woke up 3-4 days later, and she felt like she got bit by something. It was a little red. It was painful, itchy, and really irritated. She paid attention to it 3 days ago. She thought this wasn't right. When sleeping on that arm it would wake her up with pain. So she would switch sides. She started taking pics of it yesterday. The redness is getting bigger. She was an Emergency Medicine Physician. She didn't have a prescribing doctor. She got it at (Institution name). She noticed it was there when she first got the shot. It felt like a normal flu shot, and she was fine. She worked out the next day. She had a sore arm like usual with any type of a shot a Tetanus shot or something. She didn't notice anything out of the ordinary until later on, and there was an induration there. It was raised, red, and kind of warm. It was painful and itchy at the same time. It was almost like if a tag in the back of clothes were rubbing it, and she couldn't move all day. There would be an irritated area there. It is getting bigger. Now it was starting to go around her arm. It was not terrible debilitating. She was not allergic to anything. She has put cortisone cream on it, but it didn't change anything. Then, last night, she tried cortisone cream and Neosporin a little later. She then put a medium hot heating pad on it for a nice chunk of the night. It was growing near her lymph nodes now. She said the vial size looked to be about 10 mL. It was a small vial. The nurse did say she could get one more dose out of that vial. She did take Benadryl to sleep at night. So she didn't feel like it was an allergic reaction. Benadryl-Unysom expiration- May2022 Lot: 20E330 Cortisone: Lot: 11885 The Cortisone's lot number was imprinted, and hard to see. The outcome of the events were not resolved.
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| 40 | 2021-01-05 | pain in extremity |
approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was p...
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approximately 3 hours after vaccine, complaining of L arm pain. Patient concerned the vaccine was placed ?too high.? Patient reports she spoke with RN?s on her unit and showed location of vaccination and was educated it was placed too high. Patient reports sore arm after 1st dose but reports, ?this feels so much worse. I can barely lift my arm.? Patient educated to rotate Tylenol and motrin according to the medical directive for prescription medication and to apply ice to injection site. Patient educated to call vaccine support line for worsening symptoms, patient verbalized back understanding and denied further questions at this time.
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| 40 | 2021-01-05 | tingling |
After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling...
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After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling/weakness, difficulty ambulating.
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| 40 | 2021-01-05 | tingling | Tingling in fingers Fingers contracting without pain, only tingling |
| 40 | 2021-01-05 | tingling |
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,...
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Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
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| 40 | 2021-01-05 | seizure like phenomena |
Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling d...
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Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.
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| 40 | 2021-01-06 | weakness |
Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and...
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Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and muscle aches. Took 600mg ibuprofen. At 1am had massive headache body aches chills to the core. Took more Tylenol. At 5:30am fever of 100.4 and flu like symptoms. Called into work.
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| 40 | 2021-01-06 | weakness | HEADACHE FEVER CHILLS NAUSEA VOMITING WEAKNESS BODY ACHE |
| 40 | 2021-01-06 | weakness | Headache, chills, body-ache, fever, nausea, vomiting, and weakness. |
| 40 | 2021-01-06 | burning sensation, hot flush, tingling, pain in extremity |
After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flash...
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After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.
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| 40 | 2021-01-06 | discomfort | EE reports facial swelling with pressure and HA at 3:00 pm went to the ER at 6:00 pm |
| 40 | 2021-01-06 | pain in extremity, burning sensation |
On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful...
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On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful. The following day, Tuesday January 5th I woke up with a sore right arm and a slight headache. The headache increased in intensity throughout the day, developing also body aches and a fever of 100.4. The symptoms seemed to improve slightly after taking Tylenol. The next day, Wednesday January 6th I felt much better, the body aches were almost gone, I had no fever and no headache. When I got home from work I noticed hives all over my arms, anterior and posterior neck - going into the hairline, face, especially around my mouth, chest, abdomen, upper and lower back. The affected areas were itchy and I also felt a slight burning/stinging sensation on my neck. Even though I did not notice any hives on my legs, my right ankle was itchy, as well. I took Claritin 10 mg and I did not notice much difference. When I woke up today, Wednesday January 7th the hives were still present on my arms, chest, abdomen and back and they looked like dissipating. It is currently 6:12 pm on January 7th and my hives are almost gone
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| 40 | 2021-01-06 | pain in extremity, tingling |
Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at i...
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Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.
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| 40 | 2021-01-06 | pain in extremity |
I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really cou...
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I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.
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| 40 | 2021-01-07 | discomfort, feeling hot |
Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal...
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Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.
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| 40 | 2021-01-07 | numbness, numbness and pain in extremities |
neuropathy/ started acutely in feet bilaterally / persist intermittently in left extremities; One-ti...
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neuropathy/ started acutely in feet bilaterally / persist intermittently in left extremities; One-time episode of upper extremity (UE) numbness; This is a spontaneous report from a contactable health care professional (patient). A 40-year-old female patient (not pregnant) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown) at single dose via an unknown route at left arm on 26Dec2020 for Covid-19 immunization. COVID-19 vaccine was administered in Pharmacy or Drug Store. Medical history was reported as "none". Patient had no COVID prior vaccination, further reported as patient was not diagnosed with COVID-19 prior to vaccination. No known medications, food, or other products allergies. Concomitant drugs (Other-medications-in-two weeks) included levocabastine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL) as needed, ibuprofen (MOTRIN), and multivitamin. No other-vaccine-in-four weeks received. Patient experienced adverse-event of neuropathy, which started acutely in feet bilaterally and now (as of 02Jan2021) persist intermittently in left extremities (LEs). One-time episode of upper extremity (UE) numbness. No weakness. Patient inquired if 2nd dose should be held. Adverse-event-start-date was 26Dec2020. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received. The event was reported as non-serious. Since the vaccination, patient had not been tested for COVID-19. Outcome of the event was not resolved. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of peripheral neuropathy and upper extremity (UE) numbness due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and nerve conduction tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-07 | numbness, tingling, bell's palsy |
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ...
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Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
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| 40 | 2021-01-07 | numbness |
acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; acute bilateral nu...
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acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; acute bilateral numbness in my thumb and first 3 fingers, with loss of dexterity; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: FK1730, via an unspecified route of administration at Left arm from 19Dec2020 09:15 to 19Dec2020 09:15 at SINGLE DOSE for COVID-19 immunization. Medical history reported as none. Concomitant medication included acetylcarnitine (ACETYL L CARNITIN), magnesium, colecalciferol (VITAMIN D), and probiotics. On 29Dec2020 16:30, the patient developed acute bilateral numbness in her thumb and first 3 fingers, with loss of dexterity. It lasted approximately 30-45 minutes, and then improved somewhat but it continues to be present in all digits. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination. The outcome of the events was not recovered.
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| 40 | 2021-01-07 | pain in extremity, weakness |
I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time wa...
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I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time walking around the hospital I almost fell asleep on my desk. I fell asleep that night and felt fine the next day! Advanced maternal age because I'm 40 so I'm high risk, Low on Vitamin D3 early in my pregnancy, beginning of Dec I was lightly anemic, due date Feb 9th
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| 40 | 2021-01-07 | pain in extremity, cold sweat |
Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold s...
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Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch. Arm painful for 3-4 days
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| 40 | 2021-01-07 | pain in extremity |
Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started a...
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Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started and lasted until 5am Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours
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| 40 | 2021-01-07 | pain in extremity |
low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hour...
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low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)
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| 40 | 2021-01-07 | pain in extremity | sore arm, headache, chills, fatigue |
| 40 | 2021-01-07 | pain in extremity |
Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a conta...
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Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.
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| 40 | 2021-01-07 | tingling | Dizziness Tingling Left arm to finger tips. |
| 40 | 2021-01-07 | tingling |
Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and righ...
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Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
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| 40 | 2021-01-07 | tremor, migraine |
bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; ...
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bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
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| 40 | 2021-01-07 | tremor |
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Ra...
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After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.
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| 40 | 2021-01-08 | pain in extremity | Nausea, headache and arm pain |
| 40 | 2021-01-08 | pain in extremity |
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa...
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1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
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| 40 | 2021-01-09 | difficulty speaking |
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ...
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Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
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| 40 | 2021-01-09 | hot flush |
After sitting down in the observation area and I was just starting to register for vsafe my heart st...
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After sitting down in the observation area and I was just starting to register for vsafe my heart started to pound then I experienced a hot flushed feeling that went through my entire body and my heart started racing and felt not well. I told the nurses what happened and they said I looked pale. I laid down and started to feel better after a few minutes.
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| 40 | 2021-01-09 | numbness |
11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, sev...
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11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain and kidney pain
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| 40 | 2021-01-09 | numbness |
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ...
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I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
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| 40 | 2021-01-09 | tenderness |
Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen co...
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Woke up this morning with swollen, and extremely tender right armpit area. It is visually swollen compared to the left and is very painful. I am under the assumption this is likely a swollen lymph node post second vaccination. I have taken ibuprofen in attempt to help with pain and inflammation but does not seem to be helping much at this time. I anticipate this will improve over time.
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| 40 | 2021-01-10 | cold sweat | itchy, clammy, sweaty |
| 40 | 2021-01-10 | discomfort |
Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . ...
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Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . Described discomfort as constant. The next day on 01/10/2021 at about 8am, the discomfort started to radiate down to her left armpit area and left lateral breast area. Denied redness or fever but did state area was " swollen" . Stated affected areas felt " hard but it was probably because there was swelling". Patient states she had full range of motion to left arm, no numbness or tingling to left arm or hand. No complaints of shortness of breath , chest pain, or rash.
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| 40 | 2021-01-10 | feeling hot, weakness |
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain unde...
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Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,
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| 40 | 2021-01-10 | feeling hot |
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started ...
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0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
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| 40 | 2021-01-10 | flushing, difficulty speaking |
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r...
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This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
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| 40 | 2021-01-10 | migraine | chills, body aches and migraine beginning on 1/4/21 and lasting until 1/6/21. |
| 40 | 2021-01-10 | pain in extremity, muscle spasms |
On Friday I developed soreness in neck slowly spreading from left to right and still ongoing today w...
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On Friday I developed soreness in neck slowly spreading from left to right and still ongoing today which is Monday. Having upper back and neck pain and aching in right arm and spasms in right shoulder. Have used heat, nsaids, Tylenol, and muscle relaxers. May feel slightly improved today but not much. This could be coincidental but figured I should report in case others have experienced or will experience. I do not recall hurting my neck.
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| 40 | 2021-01-10 | pain in extremity |
Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for ano...
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Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for another 24 hours. Joint pain, headache and low grade fever for 48 hours.
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| 40 | 2021-01-10 | tingling, weakness, numbness |
shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours af...
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shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours after vaccination and developed loss of range of motion, weakness, inability to lift arm, tingling and numbness down the length of arm. Severe pain prohibiting ADLs; needing assistance with every day functions. Pain is incrementally improving but after 4 days still without recovery. Suspect nurse placed too high, injecting into bursa instead of deltoid muscle. RN seemed concerned after injection. She also was not sitting during injection, increasing the likelihood of injecting too high.
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| 40 | 2021-01-10 | tingling |
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf...
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Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-11 | weakness |
Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontane...
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Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 05Jan2021 07:45AM at a single dose for COVID-19 immunization. The patient's medical history included hypothyroid and ADD (Attention Deficit Hyperactivity Disorder), both from an unknown date and unknown if ongoing. The patient had known allergies to PCN. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included unspecified/ other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 09:00 AM, the patient experienced fever, chills head ache, severe joint pain, nausea, congestion, and severe weakness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Outcome of the events was unknown. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information about lot/batch number is requested.
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| 40 | 2021-01-11 | weakness |
severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant w...
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severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.
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| 40 | 2021-01-11 | burning sensation | Shortness of breath, chills and Burning sensation on face. I took some Benadryl to help |
| 40 | 2021-01-11 | flushing |
Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in num...
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Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in numerous anaphylactic events. The patient had been consulted by her immunologist to proceed with vaccination and due to her history she was observed for a period of 30 minutes. Upon returning for her 2nd vaccination she reported that she experienced some skin manifestations (hives) but no anaphylactic reaction resulting in difficulty breathing. She stated that she had discussed this again with her immunologist and she wished to proceed with the 2nd dose and she was prepared to receive EpiPen if necessary if reaction develops. Within 10 minutes of the vaccination she felt flushing sensation and then itching all over and her "throat closing up". She was quickly administered 0.3 mg IM epinephrine and IM diphenyhydramine with some improvement in her symptoms. While being transported to the ED an additional 0.3 mg dose of epinephrine was administered. The emergency department also administered the following treatments: famotidine 40 IV x 1 dose, methylprednisolone 125 mg IV x 1 dose, racepinephrine nebulized x 1 dose. The patient was ultimately discharged approximately 2 hours later with return to her baseline condition.
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| 40 | 2021-01-11 | flushing |
Employee immediately felt flushed. States that by 0400 the next day she awoke to fever of 102.1'F, ...
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Employee immediately felt flushed. States that by 0400 the next day she awoke to fever of 102.1'F, severe body aches, chills, and lethargy
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| 40 | 2021-01-11 | numbness |
Had a headache prior to vaccine. 20 minutes after vaccine started feel numbness on left side of face...
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Had a headache prior to vaccine. 20 minutes after vaccine started feel numbness on left side of face and it was affecting vision a little. Called them and they told me to come back. I felt light headed and they put me in the wheelchair and took me to ER. ER: assessed by Dr: heart monitor for 30 minutes. Sent me home to watch my symptoms. Numbness in my face lasted into next day but then went away after that. Still having dizziness on and off since I've received the shot. Headaches - having them, too, off and on. TeleMed appt with DR on 7th. She recommended a MRI of brain - normal.
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| 40 | 2021-01-11 | pain in extremity |
Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expec...
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Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."
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| 40 | 2021-01-11 | pain in extremity |
lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021...
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lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.
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| 40 | 2021-01-11 | pain in extremity |
Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evo...
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Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.
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| 40 | 2021-01-11 | pain in extremity |
Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on K...
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Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on Keflex 500 mg PO Q8hr x 10 days. Had a temp of 103 on 1/4/21 but resolved by 1/8/21.
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| 40 | 2021-01-12 | discomfort |
heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that we...
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heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.
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| 40 | 2021-01-12 | feeling hot, tenderness |
I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painf...
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I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painful and warm to the touch., slightly itchy but painful when itched. I did not notice the rash anywhere else that day. I feel warm in the face and ears but temperature has stayed between 98.3-98.9 since vaccination was administered. I noticed raised red bumps from my olecranon to mid forearm on the ulnar side of both arms but moreso on the right arm.
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| 40 | 2021-01-12 | flushing |
Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flus...
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Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose
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| 40 | 2021-01-12 | numbness, tingling |
Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; Tingling and mild numbnes...
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Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; Tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5.; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EK9231, via an unspecified route of administration in the left arm, on 06Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included chronic migraine and allergies to medications, food, or other products including penicillin. Concomitant medication included ethinylestradiol, levonorgestrel (SRONYX) for birth control. The patient previously took piroxicam and experienced allergy. The patient was not pregnant. The patient was not diagnosed with covid-19 prior to vaccination nor was she tested for Covid-19 since vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tingling and mild numbness on dorsal wrist, proximal palm and digits 3-5 on 07Jan2021, 10:00 AM, with outcome of not recovered. The events were reported as non-serious with no treatment received.
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| 40 | 2021-01-12 | pain in extremity | Left arm pain, headache, chills. Resolved. |
| 40 | 2021-01-12 | tingling, numbness |
?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my va...
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?Pfizer-BioNTech COVID-19 Vaccine EUA. My Left Leg (entire leg) was swollen & Numb) I received my vaccine and when I arrived home about 1pm that day My leg felt odd. when walking, standing I felt an odd sensation in my left foot/lower calf area. I had body aches mild which progressed at night especially pain running down my left side of my body. The next morning I put on my clothes for work and my body still mild aches but the pant leg was tight especially around the calf. My My left foot was swollen as well as my shoe fit tighter. I also had a numbing sensation through the leg. I had an ache behind the calf and the heel of my foot as well as the left foot of my left foot. The swelling remained and I worried I might have a DVT. I called my primary care DR office and they said I should go to the ER. I called employee health at my job and they told me go to the ER. So on 12/29/2020 I went to the ER. The providers there also thought I had a DVT especially after examining my leg and recognizing the significant swelling. My US venous doppler showed negative for DVT however a significantly enlarged lymph node. As of today the swelling is much improved however still slight. The sensation in my left foot is still not the same as before. I have a numbness and tingling sensation that runs from my Left lateral calf down to the sole of my foot.
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| 40 | 2021-01-12 | tingling, numbness |
I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was init...
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I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was initially some mild tingling in extremities. After an hour later, my legs were almost numb and I had difficulty moving them. The fatigue got increasingly worse
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| 40 | 2021-01-13 | pain in extremity |
Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that...
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Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that lasted 2 days. A couple days of fatigue. I had on episode of vomiting, I believe it was the 12/31 or 1/1/.
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| 40 | 2021-01-13 | tingling, weakness |
Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting....
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Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs
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| 40 | 2021-01-13 | tingling |
In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swolle...
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In the early morning around 3:00 a.m. presented swelling in the eyes, numbness of the tongue, swollen mouth and tingling in the face. where it took a Benadryl at the time.
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| 40 | 2021-01-13 | tingling |
After second dose of Pfizer COVID-19 vaccine, patient reported tingling sensation that started in he...
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After second dose of Pfizer COVID-19 vaccine, patient reported tingling sensation that started in her feet and traveled up her legs. Patient refused PO benadryl but took Cetirizine 10 mg PO X 1. Patient was instructed to wait for 30 minutes of observation. At that time, the patient reported that the tingling sensation remained. The patient was offered to be taken to the emergency department, but decided to leave against medical advice.
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| 40 | 2021-01-13 | cold extremities |
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand...
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Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
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| 40 | 2021-01-14 | feeling hot, feeling cold |
I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing...
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I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.
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| 40 | 2021-01-14 | numbness, tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA. Facial numbness and tingling beginning aproximately 40-45 minu...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Facial numbness and tingling beginning aproximately 40-45 minutes after injection. Resolved approximately 2-3 hours later.
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| 40 | 2021-01-14 | migraine |
within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nause...
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within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches
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| 40 | 2021-01-14 | pain in extremity |
partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I...
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partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
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| 40 | 2021-01-14 | tingling |
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/...
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1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
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| 40 | 2021-01-14 | tremor |
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro...
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Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
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| 40 | 2021-01-15 | numbness |
Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I ...
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Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb. A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist). My neck got stiff and I was really tired. The symptoms lasted about 4 hours. When I woke up this morning the left side of my face and jaw still do not feel 100%. My left eye is watery. I'm very tired.
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| 40 | 2021-01-16 | weakness | Dizziness, weakness, injection site pain, tiredness, headache, chills, joint pain, nausea. |
| 40 | 2021-01-16 | migraine, pain in extremity |
Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post in...
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Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.
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| 40 | 2021-01-17 | migraine |
Starting the evening January 14th I experienced a high fever of 102.3 which responded to Tylenol how...
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Starting the evening January 14th I experienced a high fever of 102.3 which responded to Tylenol however, was persistent for 48hours; in conjunction I experienced significant body aches, migraines, diarrhea, chills, and fatigue. Fever broke by Sunday morning however continuance of body aches and fatigue lasted through the weekend.
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| 40 | 2021-01-17 | pain in extremity |
1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. G...
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1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY ACHES.
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| 40 | 2021-01-17 | pain in extremity |
Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint ...
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Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours
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| 40 | 2021-01-17 | pain in extremity |
severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5...
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severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5 c; This is a spontaneous report from a contactable Physician .This Physician reported different events for 2 doses. This case is for 2nd dose. The 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on 08Jan2021 at SINGLE DOSE for COVID-19 immunization. She received the first dose on 17Dec2020 8:00 AM at right arm at single dose Lot number#Ej1685 and she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain.Medical history included Possible asthma and left foot post traumatic arthritis with multiple surgeries including precious allograph, meralgia parasthetica left side. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None Concomitant medications (received within 2 weeks of vaccination) .No known allergies. . After second vaccine severe aching hands, feet like arthritis bad day after vaccine. Low grade fever 99.5 c. No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering on unspecified date. Information on lot/batch number has been requested.
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| 40 | 2021-01-17 | tingling | - My fingers are tingling - I can't grab anything or type very well |
| 40 | 2021-01-18 | weakness | Back pain, headache, joint pain, weakness, fever, chest pain. |
| 40 | 2021-01-18 | weakness | Back pain, headache, joint pain, weakness, fever, |
| 40 | 2021-01-18 | difficulty speaking |
During the Covid vaccine observation period the patient complained of hoarseness, itching and throat...
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During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.
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| 40 | 2021-01-18 | hot flush, tingling |
3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some ...
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3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
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| 40 | 2021-01-18 | pain in extremity |
severe leg and foot pain/severe arm pain; difficulty lifting arm; history of mild arthritis foot/Had...
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severe leg and foot pain/severe arm pain; difficulty lifting arm; history of mild arthritis foot/Had Flare a week after first vaccine; Had flare a week after first vaccine with mild foot swelling; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ej1685), via an unspecified route of administration on 17Dec2020 at 08:00 AM on Right arm at single dose for COVID-19 immunization in hospital. Medical history included possible asthma, left foot post traumatic arthritis with multiple surgeries including precious allograft, meralgia paresthetica left side otherwise healthy (History of mild arthritis foot and ankle surgery). Known allergies was none. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had history of mild arthritis foot and ankle surgery, she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain in Dec2020, severe arm pain about 2 hours after vaccine with difficulty lifting arm for 24 hours after vaccine on 17Dec2020. Took mefenamic acid (ADVIL) for pain. Elevated feet for swelling. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of event 'severe leg and foot pain/severe arm pain' included mefenamic acid (ADVIL), for event 'foot swelling' included Elevated feet; no treatment was received for the other events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 40 | 2021-01-18 | pain in extremity |
Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore...
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Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore right arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: Mar2021), via an unspecified route of administration on the right arm on 04Jan2021 (between 16:00- 16:15) at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease about 7-8 years ago. She said she doesn't take medication all the time for the condition. Concomitant medication included azithromycin (Z-PAK), bifidobacterium infantis (ALIGN). Patient had nausea since 06Jan2021. Her sore arm started at around 3:00 AM on 05Jan2021 and lasted only one day. The caller asked if the nausea could be caused by the COVID-19 Vaccine, and if so, should she get the second dose of the COVID-19 vaccine. Reported the nausea is more of an annoyance, and she doesn't feel like she is going to throw up. Her nausea has been persisting since it started on 06Jan2021, but had worsened from 07Jan2021, to 08Jan2021. She said she woke up the morning of 08Jan2021 with a sore throat, and has had an off and on headache since the morning. Outcome of the event sore arm was recovered on 05Jan2021, for the remaining events was not recovered No prior vaccinations within 4 weeks. The reporter considered the event non-serious.
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| 40 | 2021-01-18 | tingling, pain in extremity, numbness |
STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATI...
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STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATION WITH SEVERE PAIN AND ELEVATED TEMPERATURE IN AREA, DIFFICULTY WITH ADDUCTION OF ARM, PAIN RIGHT SHOULDER WITH SWELLEING AND RIGHT TORSO PAIN,
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| 40 | 2021-01-18 | tremor |
after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 da...
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after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 days. Eye pain and pressure
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| 40 | 2021-01-19 | feeling hot, pain in extremity, feeling cold |
Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in undera...
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Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in underarm and body aches. Overnight I was restless and unable to sleep well, body aches and hot and then chilled and cold. By morning my arm was so sore and swollen it was difficult to move it, continued with all over body aches, fatigue to the point of unable to sit up, no fever but alternated chills/cold and hot/sweat. I did take ibuprofen every 4-6 hours throughout the day. This is the same type of reaction I had to tetanus when a teen.
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| 40 | 2021-01-19 | numbness, tingling |
Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21...
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Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21), she began to have numbness and tingling in the right arm and right side of face and developed dizziness, headache, nausea, and fatigue. Advised by employee COVID hotline to report to the ED.
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| 40 | 2021-01-19 | numbness |
1-2 DAYS AFTER VACCINATION PATIENT EXPERIENCED ARM NUMBNESS. TODAY AT 2ND DOSE SHE NOTIFIED US SHE S...
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1-2 DAYS AFTER VACCINATION PATIENT EXPERIENCED ARM NUMBNESS. TODAY AT 2ND DOSE SHE NOTIFIED US SHE STILL IS EXPERIENCING IT BUT HAS SLIGHTLY IMPROVED IN SENSATION
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| 40 | 2021-01-19 | nerve pain, pain in extremity |
Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit wi...
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Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched; Swollen lymph node in left armpit with pain radiating down arm; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 08Jan2021 08:45 at single dose at left arm for COVID-19 immunization. Medical history included osteopenia, vitiligo, known allergies: Demerol and Vicodin. The patient's concomitant medication received in two weeks included Vitamins. The patient previously took the first dose of bnt162b2 intramuscularly on 18Dec2020 20:45 (lot number: EH9899) at single dose at right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine received in four weeks. The patient experienced swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched on 09Jan2021 07:00. No treatment received for the events. No COVID prior vaccination. COVID test post vaccination: Nasal Swab Negative on 05Jan2021. The outcome of the events was not recovered.
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| 40 | 2021-01-19 | pain in extremity |
Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, le...
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Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-19 | pain in extremity |
Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both...
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Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)
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| 40 | 2021-01-19 | tingling, numbness | Upper back pain, shoulder and neck pain, numbness in arms, tingling- ongoing for one week |
| 40 | 2021-01-20 | cold sweat, pain in extremity, cold sweat, pain in extremity, cold sweat, pain in extremity |
My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't...
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My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat. The event lasted between 1.5-2 hours.
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| 40 | 2021-01-20 | discomfort |
40 y/o female who refers dizziness 10 minutes after vaccination covid-19. also sensation of heavines...
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40 y/o female who refers dizziness 10 minutes after vaccination covid-19. also sensation of heaviness on back of neck.
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| 40 | 2021-01-20 | difficulty speaking |
Had a hoarse voice, only could speak at a high pitch. I went the paramedics and waited it out while ...
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Had a hoarse voice, only could speak at a high pitch. I went the paramedics and waited it out while they checked my vitals. Voice came back after 15 minutes. At first I could only talk with a deep voice and then it all went back to normal. Benadryl was taken once I got home.
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| 40 | 2021-01-20 | feeling cold, nerve pain |
Experience skin nerve pain all over my body; Experience skin nerve pain all over my body; Extreme co...
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Experience skin nerve pain all over my body; Experience skin nerve pain all over my body; Extreme cold sensation after bowel movements; This is spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided), via an unspecified route of administration on 04Jan2021 10:15 at single dose for covid-19 immunization. Patient is not pregnant. Medical history included severe post concussion syndrome (5 major concussions), anxiety, depression, raynaud's syndrome, pineal gland cyst (last MRI Oct2020 reveal cyst was 12mm). The known allergies included Cipro, sensitive to many food, high allergy to mold, grasses, trees. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluoxetine hydrochloride (PROZAC), rizatriptan benzoate (MAXALT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , lactulose (LACTUL), ongoing medications included mometasone furoate (FLONASE), budesonide (BUDESONIDE), olopatadine (OLOPATADINE), ipratropium (IPRATROPIUM) , fremanezumab (AJOVY), allergy shots. 48 hours after injection on 06Jan2021 13:00, patient began to experience skin nerve pain all over body accompanied with extreme cold sensation after bowel movements, has been 6 days and getting worse. She will be going to urgent care tomorrow. She was between primary care physicians until 13Jan2021. Patient didn't receive treatment for the adverse events. The outcome of events was not recovered. Information about lot/batch number has been requested.
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| 40 | 2021-01-20 | feeling of body temperature change | Fever, (felt like she was freezing then burning up) headache, bodyache. |
| 40 | 2021-01-20 | flushing, burning sensation |
Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest...
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Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest within hours of receiving 2nd dose of vaccine. She stated that she has continued experiencing it intermittently, has taken Benadryl at night time, and is planning on trying Zyrtec.
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| 40 | 2021-01-20 | numbness |
Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upp...
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Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional. A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room. The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.
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| 40 | 2021-01-20 | pain in extremity |
Arm mildly sore; headache and vomiting after 12 midnight. Headache was positional . Lasted about 3...
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Arm mildly sore; headache and vomiting after 12 midnight. Headache was positional . Lasted about 36 hours. Ibuprofen
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| 40 | 2021-01-20 | pain in extremity |
temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experien...
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temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; She is very achy; shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand; This is a spontaneous report from a contactable nurse (patient). This 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686) intramuscular, in left deltoid, on 11Jan2021 at 10 AM, COVID-19 immunization. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing asthma diagnosed at childhood, ongoing diabetes diagnosed in her twenties, she was overweight, about 7 or 8 years ago she ended up having cellulitis due to the nurse not using aseptic technique but not due to a vaccine, she was diagnosed with COVID on 18Dec2020 (she was off quarantine as of 28Dec2020, going back to work on 31Dec2020). When she was diagnosed with COVID, it caused an asthma exacerbation and she needed a 5-day oral burst of 40 mg prednisone. Concomitant medications were none. On 11Jan2021 the patient experienced temperature elevated, at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain and she was very achy. Her temperature started last night (11Jan2021), temperature was 99.8. She tried to hydrate. She also had a temperature at 6 AM on 12Jan2021 morning. On 12Jan2021 she had temperature of 101.8 and this was after taking antipyretics 6 hours before. Then, on 12Jan2021, her temperature was 101. She was on the phone with her primary care provider and she was told to take more antipyretics. She just took more antipyretics. She stated it felt almost like they hit a nerve when administering the vaccine since she was experiencing shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand. She believed, based on anatomy, that there were nerves going right there. She knew she was overweight but her upper arms were not that bad. She tried to take a shower to cool herself down. She received the vaccine through pharmacy since she was working at a long term care facility around COVID. Pharmacist came to the long term care facility where she works to administer the vaccine. The events did not require ER visit. Relevant tests: none. Fever outcome was unknown. The other events had not yet resolved. Sharp shooting pain came and went. The reporter considered all the events serious as medically significant and related to BNT162B2 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-01-20 | tingling, weakness |
Throbbing pain; tingling fingers in left arm; pain going up the neck of left side; fever; chills; jo...
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Throbbing pain; tingling fingers in left arm; pain going up the neck of left side; fever; chills; joint pain (both shoulders, low back, hips, and knee); loss of appetite; fatigue; weakness; headache; muscle pain; This is a spontaneous report from a contactable Other HCP (patient). This 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 08Jan2021 on Arm left at single dose (Lot # 3249) for covid-19 immunisation. Medical history included Osteoporosis, vitamin D deficient. No known allergies. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. She experienced throbbing pain and tingling fingers in left arm, pain going up the neck of left side. Also experience typical side effects: fever, chills, joint pain (both shoulders, low back, hips, and knee), loss of appetite, fatigue, weakness, headache, and muscle pain on 09Jan2021. No Covid prior vaccination. No covid tested post vaccination. No treatments received. Outcome of the events was recovering.
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| 40 | 2021-01-21 | feeling hot, depressed level of consciousness, weakness |
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm...
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I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-21 | migraine |
Injection 1-muscle soreness for about 8 hrs at site and headache for a couple days. Injection 2- m...
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Injection 1-muscle soreness for about 8 hrs at site and headache for a couple days. Injection 2- muscle soreness at site, migraine that evening, and severe neck pain. Muscle pain in neck and shoulders for a few days causing ha?s in the evenings.
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| 40 | 2021-01-21 | pain in extremity | 5PM - SORE ARM (UNABLE TO LIFT) 4AM - CHILLS 2PM - FEVER 101.2 TOOK TYLENOL |
| 40 | 2021-01-21 | tingling |
Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and acr...
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Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and across her upper back. She had taken a dose of Benadryl, 50 mg p.o. prior to coming to the clinic, due to her prior history of allergies. Her blood pressure was checked in left arm, 134/94. She denied chest pain, SOB or feeling of swelling in tongue or face. After the tingling sensation, she began to experience pruritus of her arms, back and scalp. Visual inspection revealed no visible rash or hives. When she began rubbing on her left arm to relieve the itchy sensation, the area of rubbing became erythematous. She was observed for 45 minutes after the injection. Symptoms did not progress and she was discharged from the clinic. Phone follow-up 24 hours later: pruritus has resolved. She took 2 more doses of Benadryl 50 mg p.o. yesterday, at 2 p.m. and 11 p.m. Only symptom reported today is sleepiness.
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| 40 | 2021-01-22 | weakness, cold extremities |
Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak...
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Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat
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| 40 | 2021-01-22 | feeling cold | Severe Headache, body aches, cold chills |
| 40 | 2021-01-22 | muscle spasms |
A few hours after the infection, I started having small muscle spasms all over, like little pulsatio...
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A few hours after the infection, I started having small muscle spasms all over, like little pulsations throughout my whole body, especially in legs and arms. They weren't intense or painful, but still unsettling. It's been happening daily, and has subsided a little but it's still happening 5 days later. Also have very sore and tight leg muscles. I don't know if this is considered "adverse enough", but it's still concerning, as muscle spasms are not mentioned in the common side effects, and because it has not stopped completely.
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| 40 | 2021-01-22 | pain in extremity | 1/19 arm sore 1/20 achy 1/22 tightness in chest |
| 40 | 2021-01-23 | migraine |
Headache before and during, progressed to migraine the next morning 1/22, better 1/23 and feels fine...
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Headache before and during, progressed to migraine the next morning 1/22, better 1/23 and feels fine today 1/24
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| 40 | 2021-01-24 | feeling hot |
beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea,...
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beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.
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| 40 | 2021-01-24 | pain in extremity | Extreme fatigue body aches chills sore and swollen arm |
| 40 | 2021-01-24 | throat numbness |
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst...
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Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
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| 40 | 2021-01-24 | sensory loss, numbness |
On December 29th, I developed acute bilateral numbness of my fingers. This lasted for about 45 minu...
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On December 29th, I developed acute bilateral numbness of my fingers. This lasted for about 45 minutes, but since then, has remained as loss of sensation in all 10 of my fingertips.
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| 40 | 2021-01-25 | weakness, tremor |
I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I ...
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I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.
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| 40 | 2021-01-25 | weakness |
Fever, chills, myalgias, fatigue, generalized weakness , starting 12 hours after the vaccination and...
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Fever, chills, myalgias, fatigue, generalized weakness , starting 12 hours after the vaccination and lasting approximately 24 hours, except fatigue lasting 2-3 days
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| 40 | 2021-01-25 | feeling hot |
On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and starte...
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On 1/20/2021, approximately 2.5 hours after my second dose, I had nausea with dry heaving and started having intense, crushing pain in my CTL back (with the worst of it being in my thoracic and lumbar areas). *The nausea and subsequent dry heaving subsided within 6-8 hours with prescribed anti nausea. *The back pain only intensified, with me finally calling my doctor who recommended contacting ONE Parkview. This back pain continues today (1/26/2021). On 1/21/2021, in the early hours of the morning, I woke to hives over my entire trunk, left arm (injection site), and left thigh. *This subsided in maybe 10 or so hours with antihistamines. On 1/23/2021, at approximately 1100, I felt heat in my left arm. This coincided with a heavy feeling in my left arm. When examined, I noted that my upper arm was slightly swollen, blotchy, and had a reddened rash approximately 4x4 inches. Minor itching. *The swelling subsided by 1/25/2021, but the heat and reddened rash continues today (1/26/2021).
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| 40 | 2021-01-25 | numbness, pain in extremity |
Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; Thi...
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Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient. This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.
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| 40 | 2021-01-25 | numbness | Numbness of all 10 toes |
| 40 | 2021-01-25 | migraine |
nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigo...
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nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigors; nasal stuffiness; chest congestion; wet cough; This is a spontaneous report from a contactable physician. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on 08Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose last 18Dec2020 (lot number=EJ1685). The patient experienced nuchal rigidity, migraine, photosensitivity, auditory sensitivity, arthralgia, lethargy chills, rigors, nasal stuffiness, chest congestion, wet cough on 09Jan2021 05:00. The outcome of the event nuchal rigidity was not recovered while other events were recovered with sequelae.
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| 40 | 2021-01-25 | tingling, feeling hot |
a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super di...
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a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super dizzy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 12Jan2021 10:00 at a single dose for COVID-19 immunization. There were no medical history. The patient is not pregnant. Concomitant medication included amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced super dizzy on 12Jan2021 10:06, a flood of heat throughout her body, pain in her calf muscle, tingling, and it woke her up all night on 12Jan2021 12:00. Outcome of the events was recovering.
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| 40 | 2021-01-25 | tingling, numbness |
5 minutes after I received the shot my left pinky finger and left ring finger went numb. I notified ...
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5 minutes after I received the shot my left pinky finger and left ring finger went numb. I notified the nurse. She left to get the head nurse. Within 2 minutes my arm was numb below my elbow. This lasted 10 minutes. The feeling came back. Later that day my left upper back was sore. Since then (2 weeks) I still have numbness and tingling in my elbow and left pinky finger with occasional pain in my left upper back.
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| 40 | 2021-01-26 | weakness, slurring |
Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and sync...
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Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).
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| 40 | 2021-01-26 | weakness |
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs cr...
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heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
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| 40 | 2021-01-26 | weakness |
Dizziness, fatigue, nausea and vomiting, fever of 102. Felt very weak for 24. Dizziness remained aft...
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Dizziness, fatigue, nausea and vomiting, fever of 102. Felt very weak for 24. Dizziness remained after other symptoms resolved.
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| 40 | 2021-01-26 | feeling hot, weakness |
Case received dose at 11:25 am and at 12:25 pm felt a rush of heat throughout her body, back of thro...
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Case received dose at 11:25 am and at 12:25 pm felt a rush of heat throughout her body, back of throat "fuzzy", heart rate 140/min for 20 minutes. Her breathing was as if she was "trying to catch my breath" which lasted 5 minutes. At 1pm she experienced fatigue, chills, had fog, and weakness which lasted or approximately 18 hours. She felt much better 48 hours later.
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| 40 | 2021-01-26 | flushing, feeling hot |
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no ap...
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About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.
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| 40 | 2021-01-26 | numbness |
Pt received vaccine at 1611 to the left arm then waited 15 for minutes in the observation area. She ...
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Pt received vaccine at 1611 to the left arm then waited 15 for minutes in the observation area. She then stared to drive herself home and developed numbness to the right lateral face and right neck. She came back the vaccine site and had numbness to her left lateral face. She was was without edema, impaired vision, talking, swallowing and her neuro exam was normal.
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| 40 | 2021-01-26 | pain in extremity, feeling cold |
RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AR...
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RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AROUND 2AM I WOKE UP WITH A FEVER (99F), CHILLS, BODY ACHES, SORENESS IN LEFT ARM AND LEFT SIDE OF NECK, HEADACHE, NAUSEA & VOMITTING. I TOOK 4 X 200MG IBUPROFEN. I FINALLY WAS ABLE TO SLEEP AGAIN AROUND 7AM. I HAD A HEADACHE, BODY ACHES, NAUSEA AND FATIGUE THROUGH THE REST OF THE DAY. I SLEPT MOST OF THE DAY. AFTER 48 HOURS MOST SIDE EFFECTS WERE GONE, EXCEPT FATIGUE AND SORENESS IN LEFT ARM AND SIDE OF NECK.
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| 40 | 2021-01-26 | pain in extremity |
I had soreness in my arm the day after the first injectionbut no other adverse events after the firs...
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I had soreness in my arm the day after the first injectionbut no other adverse events after the first injection; This is a spontaneous report from a contactable Other-HCP (patient). This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EH9899), via an unspecified route of administration on 18Dec2020 14:45 at single dose on the right arm for COVID-19 immunization. The patient's medical history included allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years). There were no concomitant medications. No other vaccine received in four weeks. Facility type vaccine was hospital. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient had soreness in her arm the day after the first injection but no other adverse events after the first injection. No treatment received. Outcome of the event was recovered.
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| 40 | 2021-01-27 | weakness |
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy;...
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weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-27 | pain in extremity, discomfort |
Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while re...
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Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while recalling information in a conversation; Feverish feeling but no fever; Heaviness of the body like moving in honey; Achiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248, expiration date not reported) via an unspecified route of administration on the right arm on 12Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included PCOS, Raynauds, PTSD; and known allergies: Sulpha, sulfites, pseudafed, penicillin, cephalosporins, bromfed, IV contrast, pineapple. Concomitant medication in two weeks included levocetirizine dihydrochloride (XYZAL), omeprazole, escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL) and levothyroxine sodium (LEVOTHYROXIN). On 12Jan2021 08:45 PM, the patient experienced both arms hurt, fatigue, achiness, headache that moves, ear aches, noises are louder, mind goes blank while recalling information in a conversation, feverish feeling but no fever, heaviness of the body like moving in honey. Therapeutic measures were taken as a result of the events which included Ibuprofen (ADVIL) and acetaminophen (TYLENOL). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
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| 40 | 2021-01-27 | pain in extremity, numbness, tingling |
Approximately 45 minutes after I received the shot, the index finger and thumb of my left hand went ...
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Approximately 45 minutes after I received the shot, the index finger and thumb of my left hand went completely numb and my index finger turned almost white. The numbness subsided about 20 minutes later but my fingers were tingly and hurt. Shortly thereafter, my left toes were also tingly and numb. By that evening, my right hand and foot were also experiencing tingling and numbness and by the next morning my legs and arms bilaterally were experiencing the same sensations. My upper right back is also involved, with a central area radiating the pins/needles feeling with soreness around it almost like a backache. The severity and location of the pins/needles/numbness changes. For example, when I was taking a walk earlier, my feet and hands increased significantly with the pins/needles feeling and receded some as I was at rest. As I am typing now, my hands, upper back, and lower right leg are the most noticeable with the tingling. I have taken some Benadryl, which reduces the sensations some but does not take it away entirely. I am now three days post injection, and I am concerned that I am experiencing an allergic reaction of some sort that is affecting my nervous system.
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| 40 | 2021-01-27 | pain in extremity |
On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right inde...
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On 1/22, I noticed a painful red itchy bump on my left foot. Another bump appeared on my right index finger the day after, and then another bump appeared today 1/28 under my right arm. They are getting larger, more painful and swollen, itchier, and seem to be filled with white pus. The one on my left foot has burst.
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| 40 | 2021-01-27 | seizure like phenomena |
employee became light headed, dizzy and nauseous. 10-15 min after vaccine. 0956 vitals were taken a...
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employee became light headed, dizzy and nauseous. 10-15 min after vaccine. 0956 vitals were taken and employee was asked to lay down on cot (vitals 143/83 p 90) 1003 employee began to have seizure like activity a rapid response was called at 1008. Employee refused to go to ED , husband notified. 1020 Benadryl was given per MD continued monitoring until 1135 employee was recommended to go to ED by MD , she refused stated she was ok just tired. Assisted to vehicle with husband at 1140
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| 40 | 2021-01-28 | feeling cold, hot flush |
My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I ha...
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My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I had bronchitis two weeks prior next day cough wheezing completely gone and my lungs feel great I can breathe again with no mucus I have swollen lymph nodes but not to bad little headache but overall feeling ok just tired and some dizziness at times.
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| 40 | 2021-01-28 | flushing |
Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respira...
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Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.
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| 40 | 2021-01-28 | numbness, tingling |
Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a cont...
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Facial numbness and tingling; Facial numbness and tingling; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on the right arm on 08Jan2021 at 07:15 at a single dose for COVID-19 immunization. Medical history included anemia, Vitamin D deficiency, and known allergies to dairy and kiwi. Concomitant medication included iron (IRON), colecalciferol (VITAMIN D [COLECALCIFEROL]), zinc (ZINC), linum usitatissimum oil (FLAXSEED OIL [LINUM USITATISSIMUM OIL]), and cetirizine (CETIRIZINE). The patient had no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, on the right arm on 19Dec2020 at 0745AM for COVID-19 immunization. The patient had no COVID prior vaccination and had not tested for COVID post vaccination. The patient experienced facial numbness and tingling on 08Jan2021 at 08:15. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.
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| 40 | 2021-01-28 | pain in extremity |
Vaccine taken at 6:30 am. Soreness in left arm started around 8-8:30. Felt tired all day but after a...
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Vaccine taken at 6:30 am. Soreness in left arm started around 8-8:30. Felt tired all day but after a nap around 11:30ish felt nauseous, ate to try and calm it but it got worse throughout the day especially at night around 9pm finally relaxed enough to fall asleep, woke up at 7am feeling more nauseous than yesterday with a bad headache located in the front of my head not throbbed but constant. Laying down just felt really sick so I called my doctor around 9:15am.
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| 40 | 2021-01-28 | pain in extremity |
Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain ...
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Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain on day 5 and 6 after injection and calves pain and tightness.
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| 40 | 2021-01-28 | cold extremities |
on left arm, almost immediately after left hand became increasingly cold; This is a spontaneous repo...
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on left arm, almost immediately after left hand became increasingly cold; This is a spontaneous report from a non-contactable Other-HCP reporting for herself. A 40-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on arm left from 14Jan2021 07:00 to 14Jan2021 07:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Prolonged QT syndrome. The patient's concomitant medications were not reported. The patient had her first dose of BNT162B2 on 23Dec2020 to 23Dec2020. On 15Jan2021 at 07:00, on left arm, almost immediately after left had became increasingly cold. Right had was ok and did not change in temperature. Area around the shot was not cold, only hand. Coldness lasted for about 15 minutes before slowly getting back to normal temperature. The patient had not received any treatment for the event. The patient was not pregnant at the time of the report. Outcome of the event was recovered on an unspecified date. No follow up attempts are possible, information about lot/batch number cannot be obtained.
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| 40 | 2021-01-29 | burning sensation |
Pt received her first pfizer vaccination and after approximately 10 minutes, pt started itching thro...
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Pt received her first pfizer vaccination and after approximately 10 minutes, pt started itching throughout her entire body and burning to her perineal area. SQ Epi given on scene and IV benadryl given in route by EMS.
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| 40 | 2021-01-29 | numbness |
Patient c/o slight numbenss at the injection site and to the back side of the arm along with feeling...
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Patient c/o slight numbenss at the injection site and to the back side of the arm along with feelings of queasiness. Ears were flush, no redness noted at the injection site or arm after fifteen minutes. Pt was able to lift her arm and hold it without any difficulty. Pt reported not eating anything this morning before recieving the vaccine. Pt allowed to lie down and monitored for 15 more minutes. Pt verbalized that she felt better after the additional 15 minutes, ears were with in normal color.
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| 40 | 2021-01-29 | pain in extremity | Fever 101, chills, body aches, headaches, sore arm |
| 40 | 2021-01-31 | pain in extremity |
Several hours after getting 2nd dose, left arm very painful. The next morning she woke up and had in...
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Several hours after getting 2nd dose, left arm very painful. The next morning she woke up and had increase in arm pain, not able to move it, body aches, chills, nausea, and fatigue. symptoms remain today.
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| 40 | 2021-01-31 | pain in extremity | Pain, swelling and large bump in left arm. Pain down in left hand. |
| 40 | 2021-01-31 | pain in extremity |
chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot...
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chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot do her daily duties/ could not even put her seat belt or roll up the window in her car; extreme headache; received first dose of the vaccine on 24Dec2020/the second dose on 11Jan2021; Chills; feeling horrible/feels foggy; feeling tired/ exhausted; body aches; arm was really sore; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 11Jan2021 07:45 at single dose in left arm to prevent covid, since she worked in a hospital with covid patients. Medical history provided as none. There were no concomitant medications. She gets the flu vaccine annually. The patient previously received first dose of BNT162B2 vaccine intramuscularly on 24Dec2020 23:45 in left arm for COVID-19 immunization with no adverse events. There were no other prior Vaccinations within 4 weeks. The patient experienced chills on 11Jan2021, feeling horrible on 11Jan2021, extreme headache on 12Jan2021, chest discomfort/something heavy on her chest on 13Jan2021, feeling tired/ exhausted on 11Jan2021, chest discomfort, feeling tired/ exhausted was reported as worsened; body aches on 11Jan2021, feels foggy on 13Jan2021, arm was really sore on an unspecified date in Jan2021, cannot even get out of bed on 12Jan2021. Specifically, it was reported that the patient worked 12 hours overnight, she slept and when she woke up she felt chills and felt horrible. States it carried on 12Jan2021. Today on 13Jan2021 she has an extreme headache, she clarifies the headache started on 12Jan2021 (yesterday). She feels like something heavy on her chest, chest discomfort. She has body aches and feels tired. She cannot cook right, she is so exhausted and cannot do her daily duties. She is assuming it is the immune reaction. Her son told her she looks really sick. States she rarely gets sick and when she gets sick she does get chills. Her chest feels like something is heavy on her. States if she did not have a strong heart, she cannot imagine what someone that does not have a strong heart would feel like. Since she works in a hospital she deals with covid all year around and she has been strong and healthy this year. Reports her headache is strong and today on 13Jan2021 she feels foggy. States yesterday on 12Jan2021, she was horrible and today (13Jan2021) is better in regards to chills. Her arm was really sore and now her arm is better, she could not even put her seat belt on 12Jan2021 (yesterday) or roll up the window in her car. She is nervous about the chest discomfort and headache. Asking where it could be coming from. She thinks it could be a possible immune response. If the chest discomfort continues she will go get seen. Advised to contact hcp. States she feels like crap. States she never gets headaches. Yesterday on 12Jan2021, her body aches were horrible and she cannot even get out of bed. The outcome of events chills, body aches was recovering, outcome of events extreme headache, chest discomfort/something heavy on her chest, feeling tired/ exhausted was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 40 | 2021-02-01 | weakness |
Elevated temperature (almost 100); Feel weak and shaky; Feel weak and shaky; Coughing; Nasal congest...
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Elevated temperature (almost 100); Feel weak and shaky; Feel weak and shaky; Coughing; Nasal congestion; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: left arm) on 20Jan2021 11:45 for COVID-19 immunization. Facility where the recent COVID-19 vaccine was administered: Other-Drive thru vaccine POD. Medical history included Hashimoto's thyroiditis, allergies to penicillin, and sinus infection. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Other medication the patient received within 2 weeks of vaccination included doxycycline 'hydroxylate' for a sinus infection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 12:00, the patient had an elevated temperature (almost 100), felt weak and shaky, coughing and nasal congestion, and a headache. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events. No follow-up attempts are possible; information about batch number cannot be obtained.
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| 40 | 2021-02-01 | flushing, feeling hot |
bilateral hand swelling, flushing of neck and face, feeling hot. Alert and oriented x4, epi-pen to l...
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bilateral hand swelling, flushing of neck and face, feeling hot. Alert and oriented x4, epi-pen to left thigh, Benadryl 50 mg PO, reduced hand swelling, T97.8 F BP 151/91 SpO2 99% P78. 911 was called, staff assessed pt, did not transport. Pt had friend transport to ER in private vehicle to seek higher level of care as a precaution.
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| 40 | 2021-02-01 | flushing |
Two days post-injection patient developed a red rash across the neck that has not subsided. Patient ...
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Two days post-injection patient developed a red rash across the neck that has not subsided. Patient States that rash is flush red and itchy since time of the injection.
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| 40 | 2021-02-01 | numbness, tingling |
Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed...
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Left side facial numbness and tingling. tongue numbness. left eye blurred vision. Symptoms stayed active for 24-48 hours
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| 40 | 2021-02-01 | numbness, sensory loss |
My the skin of my jaw and chin started to feel numb. The sensation progressed rapidly to include nu...
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My the skin of my jaw and chin started to feel numb. The sensation progressed rapidly to include numbness of my cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic (as I was driving away on my from work to home). Less than 30 minutes after receiving the vaccine. Both sides of my face were impacted equally.
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| 40 | 2021-02-01 | numbness |
Fainted, legs and arms went numb and my hands froze, felt almost like a stroke. Was ok after about 3...
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Fainted, legs and arms went numb and my hands froze, felt almost like a stroke. Was ok after about 30 minutes,,was just very tired rest of day
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| 40 | 2021-02-01 | migraine |
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was d...
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Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Patient Reports: fatigue, body aches, persisting migraine headaches
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| 40 | 2021-02-01 | pain in extremity, feeling cold, feeling hot |
I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a cl...
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I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a claustrophobic; nauseous; Dizzy; headache; fatigue/I'm just exhausted 72 hours later; fever kept rising; I started violently projectile vomiting for a few hours; I got the chills; I was sore; felt "hungover"; the arm soreness; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her right arm, intramuscular on 16Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included anxiety, acid reflux and cholecystectomy. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), clonazepam (CLONAPAM) and an unspecified antacid. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 as first dose. It was reported that 12 hours later after vaccination, the patient felt really hot and nauseous, dizzy, headache and fatigue. But then 24 hours later her fever kept rising. She felt extremely hot/cold sensation in a claustrophobic. At peak of her fever, 100F, she started violently projectile vomiting for a few hours. Then she got the chills. Felt nauseous still. But no more vomiting, fever went down on its own. The next day 48 hours later, she was sore and felt "hungover". This time the arm soreness dissipated twice as fast. Now she just exhausted 72 hours later; all events occurred on 17Jan2021 at 02:00. No treatment was received for the events. The outcome of the events was recovered with sequel.
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| 40 | 2021-02-01 | pain in extremity |
Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left ...
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Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left arm), fatigue, headache. Lasted approximately 12 hours
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| 40 | 2021-02-01 | tingling, numbness |
Approximately 25-30 minutes after receiving the vaccine, my lower jaw and face began to tingle and f...
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Approximately 25-30 minutes after receiving the vaccine, my lower jaw and face began to tingle and felt numb and swollen. A few minutes after that began, the back of my throat was scratchy. I took Benadryl 30 minutes after symptoms began and within 45 minutes all symptoms resolved. 7 hours following the Benadryl dosing, the symptoms returned. I took another dose of Benadryl. The symptoms resolved and did not return.
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| 40 | 2021-02-02 | difficulty speaking, tingling, numbness |
tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles o...
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tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-02-02 | electric shock sensation |
Currently 25 2/7 weeks; started having night terrors 1/28/21; also accompanied with ?brain zingers? ...
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Currently 25 2/7 weeks; started having night terrors 1/28/21; also accompanied with ?brain zingers? small electrical shocks in my brain that last 1-2 seconds but are definitely not something I can ignore. I get approximately 4-5 zingers an evening.
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| 40 | 2021-02-02 | flushing |
Patient felt flushed and experienced shortness of breath (history of anxiety, panic attacks). Drank ...
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Patient felt flushed and experienced shortness of breath (history of anxiety, panic attacks). Drank water and felt better in 10 minutes.
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| 40 | 2021-02-03 | pain in extremity, numbness and pain in extremities, numbness, tingling |
12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1...
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12/30/2020: COVID Vaccine Pfizer-BioNTech dose 1 of 2 left arm. Acute onset left shoulder/arm pain 1-2 days later without inciting event (no trauma, no sports/weights), progressively worsening to severe next 2 days with onset of numbness and paresthesias in left upper arm and hand by 1/5/2021 seen at urgent care with dx: Cervical Neuropathy. Follow-up cervical MRI 1/22/21 without significant canal or foraminal impingement. Seen by Neurologist 2/3/2021, at that time pain improved and localized to left shoulder joint area radiating under scapula and paresthesia resolved to numbness. Physical exam findings: Absent triceps reflex, Left FDI atrophy, left hand finger extensor weakness, left abduction limited to 90 degrees. Dx: Neurologic Amyotrophy (Parsonage Turner Syndrome); Complication of COVID vaccination. Plan: EMG, NCS, Left shoulder MRI, labs pending. PT OT ordered. Rx: Nortriptyline, Medrol Dosepak. F/U 2-3 months with neurology.
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| 40 | 2021-02-03 | pain in extremity |
Report left arm soreness and HA 6 hours after vaccination: Treatment: Tylenol with no improvement. O...
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Report left arm soreness and HA 6 hours after vaccination: Treatment: Tylenol with no improvement. Outcome: unable to go to work, but does not interfere with ADLs.
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| 40 | 2021-02-03 | tremor, feeling cold |
December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Mond...
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December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.
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| 40 | 2021-02-04 | weakness |
felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was...
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felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 40 | 2021-02-04 | discomfort, tenderness |
Shortly after the vaccination I was still having the abdominal distention so I called to see if I co...
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Shortly after the vaccination I was still having the abdominal distention so I called to see if I could defer the 2nd vaccine because I wasnt feeling well and still experiencing AE from the 1st dose. I was advised I still had to get the vaccine so I did and by 2:30pm I begin to have severe facial swelling causing asymmetrical shaping of my face, my head was hurting extremely bad, fatigued and felt really bad. I had to lay down because my head was hurting, felt like I had pressure on the top of my head, neck and back. The pain was so bad I was transported to the ER and was isolated d/t previous COVID infection and all while there the my body felt as if it was steady swelling. I was hurting so bad I couldnt stand to be touched. I was given another round of steroids. I was advised I had COVID pnemonia and was given IM decadron, IM regalin and a subQ injection of immatrex for the headaches and administered ibuprophen and tynenol for the headache as well. I was discharged with a prescription of regalin and decadron. The ER dr. states I shouldnt have taken the 2nd vaccine because I was still suffering from COVID-19. The abdominal distention had dissolved but the congestion just will not clear up even after 3 rounds of steroids. Asoumedrol was prescribed by my ENT but it didnt help either so I have a CT Scan scheduled for next week with my ENT and has not been able to return to work since the 1st dose 12/22. I have be retested for COVID-19 on both 1/15 and 1/25 and both results are still positive for COVID.
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| 40 | 2021-02-04 | pain in extremity |
After - about 3 hours later: sore arm - lasted two days. On 28th, I started getting a runny nose; co...
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After - about 3 hours later: sore arm - lasted two days. On 28th, I started getting a runny nose; coughing and sneezing and sore throat. That kept going for a few days. On 30th, I found out I was exposed to someone that had COVID. 30th was tested and results on 31st - positive. I went to URGENT Care to get the test. Albuterol inhaler was prescribed; and an Antibiotic for my symptoms. She told me not to start the medication until I found out that I was positive or not. So I started the meds on the 31st. I got sicker before I got better - got chills and sweating (back and forth); felt really tired and out of energy and had brain fog and I tripped on things in front of me. I didn't have any appetite. Had to force myself to eat so I could take my medicine - for about a week. I was coughing a lot. Took over the counter cough medicine especially night because it was disturbing my sleep. Later, I had a telehealth appt with my primary care dr appt - on January 8th. And she prescribed a steriod inhaler - Budesonide Formoterol Fumarate Dihydate- inhalation aerosol and I'm still taking that today because I still have a cough. Had the second dose of the vaccine on January 26, 2021 at 6:30PM. No reaction to that dose except sore arm.
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| 40 | 2021-02-04 | tingling, numbness |
45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and fe...
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45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.
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| 40 | 2021-02-04 | tenderness |
Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under ey...
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Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; Tenderness under eyebrow of right eye/pain behind right eye that did not go away for more than 5 days; Shingles: Approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye.; This is a spontaneous report from a contactable healthcare professional (HCP). A 40-year-old female patient received first single dose of BNT162B2 (Pfizer- BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 14Jan2021 16:00 for COVID-19 immunization. Vaccination facility: Hospital. The patient had no relevant history. The patient was not pregnant at time of vaccination and at the time of reporting. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication (other medications in two weeks) included multivitamin (unspecified). There was no other vaccine in four weeks. On 14Jan2021 19:00, the patient experienced shingles: approximately 3 hours after receiving vaccine, experienced redness and tenderness under eyebrow of right eye. Experienced pain behind right eye that did not go away for more than 5 days. Sought medical attention and ophthalmologist diagnosed shingles on 20Jan2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment for the adverse events included antiviral medication and steroid drops. Patient was not Covid tested post vaccination. The patient had not recovered from the events at the time of reporting. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events herpes zoster, eyelid pain and erythema of eyelid cannot be excluded. The information available in this report is limited; information on previous occurrences of shingles, if any, would aid in case assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-02-06 | pain in extremity |
Sore arm 36 hours later, muscle aches, joint aches, headache I only wanted to report these because ...
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Sore arm 36 hours later, muscle aches, joint aches, headache I only wanted to report these because I had Covid in October 2020 and had this response on my second dose of the vaccine.
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| 40 | 2021-02-07 | tingling, numbness |
Symptoms: c/o tingling and numbness to left hand 3rd, 4th, 5th digits. Intervention: VS BP 162/108 ...
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Symptoms: c/o tingling and numbness to left hand 3rd, 4th, 5th digits. Intervention: VS BP 162/108 HR 85 O2sat 99% on RA, respirations 12. Patient states she is getting a work up from PCP regarding elevated BP. Advised to follow up w/ PCP. States no worsening of symptoms. No c/o dizziness, feeling of faintness. Able to ambulate and exit vaccine clinic w/o incident.
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| 40 | 2021-02-07 | tingling | tingly fingertips |
| 40 | 2021-02-07 | tremor, tingling, weakness |
inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were ...
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inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 40 | 2021-02-08 | feeling hot |
10:32 : FELT FATIGUED, SWEATY, QUEASY, 'HOT"- POST VACCINATION VS: T: 98.2, P: 72; BP: LEFT ARM...
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10:32 : FELT FATIGUED, SWEATY, QUEASY, 'HOT"- POST VACCINATION VS: T: 98.2, P: 72; BP: LEFT ARM: 150/98; RT. ARM: 152/100. has hypertension, has not been taking her BP meds for over 1 month.
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| 40 | 2021-02-08 | numbness, tingling |
numbness and tingling that began about 7 hours ago. She describes it as a "pins and needles" feeling...
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numbness and tingling that began about 7 hours ago. She describes it as a "pins and needles" feeling in her hands with numbness in her face and intermittent left sided lip twitching. She denies any numbness or tingling in BLE. She reports having a significant headache since receiving the first dose of the COVID-19 vaccine 9 days ago and some muscle aches. She also reports some dizziness which she describes as lightheadedness, but denies any LOC
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| 40 | 2021-02-08 | numbness, tingling |
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f...
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hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
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| 40 | 2021-02-08 | numbness |
Patient is having muscle pain in both arms and her neck since the second vaccination. She says her r...
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Patient is having muscle pain in both arms and her neck since the second vaccination. She says her right hand goes numb, and both grips are intermittently weak. She says she has gotten sharp stabbing pain in left arm, (shot was in right). Has indicated that it doesn't seem to be resolving. I told her to go see her primary and that we would notify the "CDC."
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| 40 | 2021-02-08 | migraine |
on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrh...
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on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrhea, fever 99.8. Did not feel well through 2/8/2021.
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| 40 | 2021-02-08 | tingling, feeling hot, flushing |
Had a flushing reaction to first vaccine. and 5 minutes after second vaccine (2/5/21 ) started havin...
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Had a flushing reaction to first vaccine. and 5 minutes after second vaccine (2/5/21 ) started having facial flushing, warm and tingling sensation. Went to urgent care.
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| 40 | 2021-02-09 | weakness | headache, dizziness, weakness and runny nose |
| 40 | 2021-02-09 | breast pain |
Headache Extreme; fatigue; Pain at injection site; armpit and breast (all L) Ncek pain; armpit and b...
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Headache Extreme; fatigue; Pain at injection site; armpit and breast (all L) Ncek pain; armpit and breast (all L) Neck pain; armpit and breast (all L) Neck pain; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 15:00 for an unspecified indication Covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, allergies to sulfa. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 20Jan2021 the patient experienced headache extreme, fatigue, pain at injection site, armpit and breast (all l) neck pain. No treatment received. COVID was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-02-09 | feeling hot, migraine |
uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; t...
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uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
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| 40 | 2021-02-09 | flushing | Systemic: Other- chest tightness, flushing, and signs of panic |
| 40 | 2021-02-09 | flushing |
Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body ache...
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Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body aches; brain fog/ overall not up to feeling like myself; This is a spontaneous report from a contactable nurse reported for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 22Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing and cerebrovascular accident from an unknown date and unknown if ongoing. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 10:30, the patient experienced raised rash on face and injection site, flushed feeling face, chills, overall not up to feeling like myself, body aches and brain fog. No treatment was received for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 40 | 2021-02-09 | numbness |
Numbness at the right side of face and neck; where I was administered I waited 30 minutes and I star...
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Numbness at the right side of face and neck; where I was administered I waited 30 minutes and I started feeling like it move across my face; This is a spontaneous report from Pfizer sponsored program from a contactable nurse (patient). A 40-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9263, intramuscular in the right deltoid on 23Jan2021 05:18 am at single dose for covid-19 immunisation. Medical history included asthma, Sjoegren's syndrome and anxiety, all from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA). Historical Vaccine included first dose BNT162B2 for COVID-19 immunization. The patient said that she was still experiencing numbness at the right side of her face and neck after taking the second dose of the COVID-19 Vaccine. She stated she literally drove away from the injection (not clarified) or where she was administered she waited 30 minutes and she started feeling like it move across her face. As to start date of the event the nurse stated that's today 23Jan2021. There was no treatment received. The outcome of the event was not resolved. Relatedness of suspect to event was reported related.
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| 40 | 2021-02-09 | cold extremities, tingling |
my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; fel...
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my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.
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| 40 | 2021-02-10 | weakness |
Started having nausea, dizziness, head ache, weakness and fatigue and chills lasted for 3 days. As t...
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Started having nausea, dizziness, head ache, weakness and fatigue and chills lasted for 3 days. As these were new symptoms and were a week and a half out from the vaccine. Went and was tested for COVID-19 and received a negative test. Missed 3 days of work. No one else in my house hold had any symptoms. No one else in the house hold has been vaccinated.
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| 40 | 2021-02-10 | feeling hot |
Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is ...
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Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Feb2021 at 03:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and dextropropoxyphene napsilate/paracetamol (DARVOCET); both from unknown dates to unknown dates for unknown indications and experienced allergy. On 02Feb2021 at 15:45, the patient experienced swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot; all reported as serious of being life-threatening. The events required a visit to the urgent care (physician's office). The patient was treated with epinephrine (EPIPEN) and unspecified medications at the urgent care after emergency medical services were called. The clinical outcomes of swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 40 | 2021-02-10 | muscle spasms | Headache, large muscle pain and cramping, and fatigue |
| 40 | 2021-02-10 | muscle spasms |
Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after ...
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Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms. Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.
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| 40 | 2021-02-11 | cold extremities | Systemic: Other- cold finger tips, raised bloodpressure; lasted 1 day |
| 40 | 2021-02-14 | pain in extremity |
red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the w...
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red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient
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| 40 | 2021-02-15 | pain in extremity, nerve pain | Weakness and Pain in muscles and nerves in legs. Swollen lymph node in right arm pit. |
| 40 | 2021-02-16 | numbness, facial paralysis |
mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her ...
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mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears; headache; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper left arm on 01Feb2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history included asthma (exercise induced) and menstruating. Concomitant medications included Ibuprofen because she was menstruating. No other vaccine in four weeks. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper right arm on 11Jan2021 at 04:30 PM at single dose for COVID-19 immunization. The patient was not pregnant. The skin of the patient's jaw and chin started to feel numb about 20 minutes after receiving the vaccine, headache came and went rapidly on 01Feb2021 17: 00. The sensation progressed rapidly to include numbness of her cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic as the patient was driving away on her from work. Both sides of her face were impacted equally. She went to an urgent care facility to be evaluated. An Urgent Care Physician's Assistant evaluated the patient. They looked inside her throat to see if it was closing up (it wasn't). They used a swab to test her sensory ability on her face by pressing with either the fuzzy-side or the blunt (wooden) side. When the patient asked the PA how she did, she indicated that she failed the test. They gave her Benadryl. At home, the patient went to bed, woke up normally, and did a "frown test" in front of the mirror. Her left side of face wasn't working the same way as the right side. She may have a mild case of Bell's Palsy in the morning of 02Feb2021. The patient had no covid prior vaccination, no covid tested post vaccination. Benadryl was received as treatment for the events. Outcome of the event "skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears" and "mild case of Bell's Palsy" was recovering, of the event "headache" was recovered.
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| 40 | 2021-02-16 | pain in extremity |
Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hou...
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Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hours The next menstrual cycle was very heavy period, soaking heavy flow tampons every hour, large clots, and lasted 6 days from a typical mild flow 3 day period
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| 40 | 2021-02-16 | tremor, numbness, feeling cold |
Approx 10 minutes post vaccine patient reported she felt a c " cold rush" through her whole body, fe...
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Approx 10 minutes post vaccine patient reported she felt a c " cold rush" through her whole body, felt like she was shaking, developed hand tremors and then bilateral feet and calf numbness
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| 40 | 2021-02-16 | tremor |
Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of brea...
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Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did
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| 40 | 2021-02-17 | numbness, tingling, pain in extremity |
severe right extremity pain, radiating down right arm; with rt arm weakness, numbness and tingling; ...
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severe right extremity pain, radiating down right arm; with rt arm weakness, numbness and tingling; with rt arm weakness, numbness and tingling; with rt arm weakness, numbness and tingling; brachial plexus neuritis / parsonage turner syndrome; brachial plexus neuritis / parsonage turner syndrome; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number=EK5730), via an unspecified route of administration on 18Dec2020 09:30 at single dose for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history was none. The patient has no allergies to medications, food, or other products. The patient did not receive concomitant medications. On 30Dec2020 at 03:00 AM the patient experienced onset of severe right extremity pain, radiating down right arm, with rt arm weakness, numbness and tingling, after extensive workup determined to have brachial plexus neuritis / parsonage turner syndrome treated with steroids still recovering would not consider have had total recovery. The events were reported as non serious and resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with steroids. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has been tested for COVID-19 (PCR Nasal Swab, negative on 24Jan2021).
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| 40 | 2021-02-17 | tingling |
approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and...
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approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and feeling like her throat was "tight" and more difficult to swallow
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| 40 | 2021-02-18 | muscle twitching, muscle spasms |
24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain...
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24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.
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| 40 | 2021-02-18 | nerve pain |
Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into lar...
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Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.
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| 40 | 2021-02-21 | facial paralysis, facial pain |
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 da...
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After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.
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| 40 | 2021-02-21 | numbness, tingling, weakness |
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti...
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A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move. Â This lasted about an hour (15 hrs post-vaccine).
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| 40 | 2021-02-21 | tingling |
malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to ...
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malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks
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| 40 | 2021-02-22 | breast pain, speech disorder |
Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminoph...
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Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.
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| 40 | 2021-02-22 | facial paralysis |
swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have litt...
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swelling on the left side of my face; Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration (at the age of 40-years-old) on 26Jan2021 10:15 at a single dose in Left arm for COVID-19 immunization. Medical history was not applicable (N/A). The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced swelling on the left side of my face and Bell's palsy/ left side can not function properly. I have little eye, mouth and forehead movement on 05Feb2021 10:30. The patient reported, "I have swelling on the left side of my face as well as Bell's palsy. My left side cannot function properly. I have little eye, mouth and forehead movement." The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Therapeutic measures were taken as a result of the events which included anti-viral medication and a steroid. The events were assessed as serious (Seriousness criteria-Disabling/Incapacitating). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 40 | 2021-02-22 | muscle twitching, pain in extremity |
Two days after the dose in my right arm, I had a nerve or a muscle that was twitching that lasted fo...
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Two days after the dose in my right arm, I had a nerve or a muscle that was twitching that lasted for the three weeks until I got my second dose in my left arm. The left arm just had a normal aching for 24 hours. My right arm has rapid twitches like once or twice a day.
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| 40 | 2021-02-22 | tremor |
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat...
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Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
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| 40 | 2021-02-23 | electric shock sensation, pain in extremity |
I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the...
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I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the pain went up my arm, over my left shoulder blade, up the left side of my neck, and up into the left side of my chest. It has lasted and seemed to be more intense more than 24 hours after. 1:00pm the next day, I got extremely light headed and dizzy, sat down and it went away after a couple of minutes. Called my Primary Dr. and was told to report it. I will be seeing a Dr tomorrow the 25th. The pain, I thought was maybe a hit nerve from the injection, its kind of like an electronical zap
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| 40 | 2021-02-23 | muscle spasms | Left hand felt sluggish almost like cramping, duration about 7 days or more. |
| 40 | 2021-02-23 | nerve pain, pain in extremity | Insomnia, nerve pain in ears and legs, headache, fatigue after the insomnia, chills. |
| 40 | 2021-02-23 | tingling, numbness | Tingly face, minor numbness in left arm (injection side) maybe mouth and tongue numbness too |
| 40 | 2021-02-23 | seizure |
Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with...
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Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with RN All extremities contracted with grunting Airway maintained After activity was alert pale diaphoretic
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| 40 | 2021-02-24 | flushing, feeling hot |
Client complained of warmth and dizziness after receiving first Pfizer Covid-19 vaccine. Client was ...
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Client complained of warmth and dizziness after receiving first Pfizer Covid-19 vaccine. Client was sitting in post vaccine waiting area approximately 10 minutes before alerting EMT she was not feeling well. EMT alerted lead PHN to assist. Client alert and oriented, faced appeared slightly flushed, PHN asked client to lower mask to assess for any swelling or hives. Client denied shortness of breath, chest pain, allergies to vaccines in the past. Client stated room feeling warm. First set of vitals at 1020: blood pressure 124/80, pulse 79, respirations 16. Client was moved to chair near exit door for breeze of air and given water. Client walked with steady gait by herself. Shortly after being closer to open doorway client stated warmth feeling was improving. Per client only allergic to gluten products, only medication she takes is for thyroid and she had taken that this morning. Client asked if she could eat her snack she had in her purse, per client no breakfast this morning. PHN just instructed client to take small sips of water and eat slowly. PHN informed client her wait time would be extended to 30 min observation to make sure symptoms had improved prior to her leaving and client agreed. EMT stayed with client and reassessed vitals after 5 minutes. Blood pressure: 128/80, pulse 75, o2 98, skin color normal, alert and oriented, and client stated symptoms resolving. PHN and EMT reassessed client at 10:40, as client was approaching 30 minute observation. Vitals: blood pressure, 128/78, pulse 78, o2 99. Alert and oriented, client stated prior complaints had resolved. PHN had patient stand up by chair to assess for dizziness and client denied at this time. ER precautions given. EMT walked client out of building at 10:45, client walked out with steady gait.
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| 40 | 2021-02-24 | throat numbness |
40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat ,...
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40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening." Received epi from medical team but initially refused ER visit. Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing being additonal symptoms. She was agreeable to transport after the second episode.
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| 40 | 2021-02-25 | muscle twitching, tingling, numbness |
Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right e...
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Paresthesias, on lower extremities and tingling on right arm all day; intermittent numbness; right eye twitching daily; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received the second dose of BNT162B2 (lot number: EG686), intramuscularly in left arm on 12Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took tramadol and experienced drug allergy, and the first dose of BNT162B2 (lot number: GK5730) in left arm for COVID-19 immunisation. The patient experienced parethesias, on lower extremities and tingling on right arm all day, intermittent numbness, right eye twitching daily on 15Jan2021. The patient underwent lab tests and procedures which included nasal swab, COVID test result: Negative on an unspecified date. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for these events. Patient was not recovered.
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| 40 | 2021-02-28 | weakness |
Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, ...
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Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.
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| 40 | 2021-02-28 | burning sensation, discomfort |
Persistent swollen lymph nodes in neck region. Persistent pain, discomfort, burning sensation in lef...
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Persistent swollen lymph nodes in neck region. Persistent pain, discomfort, burning sensation in left arm and neck region
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| 40 | 2021-02-28 | discomfort |
About 12 hours after the vaccine, I experienced a 102 degree temperature, all over body aches with t...
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About 12 hours after the vaccine, I experienced a 102 degree temperature, all over body aches with the most discomfort in my lower back, knees, and hips, headache and general fatigue. The next day all the symptoms went away except residual arthritic joint pain. The pain is more extreme during sleep and in the morning. My left knee has been swollen as well. There is a general feeling of whole body arthritis and is lessened by NSAIDs.
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| 40 | 2021-02-28 | feeling hot |
felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood press...
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felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76. Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.
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| 40 | 2021-02-28 | numbness, tingling |
Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throug...
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Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throughout my body My chest, arms and legs felt heavy. It wasn?t hard to breathe exactly, but it just felt like it was hard to actually do it. If that makes sense Then, the scary one. My brain and my mouth were saying two different things. I became really pale (per medic) and I had a hard time figuring out how to say no. My mind just wouldn?t work correctly. And when I tried to speak, it was very confusing and I was told I wasn?t making sense by the medic. Then as quickly as it started, it stopped. Periodically through out the day today, I have gotten more confused than normal about simple things. Earlier I tried to say chicken. I said potato. I was thinking chicken but my stupid mouth said something different. The medic compared my symptoms to a stroke. Which was terrifying
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| 40 | 2021-02-28 | pain in extremity |
Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant;...
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Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine) Pregnant; due date June 16 2021. First pregnancy at the age of 40.
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| 40 | 2021-02-28 | pain in extremity |
arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contact...
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arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination. Information on the lot/batch number has been requested.
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| 40 | 2021-02-28 | pain in extremity | Sore arm. Pregnant; due date June 16, 2021. First time mom at the age of 40. First pregnancy. |
| 40 | 2021-02-28 | pain in extremity |
felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Fri...
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felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-02-28 | pain in extremity |
After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting head...
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After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the right arm, on 06Jan2021 at a single dose, for Covid-19 immunization. Patient had no relevant medical history and no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility type where vaccine was administered was reported as other . On an unspecified date in Jan2021, after the first vaccine the patient had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination. Information about batch/lot number has been requested.
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| 40 | 2021-02-28 | tingling | Dizziness and tingling |
| 40 | 2021-02-28 | throat numbness |
About an hour after vaccination, my throat was tingling and my heart rate went up. It came down afte...
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About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.
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| 40 | 2021-03-01 | tremor |
Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath,...
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Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.
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| 40 | 2021-03-02 | numbness, tingling |
10 minutes after getting her first COVID-19 vaccine, patient experienced L sided numbness and tingli...
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10 minutes after getting her first COVID-19 vaccine, patient experienced L sided numbness and tingling of her face, 5 minutes later this was followed by a globus sensation. Patient had CN 2-12 grossly intact and 5/5 muscle strength of the upper extremity. She had a patent airway without stidor. She was able to swallow liquids. Due to her history of angioedema, she was evaluated by EMS and sent to ED for further evaluation.
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| 40 | 2021-03-02 | migraine |
chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue seve...
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chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue severe enough to prevent normal activity; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), intramuscularly into the left arm on 28Jan2021 14:15 at a single dose for COVID-19 immunisation. Medical history included Polycystic ovarian syndrome (PCOS), depression, obesity and allergies to latex. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B12). The patient previously took tetracycline and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly into the right arm on 06Jan2021 03:15 PM at a single dose for COVID-19 immunisation. On 28Jan2021 20:00, patient experienced chills, fatigue, migraine-like headaches, dizziness, nausea and migraine-like headache and fatigue severe enough to prevent normal activity. The events were reported as non-serious. The patient did not receive any treatment for the events reported. Outcome of events was unknown.
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| 40 | 2021-03-02 | tingling, discomfort |
Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in lef...
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Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated "I think so". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.
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| 40 | 2021-03-02 | tingling, numbness |
Pt stated that about 10 minutes after receiving vaccine she felt like she was "hit in the back of th...
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Pt stated that about 10 minutes after receiving vaccine she felt like she was "hit in the back of the head", and had developed a severe headache. Pt also c/o numbness and tingling on the L side of her face. Checked for signs of a stroke, none noted. Vitals- B/P- 148/90; P- 108; R-14; SpO2- 94-96% on RA. Lung sounds clear. Pt denies any itching, difficulty breathing, or chest heaviness. No rash noted. Pt called her PMD who told her to have her husband bring her over to his office for evaluation. PHN called pt on 3/3/21 to check on status. States she still has a headache and some numbness on her face. States she is also having trouble finding words when she is talking. Encouraged to f/u with PMD again today.
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| 40 | 2021-03-02 | tingling, nerve pain, numbness |
Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...n...
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Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...nurse had me lay down for ten mins. Still felt weird and numb in arm, she said it was normal and sent me to leave. Tem mins into my car ride home my left cheek starting tingling and going numb. The nerves in my left leg began tingling all over. By the time I got to the hospital, I had similar symptoms of Temporary paralysis on left side yet my limbs were still functioning. When I left the hospital a few hours later, I was like 50 percent numb on my left side, all test results showed everything was good, blood, EKG and cat scan. I felt like I'd been injected with novacaine all over the left side of my body and I was in the stage where it is starting to wear down with tingling and itching on my hand leg and cheek on my left side. My back on left side and neck locked up. The numbing in my face took two weeks to decipate. While exercising never agitation occurred and felt like nerves were firing for two weeks. Severe ear nerve pain occured within first week. Followed up with personal doctor had mri of brain w/ and without contrast and that looked good. I am pretty healthy, maybe a few extra covid lbs. EKG good, CT scan good, blood work good. I am waiting to see neurologist for more testing. There is still random tingling in and out, very faint on left side of my body only. Use of my left hand feels
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| 40 | 2021-03-03 | weakness |
General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back o...
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General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat
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| 40 | 2021-03-03 | difficulty speaking |
Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience t...
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Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing, patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.
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| 40 | 2021-03-03 | migraine |
I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and th...
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I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and the next day my arm was very tender where I got the shot. The adverse side effect I'm most concerned about developed 2 days later. I noticed it hurt to turn my head and realized I had a lump on the right side of my neck sort of under my chin but a little to the right of that. It's making my throat hurt even though my throat itself is fine and the pain from this knot is radiating up to my right ear. I'm sure it's a swollen lymph node. I've had swollen lymph nodes before with strep throat but never have they hurt as much as this is and I've never had just one lymph node swell until now. I got the shot on a Saturday and this symptom began on Monday. I've been dealing with it for 3 days now, so if it's now gone in 2 more days I'll be going to my doctor for evaluation. I just wanted to report this and I was also wondering if this reaction has anything to do with the brain tumor surgery I had for an acoustic neuroma brain tumor and they put a metal plate in my head that my body had a bad reaction to causing hives, itching, and a lot of extra pain and irritation.
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| 40 | 2021-03-03 | pain in extremity |
Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and pal...
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Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and palms of hands), headaches, nausea.
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| 40 | 2021-03-03 | tingling |
14:50 Client reported tingling sensation on L hand/ fingertips approximately 5 minutes after the va...
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14:50 Client reported tingling sensation on L hand/ fingertips approximately 5 minutes after the vaccine was received. No other symptoms presented. Client was A/O x 4, no respiratory distress observed. initial V/S BP 138/98, HR 81, RR18 and 02 sat of 97% on RA. 3:33, patient feels better and said she does not feel the tingling anymore. Instructed to call her PCP for further evaluation or call 911 for SOB or respiratory distress or any symptoms of anaphylactic reactions. Patient left the vaccination site without complaints
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| 40 | 2021-03-04 | feeling hot |
Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pres...
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Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pressure was running high with reports of 164/92, 169/102, 144/98 and then 135/89. Taken 10 minutes apart each time. Healthcare staff provided patient water and monitored during event. Began to feel normal again as bp went down. HR stayed between 69-79 during entire time.
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| 40 | 2021-03-04 | flushing |
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vi...
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After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
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| 40 | 2021-03-04 | pain in extremity, nerve pain |
Severe, continuous left arm pain that has been present since time of first injection. Limits arm mov...
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Severe, continuous left arm pain that has been present since time of first injection. Limits arm movement, weight-bearing ability and involves nerve pain. Have applied ice and heat, used suggested stretches & taken ibuprofen with no improvement.
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| 40 | 2021-03-04 | tingling |
At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating a...
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At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.
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| 40 | 2021-03-05 | flushing |
Fevers ranging from 99-103 daily for 3 weeks now, headache x 3 weeks, body aches, nauseous x 3 weeks...
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Fevers ranging from 99-103 daily for 3 weeks now, headache x 3 weeks, body aches, nauseous x 3 weeks, facial rash/flushing daily the past week 2 weeks from last dose. Severe fatigue unable to do my daily activities, missed work and sought care by pcp. Trying to see immunology at where vaccine was administered and Getting the run around by everyone.
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| 40 | 2021-03-05 | migraine, inability to speak, seizure like phenomena |
8 minutes after the administration of the vaccine (while in the observation area) I started to feel ...
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8 minutes after the administration of the vaccine (while in the observation area) I started to feel really off (dizzy, anxious, ringing in right ear). I ended up becoming unconscious with seizure like activity. They rushed me to the ER and kept me for 6 hours with lots of testing. XRay, blood test, CT of head, EKG, Urine test...all came back normal. Doctor said it was likely a reaction to the vaccine. I am 40 years old with no history of seizures or allergic reactions to vaccines. The week following I experienced confusion, migraines, dizziness, slow cognitive processing, eye strain, word finding difficulties, and exhaustion. I had to take a week off of work to recover. This is the second week and I am still experiencing headaches and occasional dizziness/eye strain.
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| 40 | 2021-03-05 | muscle spasms |
Initially, there was left sided neck and shoulder pain and severe headache which resolved after a fe...
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Initially, there was left sided neck and shoulder pain and severe headache which resolved after a few days. After approximately 1 week, a pinch was noted in cervical spine when turning head to the left. This quickly progressed to severe left sided muscle spasm in left neck and shoulder resulting in neck and shoulder pain and loss of range of motion in neck. At the time of this report, symptoms remain ongoing. Medications: Tylenol, Motrin, Aleve, Mobic, Toradol, Flexeril, Medrol. Muscle spasms are situation, pain has plateaued, range of motion slowly improving.
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| 40 | 2021-03-07 | weakness |
Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp....
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Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp.: 16 O2Sat: 95% Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath Sounds Clear Bilaterally Treatment: Pt assisted to cot. Requested to remain in sitting position. C/O dizziness and vertigo with head movements. Denies nausea , No flushing, skin p/w/d. Repeat Assessment: 12:45 pm Vitals: B/P: 132/82 HR: 74 Resp.: 16 O2Sat: 98% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sounds bilaterally Treatment: Remains in seated position- Offered fluids- refused. Repeat Assessment: 13:02 pm Vital Signs: B/P: 122/88 HR: 73 Resp.: 16 Skin signs: Warn and dry Circulation: Cap refill <2sec Resp.: Breath Sounds clear bilaterally Treatment: Lightheaded, states "easier to focus eyes." No syncope, No increased light or vertigo with movement of head. 13:20 pm Pt released via wheelchair to vehicle to home with a friend. ALOx3, skin p/w/d. No further c/o dizziness . F/U Call: 2/4/2021 Fine after returning home. Woke up in the middle of night fell in BR x2 (no head injury) sweating, fevers, syncope, weakness, vertigo "spinning" disoriented felt delirious with 2nd fall in BR. Extremely nauseated.
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| 40 | 2021-03-07 | cold sweat, pain in extremity |
my arm hurts; slight headache; cold sweat; This is a spontaneous report from a contactable consumer ...
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my arm hurts; slight headache; cold sweat; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: unknown), via an unspecified route of administration in the right arm on 26Jan2021 at 14:45 ( at the age of 40-year-old) as a single dose for COVID-19 immunisation at workplace clinic. Medical history included penicillin allergy (childhood). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. On 27Jan2021, at 12:00 the patient experienced my arm hurts, slight headache and cold sweat and did not last long at all (as reported). The patient did not receive any treatment for the events. The events were reported as non-serious. The outcome of the events my arm hurts, slight headache and cold sweat was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.
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| 40 | 2021-03-07 | pain in extremity, weakness |
First dose on 02/14/2021 received 10:15 am. Symptoms started approximately 8 to 10 hours later. I ex...
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First dose on 02/14/2021 received 10:15 am. Symptoms started approximately 8 to 10 hours later. I experienced Brain fog, fatigue, weakness generalized malaise, headache, sore arm . No treatment, symptoms resolved after 4 days.
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| 40 | 2021-03-07 | tingling |
Patient checked in for vaccine at 10:52am. During screening process, patient identified as needing a...
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Patient checked in for vaccine at 10:52am. During screening process, patient identified as needing additional monitoring (30 minutes) after vaccine administration. Patient received vaccine at approximately 11:00am, at which time she left vaccination site to observation site. Approximately 15 miniutes post vaccine administration, patient self-reported feeling of lightheadedness to RN at site. Doctor was informed and called over to assess patient, at which time he diverted patient to the 30 minute observation area and placed on Stryker bed.. During this period, patient continued to feel worsening of pre-syncopal type dizziness and developed parasthesias to bilateral arms and legs. VS at 11:35 am - BP 131/95; HR 82; RR 18; O2 sat 98%. Patient also endorsed some nausea, but did not vomit; negative abdominal pain. Patient did not present with any difficulty breathing, edema, urticaria, pruritis, or globus sensation. VS at 11:50am - BP 115/77; HR 72; RR 18; O2 sat 98%; patient seemed to be relatively comfortable. Clinically ,patient seemed to be improving, parasthesias resolving. Approximately 12:05pm, patient with complaint of increase dizziness, brief episode of chest pain, worsening parasthesias and exihibiting some difficulty breathing. VS at 12:07pm - BP 160/60; HR 90 12:10pm: EpiPen 0.3 mg adminstered to R thigh IM and 911 called. VS post Epi - BP 156/82; HR 151 EMS arrived at 12:15pm EMS started IV but had to wait for transfer due to social situation (2 children with patient). 12:39 pm, patient transported to Medical Center, with children, via EMS. Doctor spoke with ER physician. Patient was discharged at approximately 4:00pm after evaluated by ER physician.
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| 40 | 2021-03-07 | tingling |
Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pre...
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Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.
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| 40 | 2021-03-07 | tingling |
Patient became nauseated, light headed, pre syncopal and with diffuse paresthesia. Given epinephrin...
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Patient became nauseated, light headed, pre syncopal and with diffuse paresthesia. Given epinephrine IM, sent to ED for eval
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| 40 | 2021-03-07 | tremor |
Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shak...
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Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shaking/tremors
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| 40 | 2021-03-08 | inability to speak |
Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4...
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Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4 days. Trouble breathing, felt like a weight on my chest and it was difficult to speak lasted for 90 minutes.
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| 40 | 2021-03-09 | breast pain |
The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and l...
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The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and left breast tenderness following first dose of Pfizer vaccine. Constitutional symptoms lasted less than 1 week and were managed conservatively. The left axillary lymph node and left breast remained painful and enlarged for approximately 1 month.
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| 40 | 2021-03-09 | flushing |
flushed, rapid heart rate. No throat swelling, shortness of breath, vomiting. NO signs of anaphy...
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flushed, rapid heart rate. No throat swelling, shortness of breath, vomiting. NO signs of anaphylaxis
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| 40 | 2021-03-09 | tingling |
Patient received first dose on 9 March 2021 at approximately 1430. Patient started to experience fac...
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Patient received first dose on 9 March 2021 at approximately 1430. Patient started to experience facial tingling, right arm tingling, shortly after approximately around 1430. 1445 tingling remained, member also started to complain of difficulty swallowing. Patient assessed by medical provider. Vitals and patient history obtained from patient. Member transported to TAMC at 1513.
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| 40 | 2021-03-10 | discomfort |
About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and start...
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About 10 minutes after receiving the vaccine, the back of my neck started tightening badly and started getting uncomfortable. My throat then started to get dry and began breaking out with a rash on my neck and chest. This lasted about 30 minutes before the symptoms started to cease (in total 45 minutes after receiving the vaccine). Within 2 hours after receiving the vaccine, all symptoms had subsided. Treatment - at the vaccine clinic, EMTs observed me and took my vital signs. My blood pressure was slightly elevated, but did not require medical treatment. They continued to monitor me with the recommendation that I use my EPI-pen if symptoms got worse and instructed me to seek emergency medical treatment if symptoms got worse. No further treatment was sought out as symptoms all started to improve.
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| 40 | 2021-03-10 | flushing | 10 days of symptoms and they continue -- aches, dizziness, decreased appetite, flushed, headache |
| 40 | 2021-03-10 | numbness |
20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then r...
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20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then resolved. Myalgias, fatigue and athralgias lasted a week and improved in 1 week in severity but intermittent athrlagias continue to occur. Over 1 month post 2 nd injection developed numbness of bilateral hands and feet and numbness of the mouth had recurred and is persistent for 6 days now.
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| 40 | 2021-03-10 | migraine | Headache leading to migraine and vertigo |
| 40 | 2021-03-10 | tingling, numbness |
I have been having intermittent paresthesias that began in my R thumb on 3/10 (day 4 s/p Pfizer #2) ...
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I have been having intermittent paresthesias that began in my R thumb on 3/10 (day 4 s/p Pfizer #2) around 4pm and by 9 pm this had spread to my first 3 fingers on my R hand. My thumb was completely numb. Woke up on 3/11 with no symptoms but by 11am my R thumb was numb again and this spread to my full hand/palm by 12pm, and then my L hand digits 1-3 and my L great toe and 2nd toe began tingling and felt numb. I started getting myalgias, L axillary pain but no palpable LAD, fatigue and a headache around 3pm and the paresthesias in my 3 extremities have recurred intermittently tonight. No pain or weakness in my extremities. Non-positional. No recent change in activities (I workout daily for an hour but no new exercises). I?ve never had any neurological issues with my extremities in the past. My only side effect after my Pfizer #1 on 2/14/2021 was just a few days of intermittent fatigue.
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| 40 | 2021-03-11 | muscle twitching, hypersensitivity of all senses |
Chills, fatigue, fever, extreme muscle aches, headache, loss of appetite, mild nausea, Extreme exha...
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Chills, fatigue, fever, extreme muscle aches, headache, loss of appetite, mild nausea, Extreme exhaustion, skin that's sensitive to the touch, bone aches, difficulty moving/walking/standing. Felt dehydrated. Started at 2:30am and didn?t go away until Sunday morning. Took Tylenol at 12 and 6pm, ibuprofen at 10pm. The following day my body hurt, headache, mild nausea. Still have pain in lymph node under vaccinated arm and arm muscle twitch. Mild dehydration.
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| 40 | 2021-03-12 | breast pain | Severe sore breasts and menstrual abnormalities |
| 40 | 2021-03-12 | numbness |
Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I...
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Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I began feeling dissociated. Almost out of body, like I was under the influence. I began to struggle to answer questions and stay awake. I willed myself to stay calm and stay awake. I was given water and observed for an hour. My face began to feel numb and the roof of my mouth itchy. The ?high? feeling was eventually replaced by the feeling of being extremely tired. After and hour I was good to drive but extremely tired when I got home. About an hour after the shot I can taste a blood or metallic taste in my mouth. I still feel ?drugged? or tried.
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| 40 | 2021-03-12 | pain in extremity |
Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, ...
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Left arm pain between elbow and wrist, extreme nausea, pounding headache, dizziness, blurry vision, rash on face, extreme fatigue
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| 40 | 2021-03-13 | weakness | FEELS LIKE BP IS HIGH, ELEVATED HR, WEAKNESSS. Evaluated by EMS- refusal to transport. |
| 40 | 2021-03-13 | burning sensation |
Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like ...
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Felt fine after the shot. Woke up feeling fine the next day and then about 2 pm my tongue felt like it was on fire and so did the fingers on my right arm. Now my whole body hurts and I feel like I?m going to throw up.
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| 40 | 2021-03-14 | burning sensation |
I have a diagnosed urinary tract infection a week after the first shot. I have a burning sensation a...
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I have a diagnosed urinary tract infection a week after the first shot. I have a burning sensation and frequent urination. I was tested and confirmed a UTI by my doctor.
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| 40 | 2021-03-15 | weakness |
Progress Notes Expand AllCollapse All Patient: ...
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Progress Notes Expand AllCollapse All Patient: DOB: 4/11/1980 Date: 3/16/2021 MRN: Subjective Patient is a 40 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience generalized weakness, "need for a quick snack". She denied rash, shortness of breath, difficulty swallowing or syncope This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to red flag findings ALLERGY REVIEW OF SYSTEMS Previous Reactions: none Objective Vitals Vitals: 03/16/21 0944 BP: (!) 158/103 Pulse: (!) 102 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing or diaphoretic. Comments: Anxious on arrival to bay, "I think I just need a snack to feel better." HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: General: Normal range of motion. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert. Motor: No weakness. Psychiatric: Comments: Anxious affect Clinically, post injection anxiety related event. Elevated BP on arrival, improved with rest and granola bar. Salient anxious affect, post injection histamine response, requiring warm blanket, prolonged rest Ambulated with assist, additional snacks provided and pt discharged after 45" stay Assessment/Plan Treatment included: snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)
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| 40 | 2021-03-15 | pain in extremity |
After vaccine 1 on 02/04/2021 I only experienced a sore arm. After vaccine 2 on 02/26/2021 I exper...
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After vaccine 1 on 02/04/2021 I only experienced a sore arm. After vaccine 2 on 02/26/2021 I experienced soreness almost immediately. The next morning I had soreness at my ankles and knees. I also had extreme cold chills and a cough. I later experienced a fever of 101.8 degrees. Extreme tiredness.
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| 40 | 2021-03-16 | numbness |
patient complained of dizziness and leg numbness. PT was monitored for 45 minutes and then released ...
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patient complained of dizziness and leg numbness. PT was monitored for 45 minutes and then released when no longer complained of numbness or dizziness.
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| 40 | 2021-03-16 | nerve pain, tingling |
Approx 8 hours after the Covid vaccine I began having tingling and nerve zaps in all limbs. These pa...
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Approx 8 hours after the Covid vaccine I began having tingling and nerve zaps in all limbs. These pains have continued since for the past 10 days and have not stopped.
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| 40 | 2021-03-16 | pain in extremity, muscle spasms |
Felt tired but good Saturday afternoon. Sunday felt good, sore arm but thankful I didn?t get sick. M...
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Felt tired but good Saturday afternoon. Sunday felt good, sore arm but thankful I didn?t get sick. Monday morning 4am woke in pain in lower back. Felt Like a contraction. It was hard to rotate side to side, could not bend or twist. Stairs were very painful. Spasms in lower back would occur when back muscles were engaged, even lifting my arms or holding a cup of coffee caused strain and tension to my back. Wore salan pas patches to help with aches and at the end of the day, Took a muscle relaxer and went to bed early. Pain has subsided Tuesday. Still bending and twisting were tolerable and spasms lessen by 50%. Took motrin and slept. Wednesday walking is easier bending is better. Sit down to work and after 1/2 of not moving back began spasming.
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| 40 | 2021-03-16 | pain in extremity |
Red rash on chest. Got the same rash when I got Covid back in January. I feel very light headed and ...
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Red rash on chest. Got the same rash when I got Covid back in January. I feel very light headed and tired. Sore arm. Took 2 Tylenol. Nothing has helped .
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| 40 | 2021-03-17 | feeling jittery, weakness, tremor |
Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid...
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Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid vaccine with some feeling like throat and tongue were swelling but EMTs on the scene administered IV benadryl with the first dose. With doctor recommendation to receive the second dose about 20 minutes after she received the second dose she started feeling her tongue have a fuzzy swelling sensation and began coughing frequently around 11 a.m.. Patient took 50 mg of Benadryl of her own immediately before the vaccine in order to counteract the same reaction from the first one. Due to increasing symptoms she received Epinephrine 0.3 mg/0.3 ml one shot at 11:09 a.m. and a second shot at 11:17 a.m. Patient began to show signs of improvement from the Epipen but not enough with one shot so she proceeded with the second one. She was able to leave the vaccine clinic to see her general practitioner that afternoon. She expressed that she felt jittery after the shots and we determined that the Benadryl liquid she had with her and took had Phenylephrine in it as well which combined with the Epinephrine was causing the shakiness. She felt stabilized but weak. Her blood pressure was 140/100 at 11:50 a.m. and 137/88 at 11:55 a.m. Her allergist and general practitioner were contacted and notified of the incident and they instructed her further to use Benadryl tonight and to contact them tomorrow about any further concerns. She reported this evening at 5:27 p.m. that she was okay and did not have any further issues or the feelings of the allergic reaction.
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| 40 | 2021-03-17 | pain in extremity |
I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in ...
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I received my second dose of the COVID vaccine on 3/5/21. The symptoms began on 3/7/21 with pain in my upper left arm. The next following night, I was awakened by sharp pains from the top of my left arm to my fingers. Even the back of my left arm is swollen. It even traveled down my back. I went to urgent care on Sunday 3/9/21 to see what had happened. A CNP said it seems musculoskeletal and the pain radiated from the injection site. I've taken Tylenol, Ibuprofen, been prescribed muscle relaxers and steroids to numb the pain but it doesn't work. This is still occurring to this day.
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| 40 | 2021-03-18 | feeling cold |
03/18/2021. 3:25pm. Strange tickle in throat and coughing but couldn?t really stop. Kept trying to d...
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03/18/2021. 3:25pm. Strange tickle in throat and coughing but couldn?t really stop. Kept trying to drink water. 03/19/2021. 3:00am. Woke in the night with a horrible headache, shivering and freezing. Took 2 Advil, bundled up and went back to bed. 03/19/2021. 7:00am. Woke with horrible headache that won?t go away, body aches all over, muscles feel weak and slight fever of 99.4 (my base is 97.7). These are all the same symptoms I had when I actually was positive for Covid 11/15/2020.
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| 40 | 2021-03-18 | numbness |
Patient is a 40 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 3...
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Patient is a 40 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/19/2021. The patient experienced the following reaction(s) during the immediate of observation: 12:07pm Patient c/o numbness to bilateral hands. Denies tingling, shortness or breathing, or difficulty breathing. Patient reports anxiety. Patient was treated/managed as follows: 12:09pm VS BP 150/82, HR 80, RR 18, O2 sat 98% on room air. States symptoms are subsiding. 12:20pm VS BP 154/84, HR 74, RR 18, O2 sat 99% on room air. Patient reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:28pm. Patient escorted to car by RN.
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| 40 | 2021-03-18 | numbness |
My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic ...
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My face (cheeks) went numb. My tongue and throat started to tingle, like I was having an allergic reaction. I had taken a Claritin for allergies before I received the injection. The numbness started approximately 30 minutes after receiving the injection. It last until I took additional allergy medicine three hours after the injection.
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| 40 | 2021-03-18 | pain in extremity |
I received the 2nd shot out of the Covid 19 series on Wednesday March 10th. I had severe left arm pa...
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I received the 2nd shot out of the Covid 19 series on Wednesday March 10th. I had severe left arm pain where I received the shot, could not even sleep on it and/or lift it. The following morning I woke up to go to work and throughout the day the symptoms progressed.it began with slight dizziness, headache, fatigue, nausea, chills and fever for the 24hrs following -- I ended up taking Tylenol Extra Strength for relief of the headache/fever. Exactly 6 days later I felt an itching on my wrist that later progressed to "Covid Arm" swelling at the site of injection, onto an upper body allergic reaction with hives then later to lower body as well. it has been relieved with Benadryl nightly.
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| 40 | 2021-03-18 | tingling | Tingling sensation in arm and throughout body at least 24 hours after injection |
| 40 | 2021-03-19 | flushing |
Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pati...
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Systemic: metallic taste in mouth -Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient states that she has metallic taste in her mouth post observation of 30 minutes -- patient states she still has it upon leaving
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| 40 | 2021-03-19 | hot flush |
Fever 101.7- 102.0, body aches, fatigue, joint pain, headache, chills, nausea, hot flashes, feeling ...
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Fever 101.7- 102.0, body aches, fatigue, joint pain, headache, chills, nausea, hot flashes, feeling all around unwell. I was so tired in the middle of the night I did not wake up when I was coughing and could not breath and was gasping for air. Because i was so fatigued I almost suffocated.
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| 40 | 2021-03-19 | migraine |
Headache - extreme pain/pressure, noon until nearly 6 pm when I took an Aleve, the pain then decreas...
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Headache - extreme pain/pressure, noon until nearly 6 pm when I took an Aleve, the pain then decreased to something like a regular migraine
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| 40 | 2021-03-20 | numbness |
The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up ...
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The day after the shot I had numbness in my right leg and foot. Three days after the shot I woke up with the inability to taste. I can smell but no taste. ?Pfizer-BioNTech COVID-19 Vaccine EUA?
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| 40 | 2021-03-20 | pain in extremity, burning sensation | Burning chest pain, cough, sore throat, sweats, fever, shortness of breath, sore arm, achey |
| 40 | 2021-03-20 | pain in extremity | Sore arm, stomach pain, nausea, diarrhea, bloating |
| 40 | 2021-03-20 | tingling |
body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elb...
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body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Chills; fatigue; general malaise; This is a spontaneous report from a contactable Other HCP, the patient. A 40-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history included patient was diagnosed with COVID-19 (prior to vaccination). Since the vaccination, the patient had not been tested for COVID-19.The patient had no Known allergies. Concomitant medications included multivitamin and magnesium supplement. On 03Feb2021 at 16:00 the patient expereinced Intense pain at injection site and traveling down to elbow. Unable to raise arm overhead. Chills, body aches, fatigue, prickly skin, general malaise. No treatment was received for the events. Outcome of the events were recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 40 | 2021-03-20 | tenderness | Arm swelled and and has tenderness week after covid Pfizer vaccine |
| 40 | 2021-03-21 | flushing |
Moderate to severe joint pain in entire body ongoing. 19 hours since onset. Insomnia night of first ...
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Moderate to severe joint pain in entire body ongoing. 19 hours since onset. Insomnia night of first dose. Facial flushing and fatigue ongoing, 19 hours since onset.
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| 40 | 2021-03-21 | hot flush |
The Chief Complaint is: 40 y/o F with history of allergic rhinitis including systemic reaction to sk...
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The Chief Complaint is: 40 y/o F with history of allergic rhinitis including systemic reaction to skin testing years ago presents for COVID vaccination. She and I discussed getting vaccinated with her history a few weeks ago and I recommended vaccination. She reports that today she is in previous good health but 15 minutes after vaccination she started to feel itching all over her body which was rapidly followed by throat itching and difficulty swallowing. She was taken to the treatment area of the vaccination center and evaluated. - Pruritis, flushing, sclerae injection after COVID vaccination with PFizer vaccine. May be allergic or due to complement release. Treatment course - took patient back to the treatment area and administered 0.3mg epinephrine with rapid improvement in symptoms and signs and minimal side effects. Follow up BP lower, flushing improved, sclerae improved and throat symptoms improved. Called 911 for EMS response to observe her in the ED will complete VAERS and contact patient by phone for follow up
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| 40 | 2021-03-21 | pain in extremity |
Muscle and joint soreness in left shoulder and arm from base of neck to elbow; treated with 600 mg q...
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Muscle and joint soreness in left shoulder and arm from base of neck to elbow; treated with 600 mg qid. Resolved in 48 hours.
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| 40 | 2021-03-21 | tingling, numbness | Felt numbing/tingling on and around lips. Lasted about 30 minutes then went away |
| 40 | 2021-03-21 | tingling |
Two days after the vaccine, my right foot started to feel weird - felt wet sometimes or felt tingly....
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Two days after the vaccine, my right foot started to feel weird - felt wet sometimes or felt tingly. My foot was not swollen. I still have those weird sensations 18 days after getting the vaccine. Also, I had many small blood clots during my first menstruation after the vaccine (13 days after vaccine), which is not normal for me.
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| 40 | 2021-03-22 | weakness |
On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nause...
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On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nausea , vomiting, headache, dizziness, weakness, fatigue, diarrhea, trouble breathing, rapid heart beat. These symptoms persisted for a few days. Then came on again on March 21, 2021. I have visited urgent care center and have tested negative for covid. I have been prescribed pain for headaches and nausea. My symptoms continue and persist as of now. I have missed work due to reactions.
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| 40 | 2021-03-22 | numbness |
Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. C...
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Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes. Currently still feel numbin face.
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| 40 | 2021-03-22 | tingling |
Pt presented to the medical tent with complaints of tingling in her tongue. States has long history ...
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Pt presented to the medical tent with complaints of tingling in her tongue. States has long history of allergies, has 2 epi pens with her and premedicated herself prior to coming to the vaccination site with 50 mg of PO benadryl at 1100. As pt was monitored she developed a rash on neck that was splotchy, flat, red. Tongue tingling stopped and moved to her fingers. BP was 152/90, other VS were WNL. Seen by MD on site. 1252 pt was feeling better, rash gone, all tingling gone. Pt left on own from vaccine site.
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| 40 | 2021-03-22 | tremor | Within 10 minutes, I experienced tachycardia, hypertension, Sweating and shaking. |
| 40 | 2021-03-23 | pain in extremity, muscle spasms |
I don't know if it's related, but had severe pain in left arm, wrist, and middle& ring fingers. It ...
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I don't know if it's related, but had severe pain in left arm, wrist, and middle& ring fingers. It was like a severe cramp. I could not make a fist and lost most of my strength for about 4 days. I just woke up with the pain, I did nothing strenuous the night before. It is 80% but still hurts.
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| 40 | 2021-03-23 | tingling | Rush of tingling sensation and lightheadness. Symptoms resolved 10 mins later per pt |
| 40 | 2021-03-23 | tenderness |
After 12 days, I am still experiencing a lot of tenderness in my arm. It is slightly red and swollen...
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After 12 days, I am still experiencing a lot of tenderness in my arm. It is slightly red and swollen at the injection site and I have overall felt rundown for 12 days now.
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| 40 | 2021-03-24 | cold sweat, feeling hot |
Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self...
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Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit
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| 40 | 2021-03-24 | difficulty speaking, weakness |
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo...
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03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
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| 40 | 2021-03-24 | numbness, muscle twitching, involuntary muscle movements |
dizzy; feeling drugged; numbness; loss of most use in hands; took extreme amount of planning and eff...
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dizzy; feeling drugged; numbness; loss of most use in hands; took extreme amount of planning and effort to speak a singular word or move any part of body; nausea; vomitting; Hands/ fingers, legs, eye, all developed tics; Legs were twitching all night; little achey; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 40-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: UNKNOWN), via an unspecified route of administration in the left arm on 06Feb2021 at 16:30 PM (at the age of 40 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), gabapentin, fluvoxamine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took cephalexine and experienced drug hypersensitivity. On 06Feb2021 at 17:30 PM, the patient started to get dizzy, feeling "drugged", numbness, then loss of most use in hands (significant weakness- could not hold a cup), took extreme amount of planning and effort to speak a singular word or move any part of body, nausea, vomiting, hands/ fingers, legs, eye, all developed tics, legs were twitching all night, little achy. No treatment was taken for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 18Feb2021, Nasal Swab: Negative. Information on the lot/batch number has been requested.
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| 40 | 2021-03-24 | migraine |
Migraine within 30 minutes of vaccine. I thought I was going to have to go to the hospital it was so...
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Migraine within 30 minutes of vaccine. I thought I was going to have to go to the hospital it was so bad. I had to work from home for a few days. I got tested by my neurologist (the Wed or Thursday following the vaccine -she prescribed a couple of new medications for me. the meds may have helped make the migraine more manageable but it was still there. It lasted 8 days. I generally get two or three a month and they last a day. This one would not go away. I was fine with the second dose on 2/5/2021 - I didn't get a migraine until after 10 days after second dose.
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| 40 | 2021-03-24 | migraine | Symptoms: Migraine/Headache, nausea, vomiting, fatigue Treatment: bed rest |
| 40 | 2021-03-24 | pain in extremity |
Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At no...
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Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At noon I had severe pain the entire length of my right arm, and I felt drowsy so I fell asleep for several hours and the pain in my arm was moderate and restricted to injection sight when I woke up. I went to bed at 10 pm and woke up at 1 am with diarrhea. I spent the the next hour having a few diarrhea bowel movements. On 3/20 my right arm was still in moderate pain and injection site was swollen and red. At 8 am I woke up with a headache and so I went back to bed. By afternoon I had the chills and went to bed for another nap and when I woke up the chills were gone. On 3/21 my right arm still had moderate pain. On 3/22 I had another bout of diarrhea for one bowel movement, and my arm pain was still moderate. On 3/23 the swelling and redness at the injection site went away but the area is still slightly tender to the touch on 3/25. On 3/25 at 1 am I was in bed trying to sleep, but I kept having intense dizzy spells that lasted 3-4 hours.
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| 40 | 2021-03-24 | seizure, involuntary muscle movements |
2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It wa...
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2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It was like a seizure. I was unable to talk, my eyes rolled back, and my right shoulder and arm seized up. I was sputtering and unable to make it stop. Lasted for a minute or two then stopped for a minute and happened again. I felt disoriented, confused, scared. I was unable to walk straight or visually focus on anything. I contacted my primary care doctor and she recommended I be seen immediately but advised I call Providence and speak with a nurse. I did that and the nurse said to come in to the ER immediately. I did.
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| 40 | 2021-03-25 | feeling hot, pain in extremity |
My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. Ab...
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My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. About 15 mins after I got the vaccine, I had a racing heartrate and my palms were hot, but it went away. Around 3pm, I had a right frontal headache. I took a nap and it went away. About 5am Fri, I woke up to severe arm pain and it felt like I was being stabbed in the stomach. I took about 400mg of Ibuprofen, went to sleep and was fine when I woke up. About 5pm Friday, I began having vaginal bleeding. I called my doctor and was able to get in on Feb 11th. At my OB/GYN appointment, they tested my blood and urine, which confirmed my pregnancy. The NP examined me and told me that the bleeding was coming from my cervix, so they sent me for an ultrasound the following week. That's when I was given my calculated date of 10 weeks. A gestational sac was observed, but they weren't sure if a fetus was present. I had to see my doctor every week since I was still bleeding and that continued until March 18th, when I lost the pregnancy completely. I took my specimen to the doctor the following day. They told me that they were sending it out to be tested, but I'm not sure if the results are back. They did confirm that it was a fetus.
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| 40 | 2021-03-25 | feeling hot | Burning at tip of tongue without swelling and whole body feeling hot |
| 40 | 2021-03-25 | hot flush, tremor |
Four hours after the first immunization had malaise, mild chills alternating with hot sweats. Treatm...
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Four hours after the first immunization had malaise, mild chills alternating with hot sweats. Treatment: 500 mg Tylenol x1 dose. After second immunization experienced severe chills with uncontrollable shivering/shaking and then profuse sweating and hot sweats for approximately 4 hours. Nausea followed the next morning along with an approximately 36-hour headache. Rested x2 days in bed. Treatment: Ibuprofen 800 mg alternating with acetaminophen 500 mg without relief x multiple doses.
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| 40 | 2021-03-25 | numbness, tingling, sensory loss |
Loss of sensory waist down. Numbness and tingling waist down. Weakness in legs, heaviness in the le...
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Loss of sensory waist down. Numbness and tingling waist down. Weakness in legs, heaviness in the legs. Bladder and bowel problems - urinating frequently, urinary incontinence and constipation.
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| 40 | 2021-03-25 | numbness | B/P high, redness to face, Left arm numbness |
| 40 | 2021-03-25 | pain in extremity | Left arm pain , the next day after receiving the vaccine Pain is worse with movement |
| 40 | 2021-03-25 | tremor, seizure, muscle twitching |
FiFive (5) seizures over the course of two (2) weeks. The seizures consisted of all of my muscles te...
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FiFive (5) seizures over the course of two (2) weeks. The seizures consisted of all of my muscles tensing up and my entire body twitching/ shaking for 1-2 minutes.
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| 40 | 2021-03-26 | weakness |
After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fati...
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After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fatigue, intense muscle weakness & achiness, felt like weights in my veins. Sleep overnight was disrupted often. Intense strange dreams, perhaps lucid. 2nd Day- 9am: Fever & weakness subsided, muscles remained achy particularly with increased activity. Tiredness. 3pm: Fever returned. 5pm: Strong heart palpatations. Achy muscles. 8pm: Tiredness. Strange dreams, still lucid. 3rd Day- Still slight achiness. 3pm: Intense heart palpatations, pre-menstrual cramping (11 days early, my cycle is extremely regular). 5pm: Heart palpatations, muscles felt almost an electric pulsivity. 6pm: Tooth pain for about two hours. 8pm: Vaginal discharge (clear lubricant), lasted till 3am. 4am: Urine had extremely sour smell. *3rd day indicated to me that my hormones/hypothalamus may have been affected? Very strange, out-of-cycle behaviors. I have been sexually inactive for over 6 months.
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| 40 | 2021-03-26 | breast pain |
Very sore/tender breasts (both) and experienced what felt like a milk letdown sensation although I h...
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Very sore/tender breasts (both) and experienced what felt like a milk letdown sensation although I have not breastfed in over six years. Symptoms started the Saturday after the vaccination and have persisted since then. I have not yet been relieved of these symptoms but have not taken anything for relief.
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| 40 | 2021-03-26 | hypersensitivity of all senses, pain in extremity |
Moderate Diarrhea lasting ~4 hours, mild nausea, 102.7 fever, mild headache, sever joint & muscle pa...
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Moderate Diarrhea lasting ~4 hours, mild nausea, 102.7 fever, mild headache, sever joint & muscle pain, sever foot pain in sides of feet, severe sensitivity to touch, all beginning~11:00pm day of injection and subsiding ~24 hours later. With mild to Moderate joint pain persisting for an additional 24 hours. Moderate head pressure and Moderate dizziness starting upon waking up 3/27/2021, requiring setting medical attention with medication being prescribed, and symptoms have not eased at this time.
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| 40 | 2021-03-26 | pain in extremity |
I started my period two days after receiving the shot, which was two weeks earlier than expected. Fl...
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I started my period two days after receiving the shot, which was two weeks earlier than expected. Flow was unusually heavy and very clotted - all abnormal for me. While I may have felt some fatigue from the shot, I never felt ill in any way. I also never felt any of the points of pain I might feel with my normal period, such as sore breasts prior to my period and cramps in my upper legs when it arrived. I only had a sore arm for a day where I received the shot.
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| 40 | 2021-03-26 | pain in extremity |
Making my endmetrios worse. I have never been in this much pain on a period. It is also making my ...
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Making my endmetrios worse. I have never been in this much pain on a period. It is also making my bone pains worse and spreading it. They used to mainly happen in the arm and leg now it is everywhere.
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| 40 | 2021-03-27 | numbness |
lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lip...
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lips felt numb/Numbness spread throughout face/feel numb in both arms/legs started to feel numb; lips felt numb, swollen; Blood pressure was high; pulse was high; gasping for air; unable to straighten out my legs/couldn't lift her legs; ferritin levels were low; throat was closing up; unbalanced; couldn't stand up; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (PFIZER), first dose at the age of 40-years-old via an unspecified route of administration, administered in arm left on 09Mar2021 13:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and known allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan; vitamin b complex (VITAMIN B); vitamin c [ascorbic acid]; colecalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient reported within 10 minutes lips felt numb, swollen. Numbness spread throughout face, checked in with the medic and had vitals checked. Blood pressure was high, and pulse was high. Numbness spread throughout whole face. Ambulance was called and she was transported to the hospital. Within the hour of getting the shot she became unbalanced. She was gasping for air at times and started to feel numb in both arms. Upon arrival to the emergency room her legs started to feel numb. By nightfall she was unable to straighten out my legs. She couldn't stand up or lift her legs no matter how hard she tried. She was admitted to the hospital. A brain MRI was done and came back normal. Another one may be done. Bloodwork revealed ferritin levels were low and she was getting treatment for that (ferrous sulfate). While sleeping at night she woke up a few times gasping for air feeling like her throat was closing up. Today, she was able to stand up, but unable to stand up straight. She met with physical therapy and is using a walker. The patient was hospitalized for 3 days from 09Mar2021 to 12Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: high on 09Mar2021, heart rate: high on 09Mar2021, magnetic resonance imaging brain: normal on 09Mar2021, sars-cov-2 test: unknown results on 09Mar2021, serum ferritin: ferritin levels were low on 09Mar2021. Therapeutic measures were taken as a result of the events. The patient did not recover from the events.
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| 40 | 2021-03-27 | numbness |
Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you a...
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Facial numbness, loss of taste. Also note- my VARS account is not accurate & you cannot adjust you answers- it has not been doing daily checks on me - it says I?m good when still having symptoms- there is not way to contact or correct info on that system.
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| 40 | 2021-03-27 | night sweats |
Last night I woke up with night sweats and all night went back and forth from night sweats to chills...
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Last night I woke up with night sweats and all night went back and forth from night sweats to chills. 101 fever and a terrible headache. Extreme fatigue.
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| 40 | 2021-03-27 | tingling | nausea, tingling in left arm, waited additional 15 minutes, resolved |
| 40 | 2021-03-28 | migraine |
On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/202...
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On 3/10/2021 Migraine headache started at 6:15pm Ear ringing (tinnitus) started at 7:00 pm 3/11/2021 Additional hearing muffled was was noticeable 3/16/2021: severe migraine, throwing up, nauseous 3/17/2021: facial rash prominent **hearing loss deemed permanent, ringing continuous
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| 40 | 2021-03-29 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). This no...
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Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) intramuscularly in the left arm on 24Feb2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR DISKUS 250/50) and eletriptan hydrobromide (RELPAX 40 mg), both from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced sore arm. The event was reported as non-serious and did not require hospitalization. No treatment was provided for the event. The clinical outcome of sore arm was unknown. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-03-30 | burning sensation, pain in extremity, feeling cold, tingling |
Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to ...
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Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to the shoulder, chest, biceps, triceps, forearm, and parts of hand. Sensations of burning, cold, and tingling are also present since.
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| 40 | 2021-03-30 | numbness, tingling |
to feel a tingling sensation on the outside of her arm through to her fingertips/mid-upper arm throu...
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to feel a tingling sensation on the outside of her arm through to her fingertips/mid-upper arm through thumb. The tingling was most noticeable, in her wrist and thumb; Her fingers felt like she had fallen asleep on her arm and the circulation had been cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in arm left on 12Mar2021 14:30 as a single dose (at the age of 40-years-old) for covid-19 immunisation. The patient had no known allergies or other medical history. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The day after (13Mar2021 05:00), the patient began to feel a tingling sensation on the outside of her arm through to her fingertips. Her fingers felt like she had fallen asleep on her arm and the circulation had been cut off, it went away after a few hours and taking Advil. Day 2 (14Mar2021), the tingling was back, but on the inside of her arm, mid-upper arm through thumb. The tingling was most noticeable, in her wrist and thumb. The outcome of the events was not recovered.
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| 40 | 2021-03-30 | migraine |
Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; t...
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Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
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| 40 | 2021-03-30 | nerve pain, numbness |
Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree feve...
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Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree fever; lethargy; shivers; slept for 17 hours on and off; numbness in my face and fingers; numbness in my face and fingers; zinging pain in my teeth; This is a spontaneous report from a contactable Other HCP. This 40-year-old female Other HCP (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 11Feb2021 at 03:00 pm to 11Feb2021 at 03:00 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported other. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history included Known allergies: Sulfa (unspecified dates). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9262) via an unspecified route of administration from 21Jan2021 at 3:30 pm to 21Jan2021 at 03:30 pm on left arm at single dose (dose number; 1) on left arm for covid-19 immunisation. Concomitant medications included (other medications in two weeks) Ibuprofen and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C) and birth control from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. If other vaccine in four weeks; no. On 12Feb2021 at 02:00 pm, patient experienced nerve pain in all of her skin (including hair follicles and teeth), extreme headache, 101 degree fever, lethargy, and shivers. This hit her at almost 24 hours after injection. She slept for 17 hours on and off. She awoke this morning with numbness in her face and fingers, but also zinging pain in my teeth. The reported adverse events did not result in emergency room or physician's office visit. Treatment received was reported as no for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.
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| 40 | 2021-03-30 | pain in extremity |
Headache; dizziness; sore arm; body aches; chills; This is a spontaneous report from a contactable c...
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Headache; dizziness; sore arm; body aches; chills; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old female patient received the second of bnt162b2 (formulation: solution for injection, lot number: EL9264), via an unspecified route of administration in left arm on 02Feb2021 at 14:00 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL3302), in left arm on 12Jan2021 at 14:00 as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 14:00, the patient experienced headache, dizziness, sore arm, body aches and chills. The patient did not received treatment for the events. The outcome of the events was recovered.
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| 40 | 2021-03-30 | pain in extremity |
I did not know I was pregnant until the week after the vaccine; mild arm soreness; This is a spontan...
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I did not know I was pregnant until the week after the vaccine; mild arm soreness; This is a spontaneous report from a contactable other health care professional (reported for herself). A 40-year-old pregnant female patient received first dose of BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EL3302) via an unspecified route of administration on 11Jan2021 at single dose to her left arm for Covid-19 immunization. The patient's medical history included polycystic ovarian syndrome (PCOS) and Covid-19 (prior to vaccination, the patient diagnosed with COVID-19). Patient's last menstrual period date was 01Dec2020, pregnancy due date was 13Sep2021 and gestation period when reaction/event was observed in the fetus was six weeks. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included metformin, minerals NOS/vitamins NOS (PRENATAL VITAMINS), curcuma longa (TURMERIC) and fish oil. Facility the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, first dose had no issues, mild arm soreness, she did not know she was pregnant until the week after the vaccine in 2021. On advice of her OB that she could take TYLENOL for any possible fever side effects, she decided to take the second dose. Outcome of the event mild arm soreness was recovered on an unspecified date in 2021whereas other events was unknown.
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| 40 | 2021-03-30 | pain in extremity |
administration date=22Dec2020, dose number=1/administration date= 08Jan2021, dose number=2; arm so p...
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administration date=22Dec2020, dose number=1/administration date= 08Jan2021, dose number=2; arm so painful unable to stretch it out or to lift anything with that hand; arm so painful unable to stretch it out or to lift anything with that hand; This is a spontaneous report from a contactable other hcp. A 40-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EL3248, Expiration date: unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 08Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was administered the dose 1 on 22Dec2020 and dose 2 on 08Jan2021 (inappropriate schedule of product administration) with outcome of unknown). The patient has experienced severe pain where the patient is unable to stretch it out or to lift anything with that hand (pain in extremity) on 08Jan2021 with outcome of not recovered. No follow-up attempts are needed. No further information is expected.
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| 40 | 2021-04-01 | muscle spasms |
1/19/2021 vaccination. Felt flu like symptoms, body aches, feverish. I reported to every day on hea...
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1/19/2021 vaccination. Felt flu like symptoms, body aches, feverish. I reported to every day on health check-in. Muscle spasms, diarrhea, could not keep down water, HA, fatigue, lethargic. I thought I was dying. 1/21 0400am ER 1/22 ER 1/23 ER 1/24 ER; admitted inpatient to hospital. 11 Days inpatient. Nausea, vomiting, diarrhea, feverish, malaise, gastric spasms, HA, *12/2020 Gastrectomy *Symptoms lasted whole duration in hospital. Could not keep any liquids down.
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| 40 | 2021-04-06 | weakness |
dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, ...
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dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)
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| 40 | 2021-04-09 | seizure |
Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head ...
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Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events. Follow up attempts are possible. Further information is expected.
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| 40 | 2021-04-11 | sensory loss, numbness |
I received my first Pfizer COVID vaccination on 3-1-2021. Seven days later I had a Shingles outbrea...
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I received my first Pfizer COVID vaccination on 3-1-2021. Seven days later I had a Shingles outbreak, which I've never had before. My doctor advised that I should continue to get the second vaccination as it's a two step process, which I did on 3-25-2021. I'm now experiencing numbness and loss of sensation that started in my foot and hand which has now progressed up my leg to my hip and from my hand up my arm. My doctor ordered a MRI scan which showed lesions on my spinal cord. Based on the results of the first MRI scan my doctor has ordered a second scan (showing more of the spinal cord) and a brain scan. She has also scheduled me an appointment to speak with a Neurologist to try to determine the cause of this. I can't help but feel that this vaccine was the cause of this as it all started shortly after I was given my first dose.
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| 40 | 2021-04-14 | numbness, tingling |
Dose 1 on March1, Dose 2 on March 25. Shingles rash on March 8th. Numbness and tingling starting Mar...
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Dose 1 on March1, Dose 2 on March 25. Shingles rash on March 8th. Numbness and tingling starting March 28th. MRI showing multiple foci of enhancement suggesting demyelination vs transverse myelitis.
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| 40 | 2021-04-14 | numbness | Amphylactic shock Numb arm Breathing Throat swelling |
| 40 | 2021-04-15 | pain in extremity, tingling | Fever, chills, body aches, pain under right arm, tingling skin |
| 40 | 2021-04-15 | pain in extremity | Heavy-feeling limbs, muscle aches, sore feet, swollen gland in armpit |
| 40 | 2021-04-16 | pain in extremity |
Severe shoulder and arm pain initially. Arm pain subsided and shoulder pain still persists. Never ha...
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Severe shoulder and arm pain initially. Arm pain subsided and shoulder pain still persists. Never had shoulder pain prior to this vaccine.
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| 40 | 2021-04-17 | slurring, pain in extremity |
tiredness; arm pain; muscle weakness; intoxication; slurred speech; equilibrium off; feeling of euph...
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tiredness; arm pain; muscle weakness; intoxication; slurred speech; equilibrium off; feeling of euphoria; minor light head/dizziness/giddiness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 09:30 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. 2 hours after shot (03Apr2021 11:30), minor light head/dizziness. 3 hours after shot (03Apr2021 12:30), slurred speech, equilibrium off, feeling of euphoria, giddiness, intoxication, overall felt amazing. 7 hours after shot (03Apr2021 16:30), tiredness, arm pain, muscle weakness. 24 hours after shot (04Apr2021 09:30) no arm pain, feeling normal, still feel a sense of euphoria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive ant list of any other medications within 2 weeks of vaccination. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no allergies to medications, food, or other products. There is no known allergies and other medical history. The outcome of the events was resolving.
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| 40 | 2021-04-17 | tremor |
Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down d...
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Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
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| 40 | 2021-04-20 | numbness |
Numbness in right leg from the hip all the way down. A few days later, left leg went numb from the k...
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Numbness in right leg from the hip all the way down. A few days later, left leg went numb from the knee down. A week later, right arm went numb; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW6206), via an unspecified route of administration on 16Mar2021 10:00 AM at single dose in left arm for COVID-19 immunization at hospital. The patient medical history included asthma, syncope and had allergy to sulfa. Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included loratadine (CLARITINE), and Multivitamin within 2 weeks of vaccination. On 16Mar2021 18:00, the patient experienced numbness in right leg from the hip all the way down, a few days later, left leg went numb from the knee down. a week later, right arm went numb, and patient was hospitalized for 1 day. The patient did not receive any treatment for the event. The event resulted in Emergency room/department or urgent care. The outcome of the event was not recovered. Information on Lot/Batch number was available. Additional information has been requested
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| 40 | 2021-04-21 | feeling hot |
throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling,...
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throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.
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| 40 | 2021-04-24 | weakness, hot flush, migraine |
Diminished ovarian reserve/diminished reserve; fever; chills; hot flashes; nausea; vomiting; migrain...
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Diminished ovarian reserve/diminished reserve; fever; chills; hot flashes; nausea; vomiting; migraine headache; vertigo; weakness; They obtained an FSH level and it had skyrocketed from previous values not long before; my ovaries had shrunk in size by approximately half; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), first dose via intramuscular, administered in right arm on 19Dec2020 09:30 at a single dose (lot number and expiry date were not reported); and then received the second dose on 02Jan2021 09:30 (lot number and expiry date not reported), intramuscularly administered in right arm as a single dose; for COVID-19 immunisation. Medical history included eosinophilic esophagitis and asthma. The patient had no known allergies. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications which were taken in two weeks prior to vaccination included bupropion hydrochloride (WELLBUTRIN) and ethinylestradiol, norethisterone acetate (LOESTRIN), taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. On 19Dec2020, the patient experienced diminished ovarian reserve. Patient stated that she was extremely symptomatic after both vaccines and starting on 19Dec2020 had experienced fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness. The hot flashes persisted and worsened after each subsequent vaccine, prompting her to go to my MD. They obtained an FSH level on 19Dec2020 and it had skyrocketed from previous values (dates unspecified; unknown results) not long before. An ultrasound on 19Dec2020, showed that her ovaries had shrunk in size by approximately half and she had diminished reserve. Patient was now on supplemental hormones and will be for many years to come as she was only 40. Patient know the vaccine caused this. It was too great of a coincidence. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. As a result of the events reported patient was now on hormonal replacement therapy. The patient was tested for covid post vaccination which included nasal swab/Covid test on 14Mar2021 as negative. The outcome of the events reported was not recovered. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded, for events fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness, conversely the suspect drug is considered very unlikely related for other gynecological disturbances. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
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| 40 | 2021-04-26 | numbness, tingling |
Tingling and numb sensation beginning at left hand fingertips and emulating upwards to the shot area...
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Tingling and numb sensation beginning at left hand fingertips and emulating upwards to the shot area in the first fifteen minutes. Sensation turned to stinging sensation which continued up through through the shoulder and into the base of the neck and remained until sleep. Heating pad was used to reduce sting. Numbness and tingling continued for the next three days alternating between just fingers and fingers and arm. Stinging was reduced and there is now continued numbness and tingling in the left hand fingers, in particular when fingers are being used for typing or other activity. Sensation continues to date of report.
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| 40 | 2021-04-26 | numbness | Numbness on both sides of my face, fluttering feeling in brain and tinnitus in both ears |
| 40 | 2021-04-27 | bell's palsy |
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-...
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Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 11Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient experienced Bell's Palsy on 28Mar2021 and was diagnosed on 29Mar2021. Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered. The event resulted in emergency room/department or urgent care and disability or permanent damage.
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| 40 | 2021-04-27 | numbness |
lesions on my spinal cord which may result in permanent nerve damage; lesions on my spinal cord whic...
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lesions on my spinal cord which may result in permanent nerve damage; lesions on my spinal cord which may result in permanent nerve damage; numbness which is increasing day by day; This is a spontaneous report from a contactable consumer (patient). A 40-year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: ER8732), via an unspecified route of administration, administered in the left arm on 25Mar2021 11:00 (at the age of 40 years-old) as single dose for covid-19 immunisation. Medical history included penicillin allergy and shingles outbreak. Patient previously received bnt162b2 (lot number: EN6200) on 01Mar2021 at 09:00 in the left arm for covid-19 immunization and experienced shingles outbreak. Concomitant medication included doxycycline monohydrate taken for an unspecified indication, start and stop date were not reported. The patient was now (Mar2021) experiencing numbness which was increasing day by day. She had an MRI scan last week (Mar2021) and it's showing lesions on her spinal cord which may result in permanent nerve damage. She will be speaking with a neurologist this week and doing additional test/scans. The patient underwent other lab tests and procedures on 07Apr2021 which included Nasal Swab (for sars-cov-2 test) with negative result. the outcome of events was reported as not recovered. It was unknown whether treatment was received. The events were considered as serious,involving persistent or significant disability or incapacity. No follow-up attempts possible. No further information expected.
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| 40 | 2021-04-28 | nerve pain, muscle spasms |
Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menst...
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Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menstrual changes - ovarian cyst; menstrual changes - ovarian cyst; carpal tunnel; This is a spontaneous report from a contactable nurse (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 28Dec2020 10:00 (lot number and expiration date were not reported) as single dose (at the age of 40-years-old) for COVID-19 immunisation. The patient was vaccinated in a hospital. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient had no other vaccines in four weeks. The patient did not have COVID prior to vaccination. On 01Jan2021 at 6 pm, the patient experienced cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes - ovarian cyst and carpal tunnel. The adverse events resulted in a doctor/healthcare professional clinic visit and was considered a disability/permanent damage. The patient received treatment of "PT, Mobic, soma, ultram and trigger point injection. The patient has not recovered from the events. The patient had a negative nasal swab test on 16Jan2021. The patient received the second dose administered in the left arm on 19Jan2021 (lot number and expiration date were not reported) at a single dose. Information about the lot/batch number has been requested.; Sender's Comments: The events cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes, ovarian cyst and carpal tunnel most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-04-30 | cold sweat |
cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without mo...
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cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without more pain was very small); painful neck (back of neck) (turning radius without more pain was very small); headache; large swollen lymph node in neck (right side); Pain in neck irradiates more when coughing; 1 week after 2nd dose nose infection very prominent again (same nostril); This is spontaneous report from a contactable consumer (patient herself). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration in right arm on 19Feb2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included panic disorder. Patient (self) has no underlying medical issues outside of panic disorder. No known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), trazodone, doxycycline, sulfamethoxazole, trimethoprim (BACTRIM); All received in two weeks within the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on 28Jan2021 as a single dose for COVID-19 immunisation and presented with a nose infection (left nostril, suspected MRSA), prescribed doxycycline for 7 days. Infection reduced (but not completely resolved). The patient did not receive other vaccine in four weeks. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that, second dose 19Feb2021 approx. 1 week after 2nd dose (on an unspecified date in 2021) nose infection very prominent again (same nostril), prescribed Bactrim for 10 days. On 02Mar2021, patient experienced lethargic, fever, chills, stiff, painful neck (back of neck) (turning radius without more pain was very small), headache, large swollen lymph node in neck (right side). Pain in neck irradiates more when coughing. On 03March2021, patient experienced fever, chills, and cold sweats in addition to the same issues as 02March2021 with no resolve or progress on symptoms reducing. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included rapid COVID test: Negative, nasal swab: Negative on 04Feb2021 (performed one week after 1st dose), blood work: Nothing standing out to support symptoms, heat CT: Nothing standing out to support symptoms, neck CT: Nothing standing out to support symptoms completed in the ER, nasal swab: Negative, rapid COVID test: Negative on 02Mar2021. The events were considered as non-serious by the consumer. The patient was treated with Bactrim, fluids. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021235826 Similar report from same reporter
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| 40 | 2021-05-02 | muscle spasms, nerve pain, pain in extremity |
Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in bo...
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Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in both legs and ringing in both ears. Tinnitus. And I've did not have this before my vaccination.
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| 40 | 2021-05-04 | burning sensation, hypersensitivity of all senses |
shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blister...
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shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; shingles type blistering, weeping, oozing and kind of on fire type of feeling; hives and a rash that continues to get worse; hives and a rash that continues to get worse; When clothes touching it hurts, it is very uncomfortable; injection site soreness; This is a spontaneous report from a contactable registered nurse, the patient. This 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151; Expiration Date: 01Jul2021) via an intramuscular route of administration in the left arm on 14Apr2021 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Medical history included anxiety depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN XL) taken for 15 years (2006) and ongoing for anxiety depression. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced some expected injection site soreness. On Friday evening 16Apr2021, the patient broke out in hives and rash that continued to get worse. The patient described the hives started on right side of neck and now is on her face on the right side and neck, on left breast and right lower abdomen which spread around the back down on the leg and on the left bikini line on the groin. She stated now it is like shingles type blistering, weeping, oozing and kind of on fire type of feeling. It is mostly on the right side and there are some spots on the left. When clothes touching it hurts, it is very uncomfortable. She had a friend/physician to call in for her for oral steroids but don't seem to be doing much. The patient clarified the oral steroids as a MEDROL Dose pack, methylprednisolone 4mg tablets, and she only one full-day worth so far, she took all 6 tablets for yesterday (19Apr2021) and has taken one tablet so far today with doses being titrate down daily. It is not any worse than yesterday, but it has not started getting any better either. The patient stated that she has nothing on the left arm where she got the injection, no rash on left arm. Her second dose is scheduled 05May2021 and she does not know if she should get it. The clinical outcome of the event injection site soreness was resolved on 16Apr2021 while the events "hives and a rash that continues to get worse", "shingles type blistering, weeping, oozing and kind of on fire type of feeling" and "When clothes touching it hurts, it is very uncomfortable" were not resolved.; Sender's Comments: Based on temporal association, a contributory role of BNT162b2 to the events of broke out in hives and rash, blistering, weeping, oozing and kind of on fire type of feeling cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-05-13 | pain in extremity |
anxiety; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 va...
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anxiety; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; mental problem; so sick; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Medical history included bipolar from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Mar2021, the patient experienced sleepiness. On an unspecified date, the patient experienced anxiety, they felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine, mental problem, so sick. She had really serious problem, had to leave work and go to the hospital and get treated for anxiety in the emergency room. Causing her anxiety to go crazy. After taking the Vistaril yesterday it calmed the girlfriend down. Outcome of events anxiety, felt soreness in the arm, mental problem, so sick was unknown. Outcome of Sleepiness was recovered in 2021. No follow-up attempts are needed. No further information is expected.
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| 41 | 2020-12-31 | migraine | Migraine x 4 days, nausea off and on x 3 days, itching arms and stomach x 2 hours, fatigue x 2days |
| 41 | 2020-12-31 | tremor |
Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followe...
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Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.
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| 41 | 2021-01-01 | weakness |
Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and b...
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Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and balance was off and fell several times. Body aches and pain continued. 12/29/2020 at 8 pm had fever of 100. 12/30 fever 103f chills, slept almost all day loss of appetite. 12/31 no fever in the morning but acting different than normal. In after non could not tell my husband child?s name went to the ED where I was admitted for altered mental status. Discharge today with altered mental status, unspecified. Wife still has headache but normal level of consciousness.
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| 41 | 2021-01-02 | pain in extremity | Sore arm, diarrhea, low grade fever. No treatment. |
| 41 | 2021-01-03 | flushing |
Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and ...
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Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and became diaphoretic.
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| 41 | 2021-01-03 | pain in extremity |
12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early mo...
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12/19/2020-12/20/2020 only experiences soreness of left arm where vaccine received. Woke up early morning 12/21/2020 with moderate swelling of eyelids, face, lips that progressed over several hours before seeking care at Hospital ED. Received IV Benadryl and IV solumedrol. Prescribed oral prednisone dose pack to start next day. Symptoms mostly resolved by that evening.
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| 41 | 2021-01-03 | unresponsive to stimuli, numbness, weakness |
12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, ...
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12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
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| 41 | 2021-01-04 | weakness |
I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on t...
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I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.
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| 41 | 2021-01-04 | burning sensation |
Itching that began localized to the injection site then spread all over the body. Feels like a burni...
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Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; Itching that began localized to the injection site then spread all over the body. Feels like a burning sensation as well and an itch you can't scratch; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated itching that began localized to the injection site then spread all over the body. Felt like a burning sensation as well and an itch you can't scratch on 29Dec2020. Patient received Benadryl as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained.
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| 41 | 2021-01-04 | flushing, tremor |
15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patien...
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15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patient anxious with these symptoms, feet shaking, felt heart "beating out of chest." Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.
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| 41 | 2021-01-04 | hot flush |
20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP ...
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20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.
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| 41 | 2021-01-04 | pain in extremity | PT experienced itchiness and a sore arm on 12/23/2020. Developed hives on 1/5/2021 at injection site |
| 41 | 2021-01-04 | tingling |
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ...
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Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
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| 41 | 2021-01-05 | feeling hot | TOUNGE SWELLING , FELT HOT 5 MIN AFTER POST INJUCTION. EPINEPHRINE GIVEN. ED VISIT |
| 41 | 2021-01-05 | flushing |
approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1...
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approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1 hour after vaccine she had a headache. I took her blood pressure, it was 158/83, Pulse 92, Respirations 20, not shortness of breath or respiratory difficulty noted. She laid down and continued to feel the same way after 2 hours post vaccination. Her husband picked her up and she went home to rest for the day. She was given instructions on when to seek medical attention and to call me later today to let me know how she is feeling.
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| 41 | 2021-01-05 | muscle twitching, tingling |
Immediately upon injection, tingling all over lasted for about less than 1 minute. Within 20 minute...
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Immediately upon injection, tingling all over lasted for about less than 1 minute. Within 20 minutes, tingling & facial muscle tightness around mouth. Twitching & facial mouth muscle tightness for about 4 days, diminishing each day. Vaccine was given Wed evening...finally Sun was little to none symptoms.
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| 41 | 2021-01-05 | pain in extremity, numbness | LEFT ARM PAIN AND NUMBESS IMEDIATELY POST VACCINATION. |
| 41 | 2021-01-06 | burning sensation |
STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This ...
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STARTING ON 12/24/2020 I developed burning and itching in both feet and along both deltoids. This resulted in raised red pruritic wheals. I dosed Benadrly and used hydrocortisone cream to the area. Throughout the night, the rash appeared on both thighs, knees, back of the arms and along the back of the lower legs. Again raised pruritic wheals. It would improve with anti-histamine use. this continued until 12/29/2020. No persistent symptoms. There are no other changes in medicine, OTC medication use, no changes in foods/soaps etc.
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| 41 | 2021-01-06 | feeling hot, tingling |
tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. ...
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tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.
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| 41 | 2021-01-06 | flushing | Light headedness, skin flushing, syncope |
| 41 | 2021-01-06 | migraine |
site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and...
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site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl
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| 41 | 2021-01-06 | pain in extremity, migraine |
24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site...
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24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl
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| 41 | 2021-01-06 | pain in extremity |
Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness...
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Swollen clavicular lymph node, arm soreness, body aches. Taking tylenol and motrin for arm soreness and body aches with improvement.
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| 41 | 2021-01-06 | pain in extremity |
Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine unt...
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Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.
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| 41 | 2021-01-06 | pain in extremity |
Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore ...
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Moderate joint aches and nausea. Started 18 hours after the vaccine and lasted 24 hours. Very sore right arm lasting about 72 hours.
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| 41 | 2021-01-06 | pain in extremity |
I Initially just had a sore left arm which felt better the next day. I woke up the morning after t...
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I Initially just had a sore left arm which felt better the next day. I woke up the morning after the Vaccine (1/6/21) and experienced right jaw pain which extend it to my ear which was worse during chewing and talking. Today on January 7 it is still present however seems milder
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| 41 | 2021-01-07 | weakness, pain in extremity |
Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, b...
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Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, body aches and 102.0 fever. Fever lasted until day 3. Day 3-5 weakness, SOB with any exertion, fatigue. Had to call off work on day 3.
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| 41 | 2021-01-07 | discomfort, cold sweat |
Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, local...
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Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, localized discomfort
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| 41 | 2021-01-07 | feeling hot |
Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nur...
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Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.
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| 41 | 2021-01-07 | hypersensitivity of all senses, tenderness |
Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, li...
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Ipsilateral anterior axillary swelling/lymphadenopathy, beginning ~24 hours after administration, limiting L arm ROM x3 days. I was unable to lower my arm fully, and had significantly impaired movement due to pain and swelling. It is Improving as of report date, but still present (ROM essentially back to normal, only tender to palpation)
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| 41 | 2021-01-07 | numbness and pain in extremities, pain in extremity |
Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and la...
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Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and lasted until Saturday 12/26 - responded and improved with acetaminophen and ibuprofen; slight fatigue x 2 day and some slight chills
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| 41 | 2021-01-07 | pain in extremity, facial pain, weakness |
Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatig...
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Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatigue
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| 41 | 2021-01-07 | pain in extremity |
Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General ache...
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Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
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| 41 | 2021-01-07 | pain in extremity | body aches, fever, nausea, sore arm, up all night |
| 41 | 2021-01-07 | pain in extremity |
Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection ar...
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Axillary swelling.; Neck and hand pain in the injection arm.; Neck and hand pain in the injection arm.; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 28Dec2020 at single dose for COVID-19 immunization. The vaccine was administered at workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced axillary swelling, neck and hand pain in the injection arm on 29Dec2020. No treatment was given for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
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| 41 | 2021-01-07 | pain in extremity | chest tightness arm pain nausea diarrhea body aches fatigue lost work two days |
| 41 | 2021-01-07 | tingling, numbness |
on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on da...
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on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; on day 3 after injection severe pain in left arm and weakness unable to raise arm at shoulder; numbness in extremities; numbness and tingling in extremities, tingling in extremities more so in left upper extremity then left foot, then right hand; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration (Left arm) on 27Dec2020 14:30 at single dose for Covid-19 immunization. The patient's medical history included connective tissue undifferentiated (disorder), cervical radiculopathy, and Covid-19. No known allergies. Concomitant medications were unspecified; the patient received other medications within 2 weeks of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported numbness and tingling in extremities more so in left upper extremity then left foot, then right hand on 27Dec2020 (16:00). The patient also noticed slightly on day of injection then on day 3 (30Dec2020) after injection the patient had severe pain in left arm, weakness, and unable to raise arm at shoulder. The adverse events resulted in Emergency room/department or urgent care. The patient was treated with prednisone. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 41 | 2021-01-08 | weakness | Fever, chills, weakness, myalgias, near syncope, increased heart rate. |
| 41 | 2021-01-08 | breast pain, pain in extremity |
Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-...
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Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-vac, duration: 1.5 days) Fatigue (start: ~24 hrs post-vac, duration: 1 day) Joint & Muscle pain (start : ~24 hrs post-vac, duration: 1 day) Headache (start ~24 hrs post-vac, duration: 8-12 hrs) Armpit/upper breast pain (start ~48 hrs post-vac, duration: 2 days)
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| 41 | 2021-01-08 | flushing |
c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No ...
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c/o feeling flushed within 15 minutes of being vaccinated. Blotchy rash noted to chest and neck. No SOB, no hives, no airway involvement. Transported to ED and al symptoms resolved upon arrival without intervention.
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| 41 | 2021-01-08 | flushing |
Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flu...
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Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.
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| 41 | 2021-01-08 | flushing |
Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no h...
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Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no hives ,uticaria, SOB. @0916 VS=88-116/60-22 lungs ausc. clear. @ 0920 stated she felt increase in HR. HR = 102 RR=24 116/70 . HR 104. No c/o nausea. color continues to remain pink, lungs clear. continued observation. at 0940 HR decreased to 71, which she states is normal for her. RR-16 115/80. States she feels "better". Given instructions to call 9-1-1 if s/s of anaphylaxis or if symptoms return to notify PCP.
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| 41 | 2021-01-08 | nerve pain, facial pain | Nerve pain L face/head 9/10 pain gradual improvement over 7 days |
| 41 | 2021-01-08 | tingling |
Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vacci...
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Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine. Visited immediate care; received IV of Benadryl, Pepcid & Steroid.
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| 41 | 2021-01-08 | tenderness |
Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after re...
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Rash & UrticariaPruritus Narrative: Developed urticaria (welt) over the vaccine site hours after receiving vaccine. mild tenderness, then rash after several hours and became itchy. Employee is concerned about the level of protection (antibody titer produced)because allegedly given subcutaneous rather than intramuscular
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| 41 | 2021-01-09 | cold sweat | 1/9 0230 bodyaches, chills, fatigue, fever, tightness in chest 1/10 2139-feels clammy and bodyaches |
| 41 | 2021-01-09 | feeling hot, tremor |
Within one minute of receiving the vaccine patient became very shaky and heated. Felt like she was g...
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Within one minute of receiving the vaccine patient became very shaky and heated. Felt like she was going to pass out. I gave the patient one 25mg Benadryl at 11:18 and orange juice. Within a few minutes of taking the Benadryl and also being able to take in air outside the mask her symptoms improved and felt herself.
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| 41 | 2021-01-09 | feeling hot |
I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I ...
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I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I felt hot and faint. Ems was on site and monitored until ambulance arrived. I was given Benadryl immediately.
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| 41 | 2021-01-09 | flushing |
COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, leg...
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COVID-19 Vaccine (Pfizer) EL3302 Exo 05/21. Itching and redness (flushing) on chest, stomach, legs occurring 10 minutes after receiving vaccine. Face was flushed red no itching. Initial BP 152/99 HR 84. Benadryl 50 mg PO and famotidine 20 mg PO administered. Patient reports similar reaction following the first dose of the vaccine - COVID-19 Vaccine (Pfizer) EL0140 Exp 03/21; itching resolved without medication the first time. Patient reports that this reaction is slightly worse than previous reaction to the first dose. At 3:48pm, BP 151/87 HR 82 O2=96%. Patient itching and redness on chest and flushing of face dissipating by 3:45pm. Patient clinically stable. Patient dismissed from clinic at 3:54pm.
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| 41 | 2021-01-09 | numbness |
HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55P...
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HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55PM PATIENT STATED SHE IS NOT GETTING WORSE @1:26PM PATIENT REFUSED EMERGENCY SERVICES AND/ OR CALLING MD
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| 41 | 2021-01-09 | numbness |
About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 m...
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About 5 min after getting the first dose, I felt numbness in my left hand. I was monitored for 60 min and they did blood pressure and oxygen check. about 10 min in, I felt a little funny in my mouth, like a little bit of swelling, but never to the point of issue with breathing or swallowing. Numbness seemed to have subsided by the 60 minute time and I went home. No other symptoms.
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| 41 | 2021-01-10 | weakness, pain in extremity |
Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and bo...
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Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain
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| 41 | 2021-01-10 | burning sensation, pain in extremity |
I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected a...
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I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected and everything else was fine, until 12/31/2020. My left upper thigh had a burning feeling around the outer part and in the goin on that thigh a painful lymph node. That afternoon I had a burning sensation on my left butt cheek. When I looked I noticed a very small rash with blisters. I waited through the weekend because I knew the OBGYN was not open. I called first thing Monday morning and made an appointment as soon as they could see me which was the next day (1/5/2021)at 3:30pm. The doctor took samples and sent them to the lab for testing. The test was positive for shingles. I am now taking valtrex for shingles.
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| 41 | 2021-01-10 | muscle twitching |
Facial twitching that began about 1-2 hours after injection. The facial twitching lasted about 24 ho...
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Facial twitching that began about 1-2 hours after injection. The facial twitching lasted about 24 hours.
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| 41 | 2021-01-10 | pain in extremity |
Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following mor...
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Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following morning, I had fever of 101.4F. I also had bad headache and muscle aches. I tool 500 mg of Tylenol, had lots of fluids and rest for 2 days. Sunday when I woke up I felt better and I feel well now.
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| 41 | 2021-01-10 | pain in extremity | Arm Soreness, redness around injection site |
| 41 | 2021-01-10 | tingling |
Staff of facility experiences light headiness and extreme dizziness. Patient explained that her leg...
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Staff of facility experiences light headiness and extreme dizziness. Patient explained that her legs felt heavy and were very tingly. Monitored BP and remained within normal rages. Gave Benadryl at 11:35am. Patient also drank water and ate some food. After sitting for 45 minutes patient felt better
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| 41 | 2021-01-11 | burning sensation |
a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin;...
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a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration at Left arm on 04Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included irritable bowel syndrome. Concomitant medication included amoxicillin, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), colecalciferol (VITAMIN D), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). No other vaccine in four weeks. The patient had allergies to ciprofloxacin(CIPRO). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.Since the patient got the vaccine, she had been experiencing a huge amount of gas and bloating as well acid and burning sensation in her throat and neck and chin on 04Jan2021 15:00. The outcome of the events was not recovered. No treatment received for the events. Information about Lot/Batch number is requested.
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| 41 | 2021-01-11 | feeling hot, pain in extremity, tingling |
Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; h...
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Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.
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| 41 | 2021-01-11 | flushing, tingling | FLUSHING, LIGHT HEADED, AND TINGLING |
| 41 | 2021-01-11 | flushing |
Patient reported to observation area for monitoring post-Injection. Â No prior history of adverse ...
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Patient reported to observation area for monitoring post-Injection.  No prior history of adverse reactions or allergic reactions to any medications, vaccines or injections.  She reported to myself (Dr.) at 4:05 pm with feeling of lightheadedness, flushing and racing heart beat.  Initial Exam: Vitals: 143/87, HR 114, O2 sat 100% CV: Tachycardia, regular. No m/r/g Respiratory: CTAB. No w/r/r Skin: Facial flushing but otherwise no rash or hives. Oral: no tongue or lip swelling  Patient placed in supine position on stretcher, received water hard candy.  Repeat vitals @ 4:30: 151/84, HR 107, Sp O2 100% Exam: Unchanged.  After an additional 15 minutes of rest patient was able to ambulate without assistance and ultimately return to home via uber. Boyfriend was alerted.
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| 41 | 2021-01-11 | flushing |
Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her th...
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Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her throat is closing. Patient has some inspiratory stridor. She was moved to a room and given intramuscular epinephrine, diphenhydramine, famotidine, and methylprednisolone.
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| 41 | 2021-01-11 | hot flush, flushing |
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with rednes...
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Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .
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| 41 | 2021-01-11 | hot flush |
Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot fla...
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Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.
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| 41 | 2021-01-11 | numbness, tingling |
I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which ...
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I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 41 | 2021-01-11 | pain in extremity, numbness, one side paralysis, weakness, tingling |
Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial nu...
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Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.
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| 41 | 2021-01-11 | pain in extremity |
12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of...
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12/18/2020 Night in pain on right side of arm and she had a big ball under the arm pit the size of a base ball and ER and your lynodes had swollen. Gave you IVProphen and Tylneol Took a week in a half for swollen to go down.
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| 41 | 2021-01-11 | speech disorder, numbness |
The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of...
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The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of the mouth; difficulty speaking; her eye socket, it didn't feel like her eye was there; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK923, expiration date: Apr2021), via unknown route of administration on 30Dec2020 at single dose (first dose by injection once to left upper arm, by the shoulder, a little down) for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medications were reported none. Her blood pressure was diagnosed years prior to the report, like 10+ years prior to the report, but she did not know if it had anything to do with it. The left side of her face, it didn't go completely numb on 30Dec2020, but mostly: stated her eye socket, it didn't feel like her eye was there, and her mouth, she had difficulty speaking, she still could not chew on the side of the mouth in Dec2020. Stated it felt like pulling, like something pulling, like a rope was tied and pulling backwards to the back of head and downward. States this lasted 2 days thankfully, and she did not regret getting it. She Provided weight as a lot of pounds, said she was joking. The vaccine was not prescribed by a doctor, her job offered it, she worked at a hospital, so it was voluntary and she took it. The event started maybe 6 hours after getting the vaccine, it was while she was sleeping, she woke up, she had slept, it was in the middle of the night, and was gone by Saturday for sure. This was her first dose. States site of administration was where she typically gets flu shots. The outcome of the event The left side of her face, it didn't go completely numb was recovered on 02Jan2021. The outcome of other events was unknown.
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| 41 | 2021-01-11 | tenderness | worsening of the rash developed tender/swollen supraclavicular lymph nodes |
| 41 | 2021-01-11 | tremor |
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue...
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Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
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| 41 | 2021-01-12 | weakness, pain in extremity | Arm Sore, fatigue, weak, body aches, not feeling well |
| 41 | 2021-01-12 | slurring, inability to speak |
Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progre...
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Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok.
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| 41 | 2021-01-12 | feeling cold | 103 Fever 24 hrs chills 48 hrs tired 48 hrs nausea 72 hrs sweating 72 hrs headache 72 hrs |
| 41 | 2021-01-12 | feeling cold | 2 dose, feeling of being cold, not able to warm up, unable to sleep |
| 41 | 2021-01-12 | hot flush, burning sensation, feeling hot |
The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite ...
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The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.
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| 41 | 2021-01-12 | migraine, muscle spasms | fever loss of appetite headache/migraine body aches muscle cramps, rash |
| 41 | 2021-01-12 | pain in extremity |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have he...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain
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| 41 | 2021-01-12 | pain in extremity |
Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swellin...
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Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder. Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend. By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.
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| 41 | 2021-01-12 | cold extremities, numbness |
So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 ...
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So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 hrs later, nausea, numbness, body aches, joint pain, headache and fatigue.
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| 41 | 2021-01-13 | weakness |
Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours a...
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Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.
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| 41 | 2021-01-13 | weakness |
10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days....
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10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.
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| 41 | 2021-01-13 | burning sensation, tingling, hot flush |
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips...
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Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
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| 41 | 2021-01-13 | facial paralysis, pain in extremity, one side paralysis |
Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache...
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Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache, dull neck pain that extended all the way down to my left foot and left arm soreness. She noticed facial droop on the left side at which case, she decided to sleep it off. When she woke up the following morning, She still had a slight droop but not as noticeable. Symptoms disappeared approximately 24 -30 hours post injection.
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| 41 | 2021-01-13 | feeling hot, tingling |
Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL324...
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Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.
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| 41 | 2021-01-13 | feeling hot |
I was approached by a person in the center at approx 1000 stating she had an employee that received...
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I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
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| 41 | 2021-01-13 | hot flush, feeling hot |
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm...
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1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
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| 41 | 2021-01-13 | numbness, tingling |
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no...
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Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
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| 41 | 2021-01-13 | tingling, weakness, feeling hot |
within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over for...
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within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.
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| 41 | 2021-01-13 | tingling, feeling hot |
Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightn...
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Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days
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| 41 | 2021-01-13 | tingling |
Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I...
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Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I was aching I had a fever 102.8 I had chills, body aches, my muscles where hurting, I also felt the pins & needles on my feet everything lasted about 36hrs. The headache lasted about 3 days.
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| 41 | 2021-01-13 | sensory loss, numbness |
Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facia...
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Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facial numbness. Stroke w/u in ER with CT angio and perfusion and brain MRI with w/o gad all normal, labs normal. Sensory deficit resolved in 24hrs. Lymphadenopathy still severe at present.
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| 41 | 2021-01-14 | hot flush | hot flash and rapid heartrate |
| 41 | 2021-01-14 | numbness, cold extremities, tingling |
On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was...
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On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was numb and lock. Within minutes, I felt tingling sensations along all my fingers and thumbs. Then numbness at the tips. Then, both my hands were very cold. At about 2- 3, I fell groggy, tired. Then came the chill and fever, also light headaches. The numbness was gone. 1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight. I tried to uncurl them. But they stayed locked. It lasted about 1-2 minutes. I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm. Then at around 10 pm, I had bad warped vertigo.
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| 41 | 2021-01-14 | numbness | lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate |
| 41 | 2021-01-14 | migraine |
13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (pat...
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13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: El3246, via an unspecified route of administration on Left arm from 07Jan2021 10:00 to 07Jan2021 10:00 as SINGLE DOSE (first dose) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication includes prenatal vitamins. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient experienced 13-hour migraine the day after the vaccine on 08Jan2021. The outcome of the event was recovered.
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| 41 | 2021-01-14 | pain in extremity, tremor |
Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out ...
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Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out of bed for the entire day, severe headaches through the entire day Day 2: fever of 101, shortness of breath, severe headache, entire left arm in pain
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| 41 | 2021-01-14 | pain in extremity |
Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At app...
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Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
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| 41 | 2021-01-14 | tingling, feeling hot, hot flush, flushing |
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sic...
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Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
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| 41 | 2021-01-14 | tremor |
Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, ext...
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Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)
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| 41 | 2021-01-15 | numbness |
Numbness to central part of my face one hour after vaccination. Went home and took 800 mg of ibuprof...
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Numbness to central part of my face one hour after vaccination. Went home and took 800 mg of ibuprofen and 25 mg of benedryl then went to bed (after working night shift). Upon waking around 4pm the numbness was gone
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| 41 | 2021-01-15 | nerve pain, facial pain |
I was exposed to Covid in November. I tested negative twice but had nerve pain along the right side ...
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I was exposed to Covid in November. I tested negative twice but had nerve pain along the right side of my face when my son had tested positive. Both times I got the vaccination the nerve pain in my face came back. It was fairly painful the second time. The concern is that I had an inflammatory response similar to when I actually may have had Covid both times. It went away within 48 hours and I have been done since.
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| 41 | 2021-01-16 | feeling cold |
AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine...
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AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine injection
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| 41 | 2021-01-16 | tingling, numbness, difficulty speaking |
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n...
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Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
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| 41 | 2021-01-16 | tremor | severe shaking chills with onset at 10pm that lasted for 2 hours, no treatments used |
| 41 | 2021-01-17 | weakness |
I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to thre...
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I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to three days. I was told that if symptoms got worse to go to ER, but they started getting better with time.
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| 41 | 2021-01-17 | weakness |
Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nod...
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Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nodes left upper extremity , head and neck. Began to feel difficulty swelling due to inflamed lymph nodes Treatment: Intravenous fluids, anti-inflammatory medication, sought treatment at an urgent care center. Ultrasound of left arm, axillary and neck and chest area for enlarged lymph nodes. Outcome- all symptoms resolved by 1/14 except some fatigue
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| 41 | 2021-01-17 | difficulty speaking |
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t...
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Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-17 | feeling hot, pain in extremity |
5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm p...
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5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm pain/ache- lasted less than 5 minutes. 30 minutes after vaccine rash, itching- lasted 2 days. 1 hour after vaccine- severe headache lasted 4 days. 4 hours after vaccine- ears/throat itching. Took Benadryl 50mg, Tylenol 1000mg, Albuterol Inhaler 2 puffs, and Famotidine 20 mg 4 hrs after vaccine.
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| 41 | 2021-01-17 | migraine |
I felt off/not myself for about 30 hours after the second dose. A migraine for 48 hrs. a red welt o...
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I felt off/not myself for about 30 hours after the second dose. A migraine for 48 hrs. a red welt on my arm at the injection site, I found it 1/13 it was small and got bigger overnight. I took Benadryl on 1/17 and it got smaller. the morning of 1/18 it was back just as big as before the benadryl. It is about 5 inches accross and 3 inches up and down
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| 41 | 2021-01-17 | muscle spasms |
COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had ch...
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COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.
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| 41 | 2021-01-17 | pain in extremity | Sore arm, body aches, headache, cough, loss of smell |
| 41 | 2021-01-17 | pain in extremity | headache, dry mouth, and arm pain |
| 41 | 2021-01-17 | pain in extremity |
Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain...
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Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)
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| 41 | 2021-01-17 | tremor, weakness, tingling |
Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a ...
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Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day
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| 41 | 2021-01-17 | tremor |
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa...
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tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 41 | 2021-01-18 | facial paralysis, weakness |
Patient reports left side facial drooping, weakness, headache. Patient states symptoms have resolve...
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Patient reports left side facial drooping, weakness, headache. Patient states symptoms have resolved. Patient referred to her PCP to discuss whether she should get her second dose.
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| 41 | 2021-01-18 | flushing |
22 hours after the second dose started to have an allergic reaction, hives all over back and chest a...
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22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.
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| 41 | 2021-01-18 | numbness |
5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/...
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5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/o & talking w/friend. Over the course of 30 min cheeks feeling improved but felt that cheeks remained a bit numb. L eye puffiness gone. Left amb after 45 min HR 96, BP 112/70, pulse ox 99%.
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| 41 | 2021-01-18 | numbness | palpitations, chest heaviness, numbness in fingers and toes, fatigue, nausea lasting 1+ week |
| 41 | 2021-01-18 | muscle spasms |
Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Sym...
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Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.
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| 41 | 2021-01-18 | pain in extremity, feeling cold |
muscle aches; headache; soreness on left arm; felt cold in the evening of 08Jan2021; feels like havi...
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muscle aches; headache; soreness on left arm; felt cold in the evening of 08Jan2021; feels like having a fever/fever of 101.4F; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm, on 08Jan2021 at 09:15, at single dose, for COVID-19 immunization. Medical history included palpitations and COVID-19 on 26Mar2020 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). On 26Mar2020, the patient had nasal swab for COVID-19 which is positive. The patient has no known allergies to medications, food, or other products. Concomitant medications included ascorbic acid (VIT C), metoprolol, and unspecified multivitamins. The patient felt cold in the evening of 08Jan2021 at 20:00, feels like having a fever. The next morning (09Jan2021), the patient had a fever of 101.4F, muscle aches, headache and soreness on left arm. The patient took Tylenol, lots of fluids and bed rest. The patient started feeling better on 10Jan2021. COVID-19 vaccine was administered in a hospital. The patient is not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On unspecified date, the patient was tested for COVID post vaccination (COVID-19 PCR) with unknown result. The patient did not receive other vaccine in four weeks. The patient recovered from the events in Jan2021.
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| 41 | 2021-01-18 | pain in extremity |
muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong tha...
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muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong that I can't have my foot firmly on the floor; Fever; strong headache; muscle pain generalized; tiredness; This is a spontaneous report from a contactable other Health Professional. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, Cardiac arrhythmia, allergy to crustaceans. The patient's concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergies, and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 21Dec2020 09:30 AM at a single dose on left arm for COVID-19 immunization. The patient experienced fever, strong headache, muscle pain generalized, tiredness on 08Jan2021, and "muscle pain is so strong that I can't have my foot firmly on the floor" on 08Jan2021 07:00. No treatment was received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about Lot/Batch has been requested.
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| 41 | 2021-01-18 | pain in extremity |
Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, f...
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Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed
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| 41 | 2021-01-18 | pain in extremity | Body aches/fever/chills/headache/nausea. Arm soreness |
| 41 | 2021-01-18 | tingling, feeling hot |
Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed ...
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Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.
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| 41 | 2021-01-19 | feeling hot, flushing |
5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observati...
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5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observation RN that she began feeling short of breath. RN administered Epinephrine in left thigh. Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.
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| 41 | 2021-01-19 | numbness, weakness, feeling hot, tingling |
The patient self-reported this adverse reaction through the hospital electronic reporting system. I...
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The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".
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| 41 | 2021-01-19 | pain in extremity |
On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolve...
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On Jan 12, the patient developed positional vertigo and nausea as well as sore arm. Vertigo resolved when she fell asleep. Vertigo returned on Jan 16 and17. Diarrhea occurred 6 times on Jan 17. The patient noticed significant diffuse loss of hair from January 16 to 19. She continues to have some nausea.
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| 41 | 2021-01-19 | tingling |
NO PAST HX OF REACTIONS, AFTER IM ADMINISTERED PATIENTREPORTED TINGLING IN HAND COMPLETELY RESOLVED...
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NO PAST HX OF REACTIONS, AFTER IM ADMINISTERED PATIENTREPORTED TINGLING IN HAND COMPLETELY RESOLVED AFTER 15 MINUTES
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| 41 | 2021-01-20 | weakness, pain in extremity |
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakne...
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hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-20 | weakness |
I have had a severe headache since the day of vaccination, weakness, fatigue, dizziness, vomiting an...
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I have had a severe headache since the day of vaccination, weakness, fatigue, dizziness, vomiting and diarrhea.
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| 41 | 2021-01-20 | facial paralysis, tingling |
tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is ...
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tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-01-20 | feeling hot, weakness, feeling cold, cold sweat |
Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feel...
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Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feeling like going to pass out
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| 41 | 2021-01-20 | flushing, tremor, feeling hot |
Flushing, tremor, feeling hot 10 minutes after administration. Given Benadryl 25mg orally and Lorata...
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Flushing, tremor, feeling hot 10 minutes after administration. Given Benadryl 25mg orally and Loratadine 10mg orally transferred to ED. Received Dexamethasone 10mg IV, Benadryl 12.5mg IV, Famotodine 20mg IV, and Normal Saline 1000mL bolus. Discharged home.
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| 41 | 2021-01-20 | numbness, night sweats, hot flush |
On the 21st, I had acute fingertip numbness in the last three digits of the hand, bilateral facial n...
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On the 21st, I had acute fingertip numbness in the last three digits of the hand, bilateral facial numbness . I did go to the Hospital and everything was NEG. I started developing night sweats within a day or so. The hot flashes are between 2 and 4 am always.
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| 41 | 2021-01-20 | migraine |
general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spo...
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general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister). A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown. Information on lot/batch number has been requested.
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| 41 | 2021-01-20 | numbness and pain in extremities |
Employee received first dose of Pfizer-BioNTech Covid-19 Vaccine on 12/28/20. Per Employee's manage...
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Employee received first dose of Pfizer-BioNTech Covid-19 Vaccine on 12/28/20. Per Employee's manager: Patient began experiencing symptoms of neuropathy and was admitted to the hospital as an inpatient on 1/18/21. Informed from neurologist that most likely Guillain-Barré syndrome resulted from vaccine and instructed to not receive 2nd dose of vaccine at this time.
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| 41 | 2021-01-20 | pain in extremity |
LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; ...
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LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; body aches/all over body aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK5730), intramuscular on 19Dec2020 07:00 am at single dose at left arm for covid-19 immunization. Medical history included hypertension, covid-19 (prior vaccination). No known allergies. Concomitant medications in two weeks included amlodipine besilate (NORVASC), ascorbic acid (VIT C), ergocalciferol (VIT D), magnesium chloride (MAG), zinc and daily multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. The patient experienced sore left deltoid, body aches, headache all on 19Dec2020 16:00, all over body aches, headache, fatigue and chills all on 20Dec2020, mialgia/muscle aches, fatigue, headache and all over joint pain all on 21Dec2020, headache, LUE pain, muscle and bone pain, fatigue all on 22Dec2020, patient finally felt better with decreased symptoms on 23Dec2020. Outcome of all events was recovered on unspecified date. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient received paracetamol (TYLENOL), motrin for events.
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| 41 | 2021-01-20 | pain in extremity |
Employee developed muscle aches and pains, fever, extreme fatigue, called off work 4 days. Continue...
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Employee developed muscle aches and pains, fever, extreme fatigue, called off work 4 days. Continues to have moderate-severe leg pain as of 1/20/21. Tylenol brings pain from moderate to mild.
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| 41 | 2021-01-21 | feeling hot, tingling |
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav...
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Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
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| 41 | 2021-01-21 | numbness | Numbness in Left hand |
| 41 | 2021-01-21 | muscle spasms |
Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injectio...
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Patient received Covid19 Pfizer dose 1 vaccination at 1pm. Advised to wait 15 minutes post injection. During waiting period experienced "vision blurring" and "pressure behind eye". Spoke with Dr, monitoring vaccine site. Advised to wait 15 more minutes before leaving. Left vaccination site and started driving home. (Around 1:40pm) Within a few minutes had "extremely sore neck, couldn't turn neck left or right without discomfort" , and felt "thickening of neck." Pain spread from neck to shoulders and mid back. Called Dr, advised to go to return if close or go to nearest ER. Was already miles away from original site so patient went to ER. Received Benadryl. Felt like "giant muscle spasm that wouldn't stop."
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| 41 | 2021-01-21 | pain in extremity |
Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties ...
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Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties (I.e. driving and returning to work after) especially involving quick movements, tracking and concentrating. Moderate Arm soreness increased from the time of shot continuing beyond 24 hours and making it difficult to lift or move the arm
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| 41 | 2021-01-21 | pain in extremity |
Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer ...
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Employee developed severe left upper extremity pain immediately after she received the COVID Pfizer vaccinedose #2 on left arm on 1/6/2021 at 11:15 am. The pain persisted and increased in intensity despite the use of topical and oral anti inflammatory medications. She was evaluated by an orthopedist on 1/18/2021 who performed various imaging studies and diagnosed the acute condition as left subacromial bursitis and tendinitis secondary to vaccine infiltration in the left shoulder bursa. The employee informed employee health director on 1/20/2021 and evaluated on same day. On physical exam, she had marked tenderness on the left arm at site of injection and moderate decrease range of motion of the left shoulder. She has been prescribed physical therapy sessions of left shoulder for eight weeks and is continued on daily analgesics. SARSCov-2 Ab IgG test done on 1/20/2021 is negative She will follow up with her orthopedist for further diagnostic tests and treatment.
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| 41 | 2021-01-22 | numbness, throat numbness |
Numbness right side of throat, right side of tongue, right side of face and right side of neck. Sym...
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Numbness right side of throat, right side of tongue, right side of face and right side of neck. Symptoms still present at the time of release
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| 41 | 2021-01-22 | pain in extremity |
For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-li...
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For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and having pain at site of vaccine/upper arm. Dose 2: administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still, no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not. Thank you.
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| 41 | 2021-01-23 | facial pain |
Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbe...
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Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.
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| 41 | 2021-01-23 | flushing, pain in extremity |
L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hour...
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L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hours was gone about 27 hours after injection. Fatigue and feeling flush then chilled very mild. No fever
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| 41 | 2021-01-24 | weakness, migraine |
Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right,...
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Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right, flu like symptoms, headache, joint pain followed by migraine headache on day 3 post second dose. On Saturday day 4 hives, itching all over the body. Treated with oTC Benadryl 50mg q 6hrs. On day 5 the rash was more severe. Contacted PCP and was prescribed prednisone 20mg daily. Day 6- today, rash slightly improved but still present and itchy. Feeling weak and dizzy.
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| 41 | 2021-01-24 | feeling cold, weakness |
I had chills, severe body aches, head ache, weakness, fever of 100.5. Symptoms lasted around 36 hour...
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I had chills, severe body aches, head ache, weakness, fever of 100.5. Symptoms lasted around 36 hours.
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| 41 | 2021-01-24 | numbness, tingling, pain in extremity, burning sensation |
On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, ...
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On 1/15/21, I had numbness and tingling, pain and burning in extremities. Went to the ER, had MRI, had lumbar puncture, symptoms assessed, blood work and diagnosed with Guillian Barre.
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| 41 | 2021-01-24 | migraine, tremor, weakness |
following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose...
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following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.
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| 41 | 2021-01-24 | pain in extremity, weakness |
body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizz...
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body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizziness. Pain to left arm
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| 41 | 2021-01-24 | pain in extremity, numbness, weakness |
Left arm numbness in thumb, wrist, and upper arm. Left arm weakness and achiness. Treated with ibup...
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Left arm numbness in thumb, wrist, and upper arm. Left arm weakness and achiness. Treated with ibuprofen; tylenol; ice to neck, shoulder and wrist; range of motion exercises; heat for muscle relaxation; rest. Decreased pain and ache with rest.
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| 41 | 2021-01-24 | tingling |
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki...
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At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
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| 41 | 2021-01-25 | weakness |
Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had di...
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Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had difficulty standing. This lingered for an additional 3 days, but not as severe. Muscle pain especially in hips and back, weakness, fatigue, headache and loss of appetite.
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| 41 | 2021-01-25 | feeling hot | Itchy throat, sudden warmth, see spots, chest tightness. |
| 41 | 2021-01-25 | flushing, burning sensation |
Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially ...
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Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.
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| 41 | 2021-01-25 | flushing | Flushing, generalized itching, conjunctival injection, nasal congestion, dry cough |
| 41 | 2021-01-25 | pain in extremity |
My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in m...
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My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in my heart rate. I went from the 50's in a dead sleep to the 80's between 7-8am. Otherwise I had general lethargy, fatigue, and arm soreness. I did not have a fever.
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| 41 | 2021-01-26 | weakness |
Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous rep...
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Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiration date not reported) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, shellfish, seafood. The patient's concomitant medications were not reported. The patient experienced fever, chills, body pains, headache followed by diarrhea, nausea, vomiting and weakness on 07Jan2021 10:00 pm. Treatment was received for the events (unspecified). The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included Nasal Swab on 09Jan2021: Negative. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-26 | involuntary muscle movements, tremor |
After the first dose I began to shake uncontrollably and I had uncontrolled muscle movements in my w...
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After the first dose I began to shake uncontrollably and I had uncontrolled muscle movements in my whole body. I had the chills and a headache as well as muscle aches and a sore throat. After the second dose I had the chills again, headache, fever, sore throat, severe fatigue, muscle aches, runny nose that lasted over 24 hours.
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| 41 | 2021-01-26 | flushing, hot flush, muscle spasms, cold extremities, weakness, pain in extremity |
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding...
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weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-26 | numbness, tingling, pain in extremity |
"The morning after my COVID vaccine, I woke up with numbness, tingling, and pain in my R great toe. ...
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"The morning after my COVID vaccine, I woke up with numbness, tingling, and pain in my R great toe. The next 48 hours the symptoms got worse, and I had paresthesia in b/l upper and lower extremities, my trunk, and my face. My symptoms resolved for 2 weeks, but returned on Jan 10th. They started the same way with numbness and paresthesia in my R great toe and have progressed since them. I'm currently have frequent episodes of paresthesia all over my body and have developed numbness and pain in my hands. I saw my primary physician on Jan 15th regarding the symptoms."
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| 41 | 2021-01-26 | numbness |
severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left...
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severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested.
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| 41 | 2021-01-26 | pain in extremity, weakness |
I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days...
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I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days after the 2nd shot but within 48 hrs. Other than that, I just had a moderate left arm pain (starting on 1/21/2021). Also generalized low energy level (starting on 1/21/2021) and very mild muscle soreness especially with both legs (starting on 1/22/2021) .
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| 41 | 2021-01-26 | tingling, tenderness |
Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial a...
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Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise. More facial and tongue swelling. Followed by 1 week of swollen glands and tender jaw.
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| 41 | 2021-01-27 | weakness |
All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, sever...
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All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, severe back pain, muscle aches, chest pain on inspiration, weakness, mild nausea with loss of appitite.
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| 41 | 2021-01-27 | weakness |
All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest p...
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All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite
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| 41 | 2021-01-27 | involuntary muscle movements, facial pain |
I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed he...
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I noticed left ear, left face, and left TMJ pain ~ 48 hours post 2nd- Pfizer vaccine. I noticed headaches and increasing ear/TMJ pain up until today (1/28). The TMJ and ear pain is less today, but it's still difficult to open my mouth. I have tried Tylenol and Ibuprofen to alleviate the discomfort, but the OTC meds to not help.
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| 41 | 2021-01-27 | feeling cold, hot flush |
Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 mi...
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Patient felt flushed then cold and throat felt cold. No SOB nor difficulty breathing. Within ~22 minutes patients symptoms resolved and patient felt back to normal, leaving the clinic without further issues
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| 41 | 2021-01-27 | flushing |
40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s....
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40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.
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| 41 | 2021-01-27 | flushing |
Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within norm...
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Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within normal limits. Patient stabilized and left for home.
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| 41 | 2021-01-27 | numbness |
Decreased sensation in the L side of the face; This is a spontaneous report from a contactable nurse...
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Decreased sensation in the L side of the face; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular via the left arm on 30Dec2020 18:00 at a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ciprofloxacin. It was reported that the patient experienced decreased sensation in the L side of the face that lasted 3 days initially and now comes and goes on 30Dec2020 21:00. No treatment was given for the event. The outcome of the event was not recovered.
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| 41 | 2021-01-27 | night sweats |
Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a...
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Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the right arm on 09Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included thyroid cancer. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath with activity, night sweats, and right jaw pain on 11Jan2021. Right jaw pain resulted in physician office visit. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.
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| 41 | 2021-01-27 | pain in extremity |
Severe arm pain in the arm injection was given. Pain radiated down arm, across upper blades into nec...
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Severe arm pain in the arm injection was given. Pain radiated down arm, across upper blades into neck. No fever at any point. But did have chills and sweats. Severe pain lasted about 6 hours
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| 41 | 2021-01-27 | pain in extremity |
Fever; Headache; body aches; Sore arm; This is a spontaneous report from a contactable healthcare pr...
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Fever; Headache; body aches; Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Jan2021, at 18:30 as single dose for COVID-19 immunization. Medical history included hyperthyroidism and known allergy to latex. Concomitant medication included St. John's wort (MANUFACTURER UNKNOWN), elderberry (SAMBUCUS NIGRA), cetirizine hydrochloride (ZYRTEC). The patient experienced fever, headache, body aches and sore arm on 15Jan2021, at 04:30. No Covid prior vaccination was noted; the patient has not been tested for COVID post vaccination. No treatment was given for the events. The outcome of events was recovered in Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 41 | 2021-01-27 | pain in extremity | Pain in left arm, chills, headache, body ache, nausea |
| 41 | 2021-01-27 | tingling, numbness |
15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips...
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15-20 minutes post vaccine administration, patient experienced numbness, tingling of cheeks and lips - "very subtle". Lasted one hour then subsided. No return to numbness or tingling as of 1/28/21.
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| 41 | 2021-01-27 | tingling, pain in extremity |
5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. St...
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5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation. Started in plantar aspect of both feet and traveled upwards to my hands, in a matter of hours. Extreme pain in lower back and extremities caused me to go to the ER. Following lumbar puncture and a series of diagnostic tests, I have started on IVIG for Acute Inflammatory Demyelinating Polyneuropathy. This is a subtype of Guillain Barre syndrome, believed to be precipitated by autoimmune response generated from the 2nd covid vaccine. I am now on day 4 of my hospitalization.
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| 41 | 2021-01-28 | feeling hot, flushing |
Around 10 minutes after receiving vaccine, pt. c/o feeling flushed, hot and light headed. Pt. asses...
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Around 10 minutes after receiving vaccine, pt. c/o feeling flushed, hot and light headed. Pt. assessed by staff. BP: 100/68, HR: 68, RR: 16, O2 sats: 97%. No other symptoms noted. Pt. declines to go to emergency room. Will follow up with PCP if needed.
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| 41 | 2021-01-28 | feeling hot |
"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove h...
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"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.
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| 41 | 2021-01-28 | muscle twitching, muscle spasms |
245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bow...
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245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain. It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.
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| 41 | 2021-01-28 | pain in extremity |
Severe left arm pain unresolved; first dose of BNT162B2 in the left leg; This is a spontaneous repor...
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Severe left arm pain unresolved; first dose of BNT162B2 in the left leg; This is a spontaneous report from a contactable physician. A 41-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3246), via an unspecified route of administration in the left leg on 06Jan2021 11:15 at a single dose for covid-19 immunisation. Medical history included eczema. Concomitant medication included spironolactone. The patient previously received first dose of BNT162B2 in the left leg on 16Dec2020 12:00 for covid-19 immunisation. On 06Jan2021 11:15, the patient experienced severe left arm pain unresolved. The patient received NSAIDS as treatment for the event. The patient has not tested positive for covid post vaccination. The outcome of the event severe left arm pain was not recovered.
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| 41 | 2021-01-28 | tingling, numbness, discomfort |
About a day after getting the vaccine, I felt a strange sensation of moving up and across the left s...
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About a day after getting the vaccine, I felt a strange sensation of moving up and across the left side of my face. It stopped about half way across my face, with a tingle sensation . My face was then numb for the rest of the day. It only affected half of my face, the left side (I got the vaccine in left arm). The same sensation occurred with the second vaccine dose, but it happened earlier on the day of the vaccine about 5 hours after getting the shot. The same tingle and numbing sensation filled half of my face.
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| 41 | 2021-01-28 | tingling, pain in extremity, muscle twitching |
45 mins after the injection tingling of left leg, spread through body by end of day. Left leg, lef...
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45 mins after the injection tingling of left leg, spread through body by end of day. Left leg, left arm, face, neck and chest had tingling sensation. From time of vaccine 1/13 through current date, symptoms are twitching of nerves/muscle in the left leg, left arm and face, electrical nerve shocks on left leg and left arm, right hand, arm tingling. Sharp pain left leg and left arm. Treated with prednisone 7 day pack.
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| 41 | 2021-01-28 | tremor |
This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her ...
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This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her left arm, via an unspecified route of administration on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone, loratadine (CLARITIN) and fish oil. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (first dose). The patient experienced severe chills with body shaking for 6 hours, excruciating headache, fever, sore throat, nausea and excessively high resting heart rate (over 100- usually under 60); all on 08Jan2021 20:30. No treatment was received for the events. The outcome of the events was recovered on 09Jan2021 02:30.
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| 41 | 2021-01-30 | weakness |
Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back...
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Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back pain, joint pain, that started approximately 10 hours post injection and lasted for approximately 36 hours.
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| 41 | 2021-01-31 | numbness, cold extremities, muscle spasms, tingling |
Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue....
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Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue. Slept for 3 hours, awoke feeling better. 14 hours post injection developed severe body aches, chills, fever, numbness in hands and feet, severe abdominal pain and cramping, and a rash on arms and abdomen.
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| 41 | 2021-01-31 | numbness |
have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a ma...
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have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization. Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.
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| 41 | 2021-01-31 | muscle spasms, night sweats |
Received 2nd dose in left deltoid at 4:30pm on 1/9/21. Woke up at 3:30am with night sweats and cra...
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Received 2nd dose in left deltoid at 4:30pm on 1/9/21. Woke up at 3:30am with night sweats and cramping. Discovered started menstruating on 1/10/21, 1 week early which was unusual for me. Prior period was during 1st shot, 21 days prior. Typical cycle is 26 days +/- 2 days and tracked on a phone app. Woke up w/ same symptoms this AM (2/1/21) and got period early again, 21 days.
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| 41 | 2021-01-31 | pain in extremity |
red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area appro...
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red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. Information on the Batch/Lot number has been requested.
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| 41 | 2021-01-31 | tingling |
10 minutes post vaccination pt reported tingling in right arm that spread to the fingertips. V/S wer...
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10 minutes post vaccination pt reported tingling in right arm that spread to the fingertips. V/S were taken, HR 80, T97.9, SpO2 98%. BP monitored BP 137/93. Pt observed for additional 15 minutes. Electrolytes given for rehydration. Discharged at 1712. Pt reported feeling better.
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| 41 | 2021-02-01 | migraine | I exp severe migraine headaches lasted 5 days. |
| 41 | 2021-02-01 | nerve pain |
Bad headache that triggered a neuralgia attack; Bad headache that triggered a neuralgia attack; This...
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Bad headache that triggered a neuralgia attack; Bad headache that triggered a neuralgia attack; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EL8982) via an unspecified route of administration on arm right on 15Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included occipital and trigeminal neuralgia, C5-C6 cervical cage, temporomandibular joint syndrome (TMJD), cerebrospinal graft. Known allergy: shellfish, walnuts, mustard, sweet potato. Concomitant medication included gabapentin, acetaminophen. The patient previously took penicillin B, phenergan and chloral hydrate (PHENERGAN), Codeine and linalool, all experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Jan2021 06:00, the patient woke up with a bad headache that triggered a neuralgia attack. It persisted for 24hrs. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
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| 41 | 2021-02-01 | tremor |
Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, pani...
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Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.
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| 41 | 2021-02-02 | weakness |
Around 6pm on Monday night (the day of my injection) I was feeling nauseous, I couldn't eat dinner,...
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Around 6pm on Monday night (the day of my injection) I was feeling nauseous, I couldn't eat dinner, then around 8:30 i started vomiting this continued until around 1am (i vomited around 4 times). I also had chills and body aches through the night. Tuesday I felt exhausted and had horrible body aches. Around 3pm the body aches were mostly gone but i still had no energy for the rest of the day. Today, Wednesday, i'm a little achy and still lack energy but feel much better than yesterday.
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| 41 | 2021-02-02 | numbness | Numbness and tingling in fingers and hands, shortness of breath, tightness in chest. |
| 41 | 2021-02-02 | migraine | MIGRAINE, NAUSEA, VOMITING, LIGHTHEADED, DIZZY, SORENESS AT INJECTION SITE |
| 41 | 2021-02-02 | pain in extremity |
Got nauseous within minutes of vaccine. Waves of nausea over the next 6 hours. Headache, lethargic,...
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Got nauseous within minutes of vaccine. Waves of nausea over the next 6 hours. Headache, lethargic, achy, slight fever, very sore arm and shoulder/neck.
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| 41 | 2021-02-02 | cold extremities |
Around 7:00pm, approx. 7hrs after receiving my second vaccine my left arm (the arm I received my inj...
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Around 7:00pm, approx. 7hrs after receiving my second vaccine my left arm (the arm I received my injection in) was extremely sore. As the evening progressed so did my discomfort & pain. By the time I went to bed I wasn't able to raise my left arm above my waist. When I woke up @ 5am my joints were achy & I had a headache. Both of my feet were freezing. Throughout the day on Tuesday, 2/2/21 my arm around the injection site continued to hurt & was fevered. I kept a headache all day. Today, Wed. 2/3/21 my left arm remains extremely painful in my upper arm. My left arm is swollen, red & fevered. There is a large 4.5in x 4.5in red, swollen, fevered area around the injection site. This is extremely painful & uncomfortable. I am worried the injection may have been administered subcutaneously instead of intramuscularly & may not be as effective as it should be. I spoke with the coordinator of ocupation health (who performs the vaccinations at my workplace). She advised me to submit this form.
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| 41 | 2021-02-03 | numbness |
Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating his...
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Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating history of anaphylaxis to iodine. 30 minutes after vaccination, client reported she had numbness of her tongue (anterior 1/3), some numbness of her lower cheeks/jaw. No difficulty breathing. BP120/85; HR 80. After a few minutes was reassessed and vitals were unchanged. Client felt anxious. No rashes, no breathing issues but continued anxiety and symptoms of numbness continued. 911 called. EMS assessed and vitals unchanged. Numbness lessened to just tip of tongue. Normal speech. EMS did not transport and father arrived to pick her up at 12:15 pm.
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| 41 | 2021-02-03 | migraine |
Both times I received the vaccine on the third day I my migraine was triggered and I experienced se...
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Both times I received the vaccine on the third day I my migraine was triggered and I experienced severe migraines, nausea and vomiting with extreme pain and sensitivity to light and sound. I also experienced severe body pain after both shots. I did not see my physician who I listed but she has notes about my history or migraines. It was suggested on the CDC tracking app to report here too since my reactions were severe.
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| 41 | 2021-02-03 | pain in extremity |
Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating...
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Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration on 18Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included psoriasis, hypothyroidism and insomnia. Patient has no known allergies. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included levothyroxine, trazodone (reported as "Trazadone"), phentermine and ergocalciferol (VIT D). No other vaccines in four weeks. Facility type vaccine was Workplace clinic. The patient experienced "soreness in arm at injection, 24 hrs. Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day. Pain in walking, sitting & movement", all on 19Jan2021 11:00 AM which resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for the events, also reported a s "Call into pcp but was not helpful". Outcome of the events was not recovered. Patient was not tested for COVID since the vaccination.
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| 41 | 2021-02-03 | pain in extremity |
Fever; body aches; headache; fatigue; arm soreness; This is a spontaneous report from a contactable ...
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Fever; body aches; headache; fatigue; arm soreness; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the left arm on 20Jan2021 at 06:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (at the age of 41-years-old; Lot Number: EJ1685) on 30Dec2020 at 06:00 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination except the first dose of the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 20Jan2021 at 19:00, the patient experienced fever, body aches, headache, fatigue, and arm soreness. The patient was not treated for the events. The clinical outcomes of fever, body aches, headache, fatigue, and arm soreness, were not recovered.
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| 41 | 2021-02-03 | tingling, numbness, pain in extremity, weakness |
currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous repo...
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currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-03 | seizure |
Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of a...
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Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of appetite. She reported that she went to a store, and apparently "passed out." Employees of the store told her that she had a seizure. Pt. was transported to local ER, where she states that she had a CT of brain, blood work and was told "everything is normal." Stated that she had COVID testing both in the ER and at work, both reportedly negative. This clinic, has thus far been unable to obtain the individuals medical records from the ER. When seen in our clinic on 2/3/21, pt. stated that she is feeling better, but fatigued. No other loss of consciousness reported by pt.
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| 41 | 2021-02-04 | discomfort | Systemic: Other- tachycardia, elevated bp, radiating sensation, panic-Severe |
| 41 | 2021-02-04 | pain in extremity |
sore arm within 4hrs; fatigue; joint pain; fever; This is a spontaneous report from a contactable he...
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sore arm within 4hrs; fatigue; joint pain; fever; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3302) at left arm 08:30AM on 20Jan2021 for Covid-19 immunization. The patient had first shot 08:00AM on 30Dec2020 at right arm and experienced sore arm within 12hrs, fatigue, joint pain, skin itch, and enlarged right supraclavicular lymph node. The patient had no known allergies and other medical history was not reported. Concomitant medications included metformin. The patient experienced sore arm within 4hrs, fatigue, joint pain, fever around 12:15PM on 20Jan2021. No treatment received for the events. The patient had no Covid prior vaccination and not Covid tested post vaccination. The event did not resolve at the time of reporting.
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| 41 | 2021-02-04 | pain in extremity |
Soreness of arm ,The following day I woke up and felt fine and cup of coffer I felt nauseated , head...
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Soreness of arm ,The following day I woke up and felt fine and cup of coffer I felt nauseated , headache, Took Advil and headache was worse.. The following day I still had a really bad headache and felt nauseated .
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| 41 | 2021-02-04 | tingling |
I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was a...
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I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was about to pass out. I felt more comfortable staying at work where I could get immediate help. I had an extreme case of brain fog. That lasted about 3 hours. I started to have the feeling that you get when your limb is asleep. On day 4, I started to exhibit the symptoms again. I felt like I do when I have thyroid issues, so I went to see my endocrinologist, but he didn't do anything. I did have labs done. I started having blood pressure increases as well. I haven't been able to work out like usual since the vaccine and my sleep has been very poor. I wake up in the middle of the night and am unable to go back to sleep. I am now on heart medication, which is what I was taking previously for thyroid flare ups. I go back to see my endocrinologist in March.
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| 41 | 2021-02-05 | feeling hot |
0945 pulled into medical site @ clinic . States she received vaccine @ 9:25 an waited 15 minutes a...
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0945 pulled into medical site @ clinic . States she received vaccine @ 9:25 an waited 15 minutes after receiving the vaccine & was cleared to leave. After she left the site she started feeling hot, c/o itchy rash on left side of neck, and feeling hot and shaky. EMS on site to evaluate patient. 9:47 gave Benadryl 25 mgm PO 10:10 symptoms resolved. Doctor notified. Patient instructed to take Benadryl 25 mgm when she gets home and to notify her PCP regarding additional f/u. Patient left site @ 1020.
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| 41 | 2021-02-05 | numbness | Received 2nd dose vaccine. Experienced numbness in arm. |
| 41 | 2021-02-05 | pain in extremity, nerve pain |
After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, b...
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After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, body chills, lethargy, vomiting, head ache and arm pain. Took 50 hours to get out of bed and feel half normal. Thought I was on the road to recovery when the arm pain started to increase. No rash or swelling occurred at the sight. It presents with pain more nerve like pain in my shoulder, elbow and radiated to fingers. On Feb 5th the pain was so bad I went to see a shoulder specialist and are trying to figure out what is going on. My right arm remains painful to move with nerve issues. The specialist advise I report. In the meantime, I will follow up Monday with another specialist and also undergo some nerve testing.
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| 41 | 2021-02-06 | pain in extremity |
Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morn...
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Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morning. 2nd dose, felt foggy, L arm pain & bad headache hours after. Fatigue the same night, had chills, couldn?t sleep and woke up with a temp of 100.3, sinus & ear pressure/pain, congestion & then a runny nose, headache, L arm & neck pain, felt like I was swallowing rocks, sore throat, diarrhea
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| 41 | 2021-02-06 | tremor |
Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, head...
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Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, headache, tremors in neck overall difficulty with balance. Have had similar symptoms with antibiotic use.
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| 41 | 2021-02-07 | pain in extremity |
Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radi...
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Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radiating up to neck and skull; chest and back pain /stabbing pain in my left chest; chest and back pain; Nausea; heart palpitations; feeling of impending doom; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Jan2021 07:30 (at the age of 41-years) to as a single dose for Covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included that the patient received the first dose of BNT162B2 on 28Dec2020 at 07:15 (at the age of 41-years) in the left arm for Covid-19 immunization. There were no concomitant medications. On 18Jan2021 22:30, 15 hours after second injection the patient experienced symptoms which would best be described as a cardiac event. The patient elaborated that she woke from sleep with left arm pain radiating up to neck and skull, chest and back pain, nausea and stabbing pain in my left chest. This was associated with heart palpitations and a feeling of impending doom. The episode lasted 15 minutes and happened 4 times throughout the night. On 19Jan2021 at 07:30, 24 hours after injections the patient experienced headaches and rigors began with extreme fatigue. Unable to function type of fatigue. Fatigue persisted for 48 hours post injection. The patient was now 72 hours post injection and continued with headache and nausea. The patient did not receive any treatment for the events. The patient had not been tested post vaccination. The clinical outcome of event extreme fatigue, chest and back pain, heart palpitations feeling of impending doom, left arm pain radiating up to neck and skull and rigors was recovering. The outcome of events headaches and nausea was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
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| 41 | 2021-02-08 | weakness, migraine |
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness a...
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I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
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| 41 | 2021-02-08 | weakness, tingling, numbness |
5 minutes after vaccine injection reported bilateral arm tingling. Then proceeded to only left arm a...
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5 minutes after vaccine injection reported bilateral arm tingling. Then proceeded to only left arm and leg numbness and tingling. Subsequently, left facial numbness with left side body weakness and numbness.
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| 41 | 2021-02-08 | numbness |
Patient reported to the ED about an hour after receiving the first dose of COVID-19 vaccine (Pfizer ...
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Patient reported to the ED about an hour after receiving the first dose of COVID-19 vaccine (Pfizer brand). She complained of left sided facial numbness with no facial droop or slurred speech present at the time. Her vitals were taken, she was monitored and seen by a PA. She was given an education handout on allergic reactions to medications and scheduled to follow up with her primary care physician regarding her elevated blood pressure (182/100). Patient did not report prior history of hypertension. She was discharged and able to ambulate our of the ED and drive home. Coure of care approximately 1 hour.
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| 41 | 2021-02-09 | weakness |
Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable ...
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Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 20Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home/Senior Living Facility. Patient age at vaccination was 41 Years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia, Hashimoto's Thyroditis, allergy to Penicillin. Concomitant medications included ibuprofen (IBUPROF), loratadine (CLARITIN), sambucus nigra extract (SAMBUCOL), fluticasone propionate (FLONASE), and multivitamin. On 21Jan2021 the patient experienced fatigue, dizziness, weakness, increased heart rate, all reported as non serious. No treatment was received for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
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| 41 | 2021-02-09 | weakness |
heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable fe...
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heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable feeling; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via unspecified route on right deltoid single dose for COVID-19 immunization on 03Jan2021, at 41-year-old. No medical history. Concomitant medication was reported but unspecified. After the patient had received the shot (Jan2021), her heart started beating fast, felt lumps grow up on her arm and became little short of breath. That went away rather quickly, about within 3 hours and the patient was still kind of weak and just uncomfortable feeling. Action taken for BNT162B2 was not applicable. Outcome of the events heart started beating fast, lumps grow up on her arm, short of breath was resolved in Jan2021; outcome of the other events was unknown. Causality assessment per the reporter was checked as yes.
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| 41 | 2021-02-09 | burning sensation, nerve pain, tingling |
Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbnes...
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Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbness, and tingling in lower extremities. Feet contract and I am unable to walk on them if I do not keep them flat.
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| 41 | 2021-02-09 | cold sweat, feeling hot |
At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front ...
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At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front 4 teeth were in so much pain I cried. I took 100mg of Tylenol and the pain lessened in about 2 hours. At approximately 10am on 2/5/21, I became clammy with shivers yet I was feeling over heated. My temperature was 99.3 degrees. I did not take any medicine but instead took a nap. When I woke up, my temperature felt normal. I did feel dizzy until around 4:3pm that same day. I still get headaches in the front of my forehead since 2/5/21.
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| 41 | 2021-02-09 | discomfort, tingling |
Around 11 hours after 2nd shot I woke up with chills, full body tingling, nausea, and couldn't get c...
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Around 11 hours after 2nd shot I woke up with chills, full body tingling, nausea, and couldn't get comfortable. About 5.5 hours later I had spiked a fever (101.1 temporal) and bad headache. The fever and headache continued all day. Around 7pm on 2/3 I took 1 extra strength Tylenol. The fever broke by Thursday morning and I was feeling better though I still had a headache. I did take 1 extra strength Tylenol around the clock Thurs into Friday. The headache continued to improve Thursday and finally went away by Saturday evening.
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| 41 | 2021-02-09 | difficulty speaking |
Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen...
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Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 41 | 2021-02-09 | numbness, tingling |
Tingling/numbness in both arms and hands; Tingling/numbness in both arms and hands; stiff joints in ...
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Tingling/numbness in both arms and hands; Tingling/numbness in both arms and hands; stiff joints in hands and feel like circulation is restricted; This is a spontaneous report from a non-contactable Other HCP (patient). This 41-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on the left arm, on 22Jan2021 (at 12:00 PM) at single dose for COVID-19 immunisation, administered at Clinic. No other vaccine was received in four weeks. Relevant medical history included hypothyroidism. Relevant concomitant medications included levothyroxine sodium (SYNTHROID), ibuprofen, colecalciferol (VITAMIN D), curcuma longa root (TURMERIC CURCUMIN) and sertraline hydrochloride (ZOLOFT). On 25Jan2021, the patient developed tingling/ numbness in both arms and hands; stiff joints in hands and feel like circulation is restricted. The patient was not treated for the events. The patient had not recovered from the events. No follow up attempts are possible. No further information is expected. Information about Lot/Batch number cannot be obtained.
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| 41 | 2021-02-09 | pain in extremity |
The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chill...
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The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chills and body aches throughout the day; The next day (day 2) I experienced chills and body aches throughout the day; became suddenly tired in the afternoon; first dose was on 22Dec2020 while second dose on 22Jan2021; sore arm within a few hours of getting the shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL 3249; expiration date: unknown), intramuscular left arm on 22Jan2021 15:30 at a single dose for covid-19 immunization. Medical history included allergy to mango and passion fruit and covid prior vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EH 9899) at the age of 41-year-old intramuscular right arm on 22Dec2020 15:30 at a single dose for covid-19 immunization. The patient reported that on her second dose, she had sore arm within a few hours (22Jan2021) of getting the shot. The next day (day 2 [23Jan2021 11:45 AM]), she experienced chills and body aches throughout the day and became suddenly tired in the afternoon. The today [25Jan2021] (also reported as day 3 [24Jan2021]) her lymph nodes under her arms are swollen. As of now (Jan2021), she has no chills, body aches are not as bad, and her left arm isn't as sore, but her lymph nodes are still swollen. It was reported that the treatment was unknown. The patient has not been covid tested post vaccination. The outcome of the event shills was recovered in Jan2021, for the event swollen lymph nodes was not recovered, as for the events pain in arm and ache were recovering, while the outcome of the other events was unknown.
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| 41 | 2021-02-09 | pain in extremity |
Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This ...
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Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 22Jan2021,16:30 at SINGLE DOSE (first dose, left arm) for COVID-19 immunization. Medical history included allergies: Latex from an unspecified date. Patient did not have COVID-19 prior vaccination. Patient is not pregnant. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced head and nasal congestion, ear ache, body aches, fatigue and, sore arm all on 23Jan2021 01:00. No treatment was given. Patient was not tested for COVID-19 post vaccination. Outcome of the events was recovering.
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| 41 | 2021-02-09 | tingling, numbness |
Patient describes "numbness and tingling feeling to left cheek off and on. feels like my face was in...
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Patient describes "numbness and tingling feeling to left cheek off and on. feels like my face was injected with lidocaine".
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| 41 | 2021-02-09 | cold extremities |
States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 162...
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States shot felt weird going in to arm. Felt "thick". Ears began to ring and felt light headed 1625 BP 104/? O2 sat unable to obtain due to cold periphery 1630 BP 118/? O2 sat 97% cold periphery 1640 BP 137/86 HR 76 O2 sat 98% RR 16 lungs clear 1645 BP 127/75 HR 70 O2 sat 100% RR 16 1650 BP 130/79 HR 70 O2 sat 100% RR 18 lungs clear After 40 minutes stated felt better provided snack bar, apple and water was able to leave area at a baseline level.
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| 41 | 2021-02-10 | migraine |
got vaccine at 8:00 am around 1:00 pm started with a bad headache triggered a really bad migraine ca...
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got vaccine at 8:00 am around 1:00 pm started with a bad headache triggered a really bad migraine caused nausea and vomiting, then started with body aches, fatigue , it's been 5 days now still have migraine.
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| 41 | 2021-02-10 | pain in extremity |
Injection site was painful (more than with my typical flu shot) after 2nd COVID injfection on 2/4 (T...
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Injection site was painful (more than with my typical flu shot) after 2nd COVID injfection on 2/4 (Thursday). The arm continued to be sore. On Saturday 2/6 after removing Bandaid I noticed a large red/warm area that was painful to the touch but not indurated. I outlined the area. Took NSAID and antihistamine PO daily, ice PRN. Today 2/9 the redness continues to increased in size. It is sore, red and feels itchy. Today the area measures 6 inches x 4 inches. I have communicated with my PCP via medical message. If the area continues to increase in size I will make an appointmen in the next 1-2 days due to concerns about developing cellulitis.
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| 41 | 2021-02-10 | seizure |
Patient started having seizures after 15 minutes of receiving the vaccine. The EMS was called. The...
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Patient started having seizures after 15 minutes of receiving the vaccine. The EMS was called. The pt was place on oxygen due to O2 dropping. The EMS took the pt to hospital
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| 41 | 2021-02-14 | breast pain |
chills, fever, sweating., body aches - muscle and join pain, sore throat, mild headache, tiredness, ...
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chills, fever, sweating., body aches - muscle and join pain, sore throat, mild headache, tiredness, R arm (injection site) pain including shoulder, shoulder blade and right breast Lasted about 12 hours and resolved without sequaele. No treatment given or medication taken.
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| 41 | 2021-02-15 | migraine |
c/o headache and nausea within 5 minutes of getting the vaccination. Has a history of migraines but ...
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c/o headache and nausea within 5 minutes of getting the vaccination. Has a history of migraines but migraine was sudden onset. Pt monitored in my office states she had history of migraines and uses Imitrex. She refused to go to ER and injected her imitrex and was monitored for an hour . Again refused to go to Er called her mother in law to take her home. 1700 called her states still had minor migraine but somewhat better at this time.
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| 41 | 2021-02-15 | pain in extremity | Pain in Arm; Pain and swelling below right arm pit; Headache; Nausea |
| 41 | 2021-02-17 | hot flush |
After the first vaccine, she started getting them a little/after the first vaccine, caller started t...
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After the first vaccine, she started getting them a little/after the first vaccine, caller started to have hot flashes again; She had a hormone reaction to it; affecting her mental health; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration on 29Dec2021 at single dose for covid-19 immunization. Medical history included ongoing artificial menopause (Surgical menopause, since she was 36). The patient's concomitant medications were not reported. After the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. She had a reaction to the vaccine. She had a hormone reaction to it. The caller did research herself to look up hormonal things about the Pfizer vaccine, but she could not find anything. The only information she found was on pregnancy and breast feeding, and low estrogen with COVID. They had significantly subsided over the last year and half to two years. After the first vaccine, she started getting them a little. Then, after second vaccine her hot flashes started being unbearable. She was unsure if it had to do with the vaccine, but she felt like it did. She spoke with nurses she works with. They too had hormonal issues after the vaccine. One had difficulty getting her period for 9 months to a year, but then got their period. She talked to people in menopause who have not had their period for a year, and had one after the vaccine. She talked to women with PCOS that had difficulty getting their period, but got their period after the vaccine. She also talked to women who had normal menopause, that hadn't had their period in a long time get a period. She said this was all generalized information. She doesn't have the specifics for the people that reported it. There was something hormonal going on. It was literally driving her nuts. Her first vaccine she got on the 29Dec2020, Lot number: EJ1686. Her second vaccine she got on 19Jan2021, lot number: EL9261. This all started a week after the first shot, and got worse after the second. She felt like this was medically significant. There was a fine line between medical issues and mental health, and she felt like this was affecting her mental health. Outcome of events was not recovered. Reaction assessed: after the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-02-17 | pain in extremity |
trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report fro...
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trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report from a contactable consumer who reported for herself . This 41-years-old no pregnant female patient received first dose of bnt162b2 (BNT162B2) from LOT# E19262, on 03Feb2021 17:30 on right arm at SINGLE DOSE for covid-19 immunisation .Age at vaccination:41 years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine . The patient received other medications within 2 weeks of vaccination .Medical history included :Allergy to adhesive, ADHD, high blood pressure (HBP), depression, anxiety, gerd. On 04Feb2021 20:00 the patient experienced chills, urge to cry, trouble lifting in arm , pain in arm and she was Nauseous. Events reported as non serious .No treatment received. Outcome was not recovered. Prior to vaccination the patient was not diagnosed with COVID-19Since the vaccination, the patient has not been tested for COVID-19
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| 41 | 2021-02-21 | breast pain, tenderness |
Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and ver...
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Notice about 3 days after vaccine large painful lump in Left breast. By day 5 it was bigger and very painful. The lump took over a week to soften and go away. I am still tender with some swelling in the arm pit lymph notes.
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| 41 | 2021-02-21 | feeling hot |
Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary reg...
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Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.
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| 41 | 2021-02-21 | flushing | Flushing, tachycardia, lip tingling |
| 41 | 2021-02-21 | unresponsive to stimuli |
Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal ...
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Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.
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| 41 | 2021-02-22 | difficulty speaking |
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The followi...
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Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
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| 41 | 2021-02-22 | seizure, pain in extremity, tingling |
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache....
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Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
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| 41 | 2021-02-23 | hot flush, tingling |
Client c/o hot flashes on and off; tingling sensation L finger; slight difficulty of breathing; sl...
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Client c/o hot flashes on and off; tingling sensation L finger; slight difficulty of breathing; slight dizziness and states " feels like having anxiety."
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| 41 | 2021-02-24 | burning sensation |
About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burn...
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About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burning waves down both sides of my spine (just to the left and right) starting in my neck and settling in my groin. It felt like intense burning and buzzing waves going down from my neck. The paramedics came, said there were no signs of anaphylaxis, and took me to ER. They gave me benedryl and pepcid in an IV, I felt drowsy. The waves eventually subsided and were gone around the time of the benedryl (not sure if before or after).
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| 41 | 2021-02-24 | pain in extremity |
After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I aw...
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After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I awoke to sudden onset face swelling on my right side, severe and sudden sneezing and stuffiness, and a severe asthma attack. We called 911, and in the meantime I took 2 Benadryl and used my rescue inhaler. My breathing was assessed as diminished by the paramedics, and I was taken to the hospital. I was given oxygen and prednisone, and monitored. About 2 hours later I was released.
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| 41 | 2021-02-24 | seizure | Seizure 2 weeks later with overnight hospitalization after not having seizure since 10/2016 |
| 41 | 2021-02-25 | weakness, tremor, migraine |
Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance....
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Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
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| 41 | 2021-02-25 | muscle twitching |
Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, ...
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Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, body aches, chills, and headache. I woke the following day with severe fatigue, headache and tachycardia. Five days out I had muscle twitching and lymphadenopathy. I had tachycardia with heart rate in 120-130s at rest and higher with exertion. I had sustained tachycardia for a solid two days and then intermittently for five days.
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| 41 | 2021-02-25 | pain in extremity | Pain in the arm until last night, pain and severe dizziness since morning |
| 41 | 2021-02-25 | tingling, numbness |
Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received...
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Within 3 minutes, had facial tingling and numbness. Tongue felt ?thick? with it 30 minutes. Received 50 ml injection at that time. All symptoms resolved within 5 hours.
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| 41 | 2021-02-26 | pain in extremity |
patient that fainted today. She reported on her screening questionnaire of passing out after receiv...
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patient that fainted today. She reported on her screening questionnaire of passing out after receiving a injection. She was placed for 30 minute observation. The patient fainted several minutes after being seated. It was observed that she fell over from the chair and hit her head. Patient denied any symptoms other than her right toe being sore.. A + O x 4 medically stable. VS stable. EMS was dispatched due to patient hitting her head and c/o feeling dizzy still...however, patient declined services. She was with her husband and he agreed to drive her home.
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| 41 | 2021-02-26 | tremor |
Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The nig...
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Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The night of 2/25 (almost 6 days later) experienced flu like symptoms - chills, shaking due to cold, fever, thirst, joint and body aches, light headedness, fatigue. Morning of 2/26 chills and fever had subsided, had 8/10 severity headache that gradually decreased throughout the day. Body aches gradually subsided throughout the day and all symptoms were resolved by 6pm on 2/26. I had very similar symptoms after my first dose as well - initial injection 1/29 at 12:30pm, flu like symptoms began early morning of 2/1 that lasted about 15 hours.
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| 41 | 2021-02-27 | weakness |
Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms s...
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Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms subsided after 60 minutes. I also experienced dizziness and weakness right after taking the vaccine, which lasted for 24 hours. Other symptoms include tiredness, headache, muscle pain, chills, low-grade fever, and nausea, which have lasted for 24 hours and continue now.
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| 41 | 2021-02-28 | facial paralysis |
Bell's palsy; This is a spontaneous report from a contactable healthcare professional reporting for ...
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Bell's palsy; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 04Feb2021 08:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included attention deficit hyperactivity disorder (ADHD). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 14Jan2021 at 08:45 (at the age of 41 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced Bell's~ palsy. The event resulted in an emergency room/department or urgent care visit and received treatment which included CT scan, EKG, blood tests, and steroid prescribed. The outcome of the event Bell's palsy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-28 | flushing |
Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult ...
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Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult of breathing and was given EPI IM and Benadryl IV, transported Hospital.
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| 41 | 2021-02-28 | migraine |
Headache daily in the morning. On 2/26/21 developed a migraine with vomiting and went to ER. Today o...
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Headache daily in the morning. On 2/26/21 developed a migraine with vomiting and went to ER. Today on 3/1/21 continues to have headache every morning but not as severe and today has had 3 loose, watery stools.
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| 41 | 2021-02-28 | pain in extremity |
fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nause...
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fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nausea, fatigue
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| 41 | 2021-03-01 | feeling hot, flushing |
pt stated that soon after she received the covid vax she felt like the back of her neck was on fire....
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pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.
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| 41 | 2021-03-01 | flushing |
S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness ...
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S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness and facial flushing after 16:10 after Pfizer vaccine that was given at 16:10. First dose of vaccine. No SOB. O: Pt flushed, arms reddened and feeling uneasy. B/P 130/100, Pulse 98. RA STATS 99%. RR 16. Lungs CTA. Benadryl 25 mg PO at 16:29, water and reassurance. B/P at 16:41 126/82, Pulse 94, SATS 100%, Lungs clear, B/L arms normal color. Hands remained chapped and reddened (too much hand washing per patient). A: Mild allergic reaction to Pfizer vaccine, first dose. P: 16:56, patient improved, refused further care, refusal form signed and instructions given for post care and worsening symptoms. Pt discharged to home via W/C to care. Instructed to F/U as noted.
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| 41 | 2021-03-01 | numbness |
Patient reported that within a "couple of minutes" of receiving 1st dose of Pfizer on 03/01/21 her ...
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Patient reported that within a "couple of minutes" of receiving 1st dose of Pfizer on 03/01/21 her face bilateral became numb in addition to her right arm and right hand. Patient stated after 5 minutes, she got feeling back in her face. As of 03/02/2021, patient states the numbness in her face and arm/hand is intermittent. Patient stated she still has full ROM.
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| 41 | 2021-03-01 | pain in extremity | Sore arm Jaw pain Skin sensitive on face Headache |
| 41 | 2021-03-01 | tingling, burning sensation |
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac...
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Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
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| 41 | 2021-03-02 | facial paralysis, facial pain |
Patient received her second covid 19 vaccine on the 18th of February - about four hours after she de...
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Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room
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| 41 | 2021-03-02 | feeling hot, pain in extremity |
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really...
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face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
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| 41 | 2021-03-02 | flushing, feeling hot |
heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flush...
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heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.
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| 41 | 2021-03-02 | one side paralysis, numbness, face paralysis, facial paralysis, bell's palsy |
On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakn...
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On 2/28/21 I began feeling numbness on the right side of my tongue and mouth. 3/1/21 numbness/weakness began spreading to my right cheek and right side of lips. By 3/2/21 the numbness weakness covered the entire right side of my face and caused mouth and eye droop. Went to the ER and was diagnosed with Bell?s Palsy.
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| 41 | 2021-03-02 | night sweats |
flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a sponta...
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flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included Seizure disorder, depression, anxiety, mild hyperthyroidism and Penicillin allergy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR), and omeprazole. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced flu-like symptoms, headache, aches, chills, night sweats, and more fatigue than normal on 17Dec2020 19:00. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 41 | 2021-03-02 | speech disorder |
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. o...
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Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.
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| 41 | 2021-03-02 | tremor, weakness |
Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, l...
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Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, lymph node under arm - near breast on side of vaccination swollen for 4 days. Headache Onset of chills began at 1am. Around 5am I started shaking and nauseous and I had not been able to fall back to sleep. 5am 2/25 until I woke up for the day 2/26 at 6am, I had the nausea, chills, weak. Lymph node swollen stayed for 4 days. I felt very confused, like I couldn't hold a full thought. No reaction to 1st vaccine except a sore arm
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| 41 | 2021-03-03 | depressed level of consciousness |
After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prio...
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After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prior to syncope. Patient was given epinephrine 0.3 mg IM x1 dose. Patient was difficult to arouse and a second epinephrine 0.3 mg IM was administered! EMS was called on seen and patient was taken to the ER where patient received fluids and zofran and was discharged. Husband confirmed the patient has phobia for shot/needles.
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| 41 | 2021-03-03 | night sweats |
Patient developed headaches and night sweats the day following the second vaccine administration and...
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Patient developed headaches and night sweats the day following the second vaccine administration and symptoms still persisting one month later.
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| 41 | 2021-03-03 | tingling, numbness |
With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in m...
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With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in my legs and tingling on my tongue. Took Benadryl - tongue tingling went away and the legs tingling and numbness was the same and started getting worse - they monitored my vitals and everything looked good and numbness remained. I had a driver and they allowed me to leave due to the Benadryl _ just took that one dose of Benadryl (didn't take anymore after that) and then the numbness in my legs remained for about two and a half weeks. I used a cane for two days. I had a fever and chills that first night, body aches and injection site pain and severe fatigue and those symptoms lasted one day except fatigue was for three days. The day after the shot was the worse of the symptoms. They followed up with me that evening and they followed up with me at work. I had the next dose - February 4, 2021 and experienced everything except the numbness in the tongue. Informal doctor visit because I work there.
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| 41 | 2021-03-03 | tingling |
After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in...
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After 10 minutes, patient reported metal taste in mouth and feeling faint. She also felt tingling in her arms and lips. She struggled to get up. Her breathing seemed fine but neck was red. She laid on floor with legs elevated until her dizziness subsided. She originally said she felt better but then dizziness returned. Called 911 and had Epi-pen ready. She was breathing fine when paramedics arrived. Her husband later called at 7:45pm and reported she was feeling fine. He said the emergency room gave her a steroid, anti-histamine, and pepcid. She is not going to receive the second covid shot. Her husband later stated she got a full body rash when she had covid. I also advised them to register on the v-safe site.
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| 41 | 2021-03-04 | flushing |
Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes th...
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Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.
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| 41 | 2021-03-04 | pain in extremity | Constant dull pain throughout entire arm. Unable to lift the arm, limited back and forth movement. |
| 41 | 2021-03-04 | tingling |
About 10 minutes after her vaccine she started feeling throat thickness and was able to swallow so s...
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About 10 minutes after her vaccine she started feeling throat thickness and was able to swallow so she received 50mg of Benadryl PO. About 10 minutes later she said that she thought it was helping. About 20 minutes after the benadryl she started having dizziness/lightheadedness, visual field narrowing, worsening throat swelling with frequent throat clearing, and tingling in her hands, epinephrine pen given L thigh. After 5 minutes without improvement Epinephrine pen given R thigh. No rash/hives noted. Vitals were stable the entire time with SpO2 of 100%, RR 18-22, HR 84-98, BP 100-138/60-86.
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| 41 | 2021-03-05 | muscle spasms |
My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine...
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My left arm (site of injection on a Wednesday) began to ache within 4 hours of receiving the vaccine. I took Tylenol to treat the pain and drank a lot of water. I woke up the next morning at 630am in extremely bad pain. My left lymph node under my arm was extremely swollen and tight, agony to touch. My entire left side from head to fingertips to toes ached at a level of 9 out of 10. My neck aches across both shoulders and my lower back aches across to my right side; the rest of my right side was unaffected. I took Tylenol every 6 hours which dimmed the pain to about a 6, but it would wear off 4.5 hours later, jumping back up to a 9. I eventually started taking Aleve later that evening to help at around 6 pm. I would become warm off and on, running a very low fever. I didn?t have any other symptoms other than the extreme pain, aches, and feeling drained. The next day (Friday) my pain had decreased to a 7.5-8, but my lymph node was still extremely painful and swollen. The pain continued to decrease the next day to a 5; Sunday was the last day of the left side body aches and lymph node swelling. However, the next morning (Monday) I woke to extreme lower back spasms/seizing. I went to the clinic at 1pm and was given a shot of Toridol and prescribed Voltaire?s and Flexiril. The doctor had me stay at home until Thursday, but the pain is only now starting to ease today, Saturday, March 6. I still have fleeting aches at the injection shot in my left arm.
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| 41 | 2021-03-07 | weakness, cold sweat | weakness, nausea, vomiting, chest pain, cold sweats, heart palpitations |
| 41 | 2021-03-07 | weakness |
1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body ache...
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1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body aches, low grade fever, woke up early morning (6 or 7am) with nausea, weakness- husband had to help me to bed, headach by 4pm fever was getting higher, body aches and chills worsen. Called Telehealth for support and was advised to go to ER At ER arrived with high fever, full rigor, bones felt like they were breaking one by one so bad body aches, chills 1/12/21: First day of cognitive issues - sever fatigue, could not comprehend anything, could not work or do school 1/17/21: Realized the cognitive issues were bad and needed to see DR, dizziness, audio distorted, couldn't follow directions 1/18/21: First Dr apt at medical center Currently still in Dr's care 2/23/21: First Nuro apt with specialist
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| 41 | 2021-03-07 | cold sweat, tremor |
Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; swea...
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Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 41 | 2021-03-07 | difficulty speaking |
Pt called to inform our office that she received the covid-19 vaccine on 3/1 around 0950 and she dev...
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Pt called to inform our office that she received the covid-19 vaccine on 3/1 around 0950 and she developed itchiness, nausea and difficulty swallowing 1 hr after the administration on the Pfizer vaccine. Pt stated that she still has some difficulty swallowing but all other symptoms have resolved. Pt denies having chest pain, sob, throat itching, throat tightness or feeling of suffocation. Pt stated that she begin having hoarseness begin this morning which new onset. Patient sought care in ED room 3/1 and 3/4, follow-up visits with PCP and allergists. Unable to work.
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| 41 | 2021-03-07 | numbness, tingling | Numbness et tingling et general stiffness to lower legs et hips |
| 41 | 2021-03-07 | migraine | Extreme Migraine, nausea, puking, |
| 41 | 2021-03-07 | night sweats, slurring |
At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noti...
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At approximately 10 hours after receiving my second injection of the Covid19 vaccine, I started noticing nausea, headache and a neck ache. Within 5 minutes of these symptoms, my tongue felt swollen and my speech was slowed and slurred. Within ten minutes of these symptoms occurring, my nausea went away as well as my swollen tongue and speech problems. The neck ache and headache progressed into a migraine. I took Tylenol and went to sleep. I woke four hours later with abdominal pain, nausea, head ache and neck ache as well as pain at the injection site. Again I took Tylenol. I experienced fatigue, migraine, neck and back ache, night sweats and axillary adenopathy over the next 5 days. Today is day 6 and I haven't gone a day without neck pain and headache yet. It usually occurs in the afternoon. I continue to take Tylenol and it feels better.
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| 41 | 2021-03-07 | pain in extremity | NAUSEA, PAIN ON THE LEFT ARM |
| 41 | 2021-03-07 | tingling |
o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient st...
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o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient states she got her COVID vaccine today and rapidly started feeling SOB, dizzy and feeling tired. Per EMS, patient did receive one IM of Epi. o Time Seen 02-17-2021 11:49 o Historian patient o Objective Statement 41-year-old female brought to the emergency room by EMS for allergic reaction. Patient says just prior to arrival she received first dose of her Covid vaccination. She said she was waiting after she received her vaccination when she began to have difficulty breathing, lightheadedness and nausea. She was given a IM dose of epinephrine and sent to the emergency department for further evaluation. In the emergency department, she says difficulty breathing has improved. She said she is now having some chest pain. She says pain is across the anterior chest, pressure-like. She said she also feels nauseous. Headache, throat tightening, rash, pruritus, abdominal pain, vomiting, diarrhea, dysuria, paresthesias or focal weakness. She has never had an allergic reaction before. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, facial swelling and rhinorrhea. Eyes: Negative for discharge and visual disturbance. Respiratory: Negative for cough. Positive for chest tightness and shortness of breath. Cardiovascular: Positive for chest pain. Negative for leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, blood in stool and vomiting. Endocrine: Negative for cold intolerance and polydipsia. Genitourinary: Negative for difficulty urinating, dysuria and hematuria. Musculoskeletal: Negative for arthralgias, joint swelling and myalgias. Skin: Negative for rash. Neurological: Negative for speech difficulty, numbness and headaches. Physical Exam Nursing notes and vital signs reviewed. GENERAL: No distress HEAD: normocephalic, atraumatic EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric; moist mucous membranes. There is no pharyngeal erythema or edema, uvula midline no stridor, patient handling secretions with no difficulty NECK: Supple, non-tender; no meningismus LUNGS: Patient in mild respiratory distress, tachypneic, lungs CTA. Normal air movement. HEART: Tachycardic with regular rhythm, no murmur CHEST: No deformity; non-tender ABDOMEN: The abdomen is soft, and non-tender, no masses or bruits. EXTREM: Normal ROM; no deformity, no calf tenderness. Normal pulses palpable in all extremities. There is no pedal edema. SKIN: No rash; no diaphoresis NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit. BACK: No CVA TTP. o ED Course 1250: On reevaluation, patient resting comfortably in the room. She said she is feeling much better. She is no longer having any difficulty breathing. Chest pain has resolved. Her vital signs have normalized. She is no longer tachycardic. CBC shows a mild leukocytosis. CMP does show hypokalemia. On her EKG she does appear to have some U waves. EKG shows sinus tachycardia, no ischemic changes. Chest x-ray unremarkable. Potassium was repleted. On arrival, patient was given Benadryl, Solu-Medrol, Pepcid. She was given epinephrine at the vaccination site so no additional epinephrine was given here and at this point I do not feel she needs an additional dose. We will continue to monitor the patient in the ED. 1520: On reevaluation, patient is resting comfortably in the room. Her vital signs remained stable. She is not having any symptoms. No chest pain or shortness of breath. We will discharge the patient home. We will give her prescription for an EpiPen. Discussed warnings indications to return to ED. Told patient she should contact her primary care provider to discuss whether or not she should receive the second dose. Patient understands and agrees with the plan.
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| 41 | 2021-03-08 | weakness, numbness, pain in extremity, tingling |
Unsure if directly caused by vaccine, but wanted to report it just in case: Left arm pain, numbness...
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Unsure if directly caused by vaccine, but wanted to report it just in case: Left arm pain, numbness, tingling and weaknesses started on Monday March 1, Rash on left hand and upper body began on Wed March 5, diagnosed with Shingles on Thursday March 6.
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| 41 | 2021-03-08 | bell's palsy, tingling, numbness |
On my way home from receiving my first vaccination my right side of my face started going numb and t...
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On my way home from receiving my first vaccination my right side of my face started going numb and tinging (like I had a dental procedure). This continued and progressed into my right arm. About an hour later tried to eat something and started coughing. Called public health and ask a nurse and was told to go to the ED for possible stroke. Was assessed and later discharged. Following up on 2/25/21 with primary care team. Was assessed and diagnosed with Bells Palsy and given steroids prescription to begin on Friday (2/26/21).
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| 41 | 2021-03-08 | flushing, burning sensation |
Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes,...
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Flushing - entire body; like when you receive an injection of contrast for a CT Scan Burning - Eyes, face, abdomen Nauseous Pressure in head/face/ears Throat discomfort Headache Overall sick feeling Over the next couple days, my lips have broken out. I have some small mouth/tongue sores. Feeling of a cold coming on. Sinus pressure. Throat discomfort, congestion. Sneezing. Eyes burning. Face burning. Itchy patches on scalp. Face breaking out.
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| 41 | 2021-03-09 | feeling hot |
I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw th...
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I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.
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| 41 | 2021-03-09 | numbness, tingling, weakness |
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s...
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Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
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| 41 | 2021-03-09 | migraine |
Patient had pain: headache or migraine . Onsite EMS was called vitals BP 148/94 HR 54 100% O2. Pati...
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Patient had pain: headache or migraine . Onsite EMS was called vitals BP 148/94 HR 54 100% O2. Patient refused evaluation/care and released against medical advise.
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| 41 | 2021-03-09 | tingling, numbness | Tingling, numbness, stiffness on left side of face, piercing pain behind left ear |
| 41 | 2021-03-10 | numbness, weakness, tingling |
Racing heart Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8...
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Racing heart Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8 times over 3 days
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| 41 | 2021-03-11 | bell's palsy |
Received EL0142 on 01/04/21 at 1:30PM and EL9292 (writing difficult to read) at 1:15 PM. Went to the...
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Received EL0142 on 01/04/21 at 1:30PM and EL9292 (writing difficult to read) at 1:15 PM. Went to the emergency room on 3/9/21 (43 days after 2nd shot) for symptoms of stroke. Was diagnosed with Bells Palsy.
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| 41 | 2021-03-11 | feeling hot |
Racing heart, heat inside my body from my shoulders through my arms and my stomach. Last maybe a min...
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Racing heart, heat inside my body from my shoulders through my arms and my stomach. Last maybe a minute. I didn't tell the pharmacist.;/ it went away but my mom.daodni should report it
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| 41 | 2021-03-11 | numbness |
Numbness in both feet for three days starting the night of my shot (March 4th). I had severe back ...
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Numbness in both feet for three days starting the night of my shot (March 4th). I had severe back pain for three days, which started on Friday, the 5th. Left foot is still completely numb 8 days later.
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| 41 | 2021-03-11 | pain in extremity, tremor |
1/11/21- (24 hrs. after)- first vaccine, experienced mild body aches soreness in arm from injection ...
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1/11/21- (24 hrs. after)- first vaccine, experienced mild body aches soreness in arm from injection and slight fatigue. 2/1/21 (12hrs. after)- second vaccine experienced the following: chills/mild fever, body aches. (15-20 hrs. after) - visibly shaking with chills body aches comparable to the flu. Awoken by chills and shaking, fatigue. Fever broke, sweating 22 hrs. after receiving 2nd vaccine. Work in an office setting, was only able to stay 3 hours (0730-1030)due to exhaustion, body aches and generally feeling unwell. Day 2-6 sharp frequent headaches, and fatigue all other symptoms gone.
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| 41 | 2021-03-11 | pain in extremity |
Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe...
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Swelling and pain in left armpit on injected side (but can?t feel a lymph node), red rash and severe pain on injected arm, headache, muscle ache, joint pain, chills, stiff neck and shoulders with possibly inflamed lymph nodes.
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| 41 | 2021-03-12 | burning sensation |
Thursday evening I developed a burning sensation in the middle of my sternum/behind my sternum. It w...
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Thursday evening I developed a burning sensation in the middle of my sternum/behind my sternum. It was localized and did not radiate. It was not made worse by standing, sitting, laying, moving, eating, drinking. I was not short of breathe nor did breathing hurt. The pain was mild - a 2 to maybe a 3. Enough to know it was there but it did not limit me in any way. It has continued through the present. Saturday (3-13-2021) I started to notice a very rapid heart rate, from just walking across my house. I went down the basement stairs and walked up and I felt my heart was racing and pounding (this is something I do multiple times a day with ease). I have an oxometer and my heart was very high. I tried resting (by sitting) and my heart rate didn?t drop below the high 80s. I walked through a room and up a flight of stairs and down (in my home) and my heart rate peaked at 154 (wearing oxometer). My BP was also high for me 148/94. I called my primary care physicians office, spoke with a nurse that recommended I go to the emergency room. Tests were normal and I was released. The burning sensation remains. Since returning home heart rate gets high very easily and I can feel it pounding when I walk, though fortunately it hasn?t gone over the mid 130s. My blood pressure when checked at home was still high for me but quite a bit lower than when I first checked it at home. To be honest, I?m far from a pro at taking my BP so I?m not sure of the accuracy of either measurement.
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| 41 | 2021-03-12 | cold sweat | Severe body aches, congestion, fever, chills, cold sweats. Feel like death. |
| 41 | 2021-03-12 | feeling hot, flushing |
After receiving dose, about 15 minutes after, at 1215, patient was getting ready to leave and she as...
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After receiving dose, about 15 minutes after, at 1215, patient was getting ready to leave and she asked if she was red and the lead clincian stated that she was red in her chest, patient face red and flushed. Patient then was escorted to the observation area she was experiencing itching, no tingling, and she was very warm. Patient was placed on the litter, and her blood pressure obtained in her right arm, 201/ 113, HR 98 and oxygen 100% She was observed for a total of 60 minutes. Her redness resolved, and she was feeling more comfortable after the 60 minute observation.
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| 41 | 2021-03-12 | numbness |
2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then ...
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2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then irregular heart beat, rash on neck and chest. Nurses administered 50 mg Benadryl. 10 minutes later, heart racing again and inability to catch my breath. Dizzy and light headed. Irregular heart beat. Pulse ox was ok throughout. Total time of nurses observing these symptoms was 45 minutes. Two days later, still light headed and dizzy.
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| 41 | 2021-03-12 | numbness |
Heavy sweating, nausea, numbness in hands, dizziness, shortness of breath, fatigue. Lasted for about...
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Heavy sweating, nausea, numbness in hands, dizziness, shortness of breath, fatigue. Lasted for about 10 minutes. Still feeling very fatigued.
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| 41 | 2021-03-14 | feeling hot |
Patient received Pfizer COVID19 vaccine and went to the observation area. Others in the observation...
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Patient received Pfizer COVID19 vaccine and went to the observation area. Others in the observation area noted that she had a red rash on her chest. Patient noted that she felt warmth in area but no itching. She denied chest pain, shortness of breath, itching, oral mucosal swelling. She was given diphenhydramine 50m g by mouth one time. She was observed for 40 minutes in treatment area with improvement of redness and rash. Patient was stable when left the treatment area. She was instructed to go to ED if rash worsened or if she developed oral mucosal swelling, difficulty breathing/SOB. Recommended that patient consult her primary care physician and see an allergy specialist before getting her second dose.
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| 41 | 2021-03-14 | feeling hot |
1/13 vaccination About 6 hours later, I started to feel hot, feverish, to feel really sick. I didn't...
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1/13 vaccination About 6 hours later, I started to feel hot, feverish, to feel really sick. I didn't think much about it. I went to work, thought was a sinus infection. Went home, and felt horrible. 1/14 didn't feel great but went to beach for my birthday. It went downhill from there. I got really really sick really fast. 1/17 rapid test; positive. *still very fatigue, hard to describe the feeling. I get winded really easy. **it really did affect me; 'put me in a dark place' / the mental part is really worse then the body part.
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| 41 | 2021-03-14 | migraine, facial pain |
Neck tightness on left side at 3:15 pm on 3/12/21 (30 min after vaccine) ice,, heat, and stretchin...
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Neck tightness on left side at 3:15 pm on 3/12/21 (30 min after vaccine) ice,, heat, and stretching Migraine with pain at base of neck up to sinus areas of face bilaterally, at 10:00 am on 3/14/21 until currently (4:30 pm 3/15/21) ice, heat, stretches, anti inflammatory, muscle relaxer, and cbd oil medications, chiropractor adjustment
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| 41 | 2021-03-14 | muscle spasms |
Injection occurred at 1:30pm Friday Severe stabbing muscle pain around ribs starting in the back int...
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Injection occurred at 1:30pm Friday Severe stabbing muscle pain around ribs starting in the back intercostal muscles around 8pm Friday. Muscle spasms and pain increased and spread to back and front intercostals as well as upper back muscles making it painful lay down or walk most of the day Saturday. Muscle pain made sleeping difficult Friday and Saturday nights. By Saturday morning the pain started to subside and spasms were only affecting lower intercostal muscles. By the time I woke up at 6am Sunday all pain was gone.
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| 41 | 2021-03-14 | pain in extremity, numbness and pain in extremities, cold extremities |
I received dose 1 of Pfizer COVID-19 vaccine on Feb 24. The initial symptoms starting Feb 25 were s...
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I received dose 1 of Pfizer COVID-19 vaccine on Feb 24. The initial symptoms starting Feb 25 were somnolence, mild muscle stiffness and dizziness that lasted approx 5-6 days but gradually resolved. Approx 3 days after the shot I developed chills, which took approx 2 weeks to resolve. As for neurologic symptoms, approx 6 days after the shot, I experienced a worsening of my peripheral neuropathy that is still ongoing >2 weeks since dose 1 (normally very mild at baseline and mostly limited to the feet). This exacerbation manifested primarily as stockings/gloves sensation to the mid-calves and elbows/mid-upper arms. I have also experienced some tingling in hand/feet and a notable cold sensation in the feet (worst in the toes- when I step into hot water in the shower, the feet/toes become quite painful and a transient blotchy redness appears on the feet). The stockings/gloves sensation and foot coldness persist though approx 50% better than when it started. No muscle weakness or myalgias accompany these symptoms. I am concerned about receiving my 2nd dose on March 26 given the ongoing presence of symptoms from the first. I have scheduled an appt to discuss with my Rheumatologist. My Neurologist is unsure I should receive 2nd dose.
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| 41 | 2021-03-15 | feeling hot |
Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn...
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Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn't breathe at 9:55am. She showed no signs of any breathing difficulty. Patient reported a past history of anaphylaxis to bee stings. At 9:57am 50mg of Benadryl was given. 9:58 am she reported she was sweaty, had blurred vision, and was hot. At 10:05, patient said she started to feel better. We asked that she wait the full 30 minutes. By 10:20am, she was feeling fine and the symptoms had resolved.
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| 41 | 2021-03-15 | tingling |
Within an hour of receving the vaccine, I became dizzy, had face tingling and arm tingling and felt ...
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Within an hour of receving the vaccine, I became dizzy, had face tingling and arm tingling and felt mentally foggy. As the day progressed, I felt a fullness in my throat and fatigue. Over the next week, the dizziness became worse, I experienced intense headaches and shortness of breath for several days. I had difficulty sleeping and vivid dreams. I have had thyroiditis twice in my life after giving birth to my 2 children with similar dizziness and throat fullness. I decided to contact my doctors and had my thyroid levels checked. My TSH was abnormal and my doctor thinks I could be having another episode of thyroiditis. My menstrual cycle arrived a week early. Following this, I continued to have dizziness, throat fullness, and intense headaches. I developed sore breasts and breast discharge as well as in increase in frequency of urination. I decided to postpone the second shot until I was feeling better as past episodes of thryoiditis took about 2 months to resolve. My next menstrual period was a week late, also accompanied by mood swings, breast tenderness and intense headaches. SIx weeks later, I continue to experience occasional dizziness and throat fullness and increased urination. Prior to the vaccine, I was feeling fine and it seems like the vaccine triggered some kind of hormone/endocrine response in my body. I have not had reactions to any vaccines prior to this. I am quite hesitant to receive the second vaccine and am wondering if I should wait a period of time and try something different such as the Johnson and Johnson one. I? not quite sure what in the Pfizer vaccine ( perhaps the mRNA?) could have triggered this reaction in my thyroid and endocrine system. and would appreciate guidance on what to do next as I would like to be fully protected from COVID-19 but do not want to endure these unusual side effects.
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| 41 | 2021-03-16 | burning sensation | Swollen airway, head, and neck, intense itching and burning that lasted for 2-3 days |
| 41 | 2021-03-16 | feeling jittery |
I got my vaccination at 4pm, waited the 15 minutes at the united center waiting area and felt fine. ...
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I got my vaccination at 4pm, waited the 15 minutes at the united center waiting area and felt fine. I went home to pickup my daughter and at 6pm was back on the road driving and started to feel tired. I stopped at the light at foster and had just called my parents to tell them i had gotten the shot. I mentioned I was starting to feel tired and as I said it started to feel more tired. My mom responded maybe you should pull over and that was the last thing i remember as I fainted/blacked out immediately after. When I awoke my daughter (in the back seat along with my dog) explained that I had accelerated and hit the back of another car and then drove around that car, ending with both cars facing the direction of travel with my car in front of the car i had rear-ended. I was completely disoriented and had not recollection of hitting the gas or break much less driving. I was told two times that the driver in the other car was fine and was told when asked a third time that he did have some pain possibly and went in the ambulance to get checked out. I felt disoriented and jittery last night, took 2 Tylenol before bed and have felt fine today beyond feeling confused and horrible about what happen. My husband picked me up form the site and took me to my parents a few blocks north of the accident.
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| 41 | 2021-03-16 | night sweats |
It gets worse everyday, got vaccine on Sat morning and today is Wednesday- Headach, chills, stomach...
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It gets worse everyday, got vaccine on Sat morning and today is Wednesday- Headach, chills, stomach ach, night sweating, sleepless, shoulder ach
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| 41 | 2021-03-16 | pain in extremity | Headache, drowsiness , body aches - 24 hours Sore Arm - 48 hours |
| 41 | 2021-03-16 | pain in extremity |
45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken any...
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45 minutes after the vaccine I started with all over body itching, had not eaten, drank or taken anything between the shot and time of the itching. I did about 20 minutes after the shot have a headache, severe arm pain, and then later that evening I had body aches, and the lymph node under my arm swelled up. I am still having the arm pain, swollen lymph node and itching and its 5 days later. I have been taking my already prescribed allergy medications as well as Benadryl and Claritin as advised by my doctor.
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| 41 | 2021-03-17 | numbness, throat numbness |
30 to 40 minutes after vaccine a numbness creeped up the left side of my shoulder, then the left sid...
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30 to 40 minutes after vaccine a numbness creeped up the left side of my shoulder, then the left side of my throat/neck, then the left side of my face. It felt slightly numb, but was not paralyzed and i was able to see fine. It started to wear off after about 4 to 5 hours. Woke up in the morning and face seems back to normal.
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| 41 | 2021-03-17 | numbness |
- ten minutes after shot my top front teeth felt numb and I started to feel waves of hyper-awareness...
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- ten minutes after shot my top front teeth felt numb and I started to feel waves of hyper-awareness and disequilibrium that were accompanied with mild nausea. The numbness in teeth went away after approximately 5 min. The waves of disequilibrium continued for 24hrs, and now feel more like a pressure headache. During these ?waves? I also had increased heart rate. - an hour after the shot, my left arm felt numb down to the fingers. Then the right arm and upper back. This subsided after an hour.
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| 41 | 2021-03-17 | pain in extremity, nerve pain |
The injector could not get the shot in, and kept trying and finally after i heard a pop the shot go...
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The injector could not get the shot in, and kept trying and finally after i heard a pop the shot got in. Injection site is more towards side arm and shoulder. 3 hours after the second shot, I started to experience flu like symptoms, dizzy, achy, arm pain from awful injections, soar arm etc etc. The last 3 days I have experienced all symptoms that they say are normal, plus nerve pain running down my arm and across my chest to my other arm pit. Back pain, neck stiffness and just an overall feeling not good. I am concerned that there is damage from the injector not knowing what she was doing and now I am having a reaction to how she did the shot. Injection site is hot to the touch and bruised. My first vaccine I did experience dizziness and injection site looked like I was stung by a bee, very swollen but not hot to the touch like now. I have been on tylenol, which is doing anything so i switched to ibuprofen for pain, achinesss and overall just not feeling well. I cannot move my arm much, but can use my fingers. Today is day 4 of the same issues and at this point if my arm is not better by next week I will go see the doctor. My doctor has advised to report this, and ice areas and ibuprofen/tylenol. I am concerned I have nerve damage done at this point from whoever was the injector. I am hoping there is a way to find out who did mine. At the end of the appt, the injector did say sorry that was awful and I was so traumatized that I didn't even know what to do or say at the time. It was so bad my husband was getting his phone out to video but as soon as he did, she got it in deep where it was suppose to go????
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| 41 | 2021-03-17 | tingling | Tingling in head, light headedness. Stated she is scared. Anxious. V/S 122/56, HR 72, O2 99%. |
| 41 | 2021-03-18 | flushing |
Patient scheduled an appointment with her PCP, on 3/17/21. She presented with 2.5 weeks of flushing,...
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Patient scheduled an appointment with her PCP, on 3/17/21. She presented with 2.5 weeks of flushing, sweats, and intermittent pruritic hives since receiving her first COVID-19 vaccine on 2/27/21. She reports that the pruritis and flushing is worse with exercise. For one week, she has had a pink ovoid lesion 2-3 cm in length on right chin and left neck that are now scabbed without drainage. Neck and chin lesions treated with bactroban, patient is already on antihistamines, and instructed her to follow up if worse.
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| 41 | 2021-03-19 | flushing, tremor |
3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ...
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3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate, reported feeling flush, and was visibly shaking. Assessment : Time of assessment- 1845. Alert and oriented. Actions taken: Vitals sign taken at 1845 BP 139/84, P 74, T-98.2,R 16, O2- `100%, JUICE OFFERED AND ACCEPTED, RECHECK AT 1858, BP-156/75, P-116, DRINKING JUICE, AT 1918 BP- 131/82, P- 105, VS AT 1933 BP-113/59, P- 98, AT 1951- BP- 114/80, P-95, PATIENT FEELING BETTER AND LEFT WITH FAMILY. Medications administered: No medication administered. Disposition: PATIENT GIVEN INFORMATION OF ALLERGIC REACTION, AND ADVISED TO FOLLOW UP WITH PCP. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/19/2021 6:36 PM 0.3 mL 12/11/2020 Intramuscular
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| 41 | 2021-03-20 | flushing |
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generali...
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Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Flushed / Sweating-Mild
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| 41 | 2021-03-20 | flushing |
Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face...
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Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.
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| 41 | 2021-03-21 | weakness |
Client was in the monitoring room after receiving first dose. Reported to the nurse felt like thro...
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Client was in the monitoring room after receiving first dose. Reported to the nurse felt like throat was swelling and having difficulty breathing and swallowing. Nurse reported client was visibly having a hard time with breathing. Client reported felt weak and legs felt "like noodles." Epi Pen given Left thigh. 911 called . Client accepted transport for further evaluation.
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| 41 | 2021-03-21 | facial paralysis, numbness, flushing, tingling |
Face went immediately numb. Over the next several hours felt numbness in whole body. Facial drooping...
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Face went immediately numb. Over the next several hours felt numbness in whole body. Facial drooping. No paralysis, was able to move, minimal pins and needles, primarily a loss of sensation. It's 6 days later and I'm getting the sensation back but it hasn't fully returned. Facial flushing which continues to come and go, as well as flushing in hands and feet.
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| 41 | 2021-03-21 | feeling jittery | Swollen eyes burning skin jittery feeling |
| 41 | 2021-03-22 | weakness |
About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt ...
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About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription
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| 41 | 2021-03-22 | flushing, feeling hot, numbness |
Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into nec...
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Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.
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| 41 | 2021-03-22 | numbness |
patient experienced numbness in L hand that comes and goes. first presented night of shot and has pe...
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patient experienced numbness in L hand that comes and goes. first presented night of shot and has persisted until now. patient taking aleve to help with pain associated with numbness
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| 41 | 2021-03-22 | migraine |
Severe headache (migraine) started within a few hours and has continued with daily headaches since f...
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Severe headache (migraine) started within a few hours and has continued with daily headaches since first vaccine. Additional migraine after second dose, continued to have daily headaches since.
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| 41 | 2021-03-22 | tremor |
Became extremely sleepy around 5 PM. Around 8 PM, started vomiting, diarrhea, fever, chills, shakes,...
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Became extremely sleepy around 5 PM. Around 8 PM, started vomiting, diarrhea, fever, chills, shakes, body aches. Felt better by 6 AM Saturday except sleepiness and body aches. Sleepiness/achiness stopped around 4:30 PM Saturday. Injection site sore from shot until Sunday evening.
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| 41 | 2021-03-23 | pain in extremity |
Had typical arm pain after an injection that was to be expected. I am now a month out from the secon...
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Had typical arm pain after an injection that was to be expected. I am now a month out from the second dose of the vaccine and I continue to have residual arm pain that is worse with movement. The pain is deep into the arm, almost like a bone pain. Rates 3/10 on pain scale. Noticeable decrease in strength in arm where vaccine was administered as well. I chose the dominant arm, as I am aware that the more the movement of the muscle the less likely the vaccine would pool in the muscle. I am an RN, I received vaccines through out my life time and I have never had a similar outcome. I typically do quite well with vaccinations. I had no other symptoms or reactions to either doses. Arm pain was significant with the first dose and did resolve fully. The arm pain with the second dose was increased in severity and then did decrease however it has not resolved. Concerned due to length of time that has passed.
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| 41 | 2021-03-23 | pain in extremity |
Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2,...
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Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2, highest 99.6. Also experiencing chills, lymphnode on left side of neck, little to no appetite, diarrhea, full body aches, dizziness, ringing in ears, knee pain, headache, nausea, sweating, tiredness. I have not been to work this week.
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| 41 | 2021-03-24 | weakness |
RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "...
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RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "fait" in post-vaccine waiting room. At 2:05 with pt. experienced difficulty breathing. RN gave epinephrine 0.5ml pt. on R deltoid. Then, 911 was called. Pt. was examined by paramedics refusing to go to ER. RNs encouraged pt. to see PCP. Pt.'s husband was called by pt. for ride home.
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| 41 | 2021-03-24 | difficulty speaking |
Patient is a 41 Y female who presented today for COVID Vaccine c/o of scratchy throat, throat tightn...
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Patient is a 41 Y female who presented today for COVID Vaccine c/o of scratchy throat, throat tightness hoarseness, able to speak in full sentences, able to drink water without difficulty remains on RA no hives/rash noted, monitored closely. States throat tightness is resolving, remains on RA. 1133-patient states symptoms continue to resolve, and is ready to for discharge. BP 153/99 Pulse 81 Temp 97.4 °F (36.3 °C) (Temporal) SpO2 99%
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| 41 | 2021-03-24 | feeling of body temperature change |
Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperatu...
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Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-03-24 | feeling of body temperature change |
Vaccine administered 3:10pm, reaction started within 5 minutes. Felt lightheaded and experienced hyp...
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Vaccine administered 3:10pm, reaction started within 5 minutes. Felt lightheaded and experienced hypertension (209/152), came down to 201/140, and again to 165/100. A pillow was placed under her and her legs/feet were elevated. While in our care, patient was provided and consumed 5 bottles of water and 2 packs of peanut butter crackers (pt is prediabetic and only thing she had consumed all day was a double espresso). She complained of oscillating between hot and cold... when she was cold she was provided a blanket. Patient refused our offer to call EMS. Patient consented to us reaching out to her physician, but they did not answer and patient refused our offer to leave a voicemail for her doctor. Patient left area and went to restroom to evacuate bowels and reported she felt significantly better. Patient stated she did not have a BP cuff at home and was provided both a BP cuff and acetaminophen and was advised to check her BP in a couple of hours. She walked out on her own and was advised to contact her doctor and that we would call her later that evening. When contacted that evening, she reported she was doing well.
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| 41 | 2021-03-24 | flushing | Flushing Dizziness |
| 41 | 2021-03-24 | numbness, weakness, tingling |
Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder an...
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Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-03-24 | numbness | Nausea, dizziness, numbness face and right arm, headache |
| 41 | 2021-03-24 | numbness |
Immediately L arm numbness, then whole L side numbness which was monitored for 30 mins post 1st dose...
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Immediately L arm numbness, then whole L side numbness which was monitored for 30 mins post 1st dose by on site healthcare person then released. Numbness subside by next day except near site. Next day grouped hives on whole L leg appears then disappears 2-3x in row for 1-2mins. On & off Chills and goose bumps on L side of body & fatigue, which dissipated after about 1-2wks.
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| 41 | 2021-03-24 | migraine |
migraine; This is a spontaneous report from a contactable consumer, the patient, reported for hersel...
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migraine; This is a spontaneous report from a contactable consumer, the patient, reported for herself. A 41-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN9261), via an unspecified route of administration in the left arm on 17Feb2021 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced migraine on 18Feb2021 at 15:00 and that lasted until Friday night on 19Feb2021. The patient did not receive treatment for event, migraine. The outcome of event, migraine was recovered on 19Feb2021.
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| 41 | 2021-03-24 | pain in extremity | Arm pain. |
| 41 | 2021-03-24 | unresponsive to stimuli, flushing, numbness |
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / L...
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Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
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| 41 | 2021-03-25 | weakness |
Patient c/o generalize weakness. Pt verbalized that she had the same reaction with first dose. Pt....
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Patient c/o generalize weakness. Pt verbalized that she had the same reaction with first dose. Pt. seen and assessed by EMT and assessments are as follows: BP 113/79, HR 79, O2 100%, BS 109. 17 minutes into observation client voiced that she had felt better and was cleared to go home by EMT.. Client advised to seek medical attentions if symptoms worsen.
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| 41 | 2021-03-25 | breast pain, pain in extremity |
Sore arm - started 2 hours after dose Headache - started 4 hours after dose Pain and swelling in lef...
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Sore arm - started 2 hours after dose Headache - started 4 hours after dose Pain and swelling in left armpit - started 26 hours after dose and continues; shooting pain down to fingertips, into left breast and down left side of torso.
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| 41 | 2021-03-25 | feeling cold |
This could certainly represent allergic reaction which she has had the vaccines in the past. She ha...
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This could certainly represent allergic reaction which she has had the vaccines in the past. She has sensation of tongue edema and scratchiness in her throat, does have erythema of her face and anterior neck, has mild wheezing on exam. She is treated with epinephrine 0.3 mg IM, followed by IV, Solu-Medrol 125 mg, famotidine 20 mg, Benadryl 25 mg, NS 1 L, and improves over several hours. At no point did she worsen or express a desire to have an additional epinephrine dose. She was never hypotensive. She is cold and chilled, also complained of nausea, given Zofran and a bear hugger While the wheezing was treated with albuterol inhaler and resolved Ultimately discharged with her husband They will be picking up a EpiPen in route to home which is at a pharmacy, confirmed Prescriptions sent for Benadryl, 3 additional days of prednisone, Pepcid, albuterol inhaler Last Set of Vital Signs: Temp: 37.2 °C (98.9 °F) Pulse: 96 Resp: 12 SpO2: 100 % BP: 132/76
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| 41 | 2021-03-25 | pain in extremity |
Redness, swelling, large knot/bump in arm at injection site about 2 in in diameter, Pain in arm when...
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Redness, swelling, large knot/bump in arm at injection site about 2 in in diameter, Pain in arm when touched or when I move it. headache & fatigue
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| 41 | 2021-03-25 | tingling, throat numbness, numbness |
Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" star...
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Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over. My breathing became labored and difficult, my lips were numb. I was immediately administered an EPI pen, and was transported by ambulance to the ER . I was also treated with albuterol, solumedrol, and benedryl. I remained in the ER for the entire day, and was discharged in the evening. I was prescribed Claritin, and prednisone, and given an epi pen. I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingling in my throat/face. The Claritin was continued, and the prednisone was extended. I followed up with another doctor on Wednesday as symptoms were not resolved. Claritin has been increased and am trying to phase out the prednisone. I continue to suffer from tingling in my lips, and chest pressure. Doctors have no idea how long symptoms would last.
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| 41 | 2021-03-25 | tingling | Warm and tingly all over and blurry vision |
| 41 | 2021-03-25 | tingling | Patient complained of tingling in vaccination arm |
| 41 | 2021-03-26 | nerve pain | Pinched nerve pain, vitals wnl. |
| 41 | 2021-03-26 | pain in extremity |
Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left a...
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Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left arm and left leg, swollen lymph in left armpit
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| 41 | 2021-03-27 | tingling |
2 days after 2nd dose all day moderate headache and nausea, 3 days after 2nd dose woke up at 4am wi...
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2 days after 2nd dose all day moderate headache and nausea, 3 days after 2nd dose woke up at 4am with tingling in lungs and shortness of breath.
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| 41 | 2021-03-31 | depressed level of consciousness, difficulty speaking, tingling |
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens...
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Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
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| 41 | 2021-04-10 | pain in extremity, burning sensation, tingling |
Pins and needles in mouth and tongue 1 day following vaccine. Continued worsening until going to ER ...
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Pins and needles in mouth and tongue 1 day following vaccine. Continued worsening until going to ER April 10th, pins and needles and burning all over body for a full day period. Continuing to get worse. Have been referred to rheumatologist and neurologist, but no one knows what is going on or how to treat. Only tell me ?I am not the only one?. Feels like arthritis in hands. Pain mostly in mouth, tongue, spine, feet, legs.
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| 41 | 2021-04-15 | migraine, muscle spasms, pain in extremity |
Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started wit...
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Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started with Severe pain felt like a charlie horse in my left calf and foot that would not go away for more than 24 hours. My Blood pressure spiked and i got a migraine from the pain , My left leg and food felt like stone.. The next day I called the nurse from my insurance company and she advised I go in to the hospital. Went to ER got a Ultrasound, blood tests and the ultrasound came back positive for a DVT clot. Treatment is Xarelto and follow up with my primary. Lab Results came back normal.
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| 41 | 2021-04-15 | tenderness, night sweats, hypersensitivity of all senses, seizure |
he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp...
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he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5. The shivering quickly changed to more of a convulsing and temp got up to 104.7F. When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding. But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21. I could not brush my hair because my scalp was too tender. I couldn't let anything touch me and put pressure against any part of my body. Then at 3:30 that afternoon, I went to bathroom and had a bowel movement. It was so excruciating that I truly though my colon might have come partially out. I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying. When I was finally able to go back to the bathroom to flush, I was expecting a large BM. It was not. It was about 2" x 1" and soft. There was no blood. It just felt like it tore me up. ****Then at 7:30 PM on 3-5-21 was when things got very serious. I was sitting down watching TV after a light meal. Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades. Within 5 minutes, it was at its worst....I was have rated it 11/10 pain. The pain was just very deep, behind the spine, about palm sized radius and unrelenting. My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today." So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine. An hour later, these meds hadn't touched it. I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB). Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain). I called another provider who was on call and told her. She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER. I was asleep in an hour. I took it easy the next two days but started feeling back to normal during the days. I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out. That following Tuesday, the deep upper back pain returned.
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| 41 | 2021-04-16 | pain in extremity, muscle spasms |
Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in bo...
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Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in both lungs). Context: After the first vaccine (about a week before my second vaccine), I self diagnosed myself with a calf injury due to extreme pain in my calf that felt like a continuous cramp. The extreme pain lasted until my second shot (about a week). When going for my second shot, I reported a rash with hives on my lower abdomen that had appeared within five hours of my first shot, so they requested I stay a little longer for observation. That night I began having some breathing difficulties, but assumed they were to be expected. The breathing difficulties continued to get worse until my nurse practitioner told me to go directly to the nearest ER (2/16/21), where I was officially diagnosed with multiple bilateral pulmonary embolisms. I was admitted to healthcare facility for 24-48 hours, until an EKG revealed heart abnormalities that caused them to use a physician's transport to move me to another unit. I was discharged from the hospital on 2/2/21 after I stabilized from heparin shots, avoiding more invasive procedures. I have been in ongoing recovery since then, receiving ongoing care from a hematologist and pulmonologist. A little extra context for you - I arrived to the hospital with diabetic ketoacidosis and have an endocrinologist since hospitalization that has diagnosed me with Type 1 Diabetes (previously misdiagnosed as type 2 - I'm now on insulin which is controlling my blood glucose well).
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| 41 | 2021-04-16 | tingling, numbness |
Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occ...
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Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off. Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-04-17 | slurring |
delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were ...
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delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.
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| 41 | 2021-04-17 | migraine |
a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromya...
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a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromyalgia and Sjogren's condition; right ankle became swollen; a prolonged episode of her fibromyalgia and Sjogren's condition; joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes); migraines; fatigue; multiple naps throughout the day; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41 Years, at single dose on 17Mar2021 (Lot number EN6207) for COVID-19 immunisation. Medical history included fibromyalgia, Sjogrens syndrome and lactose intolerant. Concomitant medications included gabapentin, ciclosporin (RESTASIS), cevimeline all taken for an unspecified indication and start and stop date were not reported. The patient previously took celecoxib and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, her joint was at a 2. Her right ankle became swollen. Usually, her ankles didn't swell. She also had four migraines during this time - she typically had migraines every two to three months. She experienced fatigue which caused me to take multiple naps throughout the day. She experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, she had brain fog for 2-3 days. Basically, the patient felt like she was having a prolonged episode of her fibromyalgia and Sjogren's condition. The symptoms were still persisting. The patient reported above events was non-serious. It was reported that the adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". And she received treatments for the adverse events including ace bandage for ankles and further monitoring. The patient was not diagnosed with COVID-19 prior to vaccination and she did not test for COVID-19 since the vaccination. Events outcome was not recovered.
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| 41 | 2021-04-18 | numbness and pain in extremities, numbness, bell's palsy |
Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms aro...
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Weakness of Right Eye; Numbness in right eye; Feels tugging in the back of her head and symptoms around right eye; Weakness in arms and legs; Feels tugging in the back of her head and symptoms around right eye; Neuropathic Symptoms on Right Side of Face; Numbness on Right Side of Mouth; she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her Bell's Palsy, and the corner of mouth started to have numbness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 (at the age of 41-year-old) as single dose for covid-19 immunization. Medical history included facial paralysis from 1998 to an unknown date, Bells palsy at age 18 , ongoing temporomandibular joint syndrome , asthma exercise, depression, pain, hypoaesthesia, Numbness in face in the past (June 2020 tele-visit with neurologist), fatigue, headache, anxiety. Concomitant medications included gabapentin (GABAPENTIN) taken for neurological symptom, hydroxyzine (HYDROXYZINE) taken for anxiety. The patient experienced she started experiencing weakness in the right eye and on the right side of the face, which is the same side as her bell's palsy, and the corner of mouth started to have numbness on 01Mar2021 with, neuropathic symptoms on right side of face on 01Apr2021 with, numbness on right side of mouth on 01Apr2021, weakness of right eye numbness in right eye, feels tugging in the back of her head and symptoms around right eye, weakness in arms and legs, feels tugging in the back of her head and symptoms around right eye. Caller states basically she had Bell's Palsy years ago and was left with cranial nerve damage. She stated she noticed after the first Pfizer vaccine, that in that area of the face that she had Bell's Palsy, she started having neuropathic symptoms. and stated that it started thursday. States it has been there for a couple of days and she still has a little bit of neuropathic symptoms but not as great as when the onset began. The outcome of the events was recovering. Information about batch/lot number has been requested.
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| 41 | 2021-04-19 | burning sensation |
Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that...
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Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given
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| 41 | 2021-04-20 | numbness, tingling |
Client c/o tingling and numbness of L arm. Client seen by EMT (no v/s taken). Client observed to b...
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Client c/o tingling and numbness of L arm. Client seen by EMT (no v/s taken). Client observed to be stable, no distress noted at the moment. Client cleared to go home by EMT.
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| 41 | 2021-04-21 | pain in extremity |
- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -...
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- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS
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| 41 | 2021-04-24 | grand mal seizure |
Grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old...
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Grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 23Mar2021 at 08:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and Tourette's syndrome from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 on 23Feb2021 at 10:30 A.M. (at the age of 41-years-old), administered in right arm for COVID-19 immunisation. Concomitant medications included duloxetine hydrochloride (CYMBALTA), levothyroxine and birth control pills, all taken for an unspecified indication, start and stop date were not reported. The patient experienced grand mal seizure on 07Apr2021. The patient was hospitalized for grand mal seizure for 2 days. Therapeutic measures were taken as a result of grand mal seizure (anti-seizure medication). The outcome of the event was recovered with sequelae on an unspecified date. Information on the lot/ batch number has been requested.
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| 41 | 2021-04-24 | pain in extremity |
DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to ext...
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DVT; multiple bilateral pulmonary embolisms; rash; hives on my lower abdomen; calf injury due to extreme pain that felt like a constant cramp; This is a spontaneous report from a contactable Other HCP (patient) . A 41-years-old no pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021 16:30 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation.Age at vacciantion:41 years. No other vaccine in four weeks. No COVID prior vaccination Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing , Hashimoto's Disease from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) and levothyroxine (LEVOTHYROXINE) . The patient experienced DVT followed by multiple bilateral pulmonary . The clinical course was reported as follows:"Within 5 hours of the first dose I got a 3" in diameter rash and hives on my lower abdomen, which I reported when receiving my second dose. About a week before the second dose, I self-diagnosed myself with a calf injury due to extreme pain that felt like a constant cramp that lasted until my second dose. After the second dose, I was hospitalized 5 days (16Feb2021-20Feb2021) with multiple bilateral pulmonary embolisms/blood clots in both lungs after being sent to the ER by a nurse practitioner, and told that my previously self diagnosed leg injury was really DVT - I actually left the hospital with one blood clot still in my leg.Hospital's Cardiac ICU by physician's transport because my case was too to be treated at (Withheld). I am lucky to have survived this-please warn people of the symptoms" The patient underwent lab tests and procedures which included antiphospholipid antibodies (unknown date): unknown results (won't be in until mid-Jun because it requires testing 12 weeks apart)-tested negative for genetic conditions that could have caused the clots , sars-cov-2 test: negative on 16Feb2021.The events DVT and pulmonary embolism resulted in Emergency Room visti /Phisician office visit .The event "DVT" was treated with Heparin, still on blood thinner. The patient received the second dose on 08Feb2021 left arm (Lot#BL9269).The outcome of the event DVT was recovering.The outcome of the other events was unkonwn; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events Deep vein thrombosis, Pulmonary embolism and Pain in extremity and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : same report/patient, different dose/AE
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| 41 | 2021-04-27 | weakness, feeling hot |
asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic react...
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asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-04-27 | pain in extremity |
A couple of hours later I had arm pain, fatigue, body aches & headaches. The symptoms lasted about a...
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A couple of hours later I had arm pain, fatigue, body aches & headaches. The symptoms lasted about a week.
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| 41 | 2021-04-28 | bell's palsy |
Bell's palsy; Left wrist felt like it was jammed, stuck, or sprained; Left wrist felt like it was ja...
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Bell's palsy; Left wrist felt like it was jammed, stuck, or sprained; Left wrist felt like it was jammed, stuck, or sprained; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, batch/lot number was not reported), dose 1, via an unspecified route of administration, administered in the left arm, on 30Mar2021 11:00 (at the age of 41-years-old) as single dose for COVID-19 immunization. Medical history included thyroid issues diagnosed maybe 7 years ago. The patient has no concomitant medications. The patient reported that she had the first dose and the injection was given in her left arm about 11:00 AM on 30Mar2021, though there were thousands of people there at her appointment at the vaccine center. Around midnight or 01:00 AM on 08Apr2021, the patient woke up with the left side of her face swollen and numb - which was still swollen and numb. The patient can't move the left side of her face. The patient happened to have her neurologist appointment that day, so she brought it to his attention, and he said it was a mild form of Bell's palsy. The patient reported it has gotten worse, it was messing up her speech, she was slurring her words. The patient had a magnetic resonance imaging (MRI) on 13Apr2021, but she doesn't have the results yet. The patient reported that she will start physical therapy and was scheduled to have her blood work on 15Apr2021. The patient also reported that her left hand felt like around the wrist it was like jammed, stuck, or sprained in Apr2021. The outcome of the event Bell's palsy was not recovered while the outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
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| 41 | 2021-04-28 | numbness, cold extremities, cold sweat |
feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood ...
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feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood sugar (not diabetic); Dizziness; Clammy feet; Very scary; Thyroid was in rage during this event; This is a spontaneous report from a contactable health professional (patient). A 41-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 41-years-old), administered in Arm Left on 08Mar2021 10:00 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included Hashimoto's. The patient had no known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced Face numbness, Dizziness, Events of low blood sugar (not diabetic), SOB, Clammy feet. Most importantly, feeling of blood moving in arms/legs with cold sensation. The patient was hospitalized for the events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The onset of events was 09Mar2021 07:00. The patient also reported that it was "Very scary" and "Thyroid was in rage during this event" on an unspecified date. Went to ER twice weeks apart. Lasted for 3 weeks. The patient underwent lab tests and procedures which included blood glucose: low on 09Mar2021. No treatment received for the adverse events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation) required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events "Very scary" and "Thyroid was in rage during this event" was unknown while for the rest of the events was recovered with sequelae (Recovered with lasting effects). Not diagnosed with COVID prior vaccination, not COVID tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-04-28 | tremor |
Extreme shaking chills, intense body aches all over pain 10/10, waves of nausea, headache, worst phy...
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Extreme shaking chills, intense body aches all over pain 10/10, waves of nausea, headache, worst physical pain in lifetime
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| 41 | 2021-04-30 | facial paralysis |
Facial paralysis; This is a spontaneous report from a contactable consumer (patient). This 41-year-o...
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Facial paralysis; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female consumer (patient) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) in left arm, on 01Apr2021 at 10 AM, for COVID-19 immunisation. No other vaccine was given in 4 weeks. Medical history included asthma and migraines. The patient did not have COVID prior to vaccination. Known allergies: No. Other medications in two weeks: medications for pain in knees were injected. On an unspecified date the patient experienced facial paralysis. The event required treatment (physical therapy) and had not yet resolved at the time of report. COVID was tested post vaccination, on 05Mar2021: nasal swab sample/molecular was negative.
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| 41 | 2021-04-30 | numbness, burning sensation, tingling |
arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; ...
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arm numbness and tingling; arm numbness and tingling; feel burning in face; face began to tense up; This moved to swelling of the tongue; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533 and expiration date not provided), via an unspecified route of administration, in right arm, on 15Apr2021 16:15 (at the age of 41-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included PCOS (polycystic ovarian syndrome), allergies to sulfamethoxazole;trimethoprim (BACTRIM), metoclopramide (REGLAN) and amino acid base in iron infusion. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA, nasal spray). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Mar2021 16:00 (at the age of 41-year-old), at single dose, for COVID-19 immunization. On 16Apr2021 16:30 (reported as "initially within 5 minutes"), patient developed arm numbness and tingling. Physician prescribed diphenhydramine hydrochloride (BENADRYL) and prednisone. Within 30 minutes, began to feel burning in face and face began to tense up. This moved to swelling of the tongue and difficulty swalliwing. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 2 days. The patient underwent lab tests and procedures, which included COVID test (Nasal Swab) was negative on 17Apr2021. Therapeutic measures were taken as a result of events and included treatment with epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), famotidine (PEPCID) and diphenhydramine hydrochloride (BENADRYL). The outcome of the events was not recovered.
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| 41 | 2021-04-30 | migraine |
migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; b...
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migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; blood pressure has been so high/My blood pressure reached 200/198; I lost 30 pounds; I had a stroke; pulse high; in pain; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included pain, anxiety, two back surgeries previously, and smoke all the time. Concomitant medications included clonazepam (KLONOPIN); and pain medications for her back and anxiety medications (unspecified). She got her first dose of the Pfizer COVID vaccine 36 days ago (11Mar2021) and within 5 minutes, she had the worst migraine of her life. She has had two back surgeries previously and after the COVID vaccine, she felt like she had had her third back surgery that night (11Mar2021). That night, she was also throwing up, had diarrhea and was having horrible stomach cramps. Since then (Mar2021), her blood pressure had been so high that they were afraid that she was going to have a stroke at any minute. For her migraine, she had been to the hospital 4 times for it and they had given her three doses each time of the migraine cocktail and that hadn't touched her migraine. She went back to the doctor and her blood pressure and her pulse were both still high (2021) and with the migraine she was ready to jump off of the dock because it hurts so bad. She was on 4 medicines to try and combat what this vaccine had done to her. She can no longer function. She needed to know an antidote or something to get this out of her system. She stated that she "is going to die from this". She didn't know what to do. They said she was going to have a stroke. She can't work and no one knows what to do because there were no studies on this because it is so new. She wanted it out of her body. Her life literally has turned into her just lying in bed and moaning in pain. She was in the emergency room (due to migraine), there were 3 people in there who had complained from the Pfizer vaccine (unspecified). She was calling because she got her first shot of COVID vaccine and she had a stroke (unspecified date in 2021) and she was going to die. She needed an antidote to get it out of her system because she been to the hospital 5 times now. She had migraine that is so bad that they gave her 4 doses of Topamax, it didn't touch it, she threw up everything she eats, she lost 30 pounds (2021) & her blood pressure reached 200/198 and she smoked all the time, they said she had stroke. She had bad migraine and nothing helped at all. She had doctor appointment, and nobody can give her answer. Regarding second dose, that was 21 days after, but she was not going to get it (second shot) and they said she was 80 % vaccinated. At hospital, when she was in emergency room (for migraine), where they do lab tests (2021), they were fine. She was not getting better, getting worse (not clarified for all events). Date of hospitalization: the day after she got the vaccine and next was two days ago, 3 different times (further details unknown). She further stated that she was driving to doctor. She lost her life because she can't work, this drug had ruined her life (as reported). The outcome of the event migraine was not recovered. The outcome of other events was unknown. Information about lot and batch number was requested.
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| 41 | 2021-04-30 | migraine |
didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a sp...
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didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unspecified date, and 5 minutes after she "didn't feel good". The patient was sick, blood pressure went high, smells smoke, pulse change and migraine up until 36 days later. She was on migraine medicine, and that she lost her job because of this. The patient already went to the hospital four times, and her doctor five times. The patient sought guidance on how to remove the vaccine from her system. The patient considered the events as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 41 | 2021-04-30 | pain in extremity |
bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shou...
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bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements. The patient previously took amoxicillin and experienced allergies. The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. Information on the lot/batch number has been requested.
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| 41 | 2021-05-03 | numbness, bell's palsy, tingling |
Bell's Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the l...
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Bell's Palsy; Mild tingling in the left arm; swelling on my left cheek; musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth).; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: 03461), via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included loratadine/pseudoephedrine sulfate (CLARITIN- D), fish oil, and a multi-vitamin (unspecified). On 19Apr2021, within 5 minutes of the vaccination, the patient experienced mild tingling in the left arm. On 19Apr2021, the patient experienced a feeling of musculature changes in the left jaw, left cheek, and facial nerve regions of left cheek (feeling similar to getting an injection at the dentist to numb your mouth). The patient was concerned it was Bell's Palsy however only noticed swelling on the left cheek. The symptoms remained the same for 2 hours without worsening, then subsided a little. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of Bell's Palsy, mild tingling in the left arm, "swelling on my left cheek", "musculature changes in the left jaw, left cheek and facial nerve regions of left cheek (described as feeling similar to getting an injection at the dentist to numb your mouth)" was resolving.
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| 41 | 2021-05-05 | tingling, pain in extremity, muscle spasms |
My adverse symptoms began less than an hour after the injection. It began with tingling feelings in ...
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My adverse symptoms began less than an hour after the injection. It began with tingling feelings in my right foot. About a half an hour later I began having pain and cramping in my right foot as well. The cramping seemed to come and go in spurts. It was not constant pain. But it kept coming back in the form of cramps. This would continue into the late evening and early morning. I would have to walk around and up and down stairs to get it to calm down in intensity. It also came back in terms of cramping on the following day. It's now still with me 4 days after the vaccine.But usually only in the mornings and evenings. Today cramping started when I walked a ways towards the store from the parking lot. I'm wondering when it will stop.
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| 42 | 2021-01-01 | feeling cold, tingling |
Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, L...
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Initial: Cold sensation and tingling in left arm and hand Next 3-5 days mild tingling in Left arm, Left hand/wrist, Left fingertips and some on left side of face
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| 42 | 2021-01-01 | pain in extremity |
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s...
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Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
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| 42 | 2021-01-02 | hot flush |
After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat,...
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After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat, c/o "tonsil swelling"....
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| 42 | 2021-01-02 | tremor |
Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive...
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Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive skin, and mild headache. All symptoms resolved after 1 day.
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| 42 | 2021-01-03 | numbness | arm numbness |
| 42 | 2021-01-03 | pain in extremity |
Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. To...
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Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. Took anti nausea meds for 4 days.
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| 42 | 2021-01-03 | pain in extremity | Sore arm. |
| 42 | 2021-01-03 | pain in extremity |
began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had fin...
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began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had finally noticed was swollen. EMS was called and I was sent to the ER.I was given benedryll by ems, at ER I was given a steroid, Claritin and another medication for the reaction. Discharged with epi pens, a round of steroids, benedryl initially which was changed to Claritin by follow up dr.
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| 42 | 2021-01-03 | tremor |
Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for...
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Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for right deltoid after first dose. Hemodynamically stable and afebrile. Differential diagnosis includes but is not limited to allergic reaction, anxiety, panic attack, asthma attack, sequelae of hyperthyroidism. After resting comfortably in the room for approximately 15 minutes, she reported that her symptoms were starting to subside. She happily excepted diphenhydramine (dose not documented). She was observed for 2.5 hours and had no worsening of symptoms. Her vital signs were stable and she had appropriate SPO2 on room air throughout her stay in the emergency department. We discussed strict return precautions for evidence of allergic reaction, chest pain, worsening shortness of breath, altered mental status or fever. She will follow-up with her primary care doctor. Discharged in stable condition to the care of her husband.
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| 42 | 2021-01-04 | weakness |
Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 4...
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Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 40 minutes after vaccine was administered
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| 42 | 2021-01-04 | burning sensation |
itching immediately after injection; then burning; then redness traveling up arm into chest; immedia...
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itching immediately after injection; then burning; then redness traveling up arm into chest; immediate onset of diarrhea; This is a spontaneous report from a contactable nurse(patient). A 42-year-old female non-pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=el0140), intramuscular on 26Dec2020 09:30 at left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient had no known allergies and no other medical history. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced itching immediately after injection, then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. Adverse event start date was 26Dec2020 09:30 AM. The events result in emergency room/department or urgent care. Treatment of Pepcid, Benadryl and prednisone received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Dec2020.
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| 42 | 2021-01-04 | flushing |
flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contact...
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flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contactable nurse. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730), intramuscular on the left arm on 18Dec2020 09:30 at single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient previously took NSAIDS and experienced allergies. The patient flushed and noticed some hives on forehead and forearm on 18Dec2020 10:15. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of flushing was not recovered while for hives recovered on Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 42 | 2021-01-04 | numbness, tingling |
Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (st...
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Swelling on right side of face, tingling, numbness up to Right eye and into Right side of neck (started 1/4 - lasted approximately 10 hours)
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| 42 | 2021-01-04 | pain in extremity, weakness |
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ...
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arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
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| 42 | 2021-01-04 | pain in extremity, night sweats |
Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a...
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Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EJ1685), via an unspecified route of administration, on 18Dec2020 at 02:45 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 42-years-old. No other vaccine was received in four weeks. Medical history included prior to vaccination the patient diagnosed with COVID-19 and known allergies were Penicillin (PCN), ephedrine, calamine, calendula, pollen. Concomitant medications included escitalopram 10mh. On 19Dec2020 at 07:00 AM, the patient experienced sore arm, nocturnal diaphoresis, generalized mild pain, fatigue. The events were reported as non-serious. The patient recovered in Dec2020 form the events. No treatment was received.
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| 42 | 2021-01-04 | pain in extremity |
Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of...
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Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
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| 42 | 2021-01-04 | speech disorder |
Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to spe...
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Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to speak. 1120 25mg Benadryl liquid given, Pepcid 20 mg given PO, cough worsening. 1122 second dose of Benadryl given, called for MD. Brought pt to Private room via wheelchair. Upon arrival, audible stridor noted. Epinephrine 0.3 mg IM given at 1126. IV started, placed patient on monitor and O2 via 1L NC. MD at bedside along with RT and pharmacy. 1134 Solumedrol 125 mg IV given, 1 puff of Ventolin given. Lungs clear. 1140 Coughing stopped, pt able to speak now. Vital signs: 1130 SPO2 99% Pulse 142 1135 99% pulse 106 BP 168/102 1140 sats 100% HR 93 BP 157/105 1145 sats 100% HR 97 BP 159/93 1200 sats 99% HR 103 155/97 114
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| 42 | 2021-01-05 | weakness |
she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from ...
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she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.
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| 42 | 2021-01-05 | facial paralysis | bells palsy of right eye |
| 42 | 2021-01-05 | flushing |
had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within ...
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had swelling of mouth, flushed face, treated with 50mg of diphenhydramine. symptoms resolved within one hour
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| 42 | 2021-01-05 | numbness, tingling, feeling hot | tingling on left pinky warmth hot sensations moving up towards the cheek cheek and lips went numb |
| 42 | 2021-01-05 | night sweats |
vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontan...
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vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontaneous report from a contactable Pharmacist, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), intramuscularly in the right arm on 30Dec2020 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Graves' disease from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE), duloxetine (DULOXETINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. On 31Dec2020 at 02:00, the patient experienced vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats. No therapeutic measures were taken as a result of the events. The clinical outcome of the vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats was resolving. It was also reported that since the vaccination, the patient had been tested on 31Dec2020 for COVID-19 with results pending.
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| 42 | 2021-01-05 | pain in extremity | Sore arm and fatigue lasting 24 hours. Ibuprofen. |
| 42 | 2021-01-06 | weakness |
Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fa...
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Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fatique
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| 42 | 2021-01-06 | weakness |
I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vacci...
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I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.
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| 42 | 2021-01-06 | cold sweat | chills, cold sweats, diarrhea, muscle aches |
| 42 | 2021-01-06 | discomfort |
About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of m...
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About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.
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| 42 | 2021-01-06 | facial paralysis |
patient states started with symptoms of facial paralysis on 12/24/2020 Patient states pain on left s...
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patient states started with symptoms of facial paralysis on 12/24/2020 Patient states pain on left side of face and cephalic region on 12/25/2020 and went to ER, where was diagnosed with Facial Paralisis
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| 42 | 2021-01-06 | feeling cold, feeling jittery |
About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold fee...
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About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold feeling in the chest. Pt reported eating breakfast and being adequately hydrated. Patient returned to vaccine clinic, remained seated for about 30 minutes, drank water, and feeling dissipated.
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| 42 | 2021-01-06 | feeling hot |
12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discha...
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12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discharged. On 12/24/2020 developed cyanosis to lips. Returned to ED and placed on 5 day steroid therapy and diphehydramine. Mildly improved.
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| 42 | 2021-01-06 | numbness, cold extremities, weakness |
Transient weakness, numbness in bilateral lower extremities and cold left arm. Patient rested and s...
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Transient weakness, numbness in bilateral lower extremities and cold left arm. Patient rested and symptoms resolved
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| 42 | 2021-01-06 | numbness | Left arm and fingers became numb for over 24hours |
| 42 | 2021-01-06 | pain in extremity |
Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't ...
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Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't lift her arm. 12/24 arm pain improved. 12/25 felt normal and healthy 12/26 stomach sharp pain, diarrhea and felt shaky. 12/30 tested negative for COVID-19. 12/31 - symptoms persisted through today and have improved for the first time today. Left with only mild abdominal ache. Not sure the abdominal symptoms are related to the vaccine. She was advised to seek medical care if symptoms persist or worsen.
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| 42 | 2021-01-06 | pain in extremity |
Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sor...
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Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sore arm, though mine lasted about a week. I received my vaccine the morning of the 21st and by the evening I was experiencing what I have been called "tantrum moodiness". Short fuse, unreasonably angry, felt like crying, yelling, arguing. By the next day some general malaise that led to aching, especially it seemed in connective tissue. More moodiness, crying, some yelling. By Wednesday it seemed to resolve."
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| 42 | 2021-01-06 | tingling |
Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Re...
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Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview. At about 9pm on the day of vaccine patient reports a rash all over her body. Describes it as bumpy and very itchy, getting worse. Patient reports taking Benadryl. States it helped with the itching but rash is continuing to spread. Denies respiratory complaints at time of phone interview. Patient instructed to see her provider as soon as possible for evaluation and treatment.
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| 42 | 2021-01-07 | weakness |
1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and a...
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1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.
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| 42 | 2021-01-07 | feeling hot, flushing |
Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side o...
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Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.
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| 42 | 2021-01-07 | nerve pain |
Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache le...
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Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; This is a spontaneous report from a non-contactable nurse. A 42-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 19Dec2020 11:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient experienced deep ache left deltoid at injection site with severe nerve pain when lifting left arm on 23Dec2020 16:30. The patient received no treatment. The outcome of the events was not recovered.
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| 42 | 2021-01-07 | pain in extremity |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTIO...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. AT THIS TIME AWAITING FURTHER DIRECTION FROM PRIMARY PROVIDER.
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| 42 | 2021-01-07 | pain in extremity |
I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a hea...
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I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a headache and full body muscles aches. I checked my temperature at 7am and it was 100.5 oral. I could barely get out of bed all day. My temperature peaked at 101 despite taking 400mg of Ibuprofen at 9am. It is currently 8 pm on 1/8/20 and I still have a fever, muscle aches, headache and fatigue.
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| 42 | 2021-01-07 | pain in extremity |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECT...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. CURRENTLY AWAITING INSTRUCTIONS FROM PRIMARY PROVIDER.
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| 42 | 2021-01-07 | pain in extremity |
whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was...
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whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was excruciating/the vaccine amplified the pain; sore arm; progressed to Flu like symptoms; Arthritis in her knee/vaccine amplified the pain; This is a spontaneous report from a contactable healthcare professional. A 42-year-old female patient received bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; lot number: EH 9899; expiration date: unknown), intramuscular left arm on 30Dec2020 20:30 at a single dose for covid-19 vaccination. Medical history included arthritis in my knee, labrum hip tear, HSV2 (herpes simplex virus type 2), haven't had an OB [pending clarification] in over 2 years and herpes. Concomitant medication included omeprazole (PRILOSEC), ondansetron (ZOFRAN MELT), alprazolam (XANAX; reported as Xanax ER), lamotrigine (LAMICTAL), famotidine (PEPCID AC) , colecalciferol (VITAMINS D3; reported as vitamin D), ascorbic acid (VIT-C) and zinc. The reporter stated that after the vaccine (31Dec2020 12:00), the patient had a sore arm and it progressed to Flu like symptoms and pain in her joints. Her whole body ached. The patient mentioned that she has arthritis in her knee and a labrum hip tear, and the vaccine amplified the pain. She also has HSV2 and she haven't had an OB in over 2 years, and she had a bad OB and shingles like pain in her butt/legs/groin to where her skin hurt to touch it. The pain was excruciating. The patient did not received treatment for the adverse event. The patient considered the event as non-serious. She received the COVID-19 vaccine in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.
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| 42 | 2021-01-07 | pain in extremity |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SI...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SITE WHICH IS WARM TO THE TOUCH. AS OF THIS REPORTING IS AWAITING A CALL FROM HER PRIMARY PROVIDER.
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| 42 | 2021-01-07 | tingling, tenderness |
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint...
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3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
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| 42 | 2021-01-07 | tingling |
Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination -...
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Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.
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| 42 | 2021-01-07 | tremor |
Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin;...
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Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization. Medical history included hypertension, and glaucoma. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.
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| 42 | 2021-01-08 | weakness, pain in extremity |
The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the ...
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The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks
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| 42 | 2021-01-08 | pain in extremity |
2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp w...
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2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.
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| 42 | 2021-01-09 | feeling cold, pain in extremity | Sore arm, cold chills, irritable skin all over, achy muscles, headache |
| 42 | 2021-01-09 | feeling hot |
Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions an...
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Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.
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| 42 | 2021-01-09 | pain in extremity, tingling, weakness |
Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscl...
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Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscle and joint pain.
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| 42 | 2021-01-10 | difficulty speaking |
Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 mi...
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Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.
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| 42 | 2021-01-10 | facial pain, facial paralysis, migraine |
Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergenc...
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Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular, on 17Dec2020 04:15, single dose arm left for COVID-19 immunization. Relevant medical history included hypothyroidism, hypertension, hyperlipidemia, obesity, and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), butalbital, caffeine, paracetamol (FIORICET 50-40- 325mg), dexamethasone 4mg Inj., diclofenac (VOLTAREN 1% Gel), Magnesium, valsartan (VASOFLEX) (pending confirmation), cyanocobalamin (VITAMIN B12), losartan potassium. The patient was not pregnant and did not received any vaccine in four weeks. The patient previously took cephalosporin and experienced allergy. On 24Dec2020, the patient experienced pain left side of the face and migraine, and came to emergency room where apparently they diagnosed facial paralysis. The events resulted in emergency room visit/ urgent care where the patient was administered dexamethasone 4mg Inj, Medrol dose pack, Vit B12 500mcg, and Fioricet 50-325-40. Facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. It was unknown if the patient was diagnosed with COVID-19 prior or since the vaccination. The events were assessed by the nurse as non-serious. Outcome of the events was recovering at the time of the report.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-10 | feeling hot | Left axilla pain, left outer arm red, hot, firm. |
| 42 | 2021-01-10 | flushing |
After 15 minute waiting period, patient returned to work in healthcare system, reported flushing and...
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After 15 minute waiting period, patient returned to work in healthcare system, reported flushing and difficulty swallowing. Patient presented to emergency department.
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| 42 | 2021-01-10 | pain in extremity, night sweats |
Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and f...
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Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and fatigue. I slept most of the day on Sunday after getting the shot the day before. I never checked my temperature to tell if I had a fever. The night sweats continued into sunday night. I took 600mg of advil for the body aches and went to bed. When I woke up around 1:00 in the afternoon the body aches were gone and haven't returned. Sunday night I was sweating most of the night and felt over heated until around 11:00 Monday morning. I am always cold, I am the type who wears sweaters in the house all year long. For me to be that hot in the house is very unusual.
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| 42 | 2021-01-10 | pain in extremity |
Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pai...
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Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pain
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| 42 | 2021-01-10 | tingling |
"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling,...
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"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling, and pain in my right shoulder and neck. It steadily progressed, and by the morning of 12/25/20, I had almost no range of motion in my neck and right shoulder, and severe pain in my right shoulder/neck/upper back area (heat/ice/ibuprofen/Aleve/Tylenol offered zero relief) . This lasted for a few days, then steadily improved until I returned to work on 12/28/20, where I had mild-moderate pain and most of my range of motion had returned. I still feel like the muscles in my neck and shoulder are tight, but I?m doing stretching exercises with heat/ice at home and it seems to be working its way out. The other symptoms were expected and mild: fever, muscle/joint aches, fatigue. These symptoms come and go ? I?ve had them since being COVID positive in March/2020. Just to be extra safe, I was swabbed for COVID on the 30th and was negative."
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| 42 | 2021-01-11 | weakness | Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness. |
| 42 | 2021-01-11 | feeling hot |
became hot and sweaty in monitoring room. Stayed for 30minutes in monitoring room and symptoms reso...
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became hot and sweaty in monitoring room. Stayed for 30minutes in monitoring room and symptoms resolved and colleague returned to department to resume work. Symptoms re-occurred
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| 42 | 2021-01-11 | flushing |
Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush fa...
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Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush face
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| 42 | 2021-01-11 | migraine |
Migraine started at approximately 7:30pm and lasted through midday Saturday. Migraine was intense e...
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Migraine started at approximately 7:30pm and lasted through midday Saturday. Migraine was intense enough for me to have to call off sick from work on Friday.
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| 42 | 2021-01-11 | muscle spasms |
headache starting 1 hour after the injection and persists until present day, 1/12/21. Severe spasm l...
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headache starting 1 hour after the injection and persists until present day, 1/12/21. Severe spasm left trapezius muscle on same side as injection. I discussed by symptoms with my PCP and he advised I report as an adverse reaction.
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| 42 | 2021-01-11 | tingling, numbness |
Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face...
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Within approximately 20 minutes of receiving the vaccine, numbness and tingling was felt in the face, burning of the eyes, and a metallic taste was noticed in the mouth. However, all of these sensations went away on their own within five minutes of onset, without any intervention.
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| 42 | 2021-01-12 | weakness | weakness, breathlessness, pain at sight, body aches over two days I am not feeling better yet |
| 42 | 2021-01-12 | discomfort |
Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM...
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Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM-108 14:00 p.m. symptoms continuing, symptom improvement beginning at 13:00 p.m.
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| 42 | 2021-01-12 | numbness, pain in extremity |
1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted thro...
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1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted throughout the day. 1/9/21 - I woke up at 4am the follow day after receiving the vaccine and my left side of my face was numb, I could still taste metal in my mouth, I had a headache and pain in my right arm. I watch my symptoms and checked to see if I was having a stroke, but nothing pointed to that. 1/10/21 - I still was experiencing the same symptoms from 1/9/21 with not increased or decreasing of symptoms. Watched them throughout the day but nothing changed. 1/11/21 - I continued to have the same symptoms and reported to the ED after work for the symptoms listed above with no improvement. 1/12 & 1/13 - I continue to have the same symptoms with no changes.
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| 42 | 2021-01-12 | pain in extremity, inability to speak |
Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficul...
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Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficulty coming up with words to use Exhaustion
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| 42 | 2021-01-12 | pain in extremity |
About ten minutes after administration I began to feel prickly, burning on my arms which gradually g...
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About ten minutes after administration I began to feel prickly, burning on my arms which gradually got worse over the next 20 minutes and spread to my hands, sides, back and legs. Arms were very red. Informed clinic medical provider who took vitals. blood pressure was 186/116 o2 sat were normal. was given an im shot of benedryl and water, vitals were continued to be monitored and blood pressure came down to 145/84. Prickly burning sensation and redness continued. Went home and examined body and did have several hives on back and upper arm. slept due to benedryl, woke up to a very sore arm, achy joints but the prickly burning had mostly resolved. next day still feel tired and achy in joints but burning is gone.
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| 42 | 2021-01-12 | pain in extremity |
1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 ...
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1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.
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| 42 | 2021-01-12 | pain in extremity |
Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid posi...
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Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid positive via PCR swab.
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| 42 | 2021-01-12 | tingling, speech disorder, throat numbness |
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok...
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2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
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| 42 | 2021-01-12 | tingling |
Patient initially experienced tingling in left hand right after injection. This resolved but then sh...
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Patient initially experienced tingling in left hand right after injection. This resolved but then she began to have tingling in her lips. Then she had tingling at the tip of her tongue and then her neck began to feel stiff. Her blood pressure also rose to 145/72. Her baseline BP is usually 96/69. She was administered 02.ml epinephrine subcutaneously, Then when her lip tingling did not resolve, Benadryl 50mg IM injection was given. After 2 hours of observation, her symptoms resolved and she was released to go home. No ER visit was necessary.
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| 42 | 2021-01-12 | paralysis, tingling |
10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation st...
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10 minutes after the shot was given, I suddenly felt my heart was racing and a tingling sensation started from my left arm and radiated to my whole body. The sensation was very intense it felt like my whole body was being paralyzed. I was fading out because of high heart rate. My heart rate was 160 and I heard someone said my blood pressure was high. I was transferred to the ER and given epinephrine, anti-histamine, steroids.
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| 42 | 2021-01-13 | weakness |
Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when g...
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Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when going to bed. Overnight, I started to experience chills followed by extreme perspiration and weakness to the point that I struggled to open a bottle of water I had by my bed. Tuesday, 1/12/2021: Headache, weak and tired but attempted to work. I had to leave shortly after arriving because my symptoms were becoming progressively worse to the point I almost passed out from standing. Upon arriving home, I started to experience nausea and vomiting x 3. Intense chills followed by the extreme perspiration still existed. Most of these symptoms subsided by 9:30p that evening. Wednesday, 1/13/2021: Intense headache, weakness and dizziness. Of note, my left underarm/armpit (the arm where the vaccine was administered) is sensitive to touch.
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| 42 | 2021-01-13 | weakness |
Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a st...
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Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
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| 42 | 2021-01-13 | cold sweat |
Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facia...
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Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facial swelling around eyes.
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| 42 | 2021-01-13 | difficulty speaking |
reported hoarseness in the voice; itching and burning sensation around the throat; shortness of brea...
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reported hoarseness in the voice; itching and burning sensation around the throat; shortness of breath; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 17:00 at single dose in the right arm for COVID-19 immunisation. The patient had anaplasias to penicillin and COVID. The concomitant medications was none. The patient experienced hoarseness in the voice on 07Jan2021, itching and burning sensation around the throat in Jan2021. She had shortness of breath in Jan2021 related to COVID-19 infection. She has had COVID already so she isn't worried about that but wants to know if it is related to the vaccine or not, if this is something she needs to be aware of. The event started and gradually was getting worse. She had her inhaler from when she had COVID. The patient clarified she has also had some shortness of breath but this has been going on since having COVID. She did try the inhaler for the hoarseness and shortness of breath she had. She has been interment shortness of breath since having COVID and she is being tested for lung damage. The inhaler didn't change the hoarseness or shortness of breath. The product used was salbutamol (ALBUTEROL), Lot: PK0358, Expiry: Jun2022, NDC: 0093317431. She has had no reactions to vaccines previously, she had no vaccines on the day of or in the previous 4 weeks. She has not been to the doctor or ER related to the event. The outcome of the event hoarseness in the voice was not recovered. The outcome of other events was unknown.
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| 42 | 2021-01-13 | flushing, feeling hot |
1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with e...
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1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
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| 42 | 2021-01-13 | numbness, burning sensation |
Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (...
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Tingling and numbness on the left side especially the fingers and toes(1/13/21). Burning sensation (1/13/21)on the left armpit and later on axillary lymph edema(1/14/21)and heaviness of the arm. Itching and joint pain on left arm. Muscle pain ,cold and injection site pain since the evening of 1/12/21.
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| 42 | 2021-01-13 | numbness, tingling |
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ...
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acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
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| 42 | 2021-01-13 | pain in extremity |
Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is o...
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Patient reports soreness to the arm, she has a lymph nodes are the size of a "golf ball". This is on the right side. No other findings
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| 42 | 2021-01-13 | cold extremities, pain in extremity |
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o...
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headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-13 | tremor |
Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone...
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Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone pain especially neck, lower back and hips, headache and congestion.
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| 42 | 2021-01-14 | cold sweat |
I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 wit...
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I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 with severe body aches, cold sweats and shivering. It was hard to walk the body aches were horrible. I checked my temp and it was 100.3 F
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| 42 | 2021-01-14 | feeling hot | After second vaccine: light-headed, chills, hot, muscle aches, headache, light feeling |
| 42 | 2021-01-14 | flushing, feeling hot |
10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breath...
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10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breathing. BP 132/82 normally 110/60s. HR 70. 30 min post vaccine, palms felt itchy and slightly more sweat but overall improved. Within the hour, symptoms resolved and patient returned to work
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| 42 | 2021-01-14 | numbness |
from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and s...
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from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and started driving home I began to notice that my face was slightly numb (Iike I'd had too much novicaine). This was maybe 20-25 minutes after the dose. When I was home I also noticed that the back of my throat felt a little swollen. This probably lasted for a couple hours.
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| 42 | 2021-01-14 | numbness |
I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had ...
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I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had a pretty big immune response. the right side of my face got numb into my neck and my chest and I feel my lymph nodes turned into marbles. I also have swelling in my lymph nodes, my neck and my back. I sought medical care on Thursday due to the swelling and my PCP does not have a clue what to do.
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| 42 | 2021-01-14 | pain in extremity | SORE ARM |
| 42 | 2021-01-14 | tingling, burning sensation, numbness | Burning , tingling of arm down to left leg. Burning on back of torso. Numbness down left arm and leg |
| 42 | 2021-01-14 | tingling |
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti...
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5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
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| 42 | 2021-01-14 | tingling |
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti...
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After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
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| 42 | 2021-01-14 | tenderness |
After normal soreness at the injection site, she started with tenderness under in the axillary area....
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After normal soreness at the injection site, she started with tenderness under in the axillary area. States no change in skin; however, is tender to palpate or to have clothes rubbing
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| 42 | 2021-01-14 | tenderness | Swelling red tender and very itchy. |
| 42 | 2021-01-15 | tingling, numbness, feeling hot, feeling cold, pain in extremity, muscle spasms |
Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fl...
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Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fluttering? muscle spasms in deltoid 1330 numbness, tingling, muscle spasms in deltoid; 6/10 burning pain in upper arm/armpit, woozy/lightheaded 1345 driving home same as above, nausea, noticed more nasal congestion, post nasal drip 1400 increased nausea, increased symptoms in shoulder/armpit, 4/10 painful deltoid...soreness, burning pain; had a snack 1430 increased severity of symptoms 5-6/10 pain, weird numb feeling in shoulder, itchiness increased; took Tylenol 1530 increased nausea and now chills, cold, shooting cold pain left neck, neck/shoulder stiffness, intermittent ?fluttering? of heart but only for a few seconds (<15sec) 1615 5/10 worsening pain in L dorsal lower arm 1730 increased nausea, chills, cold shooting pain still present intermittently, numbness extends to medial & lateral upper arm 4-5inches from biceps tendon insertion 1830 feeling a little better after eating 2100 overwhelmingly tired, significantly less numbness and tingling, 6/10 pain/soreness in Left deltoid, stretched, took Tylenol, noticeable increase in nasal congestion, post nasal drip, no trouble breathing or cough, temp 97.5F 2200 increased L shoulder pain/muscle tightness, numbness gone, replaced by armpit 4/10 tenderness upon light palpation, alternating between chills and clamminess, feel really ?hot? despite oral temp 97.5F 01/16/2021 0100 6/10 shoulder pain/tenderness/stiffness, armpit significantly less tender 1/10, significantly less numbness or cold, shooting pain; feel really hot, almost sweating despite room temp 68F and oral temp 97.3F ?totally awake? 0130 got up, void x1, made chamomile tea, took 10mg melatonin, 500mg Tylenol, a ?little nauseated? 0800 woke up, 6/10 constant pain in left deltoid, no numbness, tingling or cold sensations 0830 Took Tylenol with breakfast and rest of vitamins 1200 increased pain (6/10) in L deltoid, mild nausea; increased lightheadedness, fatigue, and ?achy? feeling throughout body. 1230 Took Tylenol 1300 pain 5/10, mild nausea, and lightheadedness, but increased fatigue and ?achy? feeling throughout body 1700 mild/moderate constant pain in L deltoid, mild nausea, fatigue, achy feeling 1800 tookTylenol with dinner 2000 increased fatigue, mild achy feeling and chills, no nausea 2200 increased nausea, 5/10 constant pain in L deltoid Took Tylenol 500mg and went to sleep.
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| 42 | 2021-01-15 | tremor |
Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, sh...
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Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea
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| 42 | 2021-01-16 | muscle spasms |
1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/202...
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1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/2021 Muscle spams (neck) - body ached, lethargy - Took Tylenol 1/12/2021 Headache (sinus pressure) started fading at around 8 pm 1/13/2021 Lightheaded 1/14/2021 Lightheaded 1/14/2021 back to normal
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| 42 | 2021-01-16 | pain in extremity, weakness |
Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the mor...
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Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21. Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea. Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16. Also had hematuria that developed on 1/15. Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea. CBC, CK, CMP all normal but 1+ hematuria on U/A. Symptoms finally improved on 1/17
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| 42 | 2021-01-16 | tingling, pain in extremity, numbness |
"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I...
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"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I awoke with chills and sweats. No fever. Felt crummy all day. Today I have left shoulder and arm pain, swelling in my left armpit and under my arm. I also have some numbness and tingling through my arm down to my hand. I have a hard knot at the injection site but its not red. I also continue to have occasional chills."
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| 42 | 2021-01-17 | bell's palsy | Left sided Bells Palsy. |
| 42 | 2021-01-17 | feeling hot |
AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NA...
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AFTER INJECTION PATIENT FELT WARM SENSATION IN HER TORSO. PATIENT ALSO STATED SHE HAD A HEADACHE, NAUSEA AND BOIDY PAIN. PATIENT WAS PALE WHEN PLACED IN AMBULANCE AND GIVEN OXYGEN AND HAD HER FEET ELEVATED. PATIENT WAS IN AMBULANCE FOR ABOUT 25 MINUTES AND COLOR DID NOT COME BACK TO NORMAL EVEN AFTER THE OXYGEN ADMINISTRATION. THE PATIENT WAS ADVISED AND CONVINCED TO ALLOW THE AMBULANCE TO TRANSPORT HER TO HOSPITAL TO BE ASSESSED WHICH SHE AGREED TO. I CALLED THE PERSON ON 1/17/2021 @ 8:54 PM AND SHE STATED THAT SHE STILL FEELS A LITTLKE UNDER THE WEATHER BUT IT HAS GOTTEN BETTER
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| 42 | 2021-01-17 | flushing |
Pt was given Pfizer vaccine dose #1 and patient's face became flushed within 1 minute of administrat...
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Pt was given Pfizer vaccine dose #1 and patient's face became flushed within 1 minute of administration. Pt has hx of multiple allergies. Pt was asked to take mask off and redness subsided within 5 mins. Pt then reported having numbness/tingling in tongue and lips. Pt was monitored for a total of 36 minutes per RN. Pt reported no further symptoms and noted improvement of symptoms. She was discharged to home with husband, who was also present for the event.
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| 42 | 2021-01-17 | migraine |
Elevated BP with migraine headache. BP 160/104, HR 106. Reported- visited doctor and BP returned to...
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Elevated BP with migraine headache. BP 160/104, HR 106. Reported- visited doctor and BP returned to normal.
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| 42 | 2021-01-17 | tingling, numbness |
PATIENT AFTER RECEIVING VACCINE AND WAS AT THE WAITING AREA FELT SOME TINGLING AND NUMBNESS IN HER F...
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PATIENT AFTER RECEIVING VACCINE AND WAS AT THE WAITING AREA FELT SOME TINGLING AND NUMBNESS IN HER FACE ON THE LEFT SIDE. THE PATIENT WAS ASKED IF SHE WAS HAVING ANY TROUBLE BREATHING AND SHE SAID NO. PATIENTS VITAL SIGNS WERE TAKEN OVER A PERIOD OF AN ADDITIONAL 30 MINUTES OF WAIT TIME. AFETR THE 30 MINUTES THE VITAL SIGNS WERE TAKEN AGAIN AND FOUND TO BE NORMAL AND THE PATIENTS TINGLING AND NUMBNESS SUBSUSIDED. SHE DID NOT WANT TRANSPORT TO HOSPITAL AND SIGNED AN RMA. PATIENT WAS ASKED TO CALL WHEN SHE GOT HOEM AND A CALL WAS RECEIVED AT 12:03 AM FROM THE PATIENT WHO ALSO STATED SHE TOOK BENADRYL.
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| 42 | 2021-01-17 | tingling, muscle twitching, nerve pain, weakness, numbness |
couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind...
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couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-17 | tingling |
Employee reported palpitations 5 minutes after vaccine was administered then began having rash on ch...
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Employee reported palpitations 5 minutes after vaccine was administered then began having rash on chest and tingling in lips and face. Benadryl 25mg and Epi-pen were administered. Symptoms got better and employee went home. Had to go back to Emergency Room for tingling all over and flushing to face.
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| 42 | 2021-01-18 | burning sensation |
mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; Thi...
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mild redness; mild swelling; itchy; burning; swelling to the eye; mild rash around her left eye; This is a spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 08Jan2021, 10:45 AM on Right arm at single dose for covid-19 immunisation. Medical history included juvaderm under her eye approximately 1 year and half to two years ago. Prior to vaccination, the patient did not diagnose with COVID-19. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 42-year-old on an 18Dec2020, 11:15 AM on Right arm at single dose for covid-19 immunisation. Day after the 2nd dose, the patient had a mild rash around her left eye only on 09Jan2021. 3rd day (11Jan2021) swelling to the eye. The day of this report is 4 days post vaccine (12Jan2021), the patient mild redness mild swelling but remain itchy and burning. The patient did not report to her dr as the symptoms seem to be resolving on its own. No covid tested post vaccination. No treatments were received. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 42 | 2021-01-18 | feeling cold |
Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, ...
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Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, arm began to feel cold at injection site area. At that point the patient realized the vaccine was given toward the back of upper left arm near the fatty tissue instead of toward the middle of the arm. Approximately 20 min after vaccine administration, patient became short of breath, dizzy, light headed, and throat felt a little swollen and almost passed out. A rapid response was called and the patient was seen by Occupational Health. The patient's BP and heart rate were elevated but normalized during observation in Occupational Health. At this time, the patient did not feel they needed to be seen in the emergency department. The patient was discharged home at this time. 12 hours after the shot, the patient began experiencing normal side effects from the vaccine. The nursing student was informed of administration at the incorrect site.
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| 42 | 2021-01-18 | feeling hot |
Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my che...
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Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my chest. I felt like I couldn't breathe. All day that day I has also experienced feeling hot but I never got a fever. The chest pressure last for a few hours every time I tried to get up. I had a couple of minor episodes over the next 2 days where my heart rate went into the 120's and I felt slightly short of breath but no pressure.
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| 42 | 2021-01-18 | tingling | c/o tingling of face and tongue, metallic taste |
| 42 | 2021-01-18 | cold extremities |
Fever 101.8, sore throat, drowsy, severe malaise, achy joints, shivering, head ache, cold hands and ...
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Fever 101.8, sore throat, drowsy, severe malaise, achy joints, shivering, head ache, cold hands and feet
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| 42 | 2021-01-19 | weakness |
Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 tha...
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Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 that lasted around another 20 hours. Muscle aches, weakness, fatigue and decreased appetite for duration of fever. Took excedrin for severe headache once fever broke. Symptoms completely resolved 12h later, after sleeping.
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| 42 | 2021-01-19 | weakness |
within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all ov...
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within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all over & I asked for Benadryl. I was taken to the ED dept. I was given zofran 4mg and Meclizine for vertigo and IV after 4 hrs. I Was told to go home and sleep it off. I've home with joint pain, muscle aches, nausea, abdominal pain, foggy mind, tiredness, weakness. Saw my PCP today. Rest, zofran and meclizine PRN hydration and rest.
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| 42 | 2021-01-19 | bell's palsy, numbness |
EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting...
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EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
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| 42 | 2021-01-19 | involuntary muscle movements, sensory loss, throat numbness, numbness |
About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throa...
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About 20 min after receiving my Covid 19 vaccine, I left Hospital and began to feel numb in my throat, my lower face, and the tops of my shoulders. I had reduced sensation, but also felt as though I had no muscle control with movement. Examples of this are when I tried to flex my head forward as if in a nodding motion, or to elevate my shoulders like a shrug, or clench my jaw like when chewing. These were all extremely difficult and I felt as though I had no awareness of if I was even moving these parts of my body whatsoever when I tried to voluntarily do so. It was very strange and also upsetting. I also began to have blurred vision; it was difficult to focus or see properly, such as when you visit the eye doctor and they dilate your pupils and everything seems blurry and out of focus for a period of time afterwards. This all lasted for about exactly 1 hour post. I did not seek medical attention for this as it did not worsen. I never had any difficulty breathing. It then completely went away.
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| 42 | 2021-01-19 | migraine |
Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until...
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Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.
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| 42 | 2021-01-19 | pain in extremity, weakness |
Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid...
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Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.
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| 42 | 2021-01-19 | pain in extremity |
arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treat...
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arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treated with ibuprofen, Tylenol, Zofran which has helped some, but all comes back and now for 2 weeks.
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| 42 | 2021-01-19 | pain in extremity |
When went from sitting to standing position noticed pain/numbness on bottom of left foot. When wen...
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When went from sitting to standing position noticed pain/numbness on bottom of left foot. When went to walk, pain shot up through foot with each step, making it difficult to walk. This lasted for approximately 35 feet before resolving.
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| 42 | 2021-01-20 | weakness, pain in extremity |
pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and ...
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pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 42 | 2021-01-20 | facial paralysis |
Acute Bell's Palsy right side occurring on 1/16/2021, total right sides facial palsy involving eyeli...
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Acute Bell's Palsy right side occurring on 1/16/2021, total right sides facial palsy involving eyelid, mouth, decreased salivary secretion, facial, ear, mastoid pain. Started prednisone 60mg daily and Acyclovir 400mg po 5x/day on 1/17/2020 x 1 week course. No improvement since onset.
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| 42 | 2021-01-20 | feeling cold | Fever, chills, body aches, nausea |
| 42 | 2021-01-20 | hypersensitivity of all senses |
minor allergic reaction; small hives on her thumb; skin was sensitive; This is a spontaneous report ...
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minor allergic reaction; small hives on her thumb; skin was sensitive; This is a spontaneous report from a contactable consumer reported for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration at the right arm on 12Jan2021 15:15 at single dose for Covid-19 immunization in a hospital. Medical history included hyperthyroidism, allergies to medication, allergies to food. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021 07:30, the patient thought she was having a minor allergic reaction, she had some small hives on her thumb earlier and her skin was sensitive. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment due to the events. The outcome of the events minor allergic reaction, small hives on her thumb, and skin was sensitive was recovering. The reporter considered the events non-serious which did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
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| 42 | 2021-01-20 | numbness | transient numbness in left arm resolved within 10 minutes of onset. |
| 42 | 2021-01-20 | pain in extremity |
High fevers; chills; sweating; Extreme knee joint and calf muscle pain; Extreme knee joint and calf ...
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High fevers; chills; sweating; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) on 09Jan2021 08:00b for Covid-19 immunisation, administered at hospital. Medical history included Crohn's disease, allergies to sulfa drugs. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 19Dec2020 14:30 for Covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced high fevers, chills, sweating and extreme knee joint and calf muscle pain on 09Jan2021 20:30. No treatment received. Post vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information about Lot/Batch number is requested.
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| 42 | 2021-01-20 | pain in extremity |
Vaccine received on Jan 18-- Jan 19th- body aches, fever,fatigue jan 20th- body aches, fatigue jan ...
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Vaccine received on Jan 18-- Jan 19th- body aches, fever,fatigue jan 20th- body aches, fatigue jan 21st-rash on left hand/arm- left arm pain
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| 42 | 2021-01-20 | tremor, pain in extremity |
14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120....
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14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms . At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea . I messaged my Dr the next AM. By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine. It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches and nausea as well.
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| 42 | 2021-01-21 | pain in extremity, electric shock sensation |
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ...
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12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
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| 42 | 2021-01-21 | pain in extremity, tenderness |
Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axill...
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Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axilla/ breast, tenderness soreness to left brachial inner elbow up left bicep into axilla
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| 42 | 2021-01-21 | tremor |
Systemic: Chills-Medium, Systemic: Joint Pain-Medium, Systemic: Shakiness, weakness in the legs-Medi...
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Systemic: Chills-Medium, Systemic: Joint Pain-Medium, Systemic: Shakiness, weakness in the legs-Medium
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| 42 | 2021-01-22 | tingling, discomfort, pain in extremity |
At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg...
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At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg Advil max. At minute 45 after shot, I began to feel light tingling under my skin near the injection site, which slowly progressed to my elbow then my shoulder then my wrist, then to my neck and chin (all on left side) at which point I asked the HCP who gave the shot if I should take an antihistamine, she asked me if I was having trouble breathing and I said no, she recommended I take 500 mg of Benadryl 3x every 8 hrs. I took the dose about 75 min after my shot, by which time I felt tingling in my foot and pain in my wrist, slight feverishness. Fell asleep, woke up 4.5 hrs after the shot. The tingling sensation was gone. Only some drowsiness and pain in my arm. Applied ice pack to arm, took 250 mg Benadryl at 9.5 hrs after shot and woke up next morning with negligible symptoms, mild arm pain.
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| 42 | 2021-01-23 | bell's palsy, tingling, slurring |
Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech, no left facial mo...
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Bells Pallsey event Left arm, face, tongue numbness and tingling, slurred speech, no left facial movement Last approximately 1hr 1/2 then full function returned
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| 42 | 2021-01-23 | muscle spasms |
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, ...
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Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
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| 42 | 2021-01-24 | weakness, feeling cold, pain in extremity |
Timeline reported by patient as follows. Monday: 1-4-2021 Cold feeling down my arm, within 30 mins ...
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Timeline reported by patient as follows. Monday: 1-4-2021 Cold feeling down my arm, within 30 mins felt nauseous- got something to eat since didn't eat before- felt better throughout the day until around 3 pm. That is when my arm was very sore and pain down my right leg. This pain increased throughout the evening and other joints were affected including hips shoulders sternum, knees and ankles- overall body aches. Difficulty sleeping due to pain. Low grade fever of 99.9. Tuesday: 1-5-2021 Very sore arm but went away by midafternoon. about 5:30pm started having stabbing stomach pains that came and went throughout the night. Heat applied to help a little bit. Low grade fever 99.6 Wednesday: 1-6-2021 Woke up with some stomach pain but not stabbing. Still had body aches and still not able to sleep through the night (this is uncommon for me- i sleep hard through the night)- Keft work early due to not feeling well. Temp 99.9 Thursday: 1-7-2021 Tired, body aches, still some stomach issues, not able to sleep through the night Friday:1-9-2021 Tired, stomach feels unsettled, body aches, up again throughout the night Saturday: 1/10/2021 Tired, no energy, stomach feel nauseous at times, body aches still present- tried to get some sleep during the day as well Sunday: 1-11-12021 Tired, still not restful sleep, bodys aches, chills, temp 99.9 Monday: 1-12-2021 Woke up in pain throughout body, some nausea, fever comes and go with high of 99.9 and low of 97.8. Chills with the higher temp., Emotional unable to stop crying for no reason (maybe because I'm not getting sleep?) Took 1/2 day of PTO due to not feeling well. headache Tuesday: 1-13-2021 Took PTO all day Pain throughout the body, nausea, exhausted, still not able to sleep all the way through the night- up multiple times for multiple hours, trying to get sleep thoughtout the day but still not getting a lot. Wedensday: 1-14-2021 Took PTO, continued body aches, stomach issues, no fever Thursday: 1-14-2021 Body aches, stomach pain and issues, no fever as of yet, headache,
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| 42 | 2021-01-24 | feeling cold |
Saturday 01/23/2021 staff started having headache and chill. Sunday, staff started sore throat. To...
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Saturday 01/23/2021 staff started having headache and chill. Sunday, staff started sore throat. Took Tylenol but it didn't help. On 01/19/2021 Covid test done and the result was negative. Scheduled 2nd vaccine on 01/28/2021.
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| 42 | 2021-01-24 | feeling hot |
Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, he...
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Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.
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| 42 | 2021-01-24 | feeling jittery |
About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, ...
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About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
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| 42 | 2021-01-24 | flushing |
reports that on 1/21 she received 2nd dose of Covid vaccine. Went to work Friday 1/25--started havin...
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reports that on 1/21 she received 2nd dose of Covid vaccine. Went to work Friday 1/25--started having chills, body aches, HA. On Saturday,- fever and chills, body aches, HA. Reports on Sunday she felt slightly better, but still some s/s. Today 1/25: reports she feels flushed and HA still present.
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| 42 | 2021-01-24 | hot flush | Felt miserable, collapsed, blacked out for unknown length of time, diarrhea, sweating, hot flashes. |
| 42 | 2021-01-24 | numbness |
Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; m...
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Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.
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| 42 | 2021-01-24 | numbness |
Left side of face is numb, increases with nasal congestions, below cheek and above eye but vision is...
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Left side of face is numb, increases with nasal congestions, below cheek and above eye but vision is not affected at this time, no noticeable facial droop. So far cannot tell by looking at face. started out feeling like "tingly after seeing the dentist" then turned to numb and progressed to the eye. now eye is numb.
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| 42 | 2021-01-24 | migraine |
Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I...
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Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I had temperature of. 101.8. Achy, body/joints, headache. About 11pm I had a temp of 102.8. All the same symptoms, slightly heavy chest with breathing but not problematic. Very tired and no energy.The symptoms 36 hrs. Medication to help reduce fever did not work. After 36 hours I felt better except I still had no energy, and I had a migraine that lasted approximately 5 days ( lasted through Sunday January 10, 2021) I am a white female with red hair.
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| 42 | 2021-01-24 | pain in extremity, tingling, numbness, facial paralysis |
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j...
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left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-24 | pain in extremity |
Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after...
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Approximately 12 hours after receiving the second dose of Covid I begin having chills. Shortly after that I also experienced nausea bodyaches headache lack of appetite dizziness as well as a sore arm with redness at the injection site. My arm is red, warm to touch, firm and has gotten slightly larger since day 2. It is now day 4 and I still have this red welt on my arm that is tender to touch. The other symptoms resolved after 24 hours.
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| 42 | 2021-01-24 | pain in extremity |
Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to sho...
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Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to shoulder, red swelling at injection site and hot to the touch, fatigue, and minor body aches. Pain at injection site started first at around 4pm on the day of the 2nd dose(Th). I woke the next morning (Fri) with arm pain and a little tired. Later that day around 4pm the fatigue, chills and fever started. Fever hit 101.5F overnight and then the fever broke by the morning (Sat). I felt a little tired on Sat, but all that remained as pain, redness and the feeling of a knot at the injection site (improved from Fri). Today (Mon) the knot still remains and the pain is gone. Slight pink around injection site, but much better.
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| 42 | 2021-01-24 | pain in extremity |
No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with ...
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No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with hives, uticaria, and mild angioedema that has not yet subsided despite having received treatment. was told it could be a late reaction and that i should report it.
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| 42 | 2021-01-24 | pain in extremity |
12 hours after receiving the first dose I started having chills. Shortly after that I begin to exper...
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12 hours after receiving the first dose I started having chills. Shortly after that I begin to experience nausea vomiting bodyaches dizziness headache and arm soreness. This lasted for approximately 24 hours. After that symptoms went away except for arm soreness which lasted for a few more days.
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| 42 | 2021-01-24 | pain in extremity |
Initially was just arm soreness and then 3 days later I woke up and noticed swollen glands on my col...
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Initially was just arm soreness and then 3 days later I woke up and noticed swollen glands on my collarbone and on my neck and on the side of my neck on the left side, they were tender and mobile. They got considerably smaller in a week but it took about a 2 weeks and one of them went away I still feel the others. Consulted with PCP who ordered labs. All normal results.
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| 42 | 2021-01-24 | tremor |
Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable c...
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Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 42 | 2021-01-24 | tremor |
12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injec...
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12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injection site, extreme fatigue, high fever (103), shaking, muscle/body aches, nausea
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| 42 | 2021-01-25 | weakness |
Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, h...
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Extreme fatigue, weakness, slept 36 hrs, stomach cramping, nausea, diarrhea, chills, muscle aches, headaches, chest pain, tachycardia up to 201, bp up to 210/101 with no cardiac history
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| 42 | 2021-01-25 | bell's palsy | Development of mild right sided Bell's Palsy 16 days after second Pfizer COVID vaccination |
| 42 | 2021-01-25 | cold sweat |
Woke up at 01:00 with severe body aches; was hard to walk or move; cold sweats; Chills; fever of 100...
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Woke up at 01:00 with severe body aches; was hard to walk or move; cold sweats; Chills; fever of 100.3 F; This is a spontaneous report from a contactable nurse reported for herself. A 42-years-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular on 14Jan2021 10:00 at single dose on left arm for covid-19 immunisation. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), clonazepam (KLONOPIN), quetiapine fumarate (SEROQUEL), aspirin [acetylsalicylic acid] (ASPIRIN). The patient received first dose of COVID 19 for covid-19 immunisation at 42-years-old, lot unknown=False, administration date=on 24Dec2020 09:00 AM, administrator route=Intramuscular, vaccine location=Left arm. The patient experienced woke up at 01:00 with severe body aches, was hard to walk or move, cold sweats, chills, fever of 100.3 f on 15Jan2021 13:00. Lab data included body temperature 100.3 f on 15Jan2021 13:00. The event outcome was recovering. No treatment was received for the adverse event. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 42 | 2021-01-25 | feeling hot | Felt hot |
| 42 | 2021-01-26 | weakness |
DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK ...
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DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK 5 DAYS TO RESOLVE. WAS PRESCRIBED AN INHALER BY PCP (UNSURE WHAT IT WAS)
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| 42 | 2021-01-26 | bell's palsy | The patient presented with L side Bell's Palsy |
| 42 | 2021-01-26 | facial pain, tingling |
Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1...
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Herpes Zoster (Shingles)- tingling, rash, sharp shooting pains all on left side of face. Acyclovir 1 GM tablet TID
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| 42 | 2021-01-26 | migraine, numbness, tingling |
Within a few minutes right hand and forearm (shot arm) was numb then tingling and neck got hot. On ...
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Within a few minutes right hand and forearm (shot arm) was numb then tingling and neck got hot. On the drive home developed a headache. No fever. Day 2 migraine like headache most of the day and numb right hand when woke up, shot sight sore Day 3 better slight headache, shot site sore Day 4/5 woke both mornings by migraine like headache that went to neck (neck and shoulder pain) Day 6 okay so far
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| 42 | 2021-01-26 | migraine, numbness |
Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept fo...
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Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept for 16 hours
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| 42 | 2021-01-26 | migraine |
About 7 hours after I started to get migraine/sinus pain Dizzy Exhausted Arm pain at injection site ...
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About 7 hours after I started to get migraine/sinus pain Dizzy Exhausted Arm pain at injection site Fever and chills that rolled in and out The above symptoms lasted for three days. The extreme exhaustion lasted for 9 days. I was sleeping the whole night and taking 2-3 naps throughout the day for 2-3 hours.
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| 42 | 2021-01-26 | pain in extremity, weakness |
Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Sti...
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Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Still have headache not as severe and weakness a little less but still have all symptoms except chills.
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| 42 | 2021-01-26 | pain in extremity, tingling, numbness |
While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face ...
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While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face began to feel numb and tingly. I immediately took Benadryl when I arrived home and had no further facial symptoms. However, approximately 23 hours post vaccination I developed a fever of 102 and chills that lasted approximately 6 hours. After the fever broke, I have had no further symptoms other than a sore arm and have not missed any work.
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| 42 | 2021-01-26 | paralysis, speech disorder, tingling |
heart started to race; tingling sensation from her left arm that radiated to all over her body to th...
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heart started to race; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed; heart rate jumped to 160; heart rate jumped to 160 and blood pressure went up; choking sensation on her neck; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date), dose number 2 via an unspecified route of administration on 12Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history was not reported. The patient did not have COVID prior vaccination. The patient previously took nitroglycerin and experienced drug allergy. Historical vaccine included BNT162B2 (lot number EL0140, dose number 1) for immunization on 22Dec2020 after which the patient experienced mild headache. Concomitant medications were not reported. There were no other vaccines received within 4 weeks. The patient had no adverse reaction other than mild headache after the first dose, so she was very relaxed and she felt comfortable getting the 2nd dose. However, after 10 minutes after the second dose, her heart started to race and she started to feel a tingling sensation from her left arm that radiated to all over her body to the point where she felt paralyzed. Her heart rate jumped to 160 and her blood pressure went up. She couldn't even open her eyes nor speak a word. She was transported to the ER and was given steroids and anti-histamine. She refused to get an epinephrine shot at first, but she started to feel choking sensation on her neck so she asked for an epi shot. The patient had not been tested for COVID post-vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events heart racing, tingling sensation, paralyzed, heart rate high, blood pressure increased and chocking sensation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-27 | pain in extremity | Fever, extremely sore arm (could barely move it), terrible headache, body aches. |
| 42 | 2021-01-27 | tingling |
After 10 days, still have fatigue and facial and scalp tingling (comes and goes). Pain in injection...
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After 10 days, still have fatigue and facial and scalp tingling (comes and goes). Pain in injection site reoccured overnight (night 10) and injection site is sore to the touch after 10 days. New feeling of some leg weakness today. First seven days included fatigue, chills, facial/scalp tingling, headache.
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| 42 | 2021-01-28 | feeling hot |
Severe vomiting lasting 10.5 hours, Fever 101.7, headache, chills, hot sweats. All all lasting bet...
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Severe vomiting lasting 10.5 hours, Fever 101.7, headache, chills, hot sweats. All all lasting between 12am-10:30am. After the vomiting subsided I was able to take Tylenol for the fever and all symptoms resolved.
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| 42 | 2021-01-28 | feeling of body temperature change |
Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 h...
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Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 headache, body ache, chest pain probably from coughing. Cough was deep and hard in the morning after waking through out the morning I would cough a couple more time by noon I'm not coughing but my chest is heavy.
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| 42 | 2021-01-28 | flushing |
Sudden onset of flushing of the chest and upper extremities, subjective throat tightness and tongue ...
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Sudden onset of flushing of the chest and upper extremities, subjective throat tightness and tongue swelling not evident on exam. Onset within 10 minutes of administration, provided 50 mg diphenhydramine, symptoms resolved within 1 hour completely. No wheezing, stridor, urticaria.
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| 42 | 2021-01-29 | numbness, flushing |
Elevated heart rate, dizziness, flushing, numbness in hands - twice, one and five hours after shot. ...
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Elevated heart rate, dizziness, flushing, numbness in hands - twice, one and five hours after shot. Passed by itself.
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| 42 | 2021-01-29 | pain in extremity | Fever 100.8. Body aches. Headache. Fatigue. Nausea. Arm pain |
| 42 | 2021-01-30 | pain in extremity |
That evening I felt my arm painful, warm to touch and felt like a hard ball at the injection site wh...
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That evening I felt my arm painful, warm to touch and felt like a hard ball at the injection site while I was trying to sleep. The next day I looked and saw there was a red circle around the injection size about the size of a quarter, now it?s the size of a silver dollar still red, hot, hard, and painful.
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| 42 | 2021-01-30 | tremor |
The morning after vaccination, fever to 100.7, severe body aches from the waist down (especially low...
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The morning after vaccination, fever to 100.7, severe body aches from the waist down (especially lower back, buttocks and thighs) and severe fatigue. These symptoms lasted all day. For a 5 hour period lasting 18 to 23 hours following the vaccination, I also had severe chills. I laid under 8 layers of blankets and still could not feel warm and stop shaking (that was the most severe period of symptoms). The next day I awoke feeling normal, just tired form the day prior.
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| 42 | 2021-01-31 | numbness | Left facial numbness |
| 42 | 2021-01-31 | pain in extremity | Body aches, fever = 101.5, swelling in arm, soreness in arm |
| 42 | 2021-02-01 | weakness, pain in extremity |
Reported to me over the phone:The night of the vaccination the left arm became very painful and swol...
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Reported to me over the phone:The night of the vaccination the left arm became very painful and swollen. The next day the swelling continued into armpit, noticed chills from waist down and a decrease in ROM with weakness.
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| 42 | 2021-02-01 | weakness |
approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my...
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approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my heart racing, throat swelling, chills,weakness, tired, pain and swelling at injection site(right arm)
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| 42 | 2021-02-01 | burning sensation |
very tiny rashes on the back of her right hand; cannot see them but she can feel them since they are...
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very tiny rashes on the back of her right hand; cannot see them but she can feel them since they are drying , reports it is a burning sensation; This is a spontaneous report from a contactable consumer reporting for self. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Dose 1) as a single dose, right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Dec2020 in the morning, she had very tiny rashes on the back of her right hand, opposite side of her palm; she received the injection in the right arm. The very tiny rashes were there for 4 or 5 days and then slowly disappeared. Then the same rashes came back again on the same hand. She stated she "cannot see them but she can feel them since they are drying;" she reported it as a burning sensation and she wished she could put something cool on there. At the time of the report, the rashes and burning sensation were going away(recovering). She took a picture of it and she can send that in. She can get the second dose today or tomorrow and wanted to know if it was ok for her to get the second dose. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 42 | 2021-02-01 | facial paralysis, facial pain |
facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-y...
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facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on an 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history includes ongoing facial paralysis (it was reported that the patient experienced facial paralysis caused by stress a couple of year ago and then again after the vaccination). Concomitant medications were not reported. The reporter felt worried about the patient (partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of COVID-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. As of 15Jan2021, it was reported that the patient experienced facial paralysis caused by stress a couple of years ago and then again after the vaccination (24Dec2020). The patient also experienced pain in face on 24Dec2020. The patient underwent MRI on an unspecified date. Treatment was given for the events facial paralysis and pain in face (Anti-inflamatories). The outcome of the stress was unknown while not recovered for the other events. Information on the lot/batch number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: country of incidence was updated. Additional information received on 15Jan2021 from a contactable nurse includes: patient details (medical history and lab data), product details (therapy dates), reaction data (additional event: pain in face) and clinical course details.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of facial paralysis cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 42 | 2021-02-01 | facial paralysis | After first vaccine had LR rash after second vaccine had Bell?s palsy possible stroke |
| 42 | 2021-02-01 | flushing, feeling hot, tingling |
Pt noted she "tingling" in her left hand and her arms/face/neck became very hot and flushed approxi...
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Pt noted she "tingling" in her left hand and her arms/face/neck became very hot and flushed approximately 20 min after injection . This progressed into red itchy bumps she described as "hive - like" 3 hours after vaccine administration. She did not seek medical attention and denies any tongue swelling or difficulty breathing. She took benedryl that helped with the itching. She notes the "tingling" resolved in 6 hours, "flushing" improved in 9 hours and the hives resolved as of 02/01/2021 at 1130 AM.
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| 42 | 2021-02-01 | muscle spasms, flushing |
Heart palpitations, flushing, stomach upset with loose stools, headache, leg cramps, fatigue resolve...
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Heart palpitations, flushing, stomach upset with loose stools, headache, leg cramps, fatigue resolved within 12 hours
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| 42 | 2021-02-01 | pain in extremity |
Pain in left arm at 0200 woke me up and kept me awake. By noon on 1/12 I had fever that got to 101,...
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Pain in left arm at 0200 woke me up and kept me awake. By noon on 1/12 I had fever that got to 101, but responded to Tylenol. Ongoing chills. Fatigue, headache. All common side effects of vaccine per the education given at the time of the shot. I did go to work on 1/12 but ended up leaving around 1000. Fever, chills resolved around 0500 on 1/13. Fatigue, headache resolved around 1300 on 1/13. This is my 2nd baby, due June 7th 2021. All normal pregnancy so far. Recently had 20 week anatomical ultrasound that showed baby has slightly large tummy, doc will check for gestational diabetes at 28 weeks, did not express major concern.
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| 42 | 2021-02-01 | tingling | tingling in hands |
| 42 | 2021-02-02 | feeling hot, flushing |
Patient received her 2nd dose of the Pfizer Covid 19 vaccine at 8:30 am. At approximately 9:48 am sh...
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Patient received her 2nd dose of the Pfizer Covid 19 vaccine at 8:30 am. At approximately 9:48 am she returned appearing flushed and reporting that she felt very warm and was having trouble cooling down. She appeared 'blotchy' on her upper chest region, but no rash or hives anywhere else on her body. We had her lay down and checked a blood pressure, with a result of 132/70. Cold compresses were applied to the back of the neck and the forehead to help cool her down. Later rotated from the back of the neck to the upper chest/neck region. Patient was observed for 15-20 minutes by the administering pharmacist and nursing staff. During that time she appeared less flushed and redness on the chest region improved. She reported feeling improved and returned to work, with regular checks made by nursing staff to ensure symptoms did not return.
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| 42 | 2021-02-02 | muscle spasms |
1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was use...
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1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was useless. I had muscle weakness and joint pain down to my wrist. I had to do old physical therapy exercises, ice pack on upper arm, and took tylenol (really wanted to take advil). Saturday evening: I discovered my lymph gland was swollen and very sore under my left arm. Took a hot shower and it helped. As long as I don't wear a regular bra it's ok. Sore to touch or if I moved my arm a lot. Tylenol (again with the advil)and heating pad. Still sore today. Creeps me out. I also, slept all day Saturday. Took a long nap Sunday. Went to the clinic on Monday, back to another clinic on Tuesday-Tuesday was when I had the extreme exhaustion. I napped for 3 hours in the afternoon and was so tired and woozy when I woke up. I had brain fog. Couldn't concentrate or care about much for awhile. Today, I slept in, and feel fineat the moment. Waiting to see if I have that nap exhaustion thing. I plan to walk some and go pick up some Vitamin C and Zinc supplements today.
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| 42 | 2021-02-02 | tingling, bell's palsy | slight tingling in fingertips of L hand, neck tension below jaw line, h/o Bells Palsy |
| 42 | 2021-02-02 | tingling |
She took the first Pzfier vaccine December 16 and 6 days later, she had complete hearing loss in lef...
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She took the first Pzfier vaccine December 16 and 6 days later, she had complete hearing loss in left ear. She first noticed the loss of hearing occurred after a run. The pt had a piercing headache and the next morning she could not hear out of left ear. She recalls having a slight headache and tingling on the left side of her face, just after the vaccine. MRI of the brain normal. Prednisone taper, starting at 60 mg and received intratympanic steroid injections. The steroid did not help her regain her hearing. She was then seen by doctor and underwent a dozen hyperbaric O2 therapy. Pt is beginning to get her hearing back in left ear.
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| 42 | 2021-02-03 | involuntary muscle movements |
(This RN was not direct observer of initial incident. Initial events as reported by initial respondi...
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(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event. VS @0915- BP 128/77 HR 131 Sats 100% on RA. 0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband who was en route. VS @ 0940- HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109 sats 100% on RA. Husband, to bedside. Pt remains alert. 1007 EMS arrives for transport to Emergency Department
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| 42 | 2021-02-03 | hot flush |
I have had hot flashes two days after my vaccination.; I have them every night since and have not be...
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I have had hot flashes two days after my vaccination.; I have them every night since and have not been sleeping well due to them; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 05Jan2021 15:30 at single dose for covid-19 immunisation. The patient's medical history included Known allergies: PCN, latex, eggs. The patient was not pregnant at time of vaccination. There were no concomitant medications. On 07Jan2021 22:00, the patient has had hot flashes two days after vaccination. The patient has never had hot flashes before. The patient have them every night since and have not been sleeping well due to them. The patient did not received treatment for the events. The outcome of the events was not recovered.
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| 42 | 2021-02-03 | migraine | Headache- migrane, chills, muscle soreness, lethargy/ tiredness, lack of appetite/ nausea |
| 42 | 2021-02-03 | migraine |
42 yo female presented at urgent care 3 days after receiving covid 19 vaccine with migraines. Patien...
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42 yo female presented at urgent care 3 days after receiving covid 19 vaccine with migraines. Patient with past medical history of migraine in the past. Per provider assessing patient believes her symptom of headache was consistent with past migraine. Patient states she received vaccine 1/14/21 and had dizziness and chills for a day that resolved. Then yesterday she began to have a migraine which was similar to her migraine presentation in the past. Patient given ketorolac x1 and Zofran x1. Patient prescribed Zofran . Pt instructed to continue home Imitrex and follow-up with PCP.
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| 42 | 2021-02-03 | pain in extremity | Dizziness, sore arm |
| 42 | 2021-02-04 | pain in extremity, burning sensation |
On Saturday, her arm was sore, having chills, fatigued as well. The symptoms kind of went away. On...
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On Saturday, her arm was sore, having chills, fatigued as well. The symptoms kind of went away. On Thursday night, 1/28/21 had burning sensation on her feet, like fire on her feet. Went to bed, the feeling went over her entire body. The sensation continued on her hands and her feet. She went to the ER on Saturday morning, early in the AM on 1/30/21, informed her hemoglobin was a little low. Said that it could be neuro, saw her doctor and informed that she had received the vaccination and he prescribed Gabapentin for the neuropathy. He did blood work and going to check what would trigger the neuropathy pain.
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| 42 | 2021-02-04 | pain in extremity | Pain in arm Pain in shoulders and neck Very bad nausea Vomited once Fatigue |
| 42 | 2021-02-04 | tingling |
Tingling in left hand, specifically thumb and index finger. Not fully numb. Hasn't gotten better o...
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Tingling in left hand, specifically thumb and index finger. Not fully numb. Hasn't gotten better or worse since 10 min after injection. Time is now 8:35 pm
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| 42 | 2021-02-05 | tingling, numbness |
Patient self pre-medicated with diphenhydramine at 0730 due to reaction from Pfizer 1st COVID vaccin...
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Patient self pre-medicated with diphenhydramine at 0730 due to reaction from Pfizer 1st COVID vaccination. Today 2/5/2021, 2nd vaccination approximately 0800. Started to feel chills and numbness/tingling in left arm which was vaccination side. Then developed numbness/tingling in both legs below the knees. Placed on pulse oximeter and vitals monitored. Vital signs normal although initially blood pressure elevated but came back down. ~0830 Patient placed on gurney, covered with warm blankets and given oral medications: diphenhydramine 25mg, famotadine 20mg, acetaminophen 500mg. At 0930 patient taken to ED as symptoms were not resolving. Patient had difficulty transferring from gurney to wheelchair for transfer due to leg numbness.
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| 42 | 2021-02-07 | weakness |
12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. ...
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12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.
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| 42 | 2021-02-07 | feeling hot |
blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; Thi...
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blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-02-07 | muscle spasms |
Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness. ...
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Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness. Vital signs taken and assessment determined Benadryl needed. Patient was given 0.4mL =(20mg) . Patients vitals checked every 5 minutes. At 10:16 patient felt better and reposted symptoms better and no dizzy spells. Pt released at 10:38. Patient called for update on 2/5/21. Patient reported feeling better this day but reports that nausea returned with cramping and lasted until 2:30 pm day of shot. Dizziness and confusion lasted until 9:00pm day of injection, disoriented until 6pm day of injection and diarrhea that lasted until 4pm day of injection. Per medical director, Dr, patient should not get second dose of Pfizer vaccine.
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| 42 | 2021-02-07 | pain in extremity |
at first I had the expected reaction and feeling of being "hungover" on night after vaccine, 7pm on ...
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at first I had the expected reaction and feeling of being "hungover" on night after vaccine, 7pm on 1/29/2021. I felt better overall in 24 hrs, but I've continued to have mild arm pain at injection site. Now, over a week and a half later, on 1/8/2021, I have mild itching at injection site and moderate arm pain. V-safe check-in site I was using has stopped actively sending my daily checkins after a week, switching to weekly check-ins instead.
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| 42 | 2021-02-08 | burning sensation | Red, itchy face with mild burning feeling, swollen throat with itch, and tingling in tongue. |
| 42 | 2021-02-08 | pain in extremity |
Within 15 minutes I felt really lightheaded, which went away after about 1/2 hr. That night about 9p...
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Within 15 minutes I felt really lightheaded, which went away after about 1/2 hr. That night about 9pm my R arm was aching SO bad, like I've never felt. Also I got a horrible headache and lower backache, could not sleep. Felt horrible till about noon the next day started to feel better slowly.
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| 42 | 2021-02-08 | unresponsive to stimuli, inability to speak |
anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous...
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anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-09 | weakness |
I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minute...
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I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness/ same sensation in my arms, in arm that I got shot in and it came with hand weakness; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; Lethargy; Very tired; My heart kind of feel like it is pounding out from the chest like off and on throughout the day; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient got the vaccine on 17Jan2021 and she had been really brain fogged and on Tuesday and Wednesday she had a weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety and then Friday evening, patient had the same sensation in her arms, in arm that she got shot in and it lasted for about ten minutes and it came with hand weakness and then she had no muscle pain necessarily but lethargy, very tired and her heart kind of feel like it was pounding out from the chest like off and on throughout the day, events occurred on unknown date in Jan2021. Patient called the doctor and he said to wait but it is kind of there now, so she had an appointment on Wednesday. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 42 | 2021-02-09 | muscle spasms |
Headache; muscle cramps; rash; This is a spontaneous report from a contactable other hcp (patient). ...
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Headache; muscle cramps; rash; This is a spontaneous report from a contactable other hcp (patient). This 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot # unknown), via an unspecified route of administration at single dose in the left arm on 13Jan2021 for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), venlafaxine hydrochloride (EFFEXOR). The patient previously took Keflex [cefalexin] and experienced drug allergy. On 13Jan2021, the patient experienced headache, muscle cramps, rash, all with outcome of recovering. No treatment required. The vaccine was administered at Hospital Facility. The patient had not been tested for COVID-19 post the vaccination. The patient was not pregnant at the time of vaccination. Information on the lot/batch number has been requested.
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| 42 | 2021-02-10 | burning sensation, tingling |
TINGLING, DIZZINESS, BURNING IN HAND, SMOTHERING IN CHEST BUT NO BREATHING ISSUES, WHEN STANDING HAD...
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TINGLING, DIZZINESS, BURNING IN HAND, SMOTHERING IN CHEST BUT NO BREATHING ISSUES, WHEN STANDING HAD SOME TRANSIANT CHEST TIGHTING RX 25MG BYNADRYL, 16OZ WATER
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| 42 | 2021-02-10 | electric shock sensation, tingling |
About 10 min post vaccination start feeling tingling in your hands and fingers. Consulted with MD on...
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About 10 min post vaccination start feeling tingling in your hands and fingers. Consulted with MD on site that had stated others had complained about same reaction and was told to just observe. At night, I started itching really bad around 10:30PM and then I noticed a rash all over my body, both legs, specifically the right was worse. I also had patches on my arms and shoulders, also my chest and abdominal area. The rash was really read and bumpy. (I took pictures of the progression of the rash if interested). I took Benadryl and it barely helped me. Consulted with Employee Health who told me to consult with her PCP for advice. He prescribed Prednisone for a week and did some labs. And to do a FU in a week. The itching was unbearable. I even have like an electrical shock feeling in my skin since I started with this rash. I still feel it from time to time. On my FU with Dr. he noticed the rash was worse so he made me stop the Prednisone and wanted to do a biopsy from the tissue in my legs. Since I had the Prednisone in my system, I couldn't do it immediately, but was able to do it on 01/22/2021. Got my results the day before yesterday. It showed that I have what is called a Spongiopic dermatitis. Dr called me and prescribed me bleach baths 3 times a week and another antibiotic. I am scheduled for my second dose on 02/16/2021.
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| 42 | 2021-02-10 | flushing |
5 minutes after receiving vaccine became very dizzy, and flushed with fast heart rate , dropped to ...
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5 minutes after receiving vaccine became very dizzy, and flushed with fast heart rate , dropped to the floor near syncope. Laid down and took off mask for air. Was offered water and Benadryl. Drank some water then felt better.. Refused the Benadryl. 10 minutes after someone noticed a possible rash on my forehead. Went ahead and took some Benadryl. Later that night had same feelings.. fast heart rate and dizziness. The next day development flu like symptoms with fever up to 102.9. Took a half Tylenol. The next day just felt achy . The day after that had diarrhea.
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| 42 | 2021-02-10 | numbness |
c/o numbness left side of body; dissipated until it was just the left side of her face 2 days later....
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c/o numbness left side of body; dissipated until it was just the left side of her face 2 days later. H/O Bell's Palsy; team member advised to f/u with her PCP; unk. if she did seek medical treatment. She also reported HA, fatigue, fever, chills.
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| 42 | 2021-02-10 | migraine |
Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She to...
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Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine. She took medication which help dull the headache. She woke up the morning of 2/11/21 with hives on her face. She states her face was red and her eyelids swollen. The left eye lid more than the right. Employee took benedryl which helped, but her left eyelid remains red and swollen. Advised employee to contact her PCP.
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| 42 | 2021-02-14 | numbness, tingling |
Tingling/numbness throughout my left hand and some in forearm / Sudden onset of pretty severe diffus...
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Tingling/numbness throughout my left hand and some in forearm / Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; tingling/numbness throughout her left hand and some in forearm; tingling/numbness throughout her left hand and some in forearm; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Sudden onset of pretty severe diffuse pain 1.5-2 days later in left shoulder, axilla, anterior chest wall; Intermittent discomfort in forearm; winging of her left scapula; weakness of serrates anterior; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration in the right arm on 06Jan2021 07:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, raynaud's symptom, orthopedic surgeries. Concomitant medication included levothyroxine (unknown manufacturer). The patient previously took aspirin and gabapentin and experienced drug hypersensitivity. On 18Jan2021 13:00 the patient experienced tingling/numbness throughout her left hand and some in forearm, sudden onset of pretty severe diffuse pain 1.5-2 days later (Jan2021) in left shoulder, axilla, anterior chest wall, persistent and consistent significant pain that does not change with position, ROM, or much with palpation, intermittent discomfort in forearm, evolving into the progressive weakness phase with significant winging of her left scapula and weakness of serrates anterior. Events resulted in emergency room visit and physician office visit. The events were evaluated by an MD who has given the patient a tentative diagnosis of Neuralgic Amyotrophy. Seeing a neurologist on 02Jan2021. The outcome of the events was not recovered. The patient received mediation to manage pain. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
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| 42 | 2021-02-14 | pain in extremity, tenderness, feeling cold, weakness |
Approx 10- 12 hours after the shot was given, patient was home and in severe pain deep joint and mus...
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Approx 10- 12 hours after the shot was given, patient was home and in severe pain deep joint and muscle pain, shivering, sweating, freezing, low grade fever, severely weak, collapsed to the floor the first morning after receiving the 2nd dose shot bc she couldn?t make it back upstairs on her own. Injection site was red and swollen with a defined border. Severe pain at injection site as well. All symptoms listed to this point lasted for 48 hrs. After that severe joint and muscle pain diminished and pain medication (ibuprofen 800mg) was no longer being taken. However, severe arm soreness, tenderness, redness, swelling and itchiness remained/started on day 3. Itchiness spread from only the arm to entire body by day four. Patient went to hospital on day 4 but did not get admitted because they wanted to care for her in the Covid unit without knowing if she had Covid or not. Patient administered self-care by taking Benadryl continuously for approximately 48 hours starting on day 4. She stayed home after attempting to get help from redlands community hospital ER because she didn?t feel comfortable being told she could only get care if she went into the covid unit without a covid test being offered or done to her first. Patient was bedridden and severely sick from February 1 through February 7 2021. Feb 11 2021 patient took a covid test to rule out covid as the reason she felt so bad. Test result for covid was negative.
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| 42 | 2021-02-14 | pain in extremity |
woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all...
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woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; Mallampati score 4, not my baseline; Moderate fatigue rest of the day; Sore arm was experienced within 5 hours of administration; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at Left arm on 29Dec2020 17:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension (HTN), ablation corrected Wolff-Parkinson-White syndrome, pre-eclampsia. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), ibuprofen, naproxen sodium (ALEVE) and Women's multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took trolamine polypeptide oleate-condensate (CERUMENEX) and experienced allergy. The patient's sore arm was experienced within 5 hours of administration on 29Dec2020. Next morning 15 hours post, woke with swollen tongue, throat, and all mucosal linings. Mallampati score 4, not her baseline. Moderate fatigue rest of the day. Finally took Benadryl at 23-hours post vaccine, had to repeat Benadryl every 8 hours for 2 more days and monitor symptoms, events onset date was 30Dec2020 08:30. Adverse events result in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of Swollen tongue, Throat edema, Oral mucosa swollen, and Physical examination abnormal cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-14 | tenderness, weakness | developed diffuse tender adenopathy, weakness and fevers. Admitted with severe neutropenia - ANC 0. |
| 42 | 2021-02-15 | weakness, tremor |
I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vom...
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I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vomited forcefully several times. My neck and upper back became stiff and painful. Then came chills, shaking, and more nausea. My throat felt like there was a lump in it that was closing me off. I felt very weak and easily fatigued. I started to have visual issues, confusion, and was unable to focus. Neck pain continued to be severe. The next morning I woke feeling good, but within 2 hour again I went downhill. Symptoms are only about half as bad as the day before. Very very tired.
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| 42 | 2021-02-15 | nerve pain |
Lungs closing up, trouble breathing, pulse ox drop. Like an asthma attack but inhaler did not help....
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Lungs closing up, trouble breathing, pulse ox drop. Like an asthma attack but inhaler did not help. It lasted about 4 hours. Shooting nerve pain through my body for several days. Overall sluggish for two days, body aches, exhaustion.
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| 42 | 2021-02-15 | seizure |
Patients experienced a mild seizure during observation period following vaccine. EMS was called and ...
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Patients experienced a mild seizure during observation period following vaccine. EMS was called and patient came to immediately after. RN took vitals on Patient while we waited for EMS to arrive. Patient has history of seizure disorder but had no issue with 1st dose. EMS evaluated at scene and Patient returned to residence facility.
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| 42 | 2021-02-16 | feeling cold, migraine, night sweats |
Woke up at 3:30am with severe chills and night sweats, could not get warm. Fever (101.7) started at ...
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Woke up at 3:30am with severe chills and night sweats, could not get warm. Fever (101.7) started at 8am 1/10 . took Acetaminophen 1000mg for fever, headache, body aches, and weakness in extremities , increased fluids. Noticed a swollen sub clavicular lymph node on the left side That grew to the size of an almond. Migraine started at 11am same day. Took PRN Maxalt for Migraine and slept the rest of the day. Next day (1/11) slight headache that waxed and waned the rest of the day. Fever of 100.1 by 2:30 that same afternoon. Took Acetaminophen and fever resolved by the next day. Was seen for lymph node a week later by PCP and sent for an ultrasound. On 2/5 was scheduled for biopsy but on Ultrasound the lymph node had decreased in size from 2cm to 1.5cm on its own. Decided to hold off. Lymph node is now normal in size
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| 42 | 2021-02-17 | weakness |
Itching and feeling off over a week post second dose. The following day I was extremely tired and we...
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Itching and feeling off over a week post second dose. The following day I was extremely tired and weak. By that evening, day 9 or 10, I began vomiting followed by horrible diarrhea that lasted about 12 hours. I never thought it was related to the vaccine until I heard from others that had the same symptoms days after their vaccine.
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| 42 | 2021-02-17 | discomfort, pain in extremity |
smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had ...
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smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
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| 42 | 2021-02-18 | cold sweat, numbness, tingling |
Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with...
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Clammy hands/feet early 5am on 2/13/21, went to ER 2/13/21 due to numbness on R side of face with tingling on R side of head and tightness of neck. 2/14 thrush in mouth 2/15 - achiness L arm 2/16- pain swollen lymph r side, clammy hands persist with foul smell Ongoing tingling in my Whole Back, Fluctuating BP , tachycardia
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| 42 | 2021-02-18 | flushing |
I got the shot at noon on Friday, February 12th. Felt pretty well with arm pain at injection site a...
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I got the shot at noon on Friday, February 12th. Felt pretty well with arm pain at injection site and flush face the rest of the date. On Saturday, the 13th, I was fatigued, extreme arm pain at injection site, flush face, and cold all day. Sunday, the 14th, much the same as Saturday until evening when extreme dizziness and diarrhea set in. Woke up in the night with extreme dizziness and nausea. All day Monday, 2/15, I had lethargy, lightheadedness, dizziness, flush face, body aches and chills. Tuesday, 2/16, same exact symptoms as Monday. Wednesday, 2/17 was still mild body aches and flush face. Thursday, lesser body aches but still flush face. Today, 2/19, I still have flush face and fatigue.
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| 42 | 2021-02-18 | pain in extremity, tingling |
Immediately following the vaccination, I had some site pain. I felt tired that evening and went to b...
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Immediately following the vaccination, I had some site pain. I felt tired that evening and went to bed early, sleeping well (Wednesday night). Approximately 20 hours after receiving my 2nd vaccine (10am Thursday), I developed a low fever (99`), extreme lethargy, chills, and overall body aches. These symptoms lasted approximately 13 hours. When my fever broke (approximately midnight Thursday), the body aches and chills went away as well. The next day (Friday), I woke up to significant arm pain, severe headache, tingles in my arm, swollen lymph nodes in my arm pit and neck, as well as a rash on my upper arm around the injection site. These symptoms persisted until Sunday. The rash and swollen lymph nodes disappeared Sunday night/Monday morning. Since Monday, however, the headaches, arm pain, and some tingles in my arm have persisted all week. Motrin curbs the pain of the headaches and arm pain, but as it wears off the pain resurfaces.
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| 42 | 2021-02-18 | paralysis |
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ...
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could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
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| 42 | 2021-02-19 | tingling, numbness, pain in extremity |
Soar arm the day of vaccine and 2 days after. Mild dizziness every day after receiving the vaccine....
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Soar arm the day of vaccine and 2 days after. Mild dizziness every day after receiving the vaccine. The symptoms are not constant but I do feel dizzy on and off through out the day. Tingling and numbing sensation on the cheeks of my face after the vaccine, almost immediately. Then every day after that, but not constantly, more like once a day I feel the numbing sensation.
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| 42 | 2021-02-21 | pain in extremity, tenderness, migraine |
Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after i...
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Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after injection, headache and some fatigue-took Ibuprofen 36 hours after injection, migraine, arm pain, fatigue, nausea-took flexiril, Zofran, and Ibuprofen 48 hours after injection, fever of 101, armpit pain, arm pain, fatigue-took Ibuprofen 72 hours after injection arm swollen in 3"x5" oval, bright red, hot to touch, armpit very tender, mild headache-took Ibuprofen
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| 42 | 2021-02-21 | tingling |
Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February...
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Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs. Â At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though "somebody was breaking my bones" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime. Â She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face. Â Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope. Â She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine. Â No known history of allergy to polyethylene glycol. Â No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection. Â She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this. Â She denies any recent medication changes or new over-the-counter medications. Â She has not previously been diagnosed with COVID-19.
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| 42 | 2021-02-22 | weakness | Site: Pain at Injection Site-Medium, Systemic: Weakness, Error: Wrong Dose of Vaccine - Too High |
| 42 | 2021-02-23 | numbness |
30 minutes post-injection, patient reported numbness in her feet similar to when she has PEG before....
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30 minutes post-injection, patient reported numbness in her feet similar to when she has PEG before. Pt. remained another 15 minutes and was advised to go to the ER and transported there, but wanted to go home instead and left without being seen. She said she would see her doctor if she started to feel bad. She was called 2/1/21 and reported feeling great and denied any needs.
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| 42 | 2021-02-23 | pain in extremity |
02/13/2021: sore left arm, extreme fatigue started in afternoon 02/14/2021 - 02/15/2021: muscular pa...
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02/13/2021: sore left arm, extreme fatigue started in afternoon 02/14/2021 - 02/15/2021: muscular pain, headache, exhaustion, slight nausea, joint pain 02/16/2021 - 02/17/2021: extreme fatigue, joint pain 02/18/2021 - 02/24/2021: fatigue, joint pain (7 on a scale of 1-10)
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| 42 | 2021-02-23 | tingling |
per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that...
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per patient she experienced nausea and pain after 1st dose received on 1/14/2021 patient states that after her second dose she experienced facial swelling, hives, chest pain , joint pain and feels tingling in her body
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| 42 | 2021-02-23 | tremor, flushing |
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue...
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anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-24 | weakness |
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet...
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tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-24 | numbness |
Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only...
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Painful injection site after 10 minutes of injection that lasted for about 2 hours, then it was only sore. After about 2 hours, I started to had a bad headache and pain and numbness under my left jaw.
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| 42 | 2021-02-24 | pain in extremity |
A few hours after the vaccine I developed a fever, chills, a headache, muscle pain mainly in the hip...
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A few hours after the vaccine I developed a fever, chills, a headache, muscle pain mainly in the hip and thigh area all which lasted about 20 hours. The 2nd day I was a little dizzy with the headache lingering for about 2 days longer
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| 42 | 2021-02-24 | pain in extremity |
Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2...
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Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2021. Swelling is spreading further down the arm 2/25/2021.
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| 42 | 2021-02-24 | tingling, hot flush, muscle spasms |
Right arm and hand felt tingling right away then neck got hot and a headache started within 5 minute...
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Right arm and hand felt tingling right away then neck got hot and a headache started within 5 minutes. Monday 2/12 muscle fatigue and joint pain until current date 2/25 (I work out every day. After the first dose I was okay (after headaches subsided) but this time my muscles while working out have been very fatigued and spasm and cramp during workouts. Joints have been sore too)
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| 42 | 2021-02-24 | tingling, numbness |
tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by ti...
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tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; Brief period of pain in my right bicep; Headaches off and on; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN0201, expiry date: unknown), via an unspecified route of administration on the left arm, on 10Feb2021 09:30, at single dose, for covid-19 immunisation, at the hospital. Medical history included anxiety and bipolar II disorder (reported as bipolar2). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), quetiapine fumarate (SEROQUEL) and "OTC vit" (as reported). The patient previously took lamotrigine and experienced allergies (known allergies: Lamotrigine). The patient did not receive any other vaccines prior to the COVID vaccine. On 10Feb2021 at 20:00, the patient experienced "brief period of pain in my right bicep, headaches off and on, tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". Treatment for the event "headache off and on" included 2 doses of 2 pills of acetaminophen. No treatment was given for the events "brief period of pain in my right bicep" and "tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". The patient recovered from the events on an unspecified date. The events were assessed as non-serious.
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| 42 | 2021-02-24 | tingling |
Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-ye...
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Tingling to hands and feet X 3 weeks; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 19Jan2021 13:00 at a single dose for covid-19 immunization. Medical history included palpitations. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose). The patient experienced tingling to hands and feet x 3 on 21Jan2021 14:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021. No treatment has been received for the events. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 42 | 2021-02-25 | flushing | Complained of chest tightness, flushed and palpitations, self resolved |
| 42 | 2021-02-25 | flushing |
13:50- Approximately 5 minutes after vaccine administered pt became flushed, nauseated and c/o light...
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13:50- Approximately 5 minutes after vaccine administered pt became flushed, nauseated and c/o lightheadedness. Patient alerted observer and medical assistant called for transfer of the patient to the first aide office. Patient then evaluated by EMS on duty: VS: b/p 142/80, SaO2 100% on RA. PMHx: Migraines Medications: Fiornial, patient had same s/sx after 1st vaccine. 1435: Patients symptoms resolved and patient was cleared by EMS to discharge home. Ambulated on own without weakness. Escorted out by Paramedic to car.
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| 42 | 2021-02-25 | numbness, tingling |
Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneou...
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Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), via an unspecified route of administration at the right arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included carbamazepine and quetiapine. On 01Feb2021 16:00, the patient experienced face numb and tingly for several hours. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date in Feb2021.
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| 42 | 2021-02-25 | speech disorder |
felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; diff...
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felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
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| 42 | 2021-02-26 | difficulty speaking |
Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatm...
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Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatment - self treated with Benadryl (75mg), Zyrtec 10mg. Mild improvement 2 hours later, s/s not completely resolved at time of submission
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| 42 | 2021-02-26 | tremor |
extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very...
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extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off
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| 42 | 2021-02-27 | weakness |
At 3:40 pm I felt weakness in my jaw and also in the left arm (the one that received the vaccine). ...
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At 3:40 pm I felt weakness in my jaw and also in the left arm (the one that received the vaccine). I felt a little dizzy. The weakness in my jaw last aproximately two minutes and the sensation in my arm improved but last a couple of hours more. The dizziness improved at the moment that the weakness of the jaw wore off. I did not receive treatment, because I didn't go to a hospital.
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| 42 | 2021-02-27 | pain in extremity |
9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue...
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9 hours after vaccine: Unable to lift arm more than 30 degrees up. 12 hours after vaccine: fatigue 15 hours after vaccine: fever 100.3-100.6. severe body aches. chills. elevated heart rate (100bpm), extreme fatigue. arm pain. unable to sleep 24 hours after vaccine: body aches, fatigue, skin did not want anything on it. general feeling unwell 36 hours after vaccine: fatigue 48 hours after vaccine: no symtoms
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| 42 | 2021-02-28 | cold sweat |
Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thou...
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Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thought fresh air might help. Felt shaky and cold sweats. Was very itchy. No visible rash. Felt a lump in her throat and tightness in her chest. Paramedics sat with her outside. Dizzy and confused and had to sit for an hour before feeling comfortable driving home. Then slept for the entire day. Felt heart palpitations throughout the day. HR was up to 128 at home. 2 days later started to feel better. Felt normal 4 days later.
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| 42 | 2021-02-28 | pain in extremity |
sore left arm shot area chemosis- thought I had something in my eye, a cat hair since I had been p...
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sore left arm shot area chemosis- thought I had something in my eye, a cat hair since I had been petting put cat. skin around right eye slightly swollen. Realized the liquid was under clear part of eye. Looked like some bubbled coming from top of eye, so weird. Could feel the liquid moving in eye when moving head. Touched the eye, liquid spread around iris and pupil not going over it. Was so weird. No pain. Felt that it had to be a reaction to the shot. My body seems to be pretty sensitive. I have had cold sore a few times back to back due to stress. My youngest has Cystic Fibrosis that is what allowed us to get the vaccine, in home caregiver of medically fragile child. Went to urgent care, just needed a professional to say it would go away in a few days and note the reaction. The PA said it was not a reaction to the vaccine, that it is not listed as a reaction in the data. Blah blah blah. I disagreed and left it at that. Had a benedylt last night and put a pataday drop in eye as recommended by PA
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| 42 | 2021-02-28 | pain in extremity |
Persistent arm and shoulder pain. Cannot lift arm above shoulder without causing pain. Also painfu...
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Persistent arm and shoulder pain. Cannot lift arm above shoulder without causing pain. Also painful when laying on the right side. Symptoms have been present since the day of the vaccine. Initial arm tenderness at the vaccine site has gone away.
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| 42 | 2021-03-01 | numbness |
Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues...
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Received vaccine 1/07/2021. 1/08/2021 had soreness to the injection site and the soreness continues Numbness then developed 5 days later on 1/12/2021. Numbness starts at the infection site and runs down the arm and numbness extends to the left thumb and part of the left index finger. 1/18 Left thumb ridge started. 1/19/2021 PCP advised take naproxen 500 twice a day, vitamin B12, EKG unremarkable; 1/28/2021 reported to ED 5:00am as began experiencing numbness sensation on the bottom aspect of her face, bilaterally about 4 hours ago while working. Still having persistent numbness in left arm. Arm swelling. CT unremarkable; 1/29/2021 Neurologist believes related to the vaccine and order EMG, treating conservatively; 2/17/2021 had EMG that was unremarkable
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| 42 | 2021-03-01 | muscle twitching, weakness, numbness, tingling |
About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic we...
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About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic were normal. No respiratory distress. After 30 minutes of observation, I left back to my work unit within the hospital and walking back I became dizzy, felt faint and weak. Developed a headache and felt mentally foggy. It lasted about 2-4 hours. No further medical attention seeked at that time. 3 days later at rest at home about 6/7pm, I experienced dizziness, headache, pain to base of neck R side, pain down my spine and lateral back. Numbness to R cheek bone. Twitching to L hand. Numbness, tingling and weakness to L arm. Tightness to chest and back. Emergency department diagnosed degenerative cervical disk disease. Negative on neuro exam.
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| 42 | 2021-03-02 | hot flush |
18-19 hours after vaccination, pt experienced chest pain, dizziness, hot flash while at rest. She w...
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18-19 hours after vaccination, pt experienced chest pain, dizziness, hot flash while at rest. She was not anxious. She was in between classes of teaching virtually
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| 42 | 2021-03-02 | numbness |
vaccine @1539 within 5 minutes of vaccine left forearm numbness started. Then progressed to wrist, ...
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vaccine @1539 within 5 minutes of vaccine left forearm numbness started. Then progressed to wrist, hand, and fingers. b/p 102/62, hr-58, 02 sat 98% ra. 1601 numbness only on palm of hand. 1642 numbness resolved . b/p 104/60. hr-56, r-18, 02 sat 98%ra. Pt discharged to home with husband.
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| 42 | 2021-03-02 | pain in extremity |
Pain in legs and joints. A week later, left knee is painful, feels like it has locked up. Struggle...
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Pain in legs and joints. A week later, left knee is painful, feels like it has locked up. Struggled to walk on it due to pain for about a week. Taken Tylenol, Ibuprofen, Naproxen but doesn't seem to be effective. Massage helps for a little while. Pain present for 24 hours after first dose. Have not sought care from PCP but will if pain does not resolve soon.
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| 42 | 2021-03-02 | tingling |
tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down bo...
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tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down both sides of spine - Severe pain to adjust head on pillow or shift in bed even the slightest bit felt no need to blink for a few hours slept from 8pm Saturday until 10am Monday - Sleep was the only way to avoid the pain Alleve didn't touch the pain Tylenol began to help after 24 hours low fever around 100.4 skin was super-sensitive to touch swollen lymph nodes in neck on vaccine side swollen lymph nodes under arm on vaccine side - baseball-sized and painful to the touch
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| 42 | 2021-03-03 | weakness |
Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For ...
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Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For the next 2 days I was weak, headache, light headed, dizzy, couldn't concentrate. Nausated. I had covid in November 2020 and it was some of the symptoms I had then. I am very worried about the second shot
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| 42 | 2021-03-03 | feeling hot, tremor, pain in extremity |
3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low gra...
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3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low grade fever and tired. 6:30 high fever 103 fever chills, shaking from chills. Lasted about 4 hours. No meds taken to offset. About 11 hot and tired. Hot with fever about 99-100.5. Up and down all night from being sore and not able to get comfortable. As well as feeling hot. Thirsty. Mental fog. 3/3/21: very tired. Wore out by simple tasks. Slept most of day. Achy body. A few slight fever times but not bad. Slept 18 of 24 hours. Times awake we?re just sitting. Mental fog. Even hearing someone else talk would wear me out. Went to bed at 6:30 pm. Was very tired but trouble falling asleep because could not get comfortable so took an Advil pm. Slept until 5:50 only getting up once to use bathroom. Did wake up in puddle of sweat when we to bathroom. 3/4/21: still tired feeling but feel much better. Mental fog way better. No fever. Feel alert and awake. Not feelingwore out by simple tasks. Location of injection: and arm response. Vaccine 1 given was about 2-3 inches down from shoulder joint. Very sore arm for 5 days. 3 days could raise arm or move without it hurting. Vaccine 2 given was no more than 1 inch down from shoulder joint. I was asked to pull T-shirt sleeve up further before getting it. It was much higher in arm than vaccine #1. 2 hours after vaccine arm was very sore. By 4 hours after arm hurt and not able to move it without pain. Did not use arm for even small normal tasks like taking a drink. By time fever broke around 11 pm, Arm felt much better. Sore but no pain to move it or use it for normal activities.
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| 42 | 2021-03-03 | flushing, tremor |
nausea, no vomiting. feeling flush, shakey, and anxious. No SOB, pruritis. Moved to a quiet room. ...
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nausea, no vomiting. feeling flush, shakey, and anxious. No SOB, pruritis. Moved to a quiet room. Lay down for 45 minutes and observed. symptoms spontaneously subsided.
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| 42 | 2021-03-03 | numbness | Pt reported itching on left arm, numbness left hand. MD offered Zyrtec, pt refused. |
| 42 | 2021-03-03 | tingling, flushing |
overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flu...
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overall parathesenia, inflammation, red rash, itch, scratchy throat, ?hot throat?, ?warm lungs?, flushing, dizziness; prickly sensations
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| 42 | 2021-03-04 | weakness |
Woke with fever 102.5, shivering had body aches swollen glands in throat weakness dizzy for 24 hours...
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Woke with fever 102.5, shivering had body aches swollen glands in throat weakness dizzy for 24 hours. Then weak following 24 hours. 5days after had menstrual period start even though had just ended prior 2 days prior.
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| 42 | 2021-03-04 | pain in extremity, numbness |
Post vaccination, pt. complaints of L arm pain and numbness, light headedness. VS 108/72, o2 sat at ...
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Post vaccination, pt. complaints of L arm pain and numbness, light headedness. VS 108/72, o2 sat at 97% on RA, HR 76. Pt. alert and oriented, with her husband @1139 patient complained of LA and LL numbness and mild itchiness of the injection site. At 11:58 patient said she feels better and is ready to leave the facility, very mild numbness on the left arm. Health teachings provided with emphasis on following up to their PCP for evaluation or calling 911 PRN. Released with Husband.
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| 42 | 2021-03-04 | pain in extremity |
Sever GI issues. They have continued for 8 days now. I'm allergic to ALL seafood, and the symptoms I...
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Sever GI issues. They have continued for 8 days now. I'm allergic to ALL seafood, and the symptoms I'm experiencing remind me of those: bloody sto, diarrhea, nausea, bloating, stomach cramping. The symptoms started about 30 minutes after the vaccine was administered. It took me this long to figure out it may have been the vaccine. (The above is my main concern. I did also experience a stiff and painful arm which limited my range of motion, and fever. But I expected those reactions. )
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| 42 | 2021-03-04 | pain in extremity |
Elevated temperature (100.2), body aches, chills, sore arm, extremely swollen auxiliary lymph nodes ...
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Elevated temperature (100.2), body aches, chills, sore arm, extremely swollen auxiliary lymph nodes on left side. All symptoms began about 24hrs post vaccine. Swollen lymph nodes and near breast , below armpit stayed very sore and swollen for 5 days. All other symptoms were gone after about 24 hrs (48hrs post vaccine). Treated with ice, cool compress, probiotic, ibuprofen.
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| 42 | 2021-03-05 | flushing | Facial flushing, throat tightness, transported to nearest ER by EMS. |
| 42 | 2021-03-05 | numbness, migraine |
I got the first dose of the Pfizer vaccine on Weds (3/3) at 9am. As I was driving home I noticed the...
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I got the first dose of the Pfizer vaccine on Weds (3/3) at 9am. As I was driving home I noticed the left side of my face was numb which stopped after a period of time but ever since I have been having similar numbness on my cheeks and cheekbone. I am also having pretty bad stomach pain. It started Thursday night at 1am and has continued. It started as cramping through my entire tummy and now its burning in my stomach area. I also woke up with a migraine today. Also having chills sweating and fatigue
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| 42 | 2021-03-05 | tingling |
Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, a...
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Guillain-Barre-Landry Syndrome (AIDP). Presented with paresthesia's, loss of Deep Tendon Reflexes, and proximal > distal LE weakness. Placed on IVIG on 3/4/2021 with improved symptoms of LE weakness but noted residual abnormal sensation
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| 42 | 2021-03-06 | tingling | New onset tingling in left hand still continuing 36+ hours after receiving vaccine. |
| 42 | 2021-03-07 | pain in extremity | arm pain, fatigue, fever, nausea |
| 42 | 2021-03-07 | cold extremities, tremor, feeling of body temperature change |
10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feel...
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10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feeling of being hot and cold, sheer panic. Symptoms were very strong for the first few hours after injection. Jittery, shaky, uneasy feeling persisted for about 48 hours.
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| 42 | 2021-03-08 | discomfort, numbness, cold extremities |
30 hours after vaccine a warm, red, hard marking, approximately 3 inched in diameter , appeared at t...
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30 hours after vaccine a warm, red, hard marking, approximately 3 inched in diameter , appeared at the injection site. Treatment was Ibuprophen and Ice. The next morning the mark spread, appeared lighter, warm and hard to the touch. As the day progressed my arm felt heavy, by the afternoon my arm and hand (not the red spot) felt cold. That evening my shoulder to my fingertips were numb with a "falling asleep" sensation. I still had control of movement but was unable to feel any touch. I wrapped a heating pad around my arm for two hours, unable to feel the heat, and took Ibuprofen and Benadryl. Around 11:00 that night I was able to feel my pinky finger. Continued to apply heat every 20 minutes for 20 minutes throughout the night and continued with ibuprofen and Benadryl. The next morning I was able to feel my ring finger, the red spot had disappeared, and the hardness was decreasing. That evening, continuing with heat, Ibuprofen, and Benadryl, I was able to feel 4 fingers. Continued into Sunday with same treatment and by Sunday morning I was able to feel my entire hand and wrist. As the day progressed I regained feeling up to my elbow and the shoulder by the night. Monday I discontinued treatment. Had full feeling of my arm, with pain in my elbow and shoulder. Tuesday morning all was back to normal.
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| 42 | 2021-03-09 | flushing |
Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen li...
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Allergic reaction 12 hours after vaccination. Diahrea, hives, flushing, rapid heart rate, swollen lips
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| 42 | 2021-03-09 | flushing |
4 minutes after the vaccine my heart rate increased drastically. I also felt faint. I stayed with ...
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4 minutes after the vaccine my heart rate increased drastically. I also felt faint. I stayed with EMTs for 1.5 hours until I was comfortable to leave. Heart rate came back to normal over this time period. There were still moments when I felt flush/faint-like.
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| 42 | 2021-03-09 | numbness |
17 mins after the vaccine I had a weird feeling in both my legs and both my lips went numb (cheekbon...
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17 mins after the vaccine I had a weird feeling in both my legs and both my lips went numb (cheekbones down to my chin) and numbness in my fingertips.
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| 42 | 2021-03-09 | numbness and pain in extremities |
Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensi...
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Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.
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| 42 | 2021-03-10 | tremor, feeling hot, weakness |
Faint, hot and red head, painful heart, nausea, shaky, dizziness, weakness, headache,, stiff neck....
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Faint, hot and red head, painful heart, nausea, shaky, dizziness, weakness, headache,, stiff neck.It happened about 20 to 30 seconds after shot. After my bandage was on and we were checking why I hadn't received a text reminder to sign up for 2nd dose. Nurses put me in wheelchair and took me to bed. Kept me for 30 mins. Its been 1.5 hours since shot and I'm still dizzy, weak and I have joint pain. I threw up. I still have headache and my heart still hurts.
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| 42 | 2021-03-11 | bell's palsy | Bell?s palsy on March 9th Last dose vaccine taken Jan 13 |
| 42 | 2021-03-11 | breast pain |
I experience breast tenderness and eventually soreness approximately 28 hours after my vaccination. ...
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I experience breast tenderness and eventually soreness approximately 28 hours after my vaccination. Rest, ice, and motrin helped with the symptoms. Approximately 10 hours after the initial breast pain, the pain/tenderness went away.
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| 42 | 2021-03-11 | muscle spasms |
Muscle spasms on left side of body (arm, shoulder, leg, face). The muscle spasms are worse in the ar...
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Muscle spasms on left side of body (arm, shoulder, leg, face). The muscle spasms are worse in the arm. The spasms are only on the left side of the body. The spasms were worst the night of the vaccine and they have improved, however the spasms are still present.
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| 42 | 2021-03-11 | pain in extremity, tremor |
Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, f...
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Extreme neck pain, difficulty moving neck, gout like symptoms in feet, extreme fatigue, shakiness, flu like symptoms, swollen red knuckles on left hand that were stiff and painful, fainted, dizziness, vision disturbances
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| 42 | 2021-03-11 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA Had vaccine shot on Thursday 3/4/21 around 8:50am. The shot spo...
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Pfizer-BioNTech COVID-19 Vaccine EUA Had vaccine shot on Thursday 3/4/21 around 8:50am. The shot spot was sore for the next couple days and no other symptoms. Then on Sunday 3/7/21 night, I started having pain on the left side of my body (same side where the shot was administered). The pain was mainly from neck to should blade area first for the next couple of days, then it traveled down from my shoulder to my hand. As of the night of Thursday 3/11/21, the pain (comes on when I move my body) gets worse and I was not able to get up from bed without other's assistance. Then throughout this morning Friday 3/12/21, it seems a bit better during the day, with still pain from neck, shoulder, shoulder blade, down to the left arm and hand.
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| 42 | 2021-03-11 | pain in extremity | Sore arm starting Tuesday, March 9-March 11. |
| 42 | 2021-03-12 | numbness |
After my second Covid 19 shot (administered on 2-12-21), my lower back was so inflamed that the nerv...
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After my second Covid 19 shot (administered on 2-12-21), my lower back was so inflamed that the nerves in both arms and my right leg became pinched. I waited one week but could not handle the pain, numbness and inability to feel my arms and legs. I went back to the Medical center and signed into the sick call. They gave me a steroid shot and took X-rays. As of today, 3-12-21, I?m still dealing with pinched nerves in both arms and my right leg. I am waiting to take the X-rays to my spine specialist to see why /how the shot reacted with my spinal fusion.
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| 42 | 2021-03-12 | pain in extremity |
My arm was sore right away. I got a headache and felt queasy several hours after getting the vaccine...
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My arm was sore right away. I got a headache and felt queasy several hours after getting the vaccine. I had a difficult time eating dinner and threw up later in the evening. The next day, my sinuses were stuffed up and I still had a headache.
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| 42 | 2021-03-12 | tingling |
Approximately 20-25 minutes after injection, dizziness, tingling in face, and throat tightness occur...
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Approximately 20-25 minutes after injection, dizziness, tingling in face, and throat tightness occurred, which resolved after about 15 minutes. No shortness of breath experienced and symptoms were not severe enough to seek medical treatment.
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| 42 | 2021-03-13 | numbness | Left side of my face doesn?t feel right. Almost numb and my vision to the left is off. |
| 42 | 2021-03-13 | pain in extremity | Sore Arm, Exhaustion both for 4 days Headache and Nausea the first day |
| 42 | 2021-03-13 | cold extremities, inability to speak |
sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip i...
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sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip in the waiting area in the first 15 minutes but I wasn?t too worried about that. Uncontrollable laughter 11:45 AM the next morning. Forgetting where I was going on day two at 2 PM when I went to pick up lunch for the family totally got the wrong lunch. Again with uncontrollable laughter for 8-10 minutes. Sharp pain 05/14/2021 in the ovary area where I have a cyst in my ovary. Words messing up all the time. Right upper chest pain, freezing cold nose and nose tip feels like it?s freezing and has numbness and a runny suddenly on day 3.
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| 42 | 2021-03-14 | flushing |
Severe Flushing (Head, Ears, Neck, Chest) for hours following injection; Slightly subsided after tak...
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Severe Flushing (Head, Ears, Neck, Chest) for hours following injection; Slightly subsided after taking Allegra; Flushing came back less severe the following day
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| 42 | 2021-03-14 | numbness, weakness, pain in extremity |
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Lo...
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unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-03-14 | nerve pain, tingling, feeling hot |
significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant ...
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significant pain in right armpit lymph node area; Severe nerve pain throughout right upper quadrant of my body, in arm and back (spine); Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; Pain similar to pinched nerves, with pain, tingling; occasional heat sensation; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 26Feb2021 17:30 at single dose in Right arm for COVID-19 immunisation. There was no medical history, no Allergies to medications, food, or other. Concomitant medication included metformin, fish oil, colecalciferol (D3) within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) at the age of 42-year-old, on 29Jan2021 17:30 at single dose in Left arm for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe nerve pain throughout right upper quadrant of her body, in arm and back (spine), began the afternoon the day after the second shot on 27Feb2021 03:00 PM and progressed throughout the day, until almost unbearable that evening, even with 800mg ibuprofen. Pain was similar to pinched nerves, with pain, tingling, occasional heat sensation, as opposed to that of a pulled or sore muscle. The patient could not lay in bed that evening and had to sleep upright in a chair with a pillow under her elbow to get minor relief. This pain continued on day 3, but was starting to lessen slightly. Day 2 (28Feb2021), the patient also developed significant pain in right armpit lymph node area, becoming more intense on day 3. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "severe nerve pain throughout right upper quadrant of my body, in arm and back (spine)", "pain similar to pinched nerves, with pain, tingling" which included 800mg ibuprofen. There was no treatment received for the remaining events. The outcome of the events was unknown. The events were reported as non-serious.
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| 42 | 2021-03-15 | weakness |
Patient c/o chest pressure and weakness about 10 minutes after receiving the vaccine. She was place...
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Patient c/o chest pressure and weakness about 10 minutes after receiving the vaccine. She was placed in supine position, was tearful and lethargic for first 4-5 minutes, never loss consciousness. After 10 minutes in supine position she reported feeling back to normal.
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| 42 | 2021-03-15 | discomfort |
WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND...
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WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND I HAD A RIGHT SIDED FRONTAL HEADACHE. I TREATED WITH ICE PACK, TYLENOL, AND CLAIRITIN. 2 HOURS LATER I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS. tHE SWELLING BROKE DURING THE NIGHT WITH MASSIVE EYE TEARING AND POST NASAL DRIP. I CRAVED BLACK LIC0RICE LIKE MAD.
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| 42 | 2021-03-15 | feeling hot |
15: 47pmPt in post Covid vaccine waiting area, 1st dose administered. Pt c/o feeling hot and "my ear...
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15: 47pmPt in post Covid vaccine waiting area, 1st dose administered. Pt c/o feeling hot and "my ears are swelling like I'm on a plane". Pt reports having history of "severe allergies" Vital Signs: BP 162/75, HR 122, SPO2 99%. Reassessment 15:52 Vital Signs\ BP 138/84, HR 100, SPO2 99% Nurse alert alarmed, Pt transported via wheelchair
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| 42 | 2021-03-15 | tenderness |
Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic ...
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Immediate large local reaction, 4" area induration/erythema/swelling/tenderness/warmth, no systemic sx
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| 42 | 2021-03-16 | depressed level of consciousness |
Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept f...
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Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept for the majority of the last 3 days. I wake up foggy and disoriented. Takes a while to focus and become alert. I use the restroom and maybe I'm able to be active for 15- 20 minutes then I'm back asleep, or too tired to keep my eyes open. Today is the first day I have been able to stay awake more than an hour. I had energy for about an hour and then felt like I was unplugged I'm just too tired to function. All I can do is go back to bed.
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| 42 | 2021-03-16 | pain in extremity, flushing |
~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min....
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~5 minutes after injection, developed flushing and altered taste. Flushing resolved within 5-10 min. Taste was very proncounced, slightly metallic and very salty and lasted remainder of the day with associated nausea. Taste alterations resolved that day. Slight arm soreness and moderate fatigue for next 2 days, then resolved. On day 6, I developed fevers, the odd taste changes that I had post-vaccine returned, and fatigue. Felt "off," similar to when I had presumed COVID in March 2020. Fevers (100.5 on Advil), fatigue, felt "off." No cough/shortness of breath. Symptoms peaked on day 8, then I woke up feeling great on day 9. Minimal reaction to dose #2.
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| 42 | 2021-03-16 | tingling, pain in extremity, nerve pain |
Immediately within minutes after the Pfizer vaccination I got quite painful tingling in the injectio...
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Immediately within minutes after the Pfizer vaccination I got quite painful tingling in the injection arm and hand that shot to the face on the same side. Dizziness and bad headache followed. At home a couple of hours later I began to get tingling in the leg on the same side as the injection side was. A day later I had the typical fever symptoms that were not of worry to me. About 7 days later I got neuropathic pain in the arm, hand and leg on the opposite side of the body also. Until this day peripheral neuropathy on both body sides continues.
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| 42 | 2021-03-17 | tingling |
After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2n...
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After I received the 2nd vaccine I experienced chills and fatigue for two days. 2 weeks after the 2nd dose I got a rash of tiny bumps starting around my neck and then spread across my entire body including my scalp. I had inflamed lymph nodes and a cyst near the lymph node was inflamed. The rash continued. I went to my family dr and she gave me 4 days of 20mg prednisone. That helped some. After I finished the medication the rash was healing and then I started having hives that covered my entire body. I am also having 'hotspots' that flare up daily. I have had at least 25 hotspots. my skin stays severely dry no matter what I try. I went back to the dr when the hives started and she gave me a heavy taper down series of prednisone. while it has helped some my body still has hotpots, under the skin is prickly, tingly, and my skin acts like it has been sunburned is is peeling off. I have sores and raw spots randomly over my body. I am also using benadryl to help.
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| 42 | 2021-03-18 | numbness |
Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoi...
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Tiredness (1 week), muscle aches (48 hours) torso numbness in the skin (ongoing), itchy torso (ongoing), swollen and sore lymph nodes under left arm (ongoing), large bump on back (ongoing)
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| 42 | 2021-03-18 | muscle twitching |
The right side of my nose, mid way up thru the first part of my eyebrow has been twitching/wuovering...
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The right side of my nose, mid way up thru the first part of my eyebrow has been twitching/wuovering since Monday evening 3/16 pretty much non stop. I received covid 19 vaccine step 1 on 3/15
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| 42 | 2021-03-18 | pain in extremity |
Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14...
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Nasuea, Fever, chills, headache, body aches, swollen lymph node, arm pain for 24 hours that began 14 hours after shot continual runny nose since shot, ongoing chills since shot, sore nostril,
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| 42 | 2021-03-18 | pain in extremity |
A little arm soreness; more tired than normal the day after receiving the 2nd dose of the vaccine.; ...
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A little arm soreness; more tired than normal the day after receiving the 2nd dose of the vaccine.; achiness; This is a spontaneous report from a contactable consumer (patient). A 42 -year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, route of administration unknown in left arm on 15Feb2021 at 09:15 (at the age of 42 years) as single dose for COVID-19 immunisation. Past vaccination included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for immunization on 25Jan2021 at 2:30pm (14:30) in left arm. The patient medical history includes hypothyroid, and the patient has a drug allergy to Bactrim. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine and since the vaccine the patient has not been tested for COVID-19. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced achiness and was more tired than normal the day after receiving the 2nd dose of the vaccine as well as a little arm soreness on 16Feb2021. The patient did not receive any treatment for the events. The outcome of a little arm soreness was not recovered, more tired than normal the day after receiving the second dose of the vaccine was not recovered and achiness was not recovered. Information on the lot/batch number has been requested.
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| 42 | 2021-03-18 | tingling |
Tingling in arm, heart racing 128/80, 80, 18 Patient refused transport informed to follow up with PC...
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Tingling in arm, heart racing 128/80, 80, 18 Patient refused transport informed to follow up with PCP if symptoms continue
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| 42 | 2021-03-18 | tenderness, muscle spasms |
left arm was tender; Cramping feeling and feels like spasms; muscles were sore on the left side; Thi...
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left arm was tender; Cramping feeling and feels like spasms; muscles were sore on the left side; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) at the age of 42-years, via an unspecified route of administration in left arm on 31Jan2021 at single dose for COVID-19 immunization, in workplace clinic. Medical history included shell-fish allergy. No other vaccine in four weeks, no COVID-19 prior vaccination. Patient was tested negative for COVID-19 virus test (Nasal Swab) on 25Jan2021. No other medications in two weeks. At 00:00 on 17Feb2021 (16Feb2021 12:00 PM), the patient experienced left arm was tender and muscles were sore on the left side. Cramping feeling and feels like spasms. Patient went to the hospital cause of pain. The adverse events resulted in emergency room/department or urgent care. No treatment. On an unspecified date, COVID-19 was tested post vaccination with unknown results. Outcome of the events was unknown.
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| 42 | 2021-03-19 | inability to speak |
Within minute of the injection, patient had severe headache. She had dizziness and became very fatig...
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Within minute of the injection, patient had severe headache. She had dizziness and became very fatigued. She could not stand up and it was hard to understand her. Within 10 minutes of the injection, patient became very nauseated. They brought her a trash bucket and she hd dry heaved twice. Pharmacist called the EMT around 6pm. The two EMTs took her blood pressure and pulse. Both were extremely high. Blood pressure was 172/96. They recommended that patient should be transported to local ER at the hospital. They put her in the ambulance andtransported her to hospital. She remained at the hospital for 5 hours. Once blood pressure and pulse came down, she was allowed to leave.
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| 42 | 2021-03-19 | burning sensation |
Pt sat down after receiving her vaccine and felt a burning in her chest that was creeping up to the ...
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Pt sat down after receiving her vaccine and felt a burning in her chest that was creeping up to the base of her throat and down her arms. Pt denied trouble breathing, drooling, speaking, or swelling. Paramedics on scene escalated the situation. Pts pulse was 98 bpm with a regular rhythm (12 lead EKG was performed). Pt was hypertensive (BP 177/104). Paramedic on scene continued to use medical language and amplify the situation. An ambulance was called. I offered to have pt wait 10 minutes and then recheck bp, as the rest of her symptoms had resolved. Paramedics encouraged patient that it was "her decision to take the ambulance, however they were concerned about a stroke with a bp that high". Pt left in an ambulance. Will f/u in a couple days.
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| 42 | 2021-03-19 | numbness, throat numbness, tingling |
Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car an...
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Started with a dry throat after 15 minutes -3:45. Thought I just needed water. Drank water in car and as we continued to drive my face started tingling and feeling numb. I called the pharmacy at 3:50 and said I should take Benadryl or go to ER if symptoms worsen. I took liquid Benadryl 10ml at 3:55. The feeling continued for the next three hours. The feeling in my throat went away but the tingling feeling continued. On 3/20/2021 I went to urgent care at 9:40am due to continued tingling and numbness in the right side of my face and heaviness in my right arm . I was prescribed prednisone.
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| 42 | 2021-03-19 | muscle twitching |
Light headache and body ache nausea after shot. Then fever started that evening and severe body ache...
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Light headache and body ache nausea after shot. Then fever started that evening and severe body aches, twitching, headache, nausea, chills
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| 42 | 2021-03-20 | tingling |
About 8 days after I received the vaccine, my arm developed a red, lumpy rash that tingles and is wa...
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About 8 days after I received the vaccine, my arm developed a red, lumpy rash that tingles and is warm to the touch.
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| 42 | 2021-03-21 | weakness |
Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and e...
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Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and elbow. my right arm (injection site) is red, swollen, tender and warm to touch"
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| 42 | 2021-03-21 | weakness |
Following second injection of COVID vaccination in a series of 2 - Syncopal episode approximately 10...
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Following second injection of COVID vaccination in a series of 2 - Syncopal episode approximately 10-15 minutes after injection (no history of reaction after first injection.) History of underlying cardiac problems, hypertrophic myopathy, V-Tach. Post injection syncopal episode; patient was bradycardic rate 40, pale, weak, alert & oriented x 4 . Medical staff on site ,care immediately turned over to staff, IV established, Fluids given, BS checked. Sustained bradycardia in 40s for approximately 10 minutes raising to mid 50's following fluid. Patient has a defibrillator/pacer stated that no lower demand set. Pacer for V-tach. Patient stated her defibrillator has fired over 200 times but did not feel defibrillator fire at time of episode. Transferred to Hospital as per patient preference stated this is where cardiologist and records are, cleared through Base prior to transferring. Seen in ED then discharged later that afternoon.
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| 42 | 2021-03-21 | discomfort |
lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, ...
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lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-03-21 | flushing | Flushing, palpitations |
| 42 | 2021-03-21 | pain in extremity | pain at injection site up through neck area and down into forearm chills headache body aches fatigue |
| 42 | 2021-03-21 | tingling |
Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All ...
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Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/22/2021 Date: 3/22/2021 Subjective Patient is a 42 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience racing heart and face tingling. She denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, rash, hives, dizziness and headaches +facial tingling: Previous Reactions: Denies Objective Vitals Vitals: 03/22/21 0811 03/22/21 0819 03/22/21 0834 BP: (!) 153/90 134/87 118/85 Pulse: 87 80 80 SpO2: 98% 100% 99% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Her symptoms completely resolved prior to discharge. PA-C Electronically Signed 3/22/2021 9:02 AM
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| 42 | 2021-03-21 | cold extremities |
Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the...
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Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the next day. Extreme body aches that started in the middle of the night that continued into the next day. Extreme headache which made me nausea until 5PM the next day. Felt 100 percent better on Sunday at 1PM. Vaccine was given on Friday at 1PM.
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| 42 | 2021-03-21 | tremor |
Progress Notes APRN (Nurse Practitioner) Cosign Needed COVID VACCINE CLINIC Date: 3/22/2021 ...
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Progress Notes APRN (Nurse Practitioner) Cosign Needed COVID VACCINE CLINIC Date: 3/22/2021 Subjective is a 42 y.o. female who was seen at today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience shakiness, feeling faint diaphoresis.. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to collapse and rapid progression of symptoms. PMH: HTN (losartan), zoloft and medications for allergies and on ocp. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + shakiness: Previous Reactions: hx of vasovagal to blood work procedures. Hx to vaccines as well but had not had any problems for a while. Objective Vitals Vitals: 03/22/21 1140 Resp: (!) 58 SpO2: 98% pt refused. states bp measurements make her pass out Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Comments: Hands shaking. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Abnormal findings above improved after laying patient down flat. Pt feels better and was able to progressively sit up in the chair without reoccurrence of symptoms. Assessment/Plan Treatment included: water and rest Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Resolution of symptoms, suspect vasovagal reaction. She is back to base line. Monitored in bay for approx 10 mintues. Pt able to ambulate w/o difficulty or w/ assistance. Pt with husband for discharge. He will drive home. Follow up with pcp as needed. Both patient and pt's husband express appreciation of care today.
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| 42 | 2021-03-22 | pain in extremity |
I started with a headache at 10pm the day of the vaccine. Throughout the evening I had arm pain, chi...
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I started with a headache at 10pm the day of the vaccine. Throughout the evening I had arm pain, chills, sweats, insomnia, joint and muscle pain. All of those things have lasted through today 3/23 and have not improved at all. I feel like I was hit by a truck.
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| 42 | 2021-03-22 | tingling |
Vaccine admin. At 8:38 am at Vaccine Clinic. The nurse (I?ve forgotten her name - boomer aged, shor...
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Vaccine admin. At 8:38 am at Vaccine Clinic. The nurse (I?ve forgotten her name - boomer aged, short gray hair) was standing when she administered the vaccine, and I remember making a note of the whole situation because it was the first time that a nurse did NOT say, ?Relax your arm.? I thought that was odd. I felt nauseous and dizzy within 1-2 min., but after my 15 min. Waiting period was up, I was no longer feeling dizzy or nauseous so I left. Within 10 min. I felt an ache in my arm, deep in the bone, and different then the regular shot-site pain. This is a dull ache that is barely tolerable. A few hours later, my shoulders and neck were experiencing very extreme, sharp pain, and I can barely move my arm, neck, and head. It hurts to hold my head up straight. This pain continues for another 2 days. It is a very intense, throbbing ache, and worse after a fitful night of rest, due to the constant pain in my left arm and neck. 48 hours later, still in intense pain and got a massage. Helped briefly but pain returned within minutes. On day 3, I got another more targeted massage on my shoulders and neck, with only a brief amount of time free from the pain. Day 4, the pain is so intense and I can barely handle it. I make an appointment with a APRN. She does not mention SIRVA but prescribes 800mg of Ibuprofen every 4 hours as needed for pain, and Flexeril, a muscle relaxer. She also gave me a shot of Toradol for the pain. The Flexeril makes me drowsy, and the ibuprofen takes the sharp edge of the pain away, but does nothing to mask the dull, deep ache in my left arm and shoulder. Day 5, 6, 7 all the same. On day 7, a new tingling sensation and numbness in my left hand and fingers start. Contacted office again to request a referral for physical therapy, and also to make a note of SIRVA in my file. Got a prescription for a stronger pain medication; neurontin to hopefully make the pain more manageable.
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| 42 | 2021-03-23 | numbness, tingling |
Tongue, lips swelling, hands and wrists (fingers) numb and tingling. Vaccine administered 1:38pm Be...
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Tongue, lips swelling, hands and wrists (fingers) numb and tingling. Vaccine administered 1:38pm Benadryl 50mg PO administered 1:50pm Epi pen given at 2:10pm
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| 42 | 2021-03-23 | nerve pain |
Shingles showed up 4 days after vaccine on side of my nose... diagnosed by my doctor , I?ve been put...
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Shingles showed up 4 days after vaccine on side of my nose... diagnosed by my doctor , I?ve been put on antiviral medication. Nerve pain in my neck/headaches on my right side (same side as shingles).
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| 42 | 2021-03-24 | feeling cold |
Light headed and dizzy beginning approximately 10 minutes post vaccination. Swelling of tongue and i...
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Light headed and dizzy beginning approximately 10 minutes post vaccination. Swelling of tongue and itching in throat beginning approximately 20 minutes post vaccination. At this point patient notified observation nurse. Assessed by EMTs and nurse practitioner on site. Received injection of 25 mg of Benadryl. Began having relief of symptoms within 3 minutes. No Transported to hospital for observation. Received oxygen during transport. ER gave famotidine and loratadine via pills at 3:44 pm. Observation for approximately 70 minutes. At this point it had been approximately 4 hours since injection. BP and oxygen levels good. No itching. Released and returned home. Patient was cold and tired, which is typical for them when receiving a Benadryl injection. Slept for approximately 14 hours. Currently tired and achy, which is again typical for them after receiving a Benadryl injection.
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| 42 | 2021-03-24 | feeling hot |
Returned to site after being released post-vaccine, went to car then noted rash to chest area and fa...
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Returned to site after being released post-vaccine, went to car then noted rash to chest area and face, +itchiness/warmth to upper extremities. On assessment well appearing, NAD airway intact/denied SOB throat irritation-visible rash (raised/reddened) to ant chest and upper back, warmth to arms bilaterally. Pt requested Benadryl, consultant with on duty Pharmacists who recommended Benadryl-Benadryl 50mg PO give, pt observed x 30 more minutes, all sx's resolved, well appearing. VSAFE hand-out given for self-reporting
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| 42 | 2021-03-24 | flushing |
12 minutes post vaccination pt stated she felt "lightheaded " and face "flushed" vitals taken at 153...
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12 minutes post vaccination pt stated she felt "lightheaded " and face "flushed" vitals taken at 1534 BP 140/80 HR 91bpm spO2 97% , at 1545 161/71 HR 89 spO2 98% Temp 97.4. Provided water and encouraged deep breathing. Pt called husband to inform him of the situation. She stated she was feeling a little better. Vitals repeated. At 1540 BP 126/65 HR 83 spO2 98% , husband arrived at 1607 and pt left with him and encouraged to check with PCP prior to second vaccination.
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| 42 | 2021-03-24 | tingling | Tingling in opposite arm 1 hour after shot, BP 124/82 |
| 42 | 2021-03-24 | tremor |
Body aches; fatigue; chills; headache; rash on hands and arms; shaking; soreness at injection site; ...
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Body aches; fatigue; chills; headache; rash on hands and arms; shaking; soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration on 11Feb2021 at 11:00 (at the age of 42-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient previously received acetaminophen, propoxyphene (DARVOCET), cephalexin, and pineapple and experienced allergy. The patient previously received dose 1 of BNT162B2 (lot number EL3249) on 21Jan2021 at 11:00 as a single dose in the left arm for COVID-19 immunization. After dose 2 of BNT162B2, on 12Feb2021 at 04:00 the patient experienced body aches, fatigue, chills, headache, rash on hands and arms, shaking, and soreness at injection site. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of body aches, fatigue, chills, headache, rash on hands and arms, shaking, and soreness at injection site were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-03-25 | weakness |
Feeling nausea, weak, dizzy. Had a brain banana since yesterday. HR 60 reg. BP 106/81, O2 Sat 100...
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Feeling nausea, weak, dizzy. Had a brain banana since yesterday. HR 60 reg. BP 106/81, O2 Sat 100%.
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| 42 | 2021-03-25 | numbness, tingling |
After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Inte...
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After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Intermittent heart racing. After shot #2 on 3/25/21: pain at injection site. Severe depression and anxiety lasting the day of injection. Intermittent racing heart. Chills, fatigue, overall malaise starting 3/26/21. Moderate headaches starting 3/26/21. Numbness/tingling in tips of fingers on right hand starting 3/26/21.
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| 42 | 2021-03-25 | tingling | the patient felt arm tingling after injection. |
| 42 | 2021-03-26 | numbness |
Numbness of the face as if I was coming out of dentist office. Still able to move my face but can no...
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Numbness of the face as if I was coming out of dentist office. Still able to move my face but can not feel my skin. Ears felt as if I was underwater or going in plane (trying to pressurize)
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| 42 | 2021-03-26 | numbness |
In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (s...
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In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am
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| 42 | 2021-03-26 | tingling | 42 YOF c/o tingling in her face. Refused further treatment. No swelling, rash noted. |
| 42 | 2021-03-26 | tenderness |
Initial soreness went away after 24 hours. Day 6 following the first vaccine my shoulder having join...
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Initial soreness went away after 24 hours. Day 6 following the first vaccine my shoulder having joint pain and bicep as well as my armpit has become sore and tender to the touch.
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| 42 | 2021-03-27 | nerve pain, pain in extremity |
Vaccine injection site high on shoulder. Severe arm pain, injection site bruising and swelling. Ner...
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Vaccine injection site high on shoulder. Severe arm pain, injection site bruising and swelling. Nerve pain, fever, muscle soreness, headache, nausea.
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| 42 | 2021-03-27 | tremor, feeling cold |
Body aches and pains, joint paint from ankles to jaw, shakes from feeling extreme cold, fever - over...
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Body aches and pains, joint paint from ankles to jaw, shakes from feeling extreme cold, fever - overnight rose to 102°
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| 42 | 2021-03-28 | facial paralysis |
Slight left side face and lip droop; This is a spontaneous report from a contactable consumer (patie...
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Slight left side face and lip droop; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration in left arm on 05Mar2021 08:00 as single dose for COVID-19 immunization. Patient had COVID prior vaccination. The patient had no known allergies and no other medical history. The patient was not pregnant. There were no concomitant medications. There were no other vaccine in four weeks and no other medications in two weeks. The patient experienced slight left side face and lip droop on 05Mar2021 09:30. There was no treatment for the event. The patient was not COVID tested post vaccination. The outcome of the event was not recovered.
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| 42 | 2021-03-28 | numbness |
Sharp pain on the left side of my neck immediately after shot in my left arm. Within 15 mins the le...
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Sharp pain on the left side of my neck immediately after shot in my left arm. Within 15 mins the left side of my face and left pinky finger started feeling numb and my left arm was heavy.
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| 42 | 2021-03-28 | pain in extremity | Extremem fatigue, some nausea, and right arm soreness. |
| 42 | 2021-03-29 | weakness, pain in extremity, tremor |
extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left s...
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extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
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| 42 | 2021-03-30 | pain in extremity |
very sore left arm; body aches; mild headache; fatigue; This is a spontaneous report from a contacta...
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very sore left arm; body aches; mild headache; fatigue; This is a spontaneous report from a contactable consumer (patient herself) of 42-years-old female received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number: EL3247) via an unspecified route in left arm on 26Jan2021 10:45 am and second dose on 16Feb2021 13:45 pm via unspecified route in left arm both as single dose for covid-19 immunisation. Patient medical history included overactive bladder, premature ovarian insufficiency and known allergies were reported as yes. Concomitant medications were not reported. Patient took other medications within two weeks before vaccination and had not received other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to the vaccination. On 16Feb2021 23:30 the patient experienced very sore left arm, body aches, mild headache, and fatigue. The patient was not tested for covid-19 post vaccination. The outcome of the events is recovering.
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| 42 | 2021-04-02 | tremor, speech disorder |
Body Tremors, dizziness, headaches, balance issue, tremors get worse when I feel cold, I blurt out w...
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Body Tremors, dizziness, headaches, balance issue, tremors get worse when I feel cold, I blurt out words,
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| 42 | 2021-04-03 | tremor, cold extremities |
i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusel...
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i felt like i was passing out; i felt like i was dying; sweating on the drive home/sweating profusely; a bout of diarrhea; nauseated; my ears started ringing really loudly, then hissing; could barely stand; my limbs started feeling cold; very thirsty; My pulse felt fast; shaky; My lips and face felt slightly swollen; My lips and face felt slightly swollen; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 42-years-old via an unspecified route of administration, administered in arm right on 18Mar2021 16:15 (Batch/Lot Number: Ep6955) as single dose for covid-19 immunisation. Medical history included known allergies: Sulfur dioxide preservative and almost died from blood loss from an unknown date and unknown if ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and venlafaxine hydrochloride (EFFEXOR XR); both taken for an unspecified indication, start and stop date were not reported. The patient reported that right after she left the waiting room, 15mins following the shot, she noticed she was sweating on the drive home, but felt normal, not expecting a problem. Then she felt terrible really fast. She had a bout of diarrhea, was nauseated and her ears started ringing really loudly, then hissing and she felt like she was passing out. She was sweating profusely and could barely stand. She laid down and her limbs started feeling cold and she got very thirsty. Her pulse felt fast it reminded her of when she almost died from blood loss. She felt like she was dying. The feeling lasted about 10 mins, then slowly started fading. She was shaky for the next hour. Her lips and face felt slightly swollen, but there was no itchiness or tightness in her throat. Her temperature was 96.0. She took a nap and woke up feeling better but my ears are still ringing. It has been about 2 1/2 hours. The events occurred on 18Mar2021 16:45. No treatment was received in response to the events. The patient was recovering from the events.
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| 42 | 2021-04-07 | muscle twitching |
My nerves are twitching in and off in my legs . Unbearable. I got really sick the day after with chi...
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My nerves are twitching in and off in my legs . Unbearable. I got really sick the day after with chills , fever and body aches and nerve twitching. Sickness is gone but nerve twitching doesn?t go away or lessen. It?s all the time I can?t even drive.
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| 42 | 2021-04-12 | weakness |
Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. The next day, she developed fever, was ...
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Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. The next day, she developed fever, was told that she had a sinus infection, and was treated with amoxicillin. Patient tested positive for COVID on 4/7/21 at her primary care doctor's office. On 4/8/21, patient presented to the ER with cough, shortness of breath, fever, chills, and weakness, but was sent home. Patient returned to the ER on 4/9/21 with worsening symptoms and was admitted to the hospital for COVID treatment.
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| 42 | 2021-04-14 | pain in extremity, tingling |
On 3/27/2020, the patient received the second dose of the Pfizer COVID vaccine. About 3 hours later...
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On 3/27/2020, the patient received the second dose of the Pfizer COVID vaccine. About 3 hours later she started to develop paresthesias in both hands and fingers, as well as pain. She continued with the same paresthesias and pains; in about a week, she developed subungual hemorrhages
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| 42 | 2021-04-14 | seizure |
During 15 minute waiting period, I started having increased heartbeat and overwhelming nausea. I rep...
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During 15 minute waiting period, I started having increased heartbeat and overwhelming nausea. I reported it to the nurse, she took my vitals and my heartbeat was 140-150. My O2 levels were fine and my lungs were clear. Approximately 15 -20 min post vaccine I started having seizures.( I have no history of seizures) I was given Epinephrine, benadryl to calm my body down. It did not change any of my symptoms. I had approx. 5 seizures in the facility before they called the ambulance. I had 3-4 on way to hospital and more once I arrived. I was given ativan to help me relieve the symptoms. I was given a CAT scan and there were no issues as per doctor. I did not have any more seizures and I was sent home. The next morning I had a doctors appointment and started having seizures again. I had about 4 at home, ambulance was called and had more seizures throughout the day. I was admitted to hospital since my seizures were not stopping. I was given another CAT scan and MRI and nothing was was found in either test.
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| 42 | 2021-04-14 | seizure |
Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was exper...
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Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive.
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| 42 | 2021-04-17 | numbness and pain in extremities, facial paralysis |
Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly ...
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Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly started a couple weeks after the vaccine and eventually worsened to the point of not being able to open my mouth. Symptoms included facial paralysis, Muscle weakness, fatigue, vision issues, Neuropathy issues. I was transfused with multiple doses of Immunoglobulin and IV steroids. Still currently in Physical therapy I have lost 3 months of not being able to work. Also had a blood clot
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| 42 | 2021-04-18 | tremor, feeling cold |
Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get wo...
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Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get worse when I feel cold; I blurt out words for no reason; Eyes can't focus, when trying to read the words seem to be shaking; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Jan2021 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 21Dec2020 (lot number: EH9899) for covid-19 immunisation. The patient experienced body tremors, dizziness, headaches, balance issue, tremors get worse when she feel cold, she blurt out words for no reason, eyes can't focus, when trying to read the words seem to be shaking on 18Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Dec2020, sars-cov-2 test: negative on 27Feb2021. There were no treatment received for the events. The patient did not recover from the events.; Sender's Comments: Based on the available information, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-04-20 | migraine |
life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nausea...
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life stopping migraine; tighten muscles around the back of my neck and shoulder muscles; VERY nauseated; small fever; be cold; chills; soaked in sweat; This is a spontaneous report from a contactable consumer(patient). A 42-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 13Mar2021 (Batch/Lot Number: F(E)N6208) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included Stroke, anorexia, gastroparesis, asthma, thyroid, low BP, hypotension, known allergies -Sulfa, Paxil, Demerol. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 10:30 AM (Batch/Lot Number: EM9809 as SINGLE DOSE for covid-19 immunisation. Concomitant medications received within 2 weeks of vaccination included Fentanyl patch, seroquel, trazodone, ambien, baclofen. The patient previously took paxil and experienced known allergies-sulfa, demerol and experienced known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 14Mar2021 at 04:00, the patient experienced life stopping migraine, tighten muscles around the back of my neck and shoulder muscles, very nauseated, small fever, be cold, chills, soaked in sweat. The patient did not receive any treatment for the events. Outcome of all the events was recovered with sequelae. Information on Lot/Batch number was available. Additional information has been requested.
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| 42 | 2021-04-24 | pain in extremity, feeling of body temperature change |
Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm ext...
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Fever of 102; chills; temperature swings hot/cold; sweating; Exhaustion; no appetite; entire arm extremely sore; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old female patient received received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 05Apr2021 at 13:30 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 15Mar2021at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 06Apr2021 at 11:30 AM, the patient experienced fever of 102, chills, temperature swings hot/cold, sweating, Exhaustion, no appetite, entire arm extremely sore. No treatment was received. The outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 42 | 2021-04-24 | tingling |
Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a de...
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Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.
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| 42 | 2021-04-26 | burning sensation, cold extremities, tingling |
Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, we...
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Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, went away after about 4 days, then came back around day 12 with chills and feeling run down/sick, but as more of a pins and needles/cold burn feeling, again mostly around legs, went away after a few days, came back again 4/26 as pins and needles and cold burning feeling with chills every now then, also experiencing off and on vertigo since vaccine and tinnitus, as well as painful lymph nodes in chest mostly on vaccine side starting in day 12ish post vaccine.
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| 42 | 2021-04-27 | feeling hot, pain in extremity |
Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sor...
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Hot, fever, arm pain to the extent I couldn?t use my arm normally, sore throat, very swollen and sore lymph nodes in neck and groin, achy, tired, no appetite
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| 42 | 2021-04-27 | numbness, numbness and pain in extremities, tingling |
neuropathy in her left foot/ numb like tingling, a lot of tingling feeling/feel it every now and the...
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neuropathy in her left foot/ numb like tingling, a lot of tingling feeling/feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; felt weird; Iinterfering with her brain; makes her "like I want to cry."; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 01Apr2021 (lot number: ER8737) as single dose (at the age of 42-years-old) for COVID-19 immunisation. Medical history included temporomandibular joint syndrome (TMJ), headache and clench my teeth; from an unknown date and unknown if ongoing. Concomitant medication included butalbital, caffeine, paracetamol (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) taken for "clench my teeth", start and stop date were not reported; the patient was also taking unspecified vitamins, supplements and an unspecified headache medication. The patient received the first shot of BNT162B2 for Covid-19 immunisation on an unspecified date. The patient had both the shots and was wondering because she was left with like this neuropathy in her left foot, it was kind of numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body. It was like setting on her left foot and she got the shot on her left side. She got the last second shot and got it on Thursday (01Apr2021). She told her doctor right away the she saw this only after the last shot. She told the guy it was weird, it felt weird and then he said, you know it was a kind off to the side and was just "mental". But it has not gone away, it was like neuropathy, she doesn't remember if it was with the first shot because it was so quick in between. She wanted this to go away, it was really annoying. It was interfering with her brain, it was not good, it makes her "like I want to cry." The patient had a lab work done on Thursday morning (08Apr2021) and stated that her blood work was fine. They did a thyroid check, did her blood sugar and everything was fine; and her B12 to make sure her B12 wasn't low but everything was fine. The patient does not know the name of the tests. The patient wanted to know if the side effects she was experiencing was normal and was it going away. The outcome of the events was unknown.
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| 42 | 2021-04-27 | numbness |
Pointer finger on left hand is numb. It started about 1 hour after the injection and has not changed...
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Pointer finger on left hand is numb. It started about 1 hour after the injection and has not changed.
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| 42 | 2021-04-27 | numbness | swelling of face, facial numbness |
| 42 | 2021-04-28 | muscle twitching |
It started with hand twitching the same week I got the Pfizer shot which I assumed was unrelated. Th...
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It started with hand twitching the same week I got the Pfizer shot which I assumed was unrelated. Then on 4/17 I noticed an internal vibration sensation. This internal vibration sensation persisted and became more frequent (chest, lower half of head predominantly but sometimes whole body as well). April 23 to 25 was happening a lot even while sleeping. On April 23 I went to Urgent care for unexplained high blood pressure, ran tests, and was released. Consulted doctor on April 26 about high blood presure and internal vibration sensation (unclear if related) and ran more tests. Still unclear cause. Will see if symptoms continue to improve.
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| 42 | 2021-04-30 | difficulty speaking |
Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the mid...
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Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs; Dizziness; At the time she was given her COVID-19 Vaccine shot, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back; dry eyes; she was coughing more; the increase in coughing had made her voice huskier sounding; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 08:45 Arm Left (Lot Number: EP6955, Expiration Date: 30Jun2021) single dose for covid-19 immunisation. Medical history included ongoing Crohn's disease from 1999, ongoing Hidradenitis suppurativa at the end of 2019, ongoing Small Fiber Peripheral Neuropathy diagnosed at the end of 2019. She said her doctor was not sure of the Small Fiber Peripheral Neuropathy's cause, or if the Small Fiber Peripheral Neuropathy was associated with any of her other medical conditions. She said she had symptoms for sometime, and was diagnosed with a lot of things at the end of 2019 because she was finally able to see a specialist. Concomitant medications included adalimumab (HUMIRA AC) from in Feb2020 at 40mg injection pen once a week for her Crohn's disease. Reported she has had no reactions to flu or pneumonia vaccines for immunisation in the past. She said she had her first COVID-19 Vaccine dose on Thursday, 18Mar2021. She said on Saturday morning (20Mar2021), she had shortness of breath, dizziness, and chest pressure. She said her shortness of breath, dizziness, and chest pressure has been lasting for 20-something days, and she doesn't know why. She said she had taken two (different) week long prescriptions of Prednisone. She said she had 2 EKGs, 2 chest x-rays, and blood work, which were all normal on 13Apr2021 and 2021. She said her doctors don't know why she was having the shortness of breath, dizziness, and chest pressure. She said she was using inhalers, medications, and everything, and still had her symptoms. She asked if what she was experiencing was a side effect of the COVID-19 Vaccine, or due to her 2 autoimmune diseases because her doctors were grasping at straws at this point. Reported she had so many medical conditions, and was taking so many different medications. Reported she has had shortness of breath and chest pressure every day, but the dizziness wasn't constant, and had lessened. She said she has never had the shortness of breath and chest pressure before. She said she has never had anything last that long either. She said she was wondering if her shortness of breath and chest pressure were caused by the COVID-19 Vaccine. Clarified the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, saying it was an odd feeling. Reported she was coughing more, and she believed the increase in coughing had made her voice huskier sounding in 2021. She said she had a cough associated with outdoor allergies, but the cough she had now didn't feel like her normal allergy cough. She said she had no mucus. She said she was not sneezing, or coughing out anything. She said the cough she had now was different. Reported at the time she was given her COVID-19 Vaccine shot 18Mar2021, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her fingertips. She said the warmth feeling also went to the left side of her back. She said she was kept longer after she got her COVID-19 Vaccine for monitoring. She said the warmth feeling in her left arm, left fingertips, and left back didn't last long, and went away. Reported she had gone to the Emergency Room on Tuesday, 13Apr2021, because she had palpitations, and a weird feeling under her skin. She said while at the Emergency Room, she had an EKG, chest x-ray, and blood work. She said the doctor was looking for a blood clot. She said all her testing came back negative for a blood clot. She said earlier that day (13Apr2021) was her 3rd visit to her doctor since her symptoms had started. Reported she had started Restasis on 19Mar2021, the day after her first COVID-19 Vaccine. She said she was prescribed Restasis for dry eyes, and didn't have the dose, NDC, Lot, and Expiration Date because she was not at home. AEs require a visit to Emergency Room and Physician Office. Treatment included Stated she had taken 2 different week long doses of Prednisone to treat her symptoms. She said she first took Prednisone 40mg, once a day, for 7 days. She said she was off the Prednisone 40mg for 2 days, and had instructions to call her doctor if she wasn't feeling better. She said she went back to her doctor, and was prescribed Prednisone 60mg for 3 days, then Prednisone 40mg for 3 days, and then Prednisone 20mg for 3 days. She said she did not have the 2 Prednisone prescription NDC, Lot, and Expiration Dates. She said she was also put on a 10-day Azithromycin 250mg tablet prescription. She said she took a Azithromycin 500mg (2-250mg tablets) dose the first day, and then Azithromycin 250mg, once a day, for the next 9 days. She said she did not have the Azithromycin 250mg tablet NDC, Lot, and Expiration Date. She said she was also prescribed an Albuterol (90mcg per actuation) inhaler, providing: NDC Number: 66993-019-68, Lot Number: A63H, Expiration Date: Jan2022. She said she didn't feel like the Albuterol inhaler was doing the rescue part, and that she could take the Albuterol inhaler every half hour. Reported she was prescribed an Albuterol inhaler (90mcg per actuation) for shortness of breath. Outcome of the event Shortness of breath, the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, coughing more, the increase in coughing had made her voice huskier sounding was not recovered. Outcome of the event Palpitations, a weird feeling under her skin was unknown. Outcome of the event Dizziness was recovering. Outcome of the event had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back was recovered on 18Mar2021. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-04-30 | pain in extremity |
It now goes up to her neck, her back, down her arm and her hand; It now goes up to her neck, her bac...
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It now goes up to her neck, her back, down her arm and her hand; It now goes up to her neck, her back, down her arm and her hand; immense pain travel down her entire left arm into her hand; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 03Apr2021 at 13:45 as a single dose for COVID-19 immunization. Medical history included migraine and unspecified known allergies both from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included topiramate (manufacturer unknown); sumatriptan (manufacturer unknown); eszopiclone (LUNESTA) and promethazine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not have other vaccines in four weeks prior to the COVID vaccine. The patient was not tested for COVID post vaccination. On 03Apr2021, it was reported that within two minutes of receiving the injection, the patient had immense pain travel down her entire left arm into her hand. She knew it wasn't normal. The patient called the paramedics over because the pain got so intense she couldn't even touch her arm nor her hand. The paramedic said this was not a normal reaction and maybe they hit a nerve but he's not sure what's going on. It's been two weeks since her vaccine injection. The pain comes and goes just as bad as that bad. It now goes up to her neck, her back, down her arm and her hand. She can't use it nor touch it. The events result in a doctor or other healthcare professional office visit and was reported to have caused disability/permanent damage. The patient had not recovered from the events. Information about lot/batch number has been requested.
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| 42 | 2021-05-04 | bell's palsy | Bell?s Palsy (right side of face) |
| 42 | 2021-05-07 | weakness |
14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, ...
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14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving. Information on Lot/Batch number was available. Additional information has been requested.
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| 42 | 2021-05-07 | migraine |
She could even barely make it to give herself to go pee, she was completely immobilized.; Migraine/l...
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She could even barely make it to give herself to go pee, she was completely immobilized.; Migraine/light sensitive/nausea/headache; Extremely dizzy; Painful and scary; scary; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the 1st of 2 reports. A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) (at the age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she woke up at 6:00 in the morning (on 17Apr2021), there were on migraine, light sensitive, extremely nauseous and extremely dizzy. She could even barely make it to give herself to go pee, she was completely immobilized. She was that nauseous and that dizzy, she was staying in the bed she could not do anything else; she could not get in the kitchen or get something to drink. She took a MOTRIN (as a treatment) around 3 after, she was still felling the symptoms, migraine got disappeared, she was able to move around but eventually got better headache. She was painful and scary. The patient outcome of migraine was recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021479302 same reporter, drug, different patient and event
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| 42 | 2021-05-10 | tingling |
My heart was racing.132bpm; I felt lightheaded; tightness in throat; tingling in my arms and hand; T...
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My heart was racing.132bpm; I felt lightheaded; tightness in throat; tingling in my arms and hand; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 05Feb2021 15:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included known allergies to Pineapple, Bananas, onions, several environmental allergies; asthma. Patient didn't have COVID prior vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); cromoglicate sodium (ALLERGY) shot; clarithromycin (CLARITIN); mometasone furoate (FLONASE); fluticasone propionate (PROAIR); all taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. Around 8 minutes after vaccine (as reported) patient felt lightheaded, tightness in throat and tingling in her arms and hand. Her heart was racing.132bpm. She told the workers and was taken by ambulance to the hospital. Adverse events start from 05Feb2021 03:15 PM and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent car. Treatment received included Oxygen, benadryl shot. The outcome of the events was recovering. COVID was not tested post vaccination. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 43 | 2021-01-02 | tenderness |
Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for...
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Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for 4 days. Painful to touch and hot. Increased tiredness within first 24 hours.
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| 43 | 2021-01-03 | numbness, nerve pain, facial paralysis, face paralysis, paralysis |
Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I ha...
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Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I had numbness and weakness in the right of my tongue which I quickly realized included the right portion of my face. Included tongue was numb and I couldn't move it. An Er trip and CT scan confirmed it was Bells Palsy. Today, My symptoms continue. Top of my head all the way to the way to bottom of neck is experiencing paralysis. Can move tongue now and it's partly numb but it's cooperating a bit more now. Nerve pain has worsened all over all the right side of face. Feels like someone has kicked face and I have a deep bruise. It's a deep ache. Nothing will take away the ache away. My eye doesn't lubricate like it should. So I have to either manually close it and wet it manually or tape it closed.
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| 43 | 2021-01-03 | migraine |
On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea...
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On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.
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| 43 | 2021-01-03 | pain in extremity | ACHINESS TO LEFT ARM. 7 HOURS AFTER RECEIVING VACCINE EXTREMELY PAINFUL WITH DECREASE ROM. |
| 43 | 2021-01-03 | pain in extremity |
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but...
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My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
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| 43 | 2021-01-03 | pain in extremity | patient developed arm pain day after vaccination that lasted about 1 day. |
| 43 | 2021-01-03 | tingling, feeling hot | Pounding heart, fast breathing, warm/tingling in arms/hands, feeling like I might faint. |
| 43 | 2021-01-04 | burning sensation |
Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burn...
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Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burned for a few days, followed by whole body burning and sweating with rash on lower arms and chest along with continued rash on upper back. These symptoms come and go and are worse on different days. This continues today and I have been advised by my healthcare provider not to receive second dose which was scheduled for today 1/5/21. I did take steroids for two days but then was advised by physician to allow my body to react if I can tolerate the symptoms. Symptoms are tolerable some days but not all. No fever with the burning and sweating. No other symptoms.
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| 43 | 2021-01-04 | feeling hot |
fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was ...
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fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.
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| 43 | 2021-01-04 | feeling hot |
Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned...
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Rushing feeling-hands turned red and warm and face turned red and warm; Rushing feeling-hands turned red and warm and face turned red and warm; redness of hands; Rushing feeling-hands turned red and warm and face turned red and warm; Palpitations-increases heart rate; Palpitations-increases heart rate; Increased blood pressure; This is a spontaneous report from a contactable Nurse. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Dec2020 at 04:15 (at the age of 43-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. The patient was allergic to morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in a workplace clinic. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 04:30 the patient experienced a rushing feeling during which her hands turned red and warm and her face turned red and warm. At this same time, she also experienced increased blood pressure, palpitations and increases in her heart. The patient did not receive any treatment for the events. The clinical outcomes of rushing feeling during which her hands and face were warm and turned red, increased blood pressure, palpitations, increased heart rate were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | flushing, feeling jittery |
No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after f...
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No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 11:00 at single dose at arm (pending clarification) for COVID-19 immunization. Medical history included asthma, allergies, depression, penicillin allergy, allergies to: Mangoes, Cashews, Peaches. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took amoxicillin and experienced known allergies: Amoxicillin. On 18Dec2020: about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant. Lasted about an hour. On 19Dec2020: afternoon - headache, nausea, fatigue started. On 20Dec2020: continued to feel fatigued and same symptoms. On 21Dec2020: headache, waves of nausea along with feeling flush (no fever ever) and elevated heart rate. On 22Dec2020: Same. The patient continued to work through all this but felt lousy. On 23Dec2020: stayed home from work because work wanted the patient to take a Covid Test (this was negative) - so laid around. Still with headache and nausea, easily fatigued. Cough started PM. On 24Dec2020: no nausea but continued headache, congested head, cough. On 25Dec2020: feeling better. No appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, and was negative on 23Dec2020. The outcome of the events was recovered. The patient did not receive treatment for the events. Information about lot/batch number has been requested.
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| 43 | 2021-01-04 | flushing |
Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 re...
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Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 remained steady at 98%. Sat with healthcare staff for additional 40 minutes. Benadryl 25mg given.
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| 43 | 2021-01-04 | muscle spasms |
Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen t...
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Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).
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| 43 | 2021-01-04 | pain in extremity |
Arm pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43...
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Arm pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the right arm on 30Dec2020 at 08:00 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 13:30, the patient experienced arm pain. No treatment was provided for the event arm pain. The outcome of the event arm pain was unknown. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | pain in extremity |
sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I cou...
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sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.
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| 43 | 2021-01-04 | pain in extremity |
arm pain/soreness; This is a spontaneous report from a non-contactable nurse reported for herself. A...
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arm pain/soreness; This is a spontaneous report from a non-contactable nurse reported for herself. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiry date unknown) via an unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain/soreness on unspecified date. The outcome of the event arm pain/soreness was unknown. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-04 | seizure |
The resident who was known to have seizures, and under control for many yeas with Keppra 1000 mg twi...
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The resident who was known to have seizures, and under control for many yeas with Keppra 1000 mg twice a day, on the second day after vaccination developed recurrent seizures requiring hospitalization to an intensive care unit, with intubation and mechanical ventilation until 1/5/21 (to be extubated today). She is still at the hospital.
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| 43 | 2021-01-05 | numbness |
I developed intermittent Bilat leg numbness on Jan 2nd and 3rd. On Jan 4th the bilat lower leg numb...
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I developed intermittent Bilat leg numbness on Jan 2nd and 3rd. On Jan 4th the bilat lower leg numbness was constant all day and around 4 pm that same day I developed right forearm numbness. On Jan 5th the symptoms have seemed to have resolved in my legs, right forearm is still slightly numb. No weakness present just numbness.
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| 43 | 2021-01-05 | tingling |
Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamet...
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Lip and nose tingling, lip swelling, metallic test in mouth Sent to the ED for 2 hours given Dexamethasone and Benadryl . Symptoms resolved
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| 43 | 2021-01-06 | flushing | Immediate flushing of skin, tachycardia, impaired cognition |
| 43 | 2021-01-06 | numbness, tingling, pain in extremity |
I initially developed left arm soreness in the evening of administration of the injection. The follo...
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I initially developed left arm soreness in the evening of administration of the injection. The following day I developed chills and myalgias. On 1218 2021, I developed shooting pain down my right leg. Later that evening I developed persistent tingling and numbness in my hands, both, as well as tingling and numbness in both my feet. Since that time I have had persistent tingling and numbness. These symptoms have persisted since this time. They are worse with cold weather. Not associated with any weakness however I do have some increased fatigue ability in my right forearm, which may be unrelated.
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| 43 | 2021-01-06 | numbness | metallic taste, numbess tonque and left arm, no treatemnt at present |
| 43 | 2021-01-06 | pain in extremity |
First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mil...
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First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mild pain arm. 12/17-12/18 arm pain got worse every day. 12/19 couldn't sleep at night. 12/20 limited motion in arm. Called doctor12/21. Took 400mg ibuprofen. Took Medrol for shoulder pain. 12/22 not able to sleep. Dr. wrote rx for Flexerol. Continued to take meds. Went back to work 12/23 with some pain. By 12/26 much better.
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| 43 | 2021-01-06 | pain in extremity |
Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection f...
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Hives of right side of body , lower and upper body .. Also in armpits... Sore arm after injection for a few days
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| 43 | 2021-01-07 | weakness |
Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mi...
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Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.
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| 43 | 2021-01-07 | weakness | Headache, muscle aches, weakness, low grade of fever |
| 43 | 2021-01-07 | burning sensation |
pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pai...
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pain at injection site. Just below left elbow to the tip of fingers c/o burning and has shooting pain sensation.
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| 43 | 2021-01-07 | discomfort |
I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began ha...
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I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; discomfort 4-5 on a 0-10 scale; I also noted stollen lymph nodes in my neck, throat, and subclavicular areas.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) (Brand: Pfizer), via an unspecified route of administration from 31Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Nursing Home/Senior Living Facility. Medical history included hypertension, aneurysm of ascending aorta, erbs-duchenne palsy right arm, asthma, seasonal allergies. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), diltiazem (DILTIAZEM SR), sertraline hydrochloride (ZOLOFT). The known allergies included PCN, bananas, passion fruit. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 12h post vaccine at 01Jan2021 08:30 AM, patient began having muscle and joint aches throughout her body, discomfort 4-5 on a 0-10 scale. She also noted stollen lymph nodes in her neck, throat, and subclavicular areas. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021. Patient didn't experience Covid prior vaccination. She took Covid tested post vaccination, covid test type post vaccination Nasal Swab on 02Jan2021, the covid test result negative. The events were reported as non-serious.
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| 43 | 2021-01-07 | flushing |
Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1...
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Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1 of the Pfizer-BioNTech COVID-19 vaccine. She self-ambulated to the clinic where she was assessed, vitals taken (which were stable), and offered an injection of Benadryl 25mg IM, which she accepted. Patient was continually monitored and reassessed 15, 30, and 60 minutes after her arrival at which time she was starting to feel better, less flushed, with a visible reduction in her mild hives. Patient was released to her own self-care and stated she would be calling her husband to pick her up from work.
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| 43 | 2021-01-07 | numbness |
Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with va...
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Numbness and tingling of lips, and jaw numb, noted on her way home from hospital. Checked in with vaccine clinic to report symptoms and be monitored for 30 minutes.Took 50mg Benedryl. Symptoms resolved 12/28/2020.
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| 43 | 2021-01-07 | muscle twitching |
Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "le...
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Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.
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| 43 | 2021-01-07 | pain in extremity, weakness | I fever 102.2 , weakness, fitage , chills, head aches and arm sores. 48 hours recovered. |
| 43 | 2021-01-07 | pain in extremity |
1/7/2021 Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with...
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1/7/2021 Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with ibuprofren and tylenol 1/8/2021 Took more ibuprofren at 4am, 'feel just fine'. *I think that severity of the symptoms, which i was expecting, the 2nd dose was more 'hard hitting' then the first; More side affects with muscle and joint pain.
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| 43 | 2021-01-07 | pain in extremity |
1/5/2021 received vaccination 1/6/2021 woke up at 6am with sore arm, muscle/joint pain, low grade fe...
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1/5/2021 received vaccination 1/6/2021 woke up at 6am with sore arm, muscle/joint pain, low grade fever of 100.4 . Treated with Tylenol and Ibuprofren. *I expected the second dose to be more 'hard hitting' then the first. The muscle / joint paint was a 6/10. 1/7 woke up at 4am and took Ibuprofren 1/8/ 'today i feel great'
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| 43 | 2021-01-08 | weakness |
Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours pos...
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Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours post immunization. Severe shaking chills occurred with decreasing frequency over next 48 hours. Headache more intense for 48 hours, but persists still today (1/9/21). Nausea for 48 hours. Diarrhea lasted 4 days with decreasing frequency. Stiff and painful neck and base of skull has steadily decreased but is still present today (1/9/21).
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| 43 | 2021-01-08 | pain in extremity |
Started menstruation that afternoon. Off cycle... 1 week - 2 weeks early. Not typical for me... I'm ...
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Started menstruation that afternoon. Off cycle... 1 week - 2 weeks early. Not typical for me... I'm very regular. Not on birth control but husband has vasectomy. Chance of pregnancy is extremely unlikely. Started with bad cramping in pelvis and aching legs. Cramps have lessened. Dark blood. Brownish in color.
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| 43 | 2021-01-08 | pain in extremity |
Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was abl...
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Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was able to sleep off her side effects. Took 800mg Ibuprofen OTC which helped. Afebrile.
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| 43 | 2021-01-08 | tingling | Tingling in right arm that radiated up to cheek and eye |
| 43 | 2021-01-09 | tingling, numbness |
Numbness and tingling in both hands, down right leg. Patient observed for 30 minutes. No worsening...
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Numbness and tingling in both hands, down right leg. Patient observed for 30 minutes. No worsening of condition and patient declined further medical care.
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| 43 | 2021-01-10 | bell's palsy, weakness |
L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose ...
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L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose #2 of the Pfizer-BioNTech vaccine
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| 43 | 2021-01-10 | burning sensation, flushing | Left side burning. Flushed, Lightheaded, Heaviness in her Chest Tylenol |
| 43 | 2021-01-10 | muscle spasms | Sever muscle spams and joint pain in my entire body felt for over 24 hours |
| 43 | 2021-01-10 | pain in extremity |
soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down ...
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soreness/The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; The pain radiates down to her left elbow and also goes up the neck; This is a spontaneous report from contactable other HCP (patient' husband). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. No concomitant medications. The patient had a whole lot of soreness on 01Jan2021 and it was not getting any better. His wife had called her health care provider. She had an appointment in several days. The pain radiates down to her left elbow and also goes up the neck in Jan2021. The reporter seriousness for soreness: Medically significant. The outcome of event pain was not recovered. The outcome of rest events was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event pain and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-10 | pain in extremity |
Severe pain in shoulder/arm, motor deficit. Treated with Tylenol and Advil and ice, pain persisted ...
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Severe pain in shoulder/arm, motor deficit. Treated with Tylenol and Advil and ice, pain persisted approx. 48 hours. Motor deficit improved, but still present
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| 43 | 2021-01-10 | pain in extremity |
Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortne...
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Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved
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| 43 | 2021-01-10 | tingling, numbness, pain in extremity, facial paralysis |
Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle ...
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Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle followed by droopy right eye and then right sided mouth drooping that comes and goes.
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| 43 | 2021-01-10 | tenderness | Erythema and tenderness with reactive lymph nodes left axillary area The size of erythema is 18x8 cm |
| 43 | 2021-01-11 | facial pain |
I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the v...
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I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the vaccine the pain began increasing to the whole left side of my face and neck and increasing in intensity. I was unable to sleep 12/24 and 12/25 and ended up going to urgent care on 12/26. Despite not having sinus fullness/drainage they diagnosed it a sinus infection and gave me antibiotics. At the end of the 5 day course my symptoms had improved some but were not gone and I was still requiring frequent Tylenol for pain so the course of antibiotics were extended. I do not know if this was caused by the vaccine, but it coincided with the vaccine.
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| 43 | 2021-01-11 | feeling hot, pain in extremity |
Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Sig...
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Redness and hard lump at injection site; Redness and hard lump at injection site; Warm to touch; Significant discomfort or pain in right arm; Rash on face and neck; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in right arm, on 05Jan2021 at 07:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to shellfish, dust mites, cats, cockroach dander, grass, trees, and pollen. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 05Jan2021, the patient experienced redness and hard lump at injection site, warm to touch (no site reported), significant discomfort or pain in right arm, and rash on face and neck. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
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| 43 | 2021-01-11 | hot flush, feeling cold |
Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM mod...
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Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM moderate fatigue and muscle aches with headache. By 4pm nausea began and temp of 99.4. Severe muscle/joint pain and fatigue progressed from there with temp reaching high of 102.6 before fever broke around 5AM 1/10. Sunday 1/10 - moderate/severe fatigue with low grade temp of 99.6., nausea, headache. Little energy to do anything other than sit on couch. Attempted to go to work Monday 1/11, did have fatigue and headache prior to leaving for work. Once at work developed severe hot/cold flashes on and off with profuse sweating spells anytime I would move around. 1/12 still with headache and nausea.
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| 43 | 2021-01-11 | numbness, tingling |
a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand o...
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a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand on the injection side; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration on the left arm on 05Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient previously took clarithromycin (BIAXIN) and experienced allergies. The patient verbalized, "I don't believe it's anything serious but I am experiencing a lot of tingling/numbness in my hand on the injection side" on 05Jan2021 11:30. Clinical outcome of the events was unknown.
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| 43 | 2021-01-11 | numbness |
developed right forearm numbness; intermittent bilat lower leg numbness / bilat lower leg numbness w...
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developed right forearm numbness; intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL1284, expiry date was unknown) via an unspecified route of administration at the left arm on 30Dec2020 09:30 AM at a single dose. for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jan2021, 6:30 pm and on 03Jan2021, the patient developed intermittent bilat lower leg numbness. On 04Jan2021, bilat lower leg numbness was constant all day and at 4pm that same day, she developed right forearm numbness. No weakness, just numbness. On 05Jan2021, leg numbness has resolved but still having slight right forearm numbness. On 06Jan2021, still no leg numbness but still having slight right forearm numbness. The events resulted in emergency room/department or urgent care. The patient recovered from the event "intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day" on 05Jan2021. Outcome of the event "developed right forearm numbness" was recovering. No treatment was performed in response to the adverse events. The events were assessed as Non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
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| 43 | 2021-01-11 | pain in extremity |
lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; ...
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lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 43 | 2021-01-11 | pain in extremity |
1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 07...
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1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 0700-Facial swelling, mostly around eyes, forehead, and nose 1/11/2021 0700-Continued facial swelling limited to around eyes only 1/12/2021 0530-Continued facial swelling limited to around left eye only
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| 43 | 2021-01-11 | tingling |
After my first vaccination, I had tingling all the way down to my fingertips. While I was driving ho...
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After my first vaccination, I had tingling all the way down to my fingertips. While I was driving home that night, my face, mouth, tongue, and cheeks became tingling. I got my second dose and and the same symptoms happened. Last night I felt feverish and was achy.
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| 43 | 2021-01-12 | weakness |
Fever 101.7, fever off and on for 24 hours beginning 14 hours after dose. Headache, muscle aches, ex...
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Fever 101.7, fever off and on for 24 hours beginning 14 hours after dose. Headache, muscle aches, extreme fatigue and weakness, same duration.
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| 43 | 2021-01-12 | burning sensation |
moderate aching/burning sensation in knees and hips started about 7pm- resolved when awoke in mornin...
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moderate aching/burning sensation in knees and hips started about 7pm- resolved when awoke in morning at 6am.
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| 43 | 2021-01-12 | feeling cold, pain in extremity | Swollen lymph nodes, fever, chills, fatigue, stiff neck, arm soreness |
| 43 | 2021-01-12 | numbness, facial paralysis, tingling |
DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED M...
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DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED MY FACE WOULD BE TINGLY AND NUMB FEELING-THEN ON SUNDAY HAD DROOPING OF RIGHT EYE LID WHEN I WAS TIRED-I NOW HAD SOME DROOPING OF MY MOUTH, ONLY SMOETIMES, AND MY EYE LID WHEN I AM TIRED. THE NUMB FEELING IS STILL THERE.:
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| 43 | 2021-01-12 | migraine |
Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 0...
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Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 01/12/21 patient started to expereince a worsened mirgraine accompanied with vomiting and severe back pain.
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| 43 | 2021-01-12 | muscle spasms, weakness |
Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of ...
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Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Too weak to perform normal activities/slept for 2 days straight; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: El1284 and Expiration Date unknown) via intramuscular route of administration on 05Jan2021 11:00 AM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: Eh9894) via intramuscular route of administration on 17Dec2020 05:00 PM (Left arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included known allergy and None other medical history. The concomitant drug was reported as Birth control medication. On 06Jan2021 1:30 am the patient woke up with severe all over muscles pains, with spasms that Tylenol 1000mg did not resolve. The patient had nausea, lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit. The patient slept for 2 days straight, too weak to perform normal activities. The patient continued to have some symptoms 3 days later. No treatment received for the adverse events of nausea, lymphadenopathy, pain in armpit, slept for 2 days straight, too weak to perform normal activities. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was recovering.
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| 43 | 2021-01-12 | pain in extremity, tenderness |
I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9...
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I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9 and took an aleve at 3pm. at 4pm i noticed mild left undereye tenderness to palpation. at 11pm i noticed left undereye swelling and and bruising. i iced and took a zyrtec. by morning on 1/10 the swelling was worse and i called my dermatologist. she felt it was a reaction to the undereye filler i had >2.5 years ago. she started me on a medrol dose pack. the swelling resolved by the morning on 1/11.
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| 43 | 2021-01-12 | pain in extremity |
The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent s...
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The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent sentences. Took Tyelenol before bed because my arm was very sore. Next morning, my whole body ached and had a severe tension headache, my jaw was very tense also. I was still very lethargic and my mind still "cloudy". Took Tylenol again after dinner, that night I started to feel relief from aches, headache and my mind can think more clearly.
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| 43 | 2021-01-12 | pain in extremity |
After vaccine I began to have sore throat, shoulder and neck discomfort. I experienced also right a...
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After vaccine I began to have sore throat, shoulder and neck discomfort. I experienced also right arm soreness which has diminished.
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| 43 | 2021-01-12 | pain in extremity |
Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took ...
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Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took 1 aleve at 3pm. at 4pm noticed some left undereye tenderness to palpation. at 11pm noticed left undereye swelling and bruising. took zyrtec and iced. in the morning 1/10 swelling was worse. continued to ice. I contacted my dermatologist who felt it was a reaction to the previous underye filler i had >2.5 years ago. she started me on a medrol dose pack. swelling resolved by 1/11 in the morning.
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| 43 | 2021-01-12 | tingling, numbness |
I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received firs...
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I?m not sure if this is in my head but I think the vaccine has flared up my reflux. I received first dose on 12/23/2020 and second dose on 1/10/2021. Since vaccine I?ve noticed my reflux has been flared. I haven?t had to take Protonix in months; however, I really started to experience indigestion and chest burning/pressure a week after first dose. I started back taking Protonix and had to increase dose to twice a day on 1/5/2021. Symptoms have improved significantly but it?s still somewhat aggravated. I also experienced lower back pain and upper and lower extremities numbness/tingling maybe 2-3 time since first vaccine
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| 43 | 2021-01-12 | tremor, bell's palsy |
Headache, Fatigue, Body Aches, Chills, Shakes, Temp 100.6 also diagnosed with Bells Palsy after see...
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Headache, Fatigue, Body Aches, Chills, Shakes, Temp 100.6 also diagnosed with Bells Palsy after seeing PCP on Monday 01/11/2021. Patient also went back to see PCP on 01/12/2021 for follow up.
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| 43 | 2021-01-13 | weakness, tingling |
Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beat...
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Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.
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| 43 | 2021-01-13 | burning sensation, burning sensation |
We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on...
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We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
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| 43 | 2021-01-13 | feeling cold |
Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at a...
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Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at about 34 hours post-injection.
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| 43 | 2021-01-13 | muscle twitching |
She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried ...
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She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried for a long time; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# either GL0140 or EL0140, Expiry date and NDC number were not written), via an unspecified route of administration in left arm on 23Dec2020 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient pregnant: No. She has had No positive test for covid before the vaccine, and No Antibody test before the vaccine either. She has had No issues with vaccines in the past. The patient had the vaccine on 23Dec2020 and then on 01Jan2021 she began to experience eye twitching and it hasn't gone away and it's very bothersome. It's still happening. Her first dose was on 23Dec2020. The eye twitching began on 01Jan2021, it's just the left eye, she can see the eye lid moving when it twitches, she felt it, like the eyeball itself was twitching or spasming. There were no issues with the vision in that eye. She did feel she was getting sleep, she was conscious about seeing if she was tired, both eyes felt as if she had cried for a long time but she had not cried at all and the eye that was twitching she felt it more in. She thought it was getting better in the morning because at that time she didn't feel it, but by mid-afternoon it was consistent. The twitching happened often sporadically every couple of minutes, and she was annoyed of it. Investigation Assessment: No. The outcome of the event left eye twitching was not recovered, outcome of other events was unknown.
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| 43 | 2021-01-13 | pain in extremity, migraine |
8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54...
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8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54hrs post vaccine-Pounding Migraine that lasted 24hrs Pain at injection arm 24 hrs post vaccine.
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| 43 | 2021-01-13 | pain in extremity | headache, chills, fever, sore arm, fatigue |
| 43 | 2021-01-13 | pain in extremity |
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne...
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arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-13 | pain in extremity |
I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a...
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I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a fungal infection of the nail, however it had felt fine until it woke me up in the night. I thought I had developed cellulitis. However by the next morning it was completely gone back to how it was which is a little painful and irritated but not bad at all.
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| 43 | 2021-01-13 | speech disorder |
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog...
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Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
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| 43 | 2021-01-14 | weakness | FEVER, BODY ACHES, NAUSEA, LOW APPETITE, WEAKNESS (FLU-LIKE SYMPTOMS) FOR 24 HOURS |
| 43 | 2021-01-14 | burning sensation |
Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-14 | burning sensation |
Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-14 | numbness, tingling |
During 30 minute observation period patient began to have a rash across their chest consistent with ...
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During 30 minute observation period patient began to have a rash across their chest consistent with hives and reported numbness and tingling of the R arm. Denied any other symptoms including SOB. Patient was taken to the ER for further observation where 50mg PO Benadryl was given.
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| 43 | 2021-01-14 | pain in extremity, burning sensation |
Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensatio...
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Metal taste back of mouth; Burning Heat; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; pain radiating down arms with nerve pulling/moving sensation to tips of fingers; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ejko85, intramuscular on 22-DEC-2020 11:45 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history had known allergies to latex. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 01:15AM, the patient experienced metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. The metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Outcome of the events metal taste back of mouth, burning heat, pain radiating down arms with nerve pulling/moving sensation to tips of fingers. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 43 | 2021-01-14 | pain in extremity |
Hospital Course: Â Patient is a 43 y.o. female patient who originally presented to the hospital on...
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Hospital Course: Â Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.
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| 43 | 2021-01-14 | pain in extremity |
Palm-sized discoloration around injection site; arm was very sore; This is a spontaneous report from...
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Palm-sized discoloration around injection site; arm was very sore; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 12:00 in left arm at single dose for COVID-19 immunization. Medical history included hay fever, asthma, various allergies and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included progesterone, metformin, atorvastatin and metoprolol. On 05Jan202115:00, the patient experienced palm-sized discoloration around injection site and arm was very sore for two days. No treatment was given to the patient for the events. The patient recovered from the events on unspecified date. The patient underwent laboratory test which includes nasal swab: negative on 07Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are possible; information about lot/batch cannot be obtained.
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| 43 | 2021-01-14 | pain in extremity |
Injection site soreness that developed to arm soreness with both doses.; Injection site soreness tha...
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Injection site soreness that developed to arm soreness with both doses.; Injection site soreness that developed to arm soreness with both doses.; This is a spontaneous report from a contactable nurse, the patient. A 43-year-old non-pregnant female patient received the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via unspecified route of administration in the right arm on 10Jan2021 at 14:45 PM (at the age of 43-year-old) as a single dose; the patient previously received the first dose of BNT162B2, Lot number: EK5730), via unspecified route of administration in the left arm on 20Dec2020 at 12:30 PM (at the age of 43-year-old) as a single dose; both for COVID-19 immunization. Medical history included asthma, obesity, hypothyroidism, hypoglycaemia, attention deficit hyperactivity disorder. The patient had allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included ibuprofen, liraglutide (SAXENDA). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021 at 20:00 PM, the patient experienced injection site soreness that developed to arm soreness with both doses. The events were reported as non-serious. The patient did not receive any treatment for the injection site soreness that developed to arm soreness with both doses. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events injection site soreness that developed to arm soreness with both doses was recovering.
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| 43 | 2021-01-14 | tingling |
1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and...
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1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and related she was feeling much better
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| 43 | 2021-01-14 | tingling |
15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in ...
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15 minutes after receiving vaccine started with tingling down the right arm. 30 minutes tingling in face, lips, and tongue. She was sent to the ER from the COVID clinic.
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| 43 | 2021-01-14 | tremor |
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Co...
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Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
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| 43 | 2021-01-15 | feeling cold |
Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute int...
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Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute interval after the vaccination. Then felt faint and called 911 who responded reported passed out while on 911 dispatch.
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| 43 | 2021-01-15 | pain in extremity |
Arm pain-heavy feeling, painful when moving Low grade fever 99.5 Moderate Body aches, especially lo...
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Arm pain-heavy feeling, painful when moving Low grade fever 99.5 Moderate Body aches, especially low back
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| 43 | 2021-01-16 | tingling |
I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole l...
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I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.
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| 43 | 2021-01-16 | tremor, pain in extremity |
Extremely tires about 9pm normal soreness to left arm started developing Wike up at 1:00 shaking, t...
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Extremely tires about 9pm normal soreness to left arm started developing Wike up at 1:00 shaking, temp 101.3 Ibuprofen 600 mg taken. Its 3:55 temp is 101 1
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| 43 | 2021-01-16 | tremor |
Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to m...
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Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to move with out shaking
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| 43 | 2021-01-17 | feeling hot, weakness |
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per...
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Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
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| 43 | 2021-01-18 | bell's palsy | Bell's palsy, diagnosed by patient's physician on January 16, 2021. |
| 43 | 2021-01-18 | burning sensation |
Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pe...
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Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pepcid and observation in ER for 3 hours. Rash, hives, burning and itching continue which worsen when exposed to someone with Covid.
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| 43 | 2021-01-18 | feeling cold |
About 7pm I began to have chills. Intense muscle aches and my knees and hips had severe joint pain....
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About 7pm I began to have chills. Intense muscle aches and my knees and hips had severe joint pain. I was so cold I could not get out of bed to use the restroom and this continued until around 11am the next morning. I also had a headache and body aches. And about 6 days out my face turned red and was super itchy. I had a prednisone prescription that I began taking 1/18 because my legs started itching and the side effects were still horrible. It made the rash begin to clear up about 50% but its still there today. No hives this time.
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| 43 | 2021-01-19 | weakness |
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ...
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Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
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| 43 | 2021-01-19 | pain in extremity, numbness |
Patient started feeling numbness of left hand and fingers after 10 minutes. Pain on forearm (Pressur...
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Patient started feeling numbness of left hand and fingers after 10 minutes. Pain on forearm (Pressure feeling) Patient was monitor for 15 more minutes, no other interventions
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| 43 | 2021-01-19 | pain in extremity |
Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and naus...
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Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and nausea.
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| 43 | 2021-01-19 | pain in extremity |
Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less ...
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Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less than 12 hours-no treatment needed Mild body aches that lasted less than 12 hours-no treatment needed Gastrointestinal upset/diarrhea that lasted less than 12 hours-no treatment needed
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| 43 | 2021-01-19 | pain in extremity |
painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated ...
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painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated from elbow up to neck and caused limited range of motion light headed, headache, severe muscle ache every joint lasting 3 days rash on torso at day 3 not itchy but red
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| 43 | 2021-01-19 | tingling |
1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl ...
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1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl 50mg 1505: BP: 134/88, HR: 91, SpO2: 100% 1510: BP: 122/81, HR: 80; SpO2: 100% 1545: BP 135/84, HR: 80, SpO2: 100%
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| 43 | 2021-01-19 | tremor | Fever 103, chills, shaking, major body and joint aches, pain at injection site, headache |
| 43 | 2021-01-20 | difficulty speaking |
After receiving the second dose of the COVID vaccine the patient went home but returned to the ED th...
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After receiving the second dose of the COVID vaccine the patient went home but returned to the ED the following day complaining of shortness of breath that feels like prior asthma attacks. She presented to the ED at 0833 short of breath with a dry cough and hoarse voice. She was given albuterol then monitored and re-evaluated at 0921. At that time the patient stated that she felt a little better, and declined any further evaluation since she reported that she felt the same as she always does while having an asthma attack. She states that she would not have come to the ER if she had not been at work and been required to. She was discharged with prednisone at 0923.
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| 43 | 2021-01-20 | feeling cold |
Starting the day after the vaccination she started feeling cold and having a headache. She then deve...
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Starting the day after the vaccination she started feeling cold and having a headache. She then developed a temperature of 101.1.
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| 43 | 2021-01-20 | pain in extremity |
Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 h...
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Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 hours after injection. Swelling of lymph nodes and pain in lymph node region in the same arm. Unable to turn a steering wheel due to pain or pick up objects with right hand. Reaction has followed the same time line as the arm. Pain is so severe that it prevents sleep.
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| 43 | 2021-01-20 | pain in extremity | Chest pain, muscle pain, left arm soreness, fatigue |
| 43 | 2021-01-20 | tenderness | SWOLLEN UNDERARM, TENDER TO TOUCH ON THE SAME ARM AS THE INJECTION. |
| 43 | 2021-01-20 | tenderness |
secondary cellulitis s/p injection site reaction - softball sized erythematous wheel that is tender ...
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secondary cellulitis s/p injection site reaction - softball sized erythematous wheel that is tender to palpation, warm to touch, and spreading. Started on keflex
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| 43 | 2021-01-21 | cold sweat | Lightheaded, pale, rapid pulse, chest pain, anxiety, clammy. |
| 43 | 2021-01-21 | discomfort |
crushing feeling all over, left neck/shoulder stiff-PT taking Tylenol around the clock but does not ...
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crushing feeling all over, left neck/shoulder stiff-PT taking Tylenol around the clock but does not touch neck/shoulder discomfort.
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| 43 | 2021-01-21 | facial pain, discomfort |
swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; Th...
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swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via unspecified route single dose for protection from COVID-19 2 o' clock or 3 yesterday (09Jan2020), at 43-year-old. Medical history included: multiple sclerosis. Concomitant medication included: sertraline 50 mg once daily at night; antidepressant (unspecified). The patient previously took glatiramer acetate (COPAXONE) once for multiple sclerosis and amantadine, was allergic to both. The patient didn't notice soreness on the side of her face, was probably from the vaccine started yesterday (09Jan2020). The patient was doing fine but then noticing was getting swelling in her lymph nodes on the right side. The patient did not notice the swelling, but she noticed the discomfort first last night (09Jan2020), '9th, 10 pm' (not clarified further). The patient thought that it was a 'pimple' (not further clarified) there. And then later today (10Jan2020), or just maybe an hour ago, when she felt that on her neck, she found lymph nodes swollen. So far, no treatment was taken. No lab work done. Action taken for BNT162B2 was not applicable. Outcome of the events was resolved.
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| 43 | 2021-01-21 | flushing, feeling hot |
Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pi...
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Vaccine given at 4:50pm, pt in observation area. C/o feeling hot/flushed, skin pink, ears bright pink. Asked to be taken to ED, stated "it could just be anxiety but I would rather be sure". Taken via wheelchair to ED immediately and placed in room on gurney. Seen by ED staff, give hydroxyzine 25mg PO at 1732. Discharged home from ED at 1847.
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| 43 | 2021-01-21 | flushing |
I started with under arm- armpit pain last night and this morning noticed that my glands and or lymp...
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I started with under arm- armpit pain last night and this morning noticed that my glands and or lymph nodes under the left arm are very swollen- knots. It alarmed me. I have also had diarrhea since the day of vaccine and just feel over all flushed and very sleepy/tired.
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| 43 | 2021-01-21 | migraine, pain in extremity |
About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizzine...
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About 40 mins after the injection, I was beyond extremely tired. Extreme body aches, nausea, dizziness and migraine followed shortly after. I felt to have more of an agitated PVC, PAC and tachycardia activity than usual. This lasted Friday 1/8 through all day Sunday 1/10. On 1/11 I only suffered from the migraine. A very sore arm was only during the first night and alleviated on Saturday afternoon.
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| 43 | 2021-01-21 | muscle twitching |
20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches i...
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20 minutes following vaccine I suddenly experienced tingling in mouth and throat, muscle twitches in hands, rapid heartbeat, and rash. I returned to vaccine clinic and was referred to ER. I was observed for several hours and symptoms resolved.
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| 43 | 2021-01-21 | tingling, numbness | Dizziness numbness tingling body aches |
| 43 | 2021-01-21 | tingling | ELEVATED BP 180 SYS, TINGLING IN FACE , DIZZY, WEAK IN LEGS. |
| 43 | 2021-01-22 | pain in extremity, muscle twitching |
Injection site soreness for about 2 days. Day 5 developed bilateral calf pain. Not unbearable, it ju...
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Injection site soreness for about 2 days. Day 5 developed bilateral calf pain. Not unbearable, it just felt like I had worked out my calf muscles at the gym the day before or something & I hadnt done any exercise at all that week and not at the gym in years. It seemed worst when I first started moving snd seemed to get better as I warmed up and moved around. Lasted about three days. I do vascular ultrasound and so checked myself for blood clots and I was negative. The last symptom that I dont think Ive had before is this weird pulsing or rapid twitching sensation on the back/left side of my head. Like a nerve firing maybe? I dont know. Felt like one small focal area, like fluttering.. It was very fast. It would last for like a minute or two and then stop . That happened about 3-4 times. On different days, not sure what day. It was so short lived I didnt pay much attention to it. It happened sometime between 1/18/21 & 1/22/21. It only happened one time a day.
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| 43 | 2021-01-22 | pain in extremity |
High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in should...
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High Fever 104.6 degree Farenheit, Bad Headache back of head, between the eyes, body aches in shoulders and back and throughout body. Fever lasted almost 48hours, fever would be about 101.8 to 104.6. would only go down a few points after tyelenol given, then motrin 2-3hrs later given, then back to tylenol, then back to motrin.....ect. I was drinking plenty of fluids, then resorted to cool showers, baths, and popsicles and freeze pops. Even yesterday 1.22.2021, had a low grade fever 99.2F. Arm is still currently sore, with giant red rash where injection was given, and extremely warm to touch. I tried to report, and it continually told me, my time has expired and comments were not accepted. 1.22.2021 took motrin and tylenol again due to eye pressure , headache and low grade fever. Finally felt better 130p.m 1.22.2021.
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| 43 | 2021-01-22 | tingling |
Patient returned 2 hrs after vaccination c/o shortness of breath and "tingling fingers." Hyperventil...
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Patient returned 2 hrs after vaccination c/o shortness of breath and "tingling fingers." Hyperventilating upon arrival. VS - 1326 - BP 129/78, HR 90, 100%. 1331 - 131/68 - HR 80, 100%. 1337 - 126/71, 83, 100%. Code yellow called. Patient to ED.
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| 43 | 2021-01-23 | flushing, hot flush |
Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Dis...
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Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Discharged to home from ED.
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| 43 | 2021-01-23 | hot flush |
Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Dis...
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Seen in ED for hives, itching and feeling flushed. Given diphenhydramine 50mg with resolution. Discharged to home from ED
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| 43 | 2021-01-23 | migraine |
I did have a scratchy throat and my arm was itchy at injection site. Next day I had a red spot and ...
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I did have a scratchy throat and my arm was itchy at injection site. Next day I had a red spot and lump around injection site. I did develop a migraine the day after but can't conclusively say it was from the vaccine since I get them somewhat frequently
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| 43 | 2021-01-24 | burning sensation, tingling |
Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, ...
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Severe joint pain, hands tingling and then after a few hours they started burning, severe headache, heart racing. These symptoms lasted throughout the night and the next morning the left side of my face was bright red and stayed that way throughout the day.
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| 43 | 2021-01-24 | pain in extremity, weakness |
Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose...
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Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose, the patient developed severe pain around vaccination site and arm, followed by muscle atrophy, weakness and clinical signs consistent with acute brachial neuritis.
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| 43 | 2021-01-24 | pain in extremity |
Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fev...
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Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills. Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs. Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
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| 43 | 2021-01-24 | pain in extremity |
Severe pain in arm, shoulder, and neck. Limited range of motion for 4 days. I could not pick thing...
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Severe pain in arm, shoulder, and neck. Limited range of motion for 4 days. I could not pick things up with my left arm or turn the steering wheel on my vehicle. Had difficulty sleeping because of pain. Feels almost back to normal as of today, 1/25, but still slight discomfort.
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| 43 | 2021-01-24 | pain in extremity |
Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, ...
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Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, headache. Most symptoms subsided the next day, headaches and dizziness continue daily one week later.
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| 43 | 2021-01-24 | tingling |
Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper b...
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Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper body, and then tachycardia. Became very nervous with the strange sensation and took pulse which was initially in normal range. This however progressed to a rapid heart rate. Overall symptoms lasted 3-4 minutes. Pulled over and exited a busy highway. Called 911 (2:22 pm) during symptoms and they said they could only call an ambulance. Had some confusion when speaking to operator, as I couldn't tell them which exit I was at although I know the exit. Ultimately, drove myself to the hospital parking lot (about 4-5 min away) as heart rate had started to return to normal. Heart rate was in normal range when I rechecked in hospital parking lot. Sat in car for about 5 minutes before deciding to drive back to vaccine clinic to report my symptoms. Clinic about 3-4 minutes away. Pulse ox was normal x 2. BP was actually elevated x 2. Waited 30 minutes before being released home.
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| 43 | 2021-01-25 | weakness | Fever, body aches, HA, fatigue, dizzy, weak, symptoms resolved by 1/10. |
| 43 | 2021-01-25 | pain in extremity, feeling hot |
Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, ha...
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Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, hard, swollen, and extremely painful; from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful.; Arm swelled up from the shoulder to the elbow and around to the inner arm; Headache; Low grade fever of 100.2F; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176; expiry date: unknown) via an unspecified route of administration in the left arm on 08Jan2021 on 15:00, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), bariatric surgery, seasonal allergies, and known allergies to bee stings, flu vaccine, and monosodium glutamate (MSG). Concomitant medications included famotidine (PEPCID) and cetirizine hydrochloride (ZYRTEC), and multivitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) on 17Dec2020, at 01:00 PM, in the left arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 09Jan2021, at 14: 30, the patient's arm swelled up from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful. She also had joint pain, headache, and low-grade fever of 100.2 Fahrenheit (F). The patient did not received therapy for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 43 | 2021-01-25 | pain in extremity, migraine |
headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; T...
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headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female non-pregnant patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3249; expiration date: unknown), intramuscular right arm on 08Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included exercise induced asthma. The patient has no known allergies. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient was not diagnosed with Covid prior to vaccination. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EJ1685) intramuscular left arm on 19Dec2020 10:00 at a single dose for covid-19 immunization but she had zero side effects. The patient reported that on her second dose, she had sore arm, fatigue, body ache, muscle ache, migraine and fogginess beginning 24 hours after receiving injection and lasting 72 hours. Slight linger of achiness and headache on the fourth day (12Jan2021) but able to work again. No treatment was received for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
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| 43 | 2021-01-25 | pain in extremity | Sever pain at the injection site and arm, chills, sever fatigue, arthralgia. |
| 43 | 2021-01-25 | pain in extremity |
Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't ta...
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Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-25 | pain in extremity |
Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report fro...
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Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=EK9231) on 10Jan2021 03:30 PM (vaccine location=Left arm, dose number=2) at single dose via unknown route of administration for unknown indication. Medical history was not reported. Concomitant medications included ibuprofen (MOTRIN); vitamins NOS (MVI); calcium carbonate, colecalciferol (OSCAL D); vitamin c. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=Ek5730), on 19Dec2020 03:15 PM, (vaccine location=Left arm, dose number=1) via unknown route of administration at single dose for unknown indication. There were unknown allergies. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination and did not have covid tested post vaccination. Patient experienced Tired, legs and arms felt sore, mild headache, fever 101.1, chills on 11Jan2021 01:30 PM. Patient did not receive any treatment. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-25 | tingling, feeling cold |
TINGLING. BODY ACHES AT BEDTIME. FREEZING THEN COLD. WOKE UP AT 2:30AM WITH A HEART RATE OF 96 AND T...
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TINGLING. BODY ACHES AT BEDTIME. FREEZING THEN COLD. WOKE UP AT 2:30AM WITH A HEART RATE OF 96 AND TEMP OF 99.6. NEXT MORNING TEMP WAS 99.9. TOOK TYLENOL.
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| 43 | 2021-01-26 | discomfort, feeling of body temperature change |
Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick...
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Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears. Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me. There was no comfortable position to alleviate any of that. I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure. I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen. It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night. I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
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| 43 | 2021-01-26 | difficulty speaking |
Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous ...
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Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-26 | numbness, pain in extremity, tenderness, tingling, hypersensitivity of all senses |
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j...
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1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-26 | numbness |
I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, howe...
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I have had ongoing facial and tongue numbness. I am unsure if my symptoms are vaccine related, however my symptoms did start within 72 hours of receiving the vaccination. As of today, my symptoms remain, but seem to be improving.
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| 43 | 2021-01-26 | pain in extremity |
hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her...
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hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
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| 43 | 2021-01-26 | pain in extremity |
Pinky toe pain on 1/21; fatigue 1/23; UTI 1/24; sacral pain 1/24-present; rash 1/24-present and stil...
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Pinky toe pain on 1/21; fatigue 1/23; UTI 1/24; sacral pain 1/24-present; rash 1/24-present and still spreading; lateral joint foot pain 1/27
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| 43 | 2021-01-26 | tingling, numbness |
2 weeks after the first dose injections I began having symptoms of an HSV2 outbreak, although I am o...
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2 weeks after the first dose injections I began having symptoms of an HSV2 outbreak, although I am on suppression therapy. I have never had one since my initial diagnosis. I also began having numbness and tingling in both feet and hands. The symptoms continued through the second vaccine dose on January 16. The numbness and tingling in my extremities has become worse. An increased dose of Valacyclovir has been ineffective in treating the HSV outbreak symptoms.
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| 43 | 2021-01-27 | weakness |
Approximately one hour after first dose I began to feel chills, very tired, and a severe headache. ...
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Approximately one hour after first dose I began to feel chills, very tired, and a severe headache. I laid down to rest after taking two 500mg Tylenol pills. I slept on and off for over 24 hours and felt very unwell. The recurring headaches, all over muscle pain, fatigue and weakness was constant over this time.
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| 43 | 2021-01-27 | feeling hot, pain in extremity |
intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, ...
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intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
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| 43 | 2021-01-27 | migraine, weakness |
Fever, chills, migraine, entire body aches, muscle pain, weakness , fatigue and restlessness for a f...
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Fever, chills, migraine, entire body aches, muscle pain, weakness , fatigue and restlessness for a full 24 hours
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| 43 | 2021-01-27 | pain in extremity |
Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccin...
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Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccination clinic. I took an Aler-Tec pill and felt better 20 minutes after. My arm was sore for 2 days after and couldn?t sleep on Right side, arm hurt. Injection site was purple and bruised one week later but no pain.
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| 43 | 2021-01-27 | pain in extremity | Nausea, diarrhea, low grade temp of 99.2. very sore arm. |
| 43 | 2021-01-27 | pain in extremity |
Arm soreness; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old fe...
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Arm soreness; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 23Dec2020 12:30 at a single dose for COVID prevention. Medical history included diabetic (On insulin only. Diabetic for six to seven years and have had no hypoglycemic events). There were no concomitant medications. It was reported that the patient experienced arm soreness on an unspecified date. The outcome of the event was unknown.
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| 43 | 2021-01-28 | weakness |
Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit ...
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Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit on 1/21 for chest pressure, lightheadedness, dizzy. Cardiac work up- negative. Discharged. Still lightheaded and dizzy 1/22 - 1/24. On 1/25 sharp chest pains went to see my PCP. She prescribed a steroid pack. 1/26 at 3:30 pm felt weak, felt like I was going to black out. Went back to the ER- full cardiac work up, head CT, admitted to the hospital for observation. Stress test on 1/27. Everything normal. Follow up with PCP on 1/29 still very lightheaded. Ordered a 48 hour heart monitor and Neurology consult.
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| 43 | 2021-01-28 | weakness |
Bad headache (migraine like, right sided) Abdominal pain Nausea Fever 100.4 Myalgias Arthralgia Pr...
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Bad headache (migraine like, right sided) Abdominal pain Nausea Fever 100.4 Myalgias Arthralgia Profound fatigue/weakness
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| 43 | 2021-01-28 | depressed level of consciousness, muscle twitching | taste/smell alteration within 1 hour of vaccine / facial twitching 3 days later / CNS depression |
| 43 | 2021-01-28 | electric shock sensation, muscle twitching, pain in extremity, nerve pain |
Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to t...
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Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to the ER where they tested me for Covid and checked my heart. Everything came back negative. The next day I started having severe muscle weakness to where I couldn't stand for more than 5 or 10 mins without feeling like I was going to fall over. I couldn't hold anything up for long without my arms giving out. I started having muscle twitching all over including in my face. I would also have what I would describe as electrical shock nerve pain all over. I went to the ER again and everything came back okay again. I went to Urgent Care and my MD. My doctor stated after looking at the results from the ER that it was related to the vaccine. I was put on high doses of vitamins to see if it would help my body fight the reaction to the vaccine. I was taken out of work for the week because I literally couldn't do anything. I took the vitamins for 5 days before I started finally feeling better. I'm okay now for the most part. I still am having muscle twitching and nerve pain, but it is far more tolerable than it was.
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| 43 | 2021-01-28 | pain in extremity |
Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. ...
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Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. Unknown is knot is hematoma, abscess or cellulitis at injection site. Symptoms started x 24 hours after injection. Arm was sore after shot but knot developed approximately 24 hours later.
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| 43 | 2021-01-28 | pain in extremity |
Arm pain , arm feels heavy and very painful. Lots of stomach growling, and some stomach discomfort,...
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Arm pain , arm feels heavy and very painful. Lots of stomach growling, and some stomach discomfort, gases and diarrhea,
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| 43 | 2021-01-28 | tingling |
Patient reported that her hand started feeling tingling after her vaccine. She denied any s/s of res...
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Patient reported that her hand started feeling tingling after her vaccine. She denied any s/s of respiratory symptoms. She has full ROM to her hand. She denied treatment to the ER. Advised her to go to the ER if the tingling continued in her hand and did not resolve or became worse. She verbalized understanding.
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| 43 | 2021-01-28 | tingling |
Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report...
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Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 14Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. 25 minutes after the vaccination on 14Jan2021 (16:55), the patient's face was tingling around her mouth. It lasted for about 30 minutes. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events on 14Jan2021 at 17:25.
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| 43 | 2021-01-29 | tremor, muscle twitching |
Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequenc...
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Muscles twitches in different parts of the body, started in left arm and have been ongoing. Frequency has gone down since the injection. Tremors (chest feels like it is shaking/pulsating) - this started about 10 days after the injection
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| 43 | 2021-01-30 | weakness, feeling hot |
Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102...
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Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102.4. I had chills, a headache, very sore injection site, and the skin on my arms hurt. I was exhausted, but couldn't sleep. I took Tylenol, but it didn't seem to help much. I didn't have much of an appetite. Around 7:00pm, I no longer had chills but instead was very hot. About 2:00am, I woke up drenched in sweat, but felt so much better.
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| 43 | 2021-01-31 | facial paralysis |
A couple of hours after receiving the vaccine a co-worker said my eyes were very low and red. I star...
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A couple of hours after receiving the vaccine a co-worker said my eyes were very low and red. I started feeling extremely exhausted and even slept on my shift on my desk. My supervisor told me to go home for the day. I went home and slept through the day and night until next morning. I then started feeling myself again.
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| 43 | 2021-01-31 | feeling hot |
dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe ...
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dizziness, woozy feeling, lightheaded; Pressure in chest; Feeling of heat across body; Frontal lobe headache; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old female patient (Not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 18Jan2021 10:45 at single dose for covid-19 immunization. Medical history included hypothyroidism, asthma, known allergies: penicillin and sulfa, bee stings. Concomitant medication in two weeks included salbutamol (ALBUTEROL), levothyroxine, liothyronine (NP THYROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness, woozy feeling, lightheaded, pressure in chest, feeling of heat across body, frontal lobe headache on 18Jan2021 at time of 11:30 am. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
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| 43 | 2021-01-31 | migraine |
01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout t...
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01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.
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| 43 | 2021-02-01 | numbness |
Severe body pain in head, neck, back, hips, knees, feet, teeth and eye sockets. Could not hold up he...
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Severe body pain in head, neck, back, hips, knees, feet, teeth and eye sockets. Could not hold up head. Feet numb bilaterally. Nausea. Exhaustion. All lasting 24 hours. Profuse sweating as well for last 8 hours. kidney pain. I have never experienced such pain in my entire life.
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| 43 | 2021-02-01 | muscle spasms |
Backache and back spasms; Backache and back spasms; Ear pain on right side of head; I have Trigemina...
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Backache and back spasms; Backache and back spasms; Ear pain on right side of head; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; I have Trigeminal Neuralgia and it made my face temporarily flare up with the side face pain; This is a spontaneous report from a contactable Other Health Professional reporting for herself A 43 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 18Jan2021 at 12:15 at single dose intramuscular on arm left for COVID-19 immunization. Medical history included Trigeminal Neuralgia, asthma, High blood pressure, CSF leak out of my nose (which has spontaneously healed), Seasonal allergies, milk allergies to lactose, Allergy to arthropod sting (tongue swelled up once from a hornet sting on hand) and allergic reaction to antibiotics (hands swell up). Concomitant medications included propranolol. On 18Jan2021 soon after vaccination (reported as 18Jan2021 at 12:15), patient experienced backache and back spasms. Ear pain on right side of head. Patient had trigeminal Neuralgia and it made her face temporarily flare up with the side face pain (as reported). Patient didn't received treatment. At the time of the reporting the patient was recovering from the events. information on the lot/batch number has been requested.
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| 43 | 2021-02-01 | pain in extremity |
Minor headache; Sore arm; This is a spontaneous report from a contactable Other-HCP. A 43-year-ol...
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Minor headache; Sore arm; This is a spontaneous report from a contactable Other-HCP. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 08Jan2021 at 15:30 at single dose on left deltoid/arm via an unspecified route of administration for COVID-19 immunization. Patient was instructed by head of infectious DZ Dept hospital to premedicate with Tylenol and Benadryl. On an unspecified date she experienced minor headache and sore arm, without other response to second dose. At the time of the reporting event outcome was unknown. Information about lot/batch number has been requested.
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| 43 | 2021-02-01 | tingling |
Tingling; site of injection was swollen and red; site of injection was swollen and red; Ache; Chills...
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Tingling; site of injection was swollen and red; site of injection was swollen and red; Ache; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) solution for injection, via an unspecified route of administration on left arm on 17Jan2021 07:00 at a single dose for Covid-19 immunization. Medical history included diabetes, cholesterol, and blood pressure. There were no concomitant medications. Patient received the first dose of the Pfizer COVID 19 vaccine on 17Jan2021 at 07:00AM in the left arm. She noticed she had aches and chills midday on Monday 18Jan2021 and also a headache all of which went away as of this morning 19Jan2021. Today (19Jan2021), this morning she woke up and her arm at the site of the injection was swollen and red. Later, she noticed she had tingling (19Jan2021) throughout the lower part of her arm and hand. The tingling was on and off and wasn't there right away. She was scheduled to receive the second dose of the vaccine 06Feb2021. Patient was looking for recommendation on second dose. Outcome of the event ache, chills, headache was recovered on 19Jan2021; tingling was not recovered; while injection was swollen and red was unknown. No follow-up activities are needed. No further information is expected.
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| 43 | 2021-02-02 | weakness |
Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness...
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Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness, fever 100.4
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| 43 | 2021-02-02 | muscle twitching, numbness |
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi...
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felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 43 | 2021-02-02 | pain in extremity |
I developed a fever at about 11:45 pm the night I received the 2nd covid vaccine. (2/1/21). I ran a...
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I developed a fever at about 11:45 pm the night I received the 2nd covid vaccine. (2/1/21). I ran a fever until about 2 am on 2/3/21. I also had a headache and intense pain in my legs and my knee and hip joints.
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| 43 | 2021-02-02 | tingling, flushing |
Immediate tingling to left side of face, followed by tachycardia & palpitations, flushing from chest...
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Immediate tingling to left side of face, followed by tachycardia & palpitations, flushing from chest & back up to the scalp. Taken straight to the ED, evaluated by MD, found to be very anxious & hypertensive (BP 203/128, P 110). Treated with IV Benadryl & Pepcid.
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| 43 | 2021-02-03 | discomfort, pain in extremity, numbness |
numbness of left hand and fingers; Pain on forearm (Pressure feeling); Pain on forearm (Pressure fee...
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numbness of left hand and fingers; Pain on forearm (Pressure feeling); Pain on forearm (Pressure feeling); This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 30Dec2020 at 12:30 on left arm at a single dose for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. The patient started feeling numbness of left hand and fingers after 10 minutes (30Dec2020 at 12:40) and pain on forearm (pressure feeling) 30Dec2020 at 12:30. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
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| 43 | 2021-02-03 | numbness |
Received covid vaccine #2 left deltoid yesterday ~ 9:40 am. Last evening she developed a feeling of ...
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Received covid vaccine #2 left deltoid yesterday ~ 9:40 am. Last evening she developed a feeling of numbness from injection site traveling down into her left thumb and fingers... "faintly feels like it's sleeping" denies discoloration, coolness to touch or difficulty with movement. Had slight localized reaction at injection site.
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| 43 | 2021-02-03 | pain in extremity |
Headache; Horrible calf pain bilaterally; I could barely walk; Horrible calf pain bilaterally; I cou...
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Headache; Horrible calf pain bilaterally; I could barely walk; Horrible calf pain bilaterally; I could barely walk; Major injection site soreness; my arm started getting super sore; Major injection site soreness; my arm started getting super sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) at left deltoid on 18Jan2021 12:45 PM at single dose for COVID-19 immunisation in Hospital. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), just the Vitamins and supplements. Patient was just calling to report the side effects to the Covid 19 vaccine, major injection site soreness, she was having headache today (19Jan2021) and horrible calf pain bilaterally. the first dose was 18Jan2021 and due date of second dose was 08Feb2021. As of causality, nurse practitioner stated Yes, yesterday (18Jan2021) her arm started getting super sore and it kept getting worse and then she woke up this morning and she could barely walk because her calf pain is so bad, in both of her legs. Treatment include she have taken Advil, she took 600 mg today and she took 400 mg last night. As Results of Lab work, she stated she don't have it. She asked if anyone had the calf pain with it. Patient was not recovered from the events. Event relatedness for Covid 19 vaccine with Major injection site soreness; my arm started getting super sore and Horrible calf pain bilaterally; I could barely walk were Related. Relatedness of drug to Major injection site soreness; my arm started getting super sore, Headache, Horrible calf pain bilaterally; I could barely walk per Source of assessment: Source of assessment. Method of assessment: Global Introspection. Drug result: Related.
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| 43 | 2021-02-04 | pain in extremity |
Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the ...
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Severe pain in injection arm run from shoulder to fingers, eventually extended to chest wall on the right side. Lymph node in right axilla sore, swollen and tender. Symptoms lasted 48 hours. Advil taken for symptoms.
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| 43 | 2021-02-05 | pain in extremity |
Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomit...
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Received dose #2. Within 10 minutes, developed metallic taste. 4 hours later severe nausea and vomiting. Began alternating Tylenol and Ibuprofen 800mg. 6 hours to the following day- severe headaches, chills, body aches, all over joint pain. Around midnight on 1/6/21 pain in the arm that radiated up her neck. 1/7- fever of 101. Small rash around injection site and slightly down arm. Stiff neck and arm pain.
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| 43 | 2021-02-06 | feeling hot |
Received the second dose of her Pfizer COVID vaccine today when she started feeling hot and felt lik...
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Received the second dose of her Pfizer COVID vaccine today when she started feeling hot and felt like her tongue was numb / swelling
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| 43 | 2021-02-07 | numbness, tingling |
Within five minutes of shot, started to feel pins and needles and slight numbness in left hand. Fiv...
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Within five minutes of shot, started to feel pins and needles and slight numbness in left hand. Five minutes later also started to feel pins and needles and slight numbness on left side of face. Within the next 40 minutes, when I was able to take off my thick coat and boots, also felt these symptoms from shoulder down to fingers and calf down to toe (all still only on left side of body). One week later also felt same effects in left breast. When using these body parts such as hand or leg, it would get tired a lot faster then the right side, but still had full mobility and function. Symptoms are still ongoing and it is now 2 weeks later.
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| 43 | 2021-02-07 | migraine |
Severe fatigue, malaise, nausea, migraine headache all began the same afternoon as injection, approx...
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Severe fatigue, malaise, nausea, migraine headache all began the same afternoon as injection, approximately four hours post-injection. Symptoms lasted (and increased in intensity) for approximately 72 hours.
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| 43 | 2021-02-08 | weakness, tremor, muscle spasms |
Woke up at 1:30 am with fever. Muscles spasming, took an Advil, didn't help. Took another Advil 30 m...
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Woke up at 1:30 am with fever. Muscles spasming, took an Advil, didn't help. Took another Advil 30 min later, restless, can?t stay still, moaning. Muscle cramping getting worse in abdomen. Get up to get more water and urinate, starting to salivate as if going to throw up. Lean over toilet for 20 min, burning hot , weak, throw cold water around face and neck. Take another Advil, lay back down in bed, muscle convulsions for next 20 min, slowly dissipating. Entire episode took 3 hours. Felt like worst period cramping with fever on top of food poisoning. Next day was mildly nausea and sore, tired.
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| 43 | 2021-02-09 | feeling cold |
Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy an...
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Patient got her 2nd covid shot on Thursday am. Felt fine Friday other then possibly a little achy and totally fine Saturday. Felt somewhat fatigued Sunday afternoon. Woke early Monday am around 1am with sudden vomiting and diarrhea. Noted multiple loose stools and multiple episodes of vomiting and unable to tolerate eating or drinking. Also noted feeling cold. Noted feeling dizzy and lightheaded. Continues to feel achy. Came into Urgent care for fluids on Monday 2/8 and Tuesday 2/9.
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| 43 | 2021-02-09 | feeling hot, flushing |
very flushed; perspiring; Feeling hot; Red face; chills; This is a spontaneous report from a contact...
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very flushed; perspiring; Feeling hot; Red face; chills; This is a spontaneous report from a contactable pharmacist reporting for herself. A 43-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacture Pfizer-BioNTech, lot# EL3249), via an unspecified route of administration, on 24Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history included endometriosis and migraine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included ibuprofen (MOTRIN) and unspecified oral contraceptives. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), on 04Jan2021 at 01:00 PM, in left arm, for COVID-19 immunisation. The patient experienced very flushed, perspiring, feeling hot, red face and chills all on 24Jan2021 at 15:00 with outcome of recovered after about 1 hour. Since the vaccination the patient has not been tested for COVID-19.
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| 43 | 2021-02-09 | feeling jittery, flushing | Lip tingling, throat tight, cough, flushing, jittery sensation |
| 43 | 2021-02-09 | muscle spasms |
Present to ER with SOB and coughing. Second COVID-19 vaccine was given at 10:30 am and she started f...
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Present to ER with SOB and coughing. Second COVID-19 vaccine was given at 10:30 am and she started feeling chills and cough about 2 hours later. Also, pt reported body aches and neck spasm. Patient given EpiPen as reports feels hard to breath, Solumedrol, Pepcid and Benadryl and reports sob resolved. Ptient watched for 2 hours, no return of symptoms, SOB resolved, and patient start eating and drinking and feeling well. discussed with patient use of Tylenol and Motrin for post vaccine aches and fever and follow up with employee health tomorrow. Patient discharge to home. Note: 1) patient doing well and get back to working the next morning (2/10/21) 2) Past medical history: Asthma and diabetes
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| 43 | 2021-02-09 | pain in extremity |
Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still u...
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Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still upset; Haven't felt like doing anything; Nausea; Abdominal pain; Threw up twice; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the right arm on 20Jan2021 (16:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), spironolactone, fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and desogestrel, ethinylestradiol (MIRCETTE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 30Dec2020 (when the patient was 43 years old) on the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On the day of the vaccination, the patient was fine. The following day, 21Jan2021 (16:30), the patient's arm was extremely sore; she had felt very fatigued and achy; stomach was upset; and had not felt like doing anything. On 21Jan2021, at night, the patient had nausea, abdominal pain, and had threw up twice. The patient did not receive any treatment for the events. The outcome of the events, 'arm was extremely sore', 'felt very fatigued and achy', 'stomach was upset', 'had not felt like doing anything', 'nausea', 'abdominal pain' and 'threw up', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. Information on the lot/batch number has been requested.
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| 43 | 2021-02-10 | weakness | Headache, chills, body aches, Muscle pain, weak, sweats |
| 43 | 2021-02-10 | migraine | Nausea, extreme fatigue, migraine |
| 43 | 2021-02-11 | burning sensation |
After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling gre...
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After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling great, Thursday evening I developed burning and itchy hives all over my neck chest and face, my face appeared swollen, I also had a smaller outbreak on my legs I took benedryl which seemed to calm the reaction some when I woke up the following morning, and another dose seemed to calm it some more
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| 43 | 2021-02-11 | feeling hot, feeling cold, discomfort |
At 5:22 pm patient reported to nurse that she was feeling "sleepy", lightheaded, and "cold" after sh...
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At 5:22 pm patient reported to nurse that she was feeling "sleepy", lightheaded, and "cold" after she recieved her first dose of Pfizer BioNTech COVID-19 vaccine EUA. Viitals taken every 5 minutes. Patient then reports that she is feeling heavyness in her body, nausea, and started to feel "warm coming from the inside." 5: 45pm Administered 50 mg of Benadryl by mouth. Patient initially declined meds. Monitored patient for one hour. Patient was alert and oriented and left clinic with her friend.
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| 43 | 2021-02-11 | numbness |
Within one minute of receiving the shot my throat felt like it was swelling and I had difficulty swa...
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Within one minute of receiving the shot my throat felt like it was swelling and I had difficulty swallowing. Lasted about 30 minutes. Two days later my right leg felt dead and big, similar feeling to when I had a spinal for a cesarean section. The sensation was off and on for 2 days and then subsided.
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| 43 | 2021-02-14 | tingling |
Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunothe...
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Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunotherapy. Pt presented with rash/itching on chest, tingling around ears and runny nose 20 minutes after vaccine administered.(0828) Doctor notified and Benadryl 25mg PO given VS at time 169/98, 60, 100%. 0847 pt c/o slight chest tightness, slight labored breathing, feeling of periorbital swelling,VS at time 173/91, 51, 99% Doctor again notified and an RN stat called, pt taken to the ER and report given to ER RN, pt appeared to be comfortable and feeling somewhat better
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| 43 | 2021-02-15 | flushing | Facial flushing, asthma, blurred vision |
| 43 | 2021-02-15 | hot flush |
Patient states to get an itchy face and felt flush with chest heaviness. She was provided a Benadryl...
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Patient states to get an itchy face and felt flush with chest heaviness. She was provided a Benadryl and monitored for 30 minutes and was better after administration of the benadryl
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| 43 | 2021-02-16 | burning sensation, numbness |
PATIENT CALLED AT 9AM 2/17 NUMBNESS TO FINGERS, VEINS IN HANDS EXPOSED AND SWOLLEN. BURNING SENSATIO...
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PATIENT CALLED AT 9AM 2/17 NUMBNESS TO FINGERS, VEINS IN HANDS EXPOSED AND SWOLLEN. BURNING SENSATION TO HANDS. REDNESS TO UPPER LEFT ARM.
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| 43 | 2021-02-16 | pain in extremity |
A few hours after the vaccination I had a lesion form on the back of my left leg, moderate pain from...
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A few hours after the vaccination I had a lesion form on the back of my left leg, moderate pain from the left hip to the back of the left knee. I sought treatment from my PCP within 24hrs and was prescribed an antiviral med. The symptoms subsided after starting the med and no new symptoms has arised.
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| 43 | 2021-02-17 | pain in extremity |
Vominting within 1 hr of vaccine. Extream arm pain. Temp of 102. Hallucination with extream chills a...
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Vominting within 1 hr of vaccine. Extream arm pain. Temp of 102. Hallucination with extream chills and body aches.
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| 43 | 2021-02-18 | weakness |
Chills began at 10 pm. Fever at 101.5. Back and neck pain. Headache. Morning 2/17/21 could not get o...
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Chills began at 10 pm. Fever at 101.5. Back and neck pain. Headache. Morning 2/17/21 could not get out of bed. Extreme weakness, joint pain, back and neck pain, swollen gland under left armpit, pain, headache, fever up to 102.5. 2/18/21 low grade temp. 99.9. joint pain, headache. Used Tylenol, 2 pills every 4 to 6 hours.
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| 43 | 2021-02-18 | pain in extremity |
Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficul...
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Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficulty swallowing. No visible swelling. At 35 minutes after injection attempted to drink water, difficulty swallowing, coughing, no visible swelling. At 45-50 minutes post vaccine attempted to eat dinner (black beans and rice) difficulty swallowing, coughing. Again no visible swelling. Took Benadryl waited 15 minutes, able to eat dinner - resolved Other not resolved: Left arm pain referring up to neck and generalized swelling (loose shirt sleeve on Right is snug over left arm) , itchy ears
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| 43 | 2021-02-18 | cold extremities, weakness, numbness |
I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I r...
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I had Covid from March 14, 2020- April 1, 2020. I treated positive for antibodies in May 2020. I received the first vaccine on 2/14/21 around 4:55 pm. 2/15-I awoke at 7am: sweating, headache, body aches/ pinging type sensation, fatigue, pain across my chest , no trouble breathing though. These are the same symptoms I had when I had Covid. 2/16 I was able to get out of bed, run errands, but still have headache, still feel achy, haven?t noticed a fever but I have had moments of sweating like one broke. Lymph nodes under my left arm are swollen and painful to touch. 2/17lymph nodes still very large and swollen, pings of 2/18: fatigue, weakness, 11pm- right arm became cold and numb like it was asleep, pinging muscle aches or more accurately pains where lymph nodes are located. Body seemed swollen overall too. 2/19: right arm and uncle still swollen and heavy Groin lymph area right side is painful today.
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| 43 | 2021-02-19 | migraine |
At onset extreme fatigue, terrible migraines and constant nausea. As of today, fatigue has finally s...
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At onset extreme fatigue, terrible migraines and constant nausea. As of today, fatigue has finally subsided. However, extreme migraines and constant nausea are not going away!!
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| 43 | 2021-02-19 | pain in extremity |
8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint,...
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8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint, right wrist joint. The joints that do normally hurt were way worse (my back, and right big toe joint). There was a pain in my right eye, and that eye had blood vessels burst in it. 36 hours after the shot= started bleeding from my vagina. My last menstruation was 2 weeks ago and this is VERY unusual for me. Normally my periods are 30-32 days apart.
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| 43 | 2021-02-21 | pain in extremity |
On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on...
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On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on the tissue. This happened a second time and then it was finished. I felt really tired and not myself. Then later that night my arm began to hurt so bad that I could not lift it. I began to rub the area that was hurting and noticed that I now had a nice size lump there . I took a Tylenol 500mg and a hot shower. When I woke up the next morning my arm was still hurting but not as bad. When I went to use the bathroom I had began to start spotting again. This continued throughout the day and now I am bleeding as if I was having my period. I am super tired. It is to the point that i cant function at work.
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| 43 | 2021-02-21 | pain in extremity |
Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. res...
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Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.
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| 43 | 2021-02-22 | bell's palsy, facial paralysis |
Within two hours of injection, headache and fever symptoms with body aches for appoximately 56 hours...
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Within two hours of injection, headache and fever symptoms with body aches for appoximately 56 hours. Approximately 40 hours after injection, noticable drooping of right side of face, which resolved 90% after 24 hours; doctor assessment was that this was likely a temporary case of Bell's Palsy.
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| 43 | 2021-02-22 | discomfort, feeling hot |
at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and f...
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at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and felt warm. States she started feeling pressure and warmth to her face with some itching. At 1500 she came to employee health. RN gave her 25 mg liquid benadryl. Her BP was 126/89, HR 87. No hives or swelling to Right arm noted. BP 117/80, HR 75. at apprx 1520, bp 137/85, HR 67. No other signs or symptoms noted. 1528, bp 121/82 At 1532, "patient states she feels good, almost back to normal".
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| 43 | 2021-02-22 | facial paralysis | Drooping eye and mouth on left side of fave |
| 43 | 2021-02-22 | numbness |
numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; ...
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numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-02-23 | weakness, tenderness |
Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and ...
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Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and into breast, bruising and tenderness. 2/20/21 to current Nausea and diarrhea 2/20/21 to current Exhaustion 2/20/21 to current
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| 43 | 2021-02-23 | weakness, tremor, discomfort |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
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| 43 | 2021-02-23 | discomfort | Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe |
| 43 | 2021-02-23 | flushing | Became lightheaded/faint and had facial flushing. Unable to stand up for fear of syncope. |
| 43 | 2021-02-23 | night sweats |
Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely ...
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Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
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| 43 | 2021-02-24 | weakness |
Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiv...
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Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.
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| 43 | 2021-02-24 | weakness |
A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vacc...
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A 43 y.o. female received her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 100% Physical Exam--Vitals and nursing note reviewed. Constitutional -- General: She is not in acute distress. Appearance -- Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal -- Cervical back: Neck supple. Skin -- General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; Thought Content: Thought content normal; Judgment: Judgment normal. Assessment/Plan -- Treatment included: water and snacks. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.
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| 43 | 2021-02-24 | bell's palsy, numbness |
Bell's Palsy right side of face. Right upper eyelid droop, righ cheek numbness on palpation, slight ...
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Bell's Palsy right side of face. Right upper eyelid droop, righ cheek numbness on palpation, slight smile effected/off from left, no ringing in ear, able to raise eye brow. Mental status WNL, able to hold conversation, made proper eye contact.
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| 43 | 2021-02-24 | feeling hot |
About 45 to 50 minutes after vaccine was administered body and face felt warm and face was itching f...
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About 45 to 50 minutes after vaccine was administered body and face felt warm and face was itching for the rest of the afternoon. 02/23/2021 itching of face and genitals. 02/24/2021 mild rash appeared on hands and face and continues to itch. Advised to take Benadryl or Claritin to help the itch.
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| 43 | 2021-02-24 | tenderness |
Extreme shooting pains left side of head. Tenderness above ear. Left eye pain. Lethargic. Neck pain....
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Extreme shooting pains left side of head. Tenderness above ear. Left eye pain. Lethargic. Neck pain. Muscle pain.
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| 43 | 2021-02-24 | tremor |
About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt lik...
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About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg - twice a day
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| 43 | 2021-02-25 | weakness |
Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spon...
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Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spontaneous report from a contactable nurse (the patient). This 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 AM (at the age of 43- years-old) for COVID-19 vaccination. The patient's medical history included hypertension, hyperlidemia, pre-cancer cells in cervix, hysterectomy and allergy to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ELO1423, expiration: 1/2021), single dose, dose 1 in the right arm on 05Jan2021 at 10:00 AM. Concomitant medications included atorvastatin, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), fluoxetine (PROZAC) and zolpidem (AMBIEN). On 27Jan2021, the patient had neck, back and chest pain, dizzy, weak and fever. The events were reported as non-serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No therapeutic measures were taken as a result of neck, back and chest pain, dizzy, weak and fever. The clinical outcome of neck, back and chest pain, dizzy, weak and fever was not recovered . The patient has been tested for COVID-19 since having the vaccine. On 25Jan2021, COVID rapid test was negative.
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| 43 | 2021-02-25 | numbness, tingling |
Sharp pins and needles feeling in the palm and fingers of left hand. Numbness of left hand/figerpad...
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Sharp pins and needles feeling in the palm and fingers of left hand. Numbness of left hand/figerpad. +Paresthesias.
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| 43 | 2021-02-27 | weakness |
Although I felt nothing during the first dose, I DID feel a prick for my second dose. It was followe...
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Although I felt nothing during the first dose, I DID feel a prick for my second dose. It was followed by a little itch, but nothing unusual. I made sure to rub my arm and keep it moving until I went to bed a couple of hours later. The next day, I woke up with no issues, just a slight tenderness at the injection site that only really hurt if I touched it. At about 9:30 am, almost 12 hours after the second dose, I became a bit tired, had a little chill, and was a tiny bit achy. I took two Tylenol, and continued to hydrate. I could feel myself getting more uncomfortable as the day went on. By 3:00 pm, I was freezing, could not get warm, and running a fever of 100. I took more Tylenol, and got bundled up and took a nap. At 4:00 pm, I woke up and was even colder, and had a fever of 102.4. At this point, I got into bed and had continued to hydrate and take ibuprofen (I had run out of Tylenol) every four hours. The fever broke at some point in the night, as I woke up and was soaking wet, but by the time I woke up the fever had returned and was 101. I took more Ibuprofen and the fever dropped back to normal around noon on February 18. By far, the worst feeling, aside from the fever, was the extremely severe joint pain I had in my ankles, knees, hips, arms, and hands. It was painful to stand and to walk. By Friday, I felt better, but was weak. I felt back to 100% on Saturday morning.
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| 43 | 2021-02-27 | feeling cold, tingling |
Approximately 25 minutes after injection, patient reported a scratchy throat, headache, bilateral ar...
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Approximately 25 minutes after injection, patient reported a scratchy throat, headache, bilateral arm tingling, cold sensation, difficulty swallowing. MD at chairside, given Benadryl and Tylenol orally. Patient continued to have cold sensation, chilling and difficulty swallowing without water. MD ordered an additional dose of oral Benadryl. After approximately 2-3 hours of observation, patient was discharged home with spouse in no apparent distress.
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| 43 | 2021-02-28 | pain in extremity |
Day 1: Arm hurt 6/10; Day 2-3: Pain 10/10 unable to move arm; Day 4-5: T-Rex arms only. Otherwise 10...
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Day 1: Arm hurt 6/10; Day 2-3: Pain 10/10 unable to move arm; Day 4-5: T-Rex arms only. Otherwise 10/10 pain in upper arm. Day 6-12: pain decreasing and regain mobility. Day 13-14: No improvement; Day 15-present increased pain.
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| 43 | 2021-03-01 | inability to speak |
I received shot 1 of the Pfizer-BioNTech mRNA vaccine on 2/17/2021. IMMEDIATELY afterward, I had a ...
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I received shot 1 of the Pfizer-BioNTech mRNA vaccine on 2/17/2021. IMMEDIATELY afterward, I had a headache and dizziness and brain fog (including trouble forming sentances and forgetting words). These symptoms have persisted every day since the vaccine. These symptoms have diminished slooooooowly over the past 14 days but are still present today.
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| 43 | 2021-03-01 | flushing |
Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by E...
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Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by EMS. 1:09PM -Jaw slightly tight. 1:20 pm pain, stiffness traveling to mid back. 1:25 pm neck feeling better, no nausea, tinling in hands, no change in sensation in legs. 1:30pm remains lightheaded, vision remains blurry, c/o left sided chest discomfort when pressure applied, pain and stiffness in neck returning. 1:42 pm transported to Hospital by rescue squad.
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| 43 | 2021-03-01 | migraine | Severe prolonged migraine headache after dose -- timed immediately after injection |
| 43 | 2021-03-01 | pain in extremity | Sorry arm, nausea, chills, cough, fatigue, light headed, dizziness |
| 43 | 2021-03-01 | tingling | Tingling like sensation/left forearm/arm, headache. Evaluated by EMS-Cleared |
| 43 | 2021-03-02 | tenderness, pain in extremity |
Pain in left elbow and in anterior muscle from elbow to mid arm. Started day after receiving second...
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Pain in left elbow and in anterior muscle from elbow to mid arm. Started day after receiving second COVID vaccine. Bruise remains at injection site, lite purple and tender to touch.
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| 43 | 2021-03-03 | numbness, tingling |
patient reports the first few days she experienced numbness ad tingling (2/12-2/15) to bladder and b...
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patient reports the first few days she experienced numbness ad tingling (2/12-2/15) to bladder and bilateral feet, around 2/18 her entire neck began to feel inflamed and she is still experiencing this, the neck inflammation is causing pain at a level 4 on the pain scale. Had visited the chiropractor with minimal reduction in symptoms. Has had some abdominal pain that is still present, began around 2 weeks post vaccine, this pain varies in location and is described as short lived shooting pains.
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| 43 | 2021-03-03 | numbness |
eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbne...
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eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbness on left side of my face, I was taken to the ER, it went down to the left side of my neck and my left arm, after an hour I couldn't move the entire left side of my body, they did an MRI and admitted me to overnight observation. next morning I was discharged (friday), physical therapy and occupational therapy came in to help me adjust because I was still numb I was given a walker and a knee brace, I went home. Saturday I started getting feeling in my face and neck. Sunday I was still gaining more sensation, Monday I had full sensation every where except my leg, Tuesday I had complete feeling on my entire left side. 7 days after my shot on wednesday I started having cold chills body aches and fever nausea and diarrhea, by thursday I couldn't eat anything in me I would have diarrhea. I went to the ER on Saturday, they ran tests CT scan and found entera colitis and was admitted again, they started me on iv antibiotics and fluids , no solid food, they tested my stool and everything came back normal. I was discharged because the diarrhea had stopped, I was having regular bowl movements. Dr said it may or may not have been a cause from the vaccine, they weren't sure.
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| 43 | 2021-03-03 | migraine, night sweats |
10:15 am Started to sweat,10:25 am Started to have the chills (chills and sweats traded off througho...
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10:15 am Started to sweat,10:25 am Started to have the chills (chills and sweats traded off throughout the day and night),11:30 am migraine began to progressively get worse and continued throughout the day, 12:00 pm became slightly nauseous ate a little bit of food and it helped. Nausea gone by 12:.35 pm, (progressively slightly more fatigued than normal lasted for 2 days). Night sweats and chills throughout the night and migraine lasted until Thursday.
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| 43 | 2021-03-03 | muscle spasms |
Sweats, nausea, muscle spasms in the injected arm for 24 hours. Spasms went away and came back a co...
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Sweats, nausea, muscle spasms in the injected arm for 24 hours. Spasms went away and came back a couple of days later and have continued off and on. On 3/3/21 a mild fever and on 3/4/21 "covid arm" at the injection site. It is red, very itchy and hard and swollen.
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| 43 | 2021-03-05 | tingling, nerve pain |
5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to...
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5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to just below the ear. Pain traveled directly from site of vaccine in arm and up through neck. 10 min after vaccine: Nerve pain down began in a line down right arm and into pinky and ring fingers of right hand. 20 min after vaccine: Tongue tingly (entire right side only, left side normal), pain in jaw, headache beginning in right temple. OTC Tylenol and then Ibuprofen taken 1 hour, 15 min after vaccine helped dull headache but not other symptoms. Nerve pain was intermittent until bedtime. The next morning, woke to right eye crusty from tearing, right eye tearing at corner (clear, like tears), consistently drippy right nostril (clear), loss of taste in tingly right side of tongue (could taste on left side of tongue), tingly right side of lips, slight drool right side mouth, outside of ear slight tingly. Headache returned, only in right temple extending to above right eye. Right side of face felt heavier than left side. Sensitivity to light, sound. Took Tylenol and Ibuprofen. Over 9 hour period (24-28 hours after vaccine given), most symptoms resolved, including taste. The next day (48 hours after shot), symptoms remaining are right eye has very slight tearing, right side of face feels a little "heavier" than left side, but drastically different from day before. I have NEVER had anything like this happen before after a vaccine or otherwise.
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| 43 | 2021-03-06 | tenderness, pain in extremity |
2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next t...
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2/26/21-3/1/21 left ear pain as if a pimple is inside 3/1/21-3/5/21 Left big toe and two toes next to it painful, itchy, hurts when push on toenails, awoken from sleep needing Tylenol Both got better without medical treatment.
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| 43 | 2021-03-07 | feeling hot |
Dizzy, nausea, felt warm. BP 171/114 (pulse 100), then 151/93. 98% O2 sat. Given juice, water, and r...
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Dizzy, nausea, felt warm. BP 171/114 (pulse 100), then 151/93. 98% O2 sat. Given juice, water, and rested.
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| 43 | 2021-03-07 | pain in extremity | Sore arm |
| 43 | 2021-03-08 | flushing |
About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strang...
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About Ten minutes after the shot my face became very flushed and I felt light headed. I had a strange swelling feeling around the backsides of my tongue, like the numbing feeling after a dentist visit. Then about 15 or 20 minutes later someone noticed a red slightly bumpy rash on my chest below my neck. It did not progress. I took Benadryl about 40 minutes after my shot and the rash and tongue feeling went away. I took Benadryl again 6 hours later . After that I had a mild headache and fatigue for two days. With some occasional nausea that would come and go for three days.
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| 43 | 2021-03-08 | numbness |
Patient had numbness in the left leg, few minutes after vaccine administration. The numbness disappe...
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Patient had numbness in the left leg, few minutes after vaccine administration. The numbness disappeared 30 minutes after she made the complaint. We monitored her further for another 30minutes, and she was fine, so no further intervention.
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| 43 | 2021-03-08 | pain in extremity, tenderness |
Started out as being light headed and tired. Then the next day noticed arm red and very sore. I watc...
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Started out as being light headed and tired. Then the next day noticed arm red and very sore. I watched it and monitored it. Then on the 8th I woke up to the red spot being bigger, warm to touch and very sore. I marked it with a pen to keep track of the red spot spreading. I took an Ibuprofen at night and put ice on the spot. Today on the 9th the red spot has spread a little, however the redness of the color has gotten lighter. It is still tender to the touch and the spot is still warm to the touch. I am going to continue to monitor it another day or two and if it gets worse I will call my doctors office to make a visit
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| 43 | 2021-03-08 | tingling, numbness, pain in extremity |
104 constant fever 3 days with first vaccine; 4 days with second vaccine; Severe back pain and stiff...
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104 constant fever 3 days with first vaccine; 4 days with second vaccine; Severe back pain and stiffness unresolved and ongoing (now on day 7); arm swelling at injection site with second vaccine - hard knot the size of a small egg, hot to the touch, bright red coloration - unresolved and ongoing (day 7); numbness of the left arm, left side, and left leg - second vaccine- ongoing and unresolved (day 7); pain, tingling varying with numbness of the left hand and finger and left foot and toes- second vaccine - ongoing and unresolved (day 7); extreme fatigue - both vaccines - ongoing and unresolved (day 7); vomiting and nausea - unable to keep down solid food, can keep down cold liquids but nothing warmer than room temperature - ongoing and unresolved (day 7) recommendation to see PCP for referral to neurologist, immunologist as soon as possible.
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| 43 | 2021-03-08 | tingling |
Around ten minutes post injection PT experienced tingling throughout body, slight constriction in th...
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Around ten minutes post injection PT experienced tingling throughout body, slight constriction in throat, lungs clear throughout no wheezing, BP: 138/89, o2 saturation: 98%, HR: 89 PT then developed facial swelling , administered benedryl at 1815 PO, constriction continued as well as facial swelling post medication admin. PT declined Epi-Pen recommendation. At 1830 an addition PO administered, no change in PT condition. Decision to contact EMS at this point, Medic responded to the scene where patient was sent to hospital.
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| 43 | 2021-03-09 | weakness |
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemi...
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Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
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| 43 | 2021-03-09 | facial paralysis, pain in extremity |
tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable ...
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tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at left arm 23Feb2021 08:00 at single dose for covid-19 immunisation. Medical history included Known allergies: Sulfa drugs, codeine, diastolic dysfunction type 1 from Jul2020, and anxiety depressive disorder (she took a medication for that and it had been diagnosed more than ten years). Concomitant medication included bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). The patient experienced facial droop (left eye and mouth) on 23Feb2021 14:30, tired and sore arm on an unspecified date. The clinical course was as following: She said her appointment for the vaccine was at 08:00AM, and around 02:30PM she was in a video meeting and her left side of her face started to droop and her coworker messaged her to ask if she was ok since she looked pretty funny with the eye and mouth droop. She said that this droop lasted about 4 hours and by 06:30PM it was mostly resolved, if she was not looking at it or trying to raise her eyebrows. She said that the only other side effects were she was tired and had a sore arm. She said doctor asked her to got to the emergency room (ER) to rule out a stroke or transient ischemic attack (TIA) so they did a couple of Computerised tomogram (CT) scans, one with contrast and one without, and a MRI and they did full blood lab work up, and did an Electrocardiogram (EKG) to rule out central nervous system events. She says that they didn't think it was a TIA, they felt it was a peripheral nervous event related to an autoimmune response and all the tests said that they did not thought she had TIA event. She said doctor said it was likely an auto immune response to receiving vaccine, since there were no intervening events between getting the vaccine and the droop, she has not been sick or had any dental events recently. the main reason she was calling was to see if she should get the second dose, since she wanted to get it but has heard the side effects can be stronger for the second dose. She says she would like to know can she or should she take it. The patient was tested was for a stroke but that test came back negative. The patient would like to know if it is contraindicated for her to receive the second dose after having this reaction. The outcome of the event Facial droop was recovering, and the outcome of the event tired and sore arm was unknown.
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| 43 | 2021-03-09 | flushing |
44 y.o. female AAO x4. PT had vaccination admin at 1250 hours, summonsed medic in observation area f...
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44 y.o. female AAO x4. PT had vaccination admin at 1250 hours, summonsed medic in observation area for a scratchy throat. PO Benadryl administered PTA 25 mg. Medical lead went to parking lot and pt. was having a hoarse cough with worsening, starting to get flush in face. ED summonsed via 911. . Pt. then started to have episode of emesis. 0.3 mg epi 1:1000 ordered to be administered, medication was drawn up, verified, and administered to left deltoid. Arrival of ED on scene, hand off given pt. transported to hospital. Allergies PCN. no hx anaphylaxis no reaction to first dose of pfizer covid-19 vaccination. Vitals BP 132/94, pulse rate 94, R 20. Pt. was contacted 1943 hours on 3.10.21 Pt. had stay in ER approximately 5 hours, was discharged home with epi-pen, and an unknown antihistamine. Pt. will follow up with PCP about anaphylactic reaction she had today.
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| 43 | 2021-03-09 | pain in extremity |
small red welt appeared at injection site; small red welt appeared at injection site; arm pain retur...
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small red welt appeared at injection site; small red welt appeared at injection site; arm pain returned; arm pain at site of injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262), via an unknown route of administration on 29Jan2021 at 17:00 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported (did not have other medications in two weeks). The patient did not receive other vaccines within 4 weeks prior to vaccination. On 29Jan2021, the patient initially experienced arm pain at the site of injection; on 06Feb2021 at 08:00 (day 8 post vaccination) the patient experienced a small red welt at the injection site and arm pain returned. The patient did not receive any treatment for the events. The clinical outcome of the event vaccination site pain was recovered within approximately 36 hours; vaccination site erythema and vaccination site reaction was resolved on day 9; and pain in arm was recovering.
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| 43 | 2021-03-09 | tingling |
Patient returns to vaccine location two hours after vaccine, stating within minutes she had sensatio...
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Patient returns to vaccine location two hours after vaccine, stating within minutes she had sensation of tingling on the left side of her face and tongue. No other symptoms. Vaccine clinic was closed for the day, encouraged to seek care at an acute care. Confirms understanding.
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| 43 | 2021-03-10 | migraine, feeling of body temperature change | Have cold and hot sweat, migraine, body ache |
| 43 | 2021-03-10 | tingling |
Bruise & rash on left arm, below injection site- started 2 days after injection, getting better afte...
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Bruise & rash on left arm, below injection site- started 2 days after injection, getting better after 2 days Dizziness - starting 4 days after injection Face tingling - starting 5 days after injection
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| 43 | 2021-03-10 | tremor | "3/6/21 9 pm, had shakes, chills, fever, brain fog, fatigue." |
| 43 | 2021-03-11 | feeling hot | Warmth feeling Intense Headache Dizzy |
| 43 | 2021-03-11 | migraine | vomiting and migraine |
| 43 | 2021-03-11 | migraine |
Already suffer from migraines. Friday started as headache turned migraines and continued to today. O...
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Already suffer from migraines. Friday started as headache turned migraines and continued to today. On Wednesday stomach started hurting, by Thursday left work early due to severe stomach pains that stayed for long time then went away & returned. Today tummy still hurts, pooping often but not diarrhea, and head is pinging
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| 43 | 2021-03-11 | tingling, numbness |
Patient was having heaviness in left arm after receiving vaccination checked vitals BP was elevated ...
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Patient was having heaviness in left arm after receiving vaccination checked vitals BP was elevated at 175/128, one minute late they checked again it was 184/109. Patient reported that heaviness on left side was getting worse. Nurse working the clinic got a wheelchair and took patient to Emergency Room. While they were on the way to the ER, patient started complaining of numbness and tingling down left side of arm.
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| 43 | 2021-03-12 | pain in extremity |
left arm is swollen and painful then it started hurting in my armpit and my lymph node underneath m...
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left arm is swollen and painful then it started hurting in my armpit and my lymph node underneath my arm pit is swollen. Also had body aches and head ache through the night. That is better but the swollen arm and lymph node is not
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| 43 | 2021-03-13 | discomfort | shaky, heaviness. Evaluated by EMS-Cleared |
| 43 | 2021-03-13 | tingling | Face swelling (cheeks,, lips, eyes); Scratchy throat; Lips and face tingling; Heavy tongue. |
| 43 | 2021-03-13 | throat numbness | Numbness and tingling in throat and tongue. |
| 43 | 2021-03-14 | pain in extremity | Entire arm from shoulder to fingers extremely swollen. Unable to close hand and painful. |
| 43 | 2021-03-15 | weakness, flushing |
signs/symptoms, not sure if true adverse event: had a taste in my mouth immediately after receiving...
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signs/symptoms, not sure if true adverse event: had a taste in my mouth immediately after receiving first dose. Two days after first dose: heart rate increased to 130's resting, systolic blood pressure increased to 140's resting, (usual heart rate 70's-90's, usual systolic blood pressure 110's-120's), dizziness, headaches, very weak, temperature up to 99F. Symptoms lasted about two days. One day after 2nd dose: temperature up to 99F, heart rate increased to 130's resting (lasted about an hour), systolic blood pressure to 140's resting (lasted about an hour), felt flushed in the face, headaches, weak, temperature up to 99F, no dizziness. Symptoms lasted about one day.
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| 43 | 2021-03-15 | discomfort |
The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 ...
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The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 Received Pfizer Vaccine #1 experienced left arm soreness at the injection site. The evening of 1/7/2021 following the injection, developed dull lower pelvic pain. Pelvic pain worsened over the next two days 1/9/2021 Symptoms of pelvic pain intensified to now excruciating, sharp pain 1/10/2021 Seen at nearby urgent care and evaluated by healthcare provider; referred to nearby emergency department for further evaluation, work up and recommended imaging. Evaluated by emergency room physician, lab work collected and imaging were completed. CT scan showed 7cm mass in the right pelvis, small amount of pelvic fluid. Pelvic ultrasound was also completed and confirmed 7 cm round lesion in the right adnexa. Discharged home with pain medication and instructions for outpatient follow up. 1/12/2021 Seen by PCP and referral sent OB/GYN; Symptoms are now as dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and weight loss. 1/14/2021 Seen by OB/GYN, repeat pelvic ultrasound ordered 1/22/2021 Repeat pelvic ultrasound completed showed 7.4 cm right adnexal cystic lesion increased in size 1/28/2021 Received Pfizer Vaccine #2, staff at vaccination clinic informed of pelvic pain onset after Vaccine #1 injection. Approximately 4 hours after Vaccine #2, I developed severe sharp pain again similar to after Vaccine #1 which required pain medication for relief. 1/29/2021 Pain improved with medication 1/30/2021 Symptoms have now returned to dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and continued weight loss until scheduled surgery 2/26/2021. 2/12/2021 Seen by PCP, cleared for surgery; labs completed 2/17/2021 Seen by OB/GYN for preoperative visit 2/23/2021 Seen at hospital for COVID Preop Testing 2/26/2021 Surgery completed under general anesthesia ? Laparoscopic myomectomy with mini-laparotomy, lysis of bowel adhesions to degenerating fibroid tumor The time prior to the vaccine, I had no pelvic pain or limitations in physical activity.
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| 43 | 2021-03-15 | numbness |
43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DE...
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43 YO F C/O NUMB SENSATION IN HER FACE SOME UNUSUAL SENSATION IN HER TONGUE FOLLOWING COVID SHOT. DENIES OTHER C/O TO INCLUDE DIFFICULTYBREATHING, SWALLOWING, SPEAKING, DENIES SWELLING IN OR AROUND FACE/MOUTH, NAUSEA, OR OTHER C/O. PT INITIALLY WAS WILLING TO GO TO ER BUT HER SXSUBSIDED WHILE WAITING FOR AMBULANCE AND SHE DECIDED TO AMA AND FOLLOW UP ON HER OWN. FOUND ABOVE PT A/O X4, NO OBV DISTRESS, NO OBVIOUS ANGIOEDEMA, SPEAKS IN FULL SENTENCES, CLEAR LS BILAT ALL, SOME HIVE LIKE RASH ON ANTERIOR CHESTBELOW THE CLAVICLES, EXTREM - PWD, GOOD PMS X4, MOVES ALL WITH PURPOSE
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| 43 | 2021-03-15 | pain in extremity |
Notes Expand AllCollapse All Patient: ...
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Notes Expand AllCollapse All Patient: DOB: 6/11/1977 Date: 3/15/2021 MRN: Subjective Patient is a 43 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and "head rush", feeling dizzy and had a metallic taste in mouth (shortly resolved). Sensation of chest tightness as reported upon her arrival to bay. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Medical hx includes asthma and allergies, pvcs and IgG deficiency ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and headaches R arm pain where injection site is. Ice pack given for site.: Previous Reactions: flu vaccine 20 years ago. She's done well with flu vaccines since then. Objective Vitals Vitals: 03/15/21 1244 03/15/21 1254 03/15/21 1310 BP: 128/85 122/65 Pulse: 86 86 86 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Hyperventilating upon arrival to bay. Pt improves with deep breathing. Pt did take her levalbuterol as well during her stay which did help her chest tightness. No wheezing heard pre/post administration. O2 sats 100% Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) R arm pain; injection R arm. Ice pack placed. Anxiety: hyperventilating, relieved with instructed deep breathing and removal of mask for short time. Lightheaded/dizzy: related to anxiety and systemic stress response. She reponded well to zyrtec, water and snack. Pt able to recover and stand w/o symptoms. She was ambulated out to the front w/o difficulty accompanied by this provider. She's to follow up with pcp/allergist. Pt voiced appreciation of care today.
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| 43 | 2021-03-16 | muscle twitching, flushing |
Received first doze today at 3:00 PM, around 4:00 PM my face became flushed/pink. 4:30 I noticed th...
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Received first doze today at 3:00 PM, around 4:00 PM my face became flushed/pink. 4:30 I noticed that both sides of my face twitch uncontrollably when I smile.
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| 43 | 2021-03-16 | pain in extremity |
Pain in left arm Swollen and painful lymph nodes in left armpit, radiating across back under shoulde...
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Pain in left arm Swollen and painful lymph nodes in left armpit, radiating across back under shoulder blades Nausea Fatigue All symptoms began roughly 12 hours after administration. Today is the fourth day, and symptoms are persisting.
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| 43 | 2021-03-16 | tingling, numbness |
Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and ...
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Began to feel facial tingling and numbness 3 minutes post vaccination; "things started spinning and vision was blurry"; nausea-began having dry heaves (had not eaten), CBG 123, HR bradycardic and erratic, developed pounding HA, EMT stated "throwing PVCs"; then went to ER in POV
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| 43 | 2021-03-17 | flushing |
Patient reported feeling flushed, itching, and redness all over body about 30 minutes after injectio...
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Patient reported feeling flushed, itching, and redness all over body about 30 minutes after injection. 50mg of IM Benadryl given in the right deltoid. Patient tolerated well. No signs of respiratory distress. Observed 30 mins after Benadryl given. Patient alert and oriented. Left in accompany of coworker. Instructed to call 911 if signs of respiratory distress.
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| 43 | 2021-03-17 | muscle spasms, feeling hot |
Client reports that she felt light-headed, nauseous and hot. She also reported that she felt sick ...
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Client reports that she felt light-headed, nauseous and hot. She also reported that she felt sick and had cramping to both hands, approximately 1-2 minutes after receiving dose one of the Pfizer vaccine. Her symptoms lasted 5-10 minutes. After approximately 15-20 of observation, client reports she was feeling better, and left the premises on her own.
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| 43 | 2021-03-17 | tremor |
Low grade fever of 100.2, shakes, Body Ache, Mild headache, and nauseous from about 8 on Tuesday and...
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Low grade fever of 100.2, shakes, Body Ache, Mild headache, and nauseous from about 8 on Tuesday and felt better by Thursday morning
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| 43 | 2021-03-18 | numbness |
generalized hypoesthesia, extreme for 36 hours, fading but still present 7 days out fatigue, nausea,...
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generalized hypoesthesia, extreme for 36 hours, fading but still present 7 days out fatigue, nausea, lack of coordination
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| 43 | 2021-03-18 | pain in extremity |
Fatigue; arm pain; general malaise; This is a spontaneous report from a contactable consumer, the pa...
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Fatigue; arm pain; general malaise; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 12Feb2021 at 16:45 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included fibromyalgia, asthma, high blood pressure and allergy to ACE inhibitors. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 13Feb2021 at 12:00 AM, the patient experienced fatigue, arm pain and general malaise. No treatment was provided for the events fatigue, arm pain and general malaise. The outcome of the events fatigue, arm pain and general malaise was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021277048 same patient, different shot/event
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| 43 | 2021-03-18 | pain in extremity |
By 4PM that day I had extreme lethargy and pain in my left arm and body. After a few days, I develo...
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By 4PM that day I had extreme lethargy and pain in my left arm and body. After a few days, I developed headaches and muscle stiffness and pain on left side of my body. At the ten day mark, I developed severe joint and muscle pain in left arm and shoulder and continued headaches, feeling unwell.
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| 43 | 2021-03-19 | muscle spasms |
Fever, aches, muscle spasms, pain, headache, dizziness, fatigue, dry mouth Started about 12 hours af...
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Fever, aches, muscle spasms, pain, headache, dizziness, fatigue, dry mouth Started about 12 hours after vaccine received, lasted 24 hours
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| 43 | 2021-03-19 | pain in extremity | Sore arm, headaches, tinnitus |
| 43 | 2021-03-20 | depressed level of consciousness |
1310-Went to the Observation area as a patient was not feeling well, after her 2nd pfizer vaccine, t...
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1310-Went to the Observation area as a patient was not feeling well, after her 2nd pfizer vaccine, to the left arm. Medical personnel and I went to the patient and she was sitting in a chair in the 30 min area and she had altered level of conscious. The patient stated she started not feeling well, had some chest pressure and felt she was going to pass out. We stayed with the patient, Vitals signs 149/87 HR 89, pulse ox 98% respiratory 12 Lungs clear in all fields. Patient denied any shortness of breath, and denied any swelling of her throat or tongue. I advised the patient to focus on her breathing and if this had happen before and she stated yes, the patient identified that she is allergic to the influenza shot and yellow fever and this happened when she had those injections, and she was ok after a few minutes. I asked the patient if she had any of these symptoms with the first Pfizer injection and she stated yes, but very little and didn't say anything to anyone during the first injection. We continued to stay with the patient. The patient never losses consciousness, however it appears to be decrease as she was speaking slowly and moving her arms slowly, then the patient start to cry and could answer the questions normally. I asked if the patient was alone or if someone was with her and she stated her husband. I asked the patient to please call her husband and she did. Other medical personnel remained with the patient and I went to the front and found the husband. While I took the husband to the patient she started to have decease level of conscious and we took the patient's vital signs again. 1321- 130/88, HR 77, pulse Ox 96% respiratory rate 14. I continued to talk with the patient and the patient level of conscious returned. The patient stated she had some chest pressure and this was her normal to the reaction, she started to cry again. I continued to comfort the patient and we spoke and the patient identified that she had this reaction with anesthesia before, also dental work, and also with Demerol. I advised the patient to please reach out to her primary physician right away, to discuss the reaction that she is encountering as they maybe able to find out what her body is reacting to and she verbalized understanding. The patient remained in observation and was communication normally. at 1328 vitals signs were completed 133/85, HR 78, pulse ox 96%, respiratory rate 14. Other medical personnel and I continued to monitor the patient and at 1344 vitals signs completed 142/87, HR 70 pulse ox 98% respiratory rate 14. Patient stated she was much better and felt good to go home to eat something and the patient was sent home with her husband.
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| 43 | 2021-03-20 | slurring |
On the second day after vaccine, about 25 hours later, I threw up, became disoriented, sleepy, and w...
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On the second day after vaccine, about 25 hours later, I threw up, became disoriented, sleepy, and was slurring my words. I have little recollection of the 2-3 hour period following throwing up and was in and out of consciousness, almost as if I had a concussion. I continued with my day, not knowing that I was not making sense, and had professional interactions with coworkers and clients, who later reported that I sounded confused, sleepy, and disoriented. I drove my car and received a parking ticket during that time. Since I did not have flu-like symptoms and felt fine for 24 hours directly following the vaccine, I thought I was fine. It actually scares me that I drove my car and that this could happen to others. I was back to normal 4-5 hours after symptoms started, and still had hazy to no recollection of the afternoon. I had to piece together the conversations and interactions the following day. I had a headache the following day and was tired.
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| 43 | 2021-03-20 | tingling |
L-arm tingling , "heaviness" - site w/o swelling redness - + pulse. 5 mins later - midline chest t...
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L-arm tingling , "heaviness" - site w/o swelling redness - + pulse. 5 mins later - midline chest tightness "uncontrollable urge to belch" without other assoc. symptoms; 125/93 -- 95 -- 120/89 chest tightness much improved - conversing & cheerful.
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| 43 | 2021-03-21 | burning sensation | VR stat burning from arm through chest, tingling tongue |
| 43 | 2021-03-21 | feeling cold, tremor |
Pt said she felt dizzy and "off" and that she needed to lie down. Brought into medical bay via wheel...
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Pt said she felt dizzy and "off" and that she needed to lie down. Brought into medical bay via wheelchair, (she was already in one) Laid down. Reported felt cold, blankets given, vitals taken and stable. Pt was shakey at times but reported she felt fine. Vitals remained stable. Shakiness subsided within 10 mins. Then pt rested comfortably for about 20 mins. sat up. VS stable. Left in her wheel chair at 11:20, felt much better.
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| 43 | 2021-03-21 | flushing, weakness |
Patient had her covid vaccine at 7:22am. Around 7:35 am she said she was flushed, diaphoretic, and w...
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Patient had her covid vaccine at 7:22am. Around 7:35 am she said she was flushed, diaphoretic, and weak. I took her bp. It was 136/102. Her HR was 97. RR 16. Pulse ox 99%. Patient reports a hx of anxiety. She also did not eat breakfast. We got her juice, water, and a breakfast bar. At 7:50, she started feeling a lot better. BP was 137/95 with HR of 79. At 8am, her bp was 124/96. Her HR was 91. Her husband took her home.
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| 43 | 2021-03-21 | flushing | Headache Diarrhea Flushed/feverish (no fever) |
| 43 | 2021-03-21 | tingling |
Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and...
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Patient received Pfizer vaccine L Deltoid at 0950. At 1003 She complained of swollen, tingling, and red hands b/l. No SOB, throat swelling, itching, scratching, no tongue swelling. AAO x 3. Talking with no difficulty. No known allergies. Benadryl 25 mg PO was administered. She was monitored. No further symptoms.
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| 43 | 2021-03-22 | weakness | very achy weak cold can not get warm temp is 100.1 |
| 43 | 2021-03-22 | numbness |
Within about 15 minutes I experienced numbness in my shoulder, then clavicle into neck, it felt odd....
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Within about 15 minutes I experienced numbness in my shoulder, then clavicle into neck, it felt odd. About 20 mins after the shot the numbness spread into the left side of my face. It was extremely numb as if I had novacaine. The numbness lasted intensely for about an hour. Then it was periodically for about 36 hours after the shot. I was very tired about 2 hours after giving the shot and that lasted about 24 hours. I could not pick up my left arm for 24 hours at all. It wasn?t until 3 days later that I could pick my arm up.
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| 43 | 2021-03-22 | migraine, facial pain |
After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 m...
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After receiving the first shot, I had a taste of metal in my mouth. I sat down and in the next 30 minutes passed out. For the next three weeks, I had migraines more frequently than my usual migraines and a new pain behind my eye. After receiving my second doses, I felt extremely tired and within 3 hours of receiving got shooting pain on left side of my face. I was diagnosed with Trigeminal Neuralgia by Dr on March 22, 2021. This pain has been constant since receiving the second dose on March 8.
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| 43 | 2021-03-22 | pain in extremity |
Left arm pain, swelling and swollen glands day of immunization. Left arm pain and limited mobility ...
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Left arm pain, swelling and swollen glands day of immunization. Left arm pain and limited mobility ongoing . (3 months now.)
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| 43 | 2021-03-22 | tingling |
Tingling in the cheeks on both sides of the face. More minor tingling in lips and tongue. Mostly r...
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Tingling in the cheeks on both sides of the face. More minor tingling in lips and tongue. Mostly resolved after 2 hours, though still felt around 6pm
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| 43 | 2021-03-23 | bell's palsy, facial paralysis |
Recurrence of left side facial Bells Palsy. tingling of left lower and upper lip and slight droop of...
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Recurrence of left side facial Bells Palsy. tingling of left lower and upper lip and slight droop of left side of mouth.
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| 43 | 2021-03-23 | throat numbness |
20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage ...
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20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage in my airways and could breathe easily through my nose, but did feel constricted in my throat for about 40 minutes.
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| 43 | 2021-03-23 | unresponsive to stimuli, weakness |
Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: PT. FAINTED, BU...
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Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: PT. FAINTED, BUT HER VITALS WERE NORMAL AND LAID HER FLAT ON FLOOR. ACCORDING TO HUSBAND, PT. HAD NEEDLE FEAR AND WHEN SHE GETS ANXIOUS USUALLY FAINTS OR DIZZY. AFTER 3 TO 4 MINUTES , WITH WATER AND GATORADE DRINK, PT. WAS FINE WITH NORMAL VITALS AND LEFT STORE WITH SPOUSE
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| 43 | 2021-03-24 | burning sensation |
Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swel...
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Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.
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| 43 | 2021-03-24 | burning sensation |
Dormant small fiber neuropathy (Erythromelalalgia) on hands only became full flare 5 days after 1st ...
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Dormant small fiber neuropathy (Erythromelalalgia) on hands only became full flare 5 days after 1st dose EN6203 on 03/02/21- never before had symtoms of burning on face, ears, hands, neck, arms, legs. Doctor treated with prednisone and flare subsided after 10 days. After second dose ER8732, extreme flare within 24 hours. Burning on hands, face, ears, arms, legs, feet. Doctor treating with prednisone.
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| 43 | 2021-03-24 | flushing | Felt Faint, flushed, panicky |
| 43 | 2021-03-24 | tingling, pain in extremity, hypersensitivity of all senses, numbness |
The day after my second dose I started having lower back pain and pain in my thighs. As days pass t...
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The day after my second dose I started having lower back pain and pain in my thighs. As days pass the pain has only intensified. I've had tingling, numbness, extreme sensitivity and a deep dull pain in my thighs. I use lidocaine patches for my back. But the pain in my legs does not go away. It intensifies in the evenings and at night. I have not been able to sleep since the pain started.
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| 43 | 2021-03-26 | weakness, unresponsive to stimuli |
Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotens...
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Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Weakness-Medium, Additional Details: Patient became unresponsive. We gave cold compress to help with this. Blood pressure was 76/46. This happened at 10:57 am. We ask if patient was a diabetic she said no. Follow up phone call was completed around 4:30pm but no response. VM was left for patient to call back with update.
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| 43 | 2021-03-26 | discomfort, pain in extremity |
By the next day, on the 26th I had mild injection site pain. During the night then between the 26th ...
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By the next day, on the 26th I had mild injection site pain. During the night then between the 26th and 27th a lymph node in the r. axilla became enlarged and sore. The entire r. arm is just achey other than the injection site pain and axillary discomfort. I do have a migraine as well, but I believe it is due to my mentrual cycle.
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| 43 | 2021-03-26 | flushing, migraine |
Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills,...
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Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills, Stomach and Chest Pains, Reflux and Heartburn, Flushing, Swelling/Edema, Dizzy, Lethargy, Brain-Fog// I?ve been trying to get diagnosed- have had some of these symptoms since September, but a couple/ few hours after the shot, I have been having all of those symptoms throughout the day and the ones I?ve had have been very-exacerbated; I?ve finally been able to hold down food.
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| 43 | 2021-03-26 | pain in extremity |
Grade 3, swelling at injection site, arm pain after injection on Friday and today, Saturday after se...
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Grade 3, swelling at injection site, arm pain after injection on Friday and today, Saturday after second dose with LVN. The nurse LVN may not have injected it correctly. I struggled to do dishes after dinner. My arm pain kept me awake last night. I didn't have any arm pain or swelling at injection site with the first Pfizer dose with nurse. No Pain or side effects whatsoever with the first Pfizer vaccine. Vaccine may be fine. It might be the way the nurse injected it.
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| 43 | 2021-03-26 | tingling | not feeling self, tingling |
| 43 | 2021-03-27 | burning sensation | Fever, brisket, burn, skin coloration |
| 43 | 2021-03-27 | feeling hot |
Fast pulse (160), tickling in throat, feeling of warmth 10 min went away, started back after 5 min. ...
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Fast pulse (160), tickling in throat, feeling of warmth 10 min went away, started back after 5 min. Took benadryl went away after 10 min
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| 43 | 2021-03-27 | numbness |
Started 15 min post vaccine injection. Dizzy, fainting, low blood pressure. Numbness in hands/feet. ...
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Started 15 min post vaccine injection. Dizzy, fainting, low blood pressure. Numbness in hands/feet. Took an hour to recover.
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| 43 | 2021-03-27 | pain in extremity |
Swollen lymph node under right arm almost immediately following injection, pain and soreness. Four d...
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Swollen lymph node under right arm almost immediately following injection, pain and soreness. Four days post vaccine, lymph node under am is still very swollen, pain and soreness down arm still present.
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| 43 | 2021-03-28 | tingling, numbness |
About 18 minutes after receiving the vaccine, I started to feel a little numb on the right side of m...
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About 18 minutes after receiving the vaccine, I started to feel a little numb on the right side of my collar bone and then a tingling in my right pinky toe and finally under my right eye. We had already left the vaccine site so I told my daughter who was driving that I felt a little funny and would let her know if she needed to take me to the hospital. I had not eaten yet that day, only coffee in the morning so we ran a couple of errands and then grabbed lunch. Around 3:30pm on the same day (3/28/2021) I started to feel better and the only side effect I currently have is tenderness in my arm where I received the shot. I did not seek medical treatment as it went away within a couple of hours.
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| 43 | 2021-03-30 | feeling jittery |
muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint ...
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muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint aches; This is a spontaneous report from a contactable female nurse reported for herself (Non pregnant). A 43-year-old female patient(nurse) received second dose of BNT162B2 (Solution for injection, lot number: unknown) via left arm on 28Jan2021, 15:00 PM, single dose for COVID-19 Immunization. Patients receive other vaccines within 4 weeks prior to the COVID vaccine the patient took other historical vaccine included first dose BNT162B2 (lot number: Unknown) on 07Jan2021, at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient received other vaccines within 4 weeks prior to the COVID. Patient had allergies to medications Bactrim.
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| 43 | 2021-03-30 | pain in extremity |
Pain in left arm; Rash in neck and upper body; heat and itching in area; heat and itching in area; T...
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Pain in left arm; Rash in neck and upper body; heat and itching in area; heat and itching in area; This is a spontaneous report received from a contactable consumer reporting for self. A 43-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Mar2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose on 14Feb2021. Medical history included asthma, lactose intolerance. Patient had allergies to Bactrim, Sudafed. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), diphenhydramine hydrochloride (BENADRYL), ibuprofen, colecalciferol (VITAMIN D [COLECALCIFEROL]), vitamins. The patient experienced Pain in left arm, Rash in neck and upper body, heat and itching in area on 08Mar2021 16:00. Outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 43 | 2021-04-01 | burning sensation |
Shingles; Shingles/she was 7 years old she had her first shingles outbreak; burning sensation; They ...
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Shingles; Shingles/she was 7 years old she had her first shingles outbreak; burning sensation; They were flu-like symptoms; Diarrhea; Nausea; achiness; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, Expiry Date: unknown), intramuscular, administered in the right deltoid (also reported as right arm) on 03Mar2021 16:00 at a single dose for covid-19 immunisation. Medical history included patient had anxiety all her life (ongoing), but reported 'started the medication about 10 years ago for the first time'; and patient had hypothyroidism, which she found out when she was going through the in-vitro fertilization. It was further reported that she was diagnosed with hypothyroidism when she and her husband were going through In-vitro fertilization and were having trouble conceiving and her TSH levels were off (date unknown). She didn't feel any different and didn't feel any different now since being on Synthroid; that was the only reason she found out. She was fairly healthy. Patient mentioned that when she was 7 years old she had her first shingles outbreak. Concomitant medications included oral levothyroxine sodium (SYNTHROID) taken for hypothyroidism at 75 ug, daily from an unspecified start date (approximately started 3 years ago) and ongoing; and oral sertraline hydrochloride (ZOLOFT) taken for anxiety at 50 mg, once a day from an unspecified start date (started about 10 years ago) and ongoing. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no prior vaccinations (within 4 weeks). Patient stated she do not want COVID and she is a pro-vaccines. Patient received first vaccine shot on 03Mar2021 and was diagnosed with shingles on the morning of 19Mar2021 and wanted to know if it was okay to take second dose of the vaccine next Thursday with active shingles diagnosis and being on antiviral medication, or should she wait. Patient stated that shingles, she was sure it was shingles, will not prevent her from getting second dose. She mentioned she was stuck, this was all new, and her doctor couldn't tell her because he didn't know. She was not sure what to do. She was not sure if she should delay getting the vaccine until she has stopped the antiviral medication, which she later clarified as Famciclovir. She stated initially her symptoms started Monday (Mar2021). They were flu-like symptoms on 17Mar2021. She was having diarrhea and feeling nauseated on 16Mar2021, thought coming down with the flu. On Wednesday (Mar2021), she felt pain, the shingles was on her buttocks. She went to the bathroom and saw red. Yesterday, 17Mar2021, she got a closer look because a burning sensation. When she looked closer, she realized it was shingles. It started more of a flu-ish feeling on Monday and noticed rash erupt on Wednesday. She also started to experience achiness on Monday (Mar2021). She was seen at her physician's office today, 19Mar2021 and was diagnosed with shingles this morning. The events shingles, nausea, diarrhea, flu-like symptoms and achiness were reported as not serious. The event burning sensation was reported as medically significant. Therapeutic measures were taken as a result of the events which included famciclovir, oral from 19Mar2021 and ongoing, at 500 mg, three times a day for shingles. The patient had not recovered from the events burning sensation (reported as worsened), shingles (reported as worsened), nausea, flu-like symptoms, and achiness. The event diarrhea was recovering. The events diarrhea, nausea, achiness, and burning sensation were reported as unrelated to the vaccine suspect product.; Sender's Comments: The events burning sensation, diarrhea, nausea and pain are considered not related to BNT162B2, but intercurrent medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-04-07 | pain in extremity, feeling hot |
could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscl...
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could not walk on her left foot; hot, painful patch on the inner left lower leg below the calf muscle; Left lower leg and foot bluer than right; vascular issue; pain and redness was present in the lower left calf/ a large red, hot, painful patch on the inner left lower leg below the calf muscle; pain and redness was present in the lower left calf/a large red, hot, painful patch on the inner left lower leg below the calf muscle/tenderness, pain on affected area; tightness, tenderness, pain on affected area; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6204), via an unspecified route of administration at the age of 43 years old, administered in arm right on 17Mar2021 19:45 at single dose for covid-19 immunisation. Medical history included diabetes, Hashimoto's, PCOS (Polycystic ovarian syndrome), allergies to medications, food, or other products: contrast dye. The patient's concomitant medications were not reported, the patient had received medications within 2 weeks of vaccination, but the patient did not provide the specified drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Thursday morning, 18Mar2021 07:00, after vaccine, pain and redness was present in the lower left calf. This progressed to a large red, hot, painful patch on the inner left lower leg below the calf muscle. This has progressed over the past eight days and the patient had gone to Urgent Care (Sat 20Mar2021) where they were concerned about a clot and sent the patient to the ER. An ultrasound in Mar2021 confirmed there was no clot, but the Dr. did not know what the issue was. The doctor started the patient on an antibiotic. This still progressed and 25Mar2021 it spread bilaterally and could not walk on her left foot. Dr. believed it to be a vascular issue with how it presented at her office 26Mar2021 and was closely monitoring the situation. Left lower leg and foot bluer than right, redness, tightness, tenderness, pain on affected area. Subsides at various points during the day, but always returns at night. The patient was told to keep elevated, try Benadryl, and Advil and keep doctor informed to determine referral vasc Dr. The outcome of the events was not recovered. Date of start of events was reported 18Mar2021 07:00. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Case was reported as non-serious by reporter: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 43 | 2021-04-09 | feeling cold, tingling |
eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; hea...
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eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; head/face is tingly/cold; eye had a hemorrhage - it got worse the next day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnant patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 08:30 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included gastric bypass from Jul2018, high blood pressure prior to gastric bypass but has had regular BP (blood pressure) since then, and allergy to penicillin. The patient's concomitant medications were not reported. The patient previously received the first dose of the same vaccine in left arm on 03Mar2021 at 08:30 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 05:00 PM, a day after she received the Pfizer vaccine (2nd dose), her eye had a hemorrhage - it got worse the next day (26Mar2021). She felt light headed and head/face was tingly/cold. Took her blood pressure and it's in a normal range (109/77 111/77). She spoke with a relative that was a nurse practitioner and was advised hemorrhage could be related to vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. Information about batch/Lot number has been requested.
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| 43 | 2021-04-15 | discomfort, speech disorder, slurring |
Was talking with husband and commented that I felt a wave of tired coming over me. Immediately follo...
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Was talking with husband and commented that I felt a wave of tired coming over me. Immediately following the statement I was having difficulties speaking, slurred speech, and my body felt weighted. This lasted 2 minutes. This experience happened two more times so we left for the ER. Another episode happened while checking in the ER and they responded as if I was having a stroke. A 5th episode happened while in the ER waiting for a room and a 6th time after admission in the room with a nurse. This last episode was at 1:00pm on 3/5/2021. I could feel each of these coming on.
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| 43 | 2021-04-15 | one side paralysis, numbness |
Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischem...
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Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischemic attack.
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| 43 | 2021-04-16 | difficulty speaking |
Tickle in throat, cough, throat clearing started approximately 10 minutes after injection. After abo...
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Tickle in throat, cough, throat clearing started approximately 10 minutes after injection. After about 40 minutes of these symptoms , received Benadryl 50 mg po, symptoms continued, tachycardia and tachypnea developed and worsened to near continuous cough, hoarseness/laryngitis, tachypnea, tachycardia, nausea, dry heaves, difficulty swallowing, trouble catching breath over next 30 minutes or so. Received solumedrol 125 mg IV, epinephrine im x2, Pepcid IV, racemic epinephrine neb, epinephrine gtt starting at 0.05 mcg/kg/min. After 2nd IM epinephrine, symptoms slightly improved. After approximately 1h on gtt, was able to be decreased to 0.02 mcg/kg/min and then turned off after another 30-60 min.
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| 43 | 2021-04-17 | bell's palsy |
Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; he...
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Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; her body started to feel strange/ just felt weird; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in left arm, on 12Mar2021 at 02:30pm (at age of 43 years old), as a single dose, for COVID-19 immunisation. Medical history included migraine and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ondansetron (ZOFRAN) and oxymetazoline hydrochloride (CLARITIN ALLERGIC), Nurtec and allergy immunotherapy; all started on an unspecified date and for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 12Mar2021 (at 6:00pm), the patient experienced a metal taste in her mouth, mild on first afternoon but stronger tasting on next two days. On Day 2, it was reported that her body started to feel strange, could not quite describe feeling, further described as it was not really a tired feeling or a painful feeling, just felt weird. On 25Mar2021, the patient experienced Bells palsy. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the events metal taste in her mouth, body started to feel strange/just felt weird. The clinical outcome of the events, metal taste in her mouth, body started to feel strange/ just felt weird, was recovered on an unspecified date. The clinical outcome of the event Bells palsy was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 43 | 2021-04-17 | pain in extremity, migraine |
This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number ER8730, Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 at 10:00 (at the age of 43-years old) as a single dose in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No lab test was performed. Prior Vaccinations (within 4 weeks) and other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as None. Patient has a few concerns, states that patient and her husband got the first dose of their Pfizer vaccines 3 days ago, on 30Mar2021, states patient is experiencing typical side effects listed like headaches and not feeling well, clarifies she turned beet red in the face right after the vaccine and sore in arm on 30Mar2021, patient had a migraine on one side of her head, felt throw uppy, woke up with a sore throat and was coughing up blood on 02Apr2021. patient states she treated herself this morning with Excedrin migraine and has completely resolved. Patient states her throat is still sore but she is no longer coughing up blood. As per the reporter seriousness criteria for the event (coughing blood) was medically significant. The outcome of the event Sore throat was not recovered, coughing blood was recovered on an unspecified date in 2021, Pain in arm, migraine, vomiting was recovered on 02Apr2021, Face red was recovered on 30Mar201 and unknown for another events. No follow-up attempts are needed. No further information is expected.
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| 43 | 2021-04-17 | speech disorder, inability to speak |
aphasia; difficulty speaking; Jaw: Trismus; This is a spontaneous report from a non-contactable othe...
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aphasia; difficulty speaking; Jaw: Trismus; This is a spontaneous report from a non-contactable other healthcare professional. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 24Mar2021 (batch/lot number: ER8727) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Mar2021 during her 15 minute waiting period after the injection, the patient began to experience difficulty speaking. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Jaw: trismus present. Treatment included: no therapy. Follow up response to treatment: no change. Patient transported to ED by ambulance. Differential diagnosis: systemic reaction (hypoglycemia, hypotension, generalized rash) and red flag symptoms (CP, SOB, NVD, visual/neuro concerns). Patient with no other neuro deficits but aphasia was clearly present. AMR called to have patient brought to ED for further evaluation. Husband, will meet her there. The report was assessed as non-serious. The outcome of the events "difficulty speaking" and "trismus" was not recovered; and unknown for aphasia. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The company cannot completely rule out a reasonable possibility that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) caused the aphasia (speech disorder) and trismus due to a reportedly close drug event chronological association. Information on further evaluation would be necessary for a more meaningful medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-04-18 | pain in extremity, numbness, numbness and pain in extremities, tingling, burning sensation |
Second dose of vaccine received on March 10, 2021. Thereafter I started having severe lower back pai...
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Second dose of vaccine received on March 10, 2021. Thereafter I started having severe lower back pain. The pain radiated to my quads, down to my shins and feet. The pain circulates throughout the lower half of my body. Symptoms include: Dull Achy pain, pins and needles, numbness, burning sensation. Because of the pain I cannot sleep at night. I have been to the emergency room 4 times for the severe pain. During my last visit I was admitted to the hospital. Running Diagnosis is : Covid Vaccine Induced Neuropathy.
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| 43 | 2021-04-20 | numbness and pain in extremities, pain in extremity, migraine |
Worsen neuropathic symptoms; migraine headache; Sore arm; fatigue; low grade fevers; chilled; This i...
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Worsen neuropathic symptoms; migraine headache; Sore arm; fatigue; low grade fevers; chilled; This is a spontaneous report from a contactable consumer(patient). This is the 1st of 2 reports, for the Second dose. A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 24Mar2021 (at age of 43 years old) 11:45AM, via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) at single dose, for covid-19 immunisation. Medical history included Ovarian cancer, blood clots, hypertension. known allergies Salfa. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 03Mar2021 (at age of 43 years old) 11:00 AM, via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) at single dose, for covid-19 immunisation and experienced Sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back# fatigue, migraine headache for 15 days. Concomitant medication(s) in two weeks included duloxetine hydrochloride (CYMBALTA) 30 mg, warfarin 1mg and hydrochlorothiazide, all taken for an unspecified indication, start and stop date were not reported. Sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back# fatigue, migraine headache for 15 days after the first dose. For second dose, same symptoms continuously for 11 days now and low grade fevers, chilled for first 4 days after the vaccine and on the 11th and 12th days after the second dose. No treatment received for events and The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. Outcome for events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377679 Same patient/drug, diff event sep for different doses.
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| 43 | 2021-04-20 | pain in extremity, feeling hot |
I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to ...
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I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to where I got the shot/ like whenever I take a step to walk it's feels like my head is going to explode; really bad back ache; My face and my back started getting like hot, like heat, like very hot reaction/like radiating heat in my back it is like surrounding my spine, its right in the middle of my back; It feels like heat and pressure around my spine area; high pressure behind the right eye; My arm started hurting; the arm I got the shot in; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733), intramuscular (reported as in the muscle) in left arm on 01Apr2021 (at the age of 43-year-old) at 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that initially, right afterward she meant her arm started hurting which was normal the arm she got the shot in, she wasn't worried about that. But then her face and her back started getting like hot, like heat, like very hot reaction. She did not know how to describe it, it was like radiating heat in her back it was like surrounding her spine, it was right in the middle of her back. It felt like heat and pressure around her spine area. And in her head, it had not lit up. She had headache so badly that her right eye which was to the opposite side to where she got the shot. She had very high pressure behind the right eye. It was literally like whenever she took a step to walk it was felt like her head was going to explode. It was for her a headache and really bad back ache. When paraphrased the above concern, patient stated It was for days at the time of this report. First adverse reaction was on the actual day that she received the vaccine that was 01Apr2021. Second shot was reported as 29Apr2021. When probed for if patient still experiencing adverse event patient stated that she was still experiencing. As per outcome of event patient stated for its persisting. As per treatment she took an ibuprofen (ADVIL) for the first-time last night before the present report. Just because she needed to get sleep. She had not slept in days. So, she took ADVIL to get rid of the pain last night that was only the things she had done since Thursday 01Apr2021. But it didn't even work. She woke up and felt the exact same. Dose of Advil was reported as 200 mg, she took one 200 mg tablet. She just took it the day before the present report (04Apr2021). The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-04-21 | discomfort, pain in extremity |
Extreme leg pain/ leg muscle stiffness and leg muscle heaviness. I?m a runner and former athlete, a...
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Extreme leg pain/ leg muscle stiffness and leg muscle heaviness. I?m a runner and former athlete, and I?ve never experienced anything like this. My legs hurt and felt more fatigued than after I did an Ironman! It started 6 days after the 2nd dose and is still there at day 9
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| 43 | 2021-04-21 | pain in extremity, numbness, flushing |
About 10 minutes after shot I felt a bit flushed and light headed, then my face felt numb for a coup...
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About 10 minutes after shot I felt a bit flushed and light headed, then my face felt numb for a couple hours. I was then just tired on and off with a sore arm. On day 3 I started feeling congested with pulsing in my right ear followed by ringing tinnitus which continues to this day. I have taken Tylenol and ibuprofen a couple times, which doesn?t help much. I am currently over the 7 day mark from first dose.
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| 43 | 2021-04-22 | pain in extremity |
Mild soreness of arm after shot. Sore throat starting on Wednesday the following week (6 days after ...
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Mild soreness of arm after shot. Sore throat starting on Wednesday the following week (6 days after injection) along with headache and swollen lymph nodes in neck/throat on Thursday night (7 days after injection). Still persisting on Friday morning and getting worse as I am typing this.
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| 43 | 2021-04-24 | numbness and pain in extremities, pain in extremity, migraine |
Worsen neuropathic symptoms- pains on fingers, wrists, feet, toes, back.; migraine headache; Sore ar...
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Worsen neuropathic symptoms- pains on fingers, wrists, feet, toes, back.; migraine headache; Sore arm; fatigue; This is a spontaneous report received from a contactable consumer (patient herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in left arm on 03Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included ovarian cancer, Blood clots, Hypertension and Sulfa: Allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA) 30 mg; warfarin 1mg and hydrochlorothiazide. On 03Mar2021, the patient experienced sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back (medically significant), fatigue, migrain headache for 15 days after the first dose. No treatment received for AE. The outcome of events was not recovered. Information about lot/batch number has been requested.
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| 43 | 2021-04-27 | feeling hot |
Patient complained of body heat. 1:10pm Patient refused to take B/P. Stated she is feeling better....
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Patient complained of body heat. 1:10pm Patient refused to take B/P. Stated she is feeling better. EMS informed patient if symptoms return to call 911 or primary care doctor. (Patient is alertx3). Verbalized understanding.
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| 43 | 2021-04-27 | migraine |
Migraine; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female pati...
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Migraine; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm (reported as right and left arm) on 18Mar2021 a little after 07:00 (at the age of 43-years-old) (Batch/Lot Number: EN6208) as SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing migraine since puberty, from around 13-14 years old, has been migraine free for five years; COVID-19 from Dec2020 to an unknown date. Concomitant medications included topiramate (TOPAMAX) taken for migraine from an unspecified start date and ongoing; butalbital, caffeine, paracetamol (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; rizatriptan benzoate (MAXALT) taken for headache, start and stop date were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. The patient experienced migraine on 18Mar2021 ever since she received the first dose of COVID-19 vaccine. The patient worked the night before she received her first dose of the Covid-19 vaccine, 17Mar2021 into 18Mar2021; she got the first dose of the Covid-19 vaccine the morning of 18Mar2021, came home, went to sleep, and woke up with a pounding headache around 1 PM on 18Mar2021. The patient considered the event medically significant as she had to get an MRI for it and the event required a physician office visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: found white matter lesions consistent with chronic migraines which was normal for her on 07Apr2021. Therapeutic measures were taken as a result of the migraine which included migraine medications topiramate, Butalbital-APAP-Caff and rizatriptan which were not helping; physician changed her medications to a different rescue medication which did not help. The clinical outcome of the event migraine was not recovered (reported as low level of migraine for 4 weeks). The reporter considered the event migraine as related to the COVID-19 vaccine.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event and the suspect vaccine BNT162B2
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| 43 | 2021-04-28 | feeling cold |
Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pu...
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Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pulse; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Batch/Lot number was not reported), at the age of 43 years, as single dose for covid-19 immunization. Medical history included fibromyalgia and t5 back fracture. The patient is not pregnant. Concomitant medications included pregabalin (LYRICA); buspirone and cannabidiol (CBD OIL). On 16Apr2021 at 2 AM, the patient fainted 12 hours later and fell down to the ground after using restroom. She was cold, sweating, slowed heartbeat and pulse, extreme nausea. The patient did not receive treatment for the events. The patient had No COVID-19 prior to vaccination and had not been COVID-19 tested post vaccination. The outcome of the events fainted, fell down to the ground after using restroom, she was cold, sweating, slowed heartbeat and pulse, extreme nausea was unknown. Information about lot/batch number has been requested.
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| 43 | 2021-04-28 | tingling |
almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a con...
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almost passing out; Racing heart; tingling hands; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot number was not reported) (age at vaccination: 43-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, and allergies: Penicillin. Concomitant medication included levothyroxine. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient was not pregnant. The patient experienced racing heart, tingling hands, almost passing out, dizziness. She was driving so she pulled over and called(#). Symptoms improved enough so that she did not request an ambulance. 10 minutes later she was home and became lightheaded again which has not resolved. It has been 1.5 hours since her dose. Adverse events started on 15Apr2021. No treatment received for the events. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 43 | 2021-04-30 | discomfort, hypersensitivity of all senses, numbness, muscle spasms, pain in extremity, burning sensation |
problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top...
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problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top of my head and my hands hurt; Nauseous; my hands and feet started going numb; they itch they burn; feet are painful; uncomfortable; blood clot/a clot or something in her legs; from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein; she thought she was having a stroke; cramps; burning from my calf to my feet; pain in her neck then to her back; pain in her neck then to her back; different temperatures like hot and cold make it bad and irritating; can't sleep well because of her symptoms; Swelling in her Feet; can't think right; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm in the morning of 01Apr2021 (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization. Medical history included ongoing complex regional pain syndrome, ongoing fibromyalgia, ongoing arthritis - all diagnosed 20 years ago. Her mother has lupus and rheumatoid arthritis and she can't have the vaccine, states she doesn't know if something could be genetic. Low potassium in the past and stated that she has a lot of allergies to medications, but she consulted with the pharmacist and he said it would be okay. There were no concomitant medications. No additional vaccine was administered on the same date of BNT162B2 and no prior vaccination within four weeks. The patient was having weird symptoms and she tried looking online and in different groups to find out if anyone has similar symptoms, but she hasn't been able to find anything. She began by saying she has health issues; she has Fibromyalgia and Complex Regional Pain Syndrome. She doesn't know if studies were performed on patients with those disorders that took the vaccine. It's been about 3 weeks since getting the vaccine (Apr2021) and she started having symptoms that she thought could be a blood clot. From the knees down, she was having a lot of pain, cramps, burning from her calf to her feet. She would keep rubbing them and massaging them. It was excruciating pain. She was having symptoms and she did go see her Nurse Practitioner on 14Apr2021 because she thought she was having a stroke or a clot or something in her legs or that she was having a problem with her cholesterol. The nurse thought maybe it was her electrolytes, because she had low potassium in the past, but everything came back normal. Her feet were painful but not as bad in Apr2021. She felt like her condition but it's flaring up like 200% it's like over a 10 on the pain scale. She can't think right, she can't work, and was very uncomfortable in Apr2021. The leg pain felt like it is really deep in the vein, it doesn't feel like it is superficial, and she can feel stuff or liquid flowing. Her pain alternates from her head to her neck to her feet and it is very uncomfortable. Her hands and feet started to go numb, not completely numb but like when they fall asleep from sitting on them and then hit something and it hurts. Her arms were burning like crazy; they itch, they burn in Apr2021. Different temperatures like hot and cold make it painful, bad and irritating, and she can't sleep well because of her symptoms. She doesn't know the exact dates, but it has been about a week, but it is changing. It started with cramps in her legs from her knees down. That is where she had injuries and she thought it was her cholesterol. From her knees down, she has cramps and pain and it is very uncomfortable, she felt a really deep pain. She has pain in her neck then to her back, it started in her lower extremities and it is going up. It has stayed the same and she has to keep taking Tylenol to control the pain. Her symptoms got worse and she started taking Tylenol and that helped and then on 15Apr2021, her hands and feet started going numb and she had a headache and pain on the top portion of her head (reported as brain) and her hands hurt, and she was nauseous. She hasn't heard back from the nurse practitioner, so she decided not to go and get it done because she felt it is from the vaccine. She also has swelling of feet in Apr2021, and now she just woke up an hour ago and she slept somewhat okay, but she had to take Tylenol. Now that she is standing, it felt like her legs are starting to hurt again. Treatment included Tylenol, which helps a little and she has to keep taking it. If she doesn't take Tylenol, she can't even function. The events from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein, cramps, my hands and feet started going numb, they itch they burn, feet are painful, uncomfortable, pain on the top of my head and my hands hurt/headache, swelling in her feet, nauseous, pain in her neck then to her back, different temperatures like hot and cold make it bad and irritating had not resolved, while the event can't sleep well because of her symptoms was resolving, and the outcome rest of the events was unknown.
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| 43 | 2021-05-03 | facial pain, burning sensation |
Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself ...
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Facial swelling, redness, burning/pain started 24 hours after injection and has not resolved itself 9 days later. Other common reactions (nausea, joint pain, chills, fatigue) started at the same time, and have since mostly resolved itself except I'm still experiencing fatigue and tiredness.
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| 43 | 2021-05-04 | breast pain |
abdominal pain; vomited; acute appendicitis; appetite decreased steadily; increasing discomfort in m...
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abdominal pain; vomited; acute appendicitis; appetite decreased steadily; increasing discomfort in my abdomen; my left breast was experiencing significant stabbing pain around nipple area; This is a spontaneous report from a contactable consumer (reporting for herself). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 10:30 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. On 12Apr2021, immediately within 15 min. of injection, the patient's left breast had significant stabbing pain around nipple area. This lasted all day, until she went to bed at 9:30 PM. On 17Apr2021 throughout the week, her appetite decreased steadily and she had increasing discomfort in her abdomen. Saturday morning, she woke up at 5 AM in severe abdominal pain, she vomited, and was still horribly uncomfortable for hours. Finally, she went to the emergency room at 11 AM, where they performed a computerized tomography (CT) scan and told me she had acute appendicitis and required surgery to remove my appendix. The events resulted in emergency room / department or urgent care and hospitalization. The patient was hospitalized for 1 day and had emergency appendectomy. The patient underwent lab test and procedure which included nasal swab negative on 17Apr2021. The outcome of the event breast pain was recovered on 12Apr2021 at 21:30 while the outcome of the other events were recovering. The patient had no COVID prior to vaccination.
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| 43 | 2021-05-04 | migraine |
Debilitating migraines; This is a spontaneous report from a contactable other HCP. A 44-year-old f...
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Debilitating migraines; This is a spontaneous report from a contactable other HCP. A 44-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 07Feb2021 12:00 (Batch/Lot Number: EN5318) as single dose at the age of 43-year-old for COVID-19 immunisation, administered at a facility. The patient medical history was none. No known allergies. The concomitant medications were not reported. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant. The female patient received bnt162b2 (BNT162B2), dose 1 on in arm left 17Jan2021 04:00 PM (Batch/Lot # EL8992) at the age of 43-year-old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced debilitating migraines on 28Mar2021. The event was considered serious as per disability or permanent damage. No treatment received for the event. COVID was tested post vaccination: Nasal Swab, PCR, resulted negative on 14Apr2021. The outcome of event was recovered with sequelae/lasting effects.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of migraine. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-05-04 | tingling, numbness and pain in extremities, pain in extremity, numbness, burning sensation |
neuropathy; lower back pain that spread to her legs; lower back pain that spread to her legs/spread ...
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neuropathy; lower back pain that spread to her legs; lower back pain that spread to her legs/spread to her hands and it had spread to her feet; tingling; burning sensation and numbness mainly in her legs/back, hands, feet and in her shoulders this sensations come and go; burning sensation and numbness mainly in her legs; severe pain/sometimes spread to her shoulders; severe pain/It was her full body; This is a spontaneous report from a contactable consumer. This consumer reported for 43-year-old female patient (sister) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the arm on 10Mar2021 (lot: EN6205) at single dose for COVID-19 immunisation. Medical history included Juvenile rheumatoid arthritis, diagnosed 20 years ago (2001) and she was in remission. Previously she had a bilateral hip replacement but that was 20 years ago (2001), there had been nothing new since then. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 09Feb2021 (Lot Number: EC3247) for COVID-19 immunisation. On 12Mar2021, patient started experiencing adverse reaction, lower back pain that spread to her legs, mainly in the quarter area (deep leg pain). They have been to ER twice. She's also experiencing tingling, burning sensation and numbness mainly in her legs but also in her back, hands, feet and in her shoulders, this sensations come and go. Patient was in severe pain, it was at 9/10, and it was in her lower back and her quads area, it sometimes spread to her shoulders and hands and it had spread to her feet on both sides for all of these. It was her full body. It's been already three weeks after the vaccine and the doctors told her that this was caused by the vaccine and they're not sure how to treat her. In the emergency room the other day had given her codeine, which didn't work, and she didn't like the way she felt when she took that so she didn't take it anymore, and they had also given her morphine (it was an injection given at the hospital through an IV drip) and she was still in pain under the morphine, which didn't work. At first, they had prescribed patient hydrocodone and it didn't help her at all. She is now on one more new medication. Patient was on prednisone 60 mg, and she started this medication on 30Mar2021, and they wouldn't say it was helping her too much and that was a pretty big steroid dose. They gave patient prednisone 20 mg on 29Mar2021, and that didn't help at all and she ended up back in the emergency room so they hyped up her prednisone dosage to 60 mg on 30Mar2021 and was still taking this medication. Patient was using the lidocaine patches 5% (NDC: 0591352511, Lot Number: 1396641, and expiry: Jun2022), and reported that it was not helping with her specific issue and she was wanting to explain that, it is not that they didn't work, it was just not specifically helping patient for the current pain that she was having. Additional treatment included methylprednisone (NDC: 68382-916-34, Lot Number: M008443, Expiry: Jul2022): this was the original dose of the type of prednisone that patient was on. It was 4 mg per pill by mouth and that didn't work. It was in a manufacturer pack. Patient only took it one day because it wasn't helping and then when they went back to the emergency room they gave her the 10 mg per pill instead of the 4 mg per pill taper package. Tramadol: from 23Mar2021 and she was still taking this medication, at 50 mg, one tablet by mouth three times daily as needed. She was taking this for the same reason as above, to try and figure out what will reduce the pain. The providers wanted to see if this is muscular pain, or whatever it is, this is used to try and reduce it. Cyclobenzaprine: from15Mar2021 and she was still taking this medication, at 5 mg, one tablet by mouth three times daily for the pain. Gabapentin: On 15Mar2021 patient was originally taking 300 mg put then she was hiked up to taking 600 mg by the neurologist starting on 30Mar2021. She had been taking 600 mg three times a day by mouth since 30Mar2021 and she was still taking that dosage. Amitriptyline: from 15Mar2021 and she was still taking this medication, at 25 mg once a day by mouth. As of follow up information on 19Apr2021, the consumer reported that patient had formally been diagnosed with COVID vaccine induced neuropathy on unspecified date. Patient had been to the emergency room 4 times and hospitalized once. The patient went to the emergency room for the 4th time on 08Apr2021 and was admitted that night at midnight, hospitalized from 09Apr2021 to 12Apr2021. The patient is now on the medication as follows: Hydromorphone- 2mg tablets, one tablet every 4 hours as needed; Morphine extended release- 15 mg one tablet 3 times daily; Dexamethasone- 2mg tablets tapered down; Pregabalin- 300 mg 3 times daily; Cefradine (VELODYNE)- 10mg once daily. The patient's providers had been changing the patient's medication a lot. Now the patient is on hydromorphone hydrochloride (DILAUDID) and morphine and nothing is happening. The outcome of tingling, burning sensation and numbness was not recovered, outcome of other events was unknown.
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| 43 | 2021-05-07 | pain in extremity |
Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/...
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Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/few days; menstruating when I had my period only 14 days before; This is a spontaneous report from contactable consumer, patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration, in the left arm on 09Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, and thyroid issues. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs included ofatumumab (KESIMPTA) from 30Mar2020. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ocrelizumab and experienced hypersensitivity. On 21Apr2021 at 12:00, the patient experienced currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before. The outcome of the events, currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before was unknown.
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| 43 | 2021-05-12 | pain in extremity |
Tested positive For Covid on 19Apr2021; Nasal Swab tested positive for Covid on 19Apr2021; body ache...
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Tested positive For Covid on 19Apr2021; Nasal Swab tested positive for Covid on 19Apr2021; body aches; Sorearm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 12:15 (Lot Number: EW0150) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypothyroidism. The patient's concomitant medications were not reported. Relevant past drug history included Pennicilin and sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient first reported she received her first dose on 05Apr2021 and then got COVID on April 15th. She was due for her second vaccine on 26Apr2021 but due to isolation she was unable. She further reported that she had body aches and sore arm on 05Apr2021 for over a week. Nasal Swab tested positive for Covid on 19Apr2021 and was out of work for 10 days. The outcome of the events body aches and sorearm was resolving and for other events was unknown. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 on 30Apr2021.
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| 43 | 2021-05-13 | weakness |
appendix ruptured/aapendicitis; mild flu symptoms; energy level was low; stool is soft; bowel moveme...
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appendix ruptured/aapendicitis; mild flu symptoms; energy level was low; stool is soft; bowel movements are not consistent; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8737), via an unspecified route of administration, administered in the right arm on 29Mar2021 as a single dose for COVID-19 immunization. Medical history included allergy to penicillin from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE, reported as 'VYVANSE Xr'); duloxetine (manufacturer unknown) and lamotrigine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the patient had stomach ache and pains. On 06Apr2021, the stomach pains were constant and sometimes sharp and there were mild flu symptoms. On 07Apr2021, the patient had severe stomach pain and flu symptoms. The patient took a nasal swab rapid COVID test also which came back negative. In the afternoon of 07Apr2021, the patient's temperature hit 104 and she went to the ER. After the CT scan, appendicitis was confirmed and the patient went into an emergency appendectomy. The patient's appendix ruptured. On 09Apr2021, the patient was released from the hospital. As of 28Apr2021, the most of the patient's symptoms are gone but bowel movements are not consistent and stool is soft. The patient's energy level was low and there was slight lower stomach pain at times. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 44 | 2020-12-31 | hot flush |
itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on si...
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itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on site with benadryl 25 mg po; VS monitored for approx 15 minutes- remained normal, slightly elevated temp, lungs sounds clear, hot flashes throughout afternoon. About 45 minutes after injection took 1000 mg tylenol and 800 mg ibuprofen. additional 50 mg benadryl and 800 ibuprofen at bedtime for continued rash & itching. Next day symptoms still present, but minor. injection site became red, warm, tender to touch with small knot, 8-00mg ibuprofen taken in the morning and then 50 mg benadryl & 800 mg ibuprofen taken at bedtime. Day 3, slight itching, faint rash remains, injection site remains red, warm, tender to touch with small knot,
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| 44 | 2020-12-31 | pain in extremity, numbness |
After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt ...
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After 12 hours of receiving the vaccination, my legs felt heavy. The bottom of my right foot felt numb after standing for a little time. The feeling of heaviness continued, but I was able to walk and completed my daily activities. My right arm felt painful similar to receiving a tetanus shot, I took some Tylenol and drank some coffee and felt better. However, the feeling of heaviness in my legs continued. On Sunday, my left leg continued to swell and I noticed that the area under my knee cap and above the upper part of the rim of my socks was visible swollen, red, and painful. I took some Motrin and the swelling improved. Later, I noticed I am having musculoskeletal pain and general body aches that improve with Mortin but returns. I am able to continue with my ADLs
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| 44 | 2021-01-01 | discomfort |
Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection ly...
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Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection lymph nodes very sore and swollen in armpit (pain with applying deodorant) Four days after injection bruising with about 3x3 cm area of redness/swelling present at injection site Daily headaches managed with ibuprofen Not anything too concerning but not comfortable. I have never reacted to a vaccine prior
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| 44 | 2021-01-02 | feeling jittery | Diaphoretic palms, palpitations, jitteriness. |
| 44 | 2021-01-02 | flushing, numbness | numb pockets on face, a little swelling of tongue and a little tired/flushed |
| 44 | 2021-01-03 | feeling hot, tingling | felt hot, prickly, right arm red. Later felt chest tightness |
| 44 | 2021-01-03 | flushing, pain in extremity |
first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong ...
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first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.
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| 44 | 2021-01-03 | numbness | Left cheek/ jaw numbness starting 10 min after injection |
| 44 | 2021-01-03 | migraine | INJECTION SITE TENDERNESS PIXELATED VISION MIGRAINE |
| 44 | 2021-01-03 | night sweats |
12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cou...
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12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cough, night sweat. 12/31 additional symptom of hypertension . As of today experiencing body aches, headache, cough, and hypertension. Medical Treatment 12/27/20 Urgent Care - 01/04/21 (virtual visit on 12/20)
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| 44 | 2021-01-03 | night sweats |
12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the a...
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12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the above 12/31 - add hypertension 1/04 - still have body aches, headache, cough, fever, hypertension
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| 44 | 2021-01-04 | flushing |
pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; te...
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pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.
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| 44 | 2021-01-04 | numbness, burning sensation, tingling, flushing |
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin...
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Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
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| 44 | 2021-01-04 | night sweats |
Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got wors...
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Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got worse and caused me to limp at work. I started feeling down. That night, I went home and had chills and fever. I was sweating in my sleep. I was fine on Christmas and now I have bronchitis like symptoms. I've seen 3 different providers at urgent care and was told that they don't know much about the vaccine. They told me to use Albuterol and go to the hospital if I get worse. I was told that I still have the antibodies from already having COVID twice and it may be causing me to have problems now. The first time was really bad and I developed pneumonia, but didn't go to the hospital due to all of the deaths occurring in city.
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| 44 | 2021-01-04 | tingling, burning sensation |
Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she...
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Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she felt as if she had a "lump in her throat". Denied any type of SOB or breathing issues. @ 1650, Ee stated she felt an itching, burning, and tingling to her lips and chin. Ee also had mild edema noted to her lips. Also stated that she had onset nasal congestion. Benadryl 25mg given @ 1652. Ee remains @ observation @ present time, 1706. @ 1715 Ee stated that she had mild itching to entire body. Around 1720, stated that the symptoms were easing up. @ 1725, Ee stated that the symptoms were better, but slight itching still remained. Insisted on leaving observation, stated she was okay. Ee left observation @ 1726.
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| 44 | 2021-01-04 | throat numbness |
lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips...
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lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; developed a cough once the numbness and tingling reached my throat; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 15:30 at a single dose for COVID-19 immunization. Medical history included thyroidectomy for thyroid cancer, anaphylaxis to mangoes and allergic to multiple medications. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine and liothyronine. The patient received the vaccine at 3:30pm, ten minutes later her lips, tongue and throat became numb and tingly. She developed a cough once the numbness and tingling reached my throat. She was given Benadryl at the time, 15 minutes after injection. She was still having numbness and tingling to the back of her tongue currently (8 days after injection). The patient was not hospitalized for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.
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| 44 | 2021-01-05 | feeling hot, pain in extremity, hot flush |
15 minutes after the injection, I got some itching on my right shoulder near the injection site. I w...
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15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.
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| 44 | 2021-01-05 | feeling hot, pain in extremity |
Hot; heaviness in right arm / sore; feeling flushed; feeling hot in legs. Monitored for total of 40...
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Hot; heaviness in right arm / sore; feeling flushed; feeling hot in legs. Monitored for total of 40 minutes. Laid on a stretcher and systems resolved. Released to home.
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| 44 | 2021-01-05 | feeling jittery |
Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shak...
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Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; This is a spontaneous report from a contactable Healthcare Professional reporting for a patient. A 44-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 09:00 as a single dose, for COVID-19 immunisation. The patient had no known medical history or allergies. Concomitant medication included rosuvastatin calcium (CRESTOR). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 2300, the patient experienced Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly. No treatment was given for the events. The clinical outcome of Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly was recovering.
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| 44 | 2021-01-05 | numbness, tingling |
I got the vaccine and three hours later I had both legs below the knee go numb and start tingling ....
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I got the vaccine and three hours later I had both legs below the knee go numb and start tingling . They are still tingling today but the numbness went away the day after I had the vaccine.
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| 44 | 2021-01-05 | migraine | Persistent migrane pain with nausea |
| 44 | 2021-01-05 | pain in extremity |
immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing ...
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immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing headaches, fatigue, dizziness and nausea on and off every day
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| 44 | 2021-01-05 | pain in extremity |
arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous ...
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arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the arm on 29Dec2020 at 15:20 at single dose for COVID-19 immunization. Medical history included thyroid issue, low blood pressure from an unknown date and unknown if ongoing, surgery for an ovarian cyst in 1999 (She had surgery for an ovarian cyst 21 years ago), cyst on her tailbone removed in 2016 (had cyst on her tailbone removed 5 times. The first removal was in 2016. It was removed twice in 2017 and then twice in 2018). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid issue. The patient got the vaccine on Monday (29Dec2020) and waited the 15 minutes then felt okay. Then on Tuesday (30Dec2020) she developed/woke up with arm pain and shivering, body aches and mild headache. She woke up with arm pain, shivering, body aches, and headache. The patient states it is very mild. She is sitting there shivering and has body aches. No joint pain. Her arm is sore where she got the shot. When you feel pain, you automatically have a headache. Side effects started this morning around 9:30AM or 9:45AM. She felt nothing when she was in the bed. When she went into living room for breakfast she felt shivering. She called her friend that got the injection yesterday too and her friend feels ok and gave her the number to call. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient was recovering from the events. Information about lot/batch number has been requested.
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| 44 | 2021-01-05 | tingling, tremor, feeling of body temperature change |
Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE le...
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Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE left work to drive home after vaccine and reports approximately 45 minutes later felt ?hot and cold? all over her body and felt ?panicky.? EE reports she pulled over and called her husband. At time of call (approx. 13:33), EE reports still feeling a little ?tingly? on her entire body and ?odd.? EE reports mild shaking to bilateral hands. EE reports last time she ate was at approximately 06:45 this am. Home remedies? - EE was in Starbucks parking lot at time of call and was going to be getting lunch after call. Recommendation? EE educated to eat and drink something, EE verbalized back understanding. EE educated to call vaccine support line for worsening symptoms, EE verbalized back understanding and denied further questions at this time.
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| 44 | 2021-01-05 | tingling |
Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to ca...
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Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to car, migraine aura started. I rarely get migraines. Got worse and worse as I drove home, could barely see. Severe headache followed.
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| 44 | 2021-01-06 | discomfort, tingling |
tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BIL...
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tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BILATERALLY - felt like she was going to pass out and have diarrhea and vomit at same time - these symptoms awakened her from sleep at 11:45pm; sxs lasted about 15 minutes and then abated; tingling in 4th/5th fingers BILATERALLY persists today- though much less intense - reports at level of 1/10; never did vomiting and never had diarrhea; never passed out; feeling well today - able to run 4 miles and teach yoga and work at a physical therapist
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| 44 | 2021-01-06 | hot flush |
Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and F...
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Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and Famotadine 40 mg prior to going to F13 clinic for her covid vaccination. Patient stayed an hour after vaccine administration to be monitored. She came to ER for further monitoring and allergic reaction concerns and received 2 doses of 25 mg diphenhydramine. She was reporting itching of her trunk and arms, itchy throat, and hot flashes. She was monitored in ER, she maintained airway and stayed on RA the entire visit.
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| 44 | 2021-01-06 | numbness |
Facial numbness bilaterally with headache 3 hours post injection. 15 hrs post injection: 101 tempera...
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Facial numbness bilaterally with headache 3 hours post injection. 15 hrs post injection: 101 temperature, severe chills and joint pain (making it difficult to walk), body aches and extreme fatigue. Headache continued but facial numbness subsided. Symptoms less severe at 48hrs, low grade temp and body aches persisted, joint pain resolved. All symptoms resolved at 72 hrs.
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| 44 | 2021-01-06 | migraine | Severe joint pain, migraine headache |
| 44 | 2021-01-06 | nerve pain, tingling, burning sensation |
Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hur...
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Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face
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| 44 | 2021-01-06 | pain in extremity, weakness | Generalized Weakness, arm sore, sore throat, runny nose |
| 44 | 2021-01-06 | tremor | Approximately 10 minutes after vaccination developed increased heart rate, dizziness, and shakiness. |
| 44 | 2021-01-07 | weakness | moderate myalgias, fatigue, back pain, extremity pain and weakness |
| 44 | 2021-01-07 | discomfort, numbness | Myalgia bottom lip feels heavy, jaw feels heavy, bottom lip and jaw numbness Narrative: |
| 44 | 2021-01-07 | hot flush |
FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, L...
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FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, LOSS OF APPETITE , PAIN AT VACCINATION SITE, LEFT AXILLARY PAIN ON ABDUCTION. UNABLE TO GO TO WORK DUE TO SYMPTOMS
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| 44 | 2021-01-07 | numbness | facial numbeness x 1h; bilateral Narrative: self limited bilateral facial numbness |
| 44 | 2021-01-07 | numbness |
Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first fing...
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Swollen area under the skin on left hand that is causing numbness in the palm, thumb and first finger. Some swelling to the hand as well
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| 44 | 2021-01-07 | migraine |
Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatr...
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Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatriptan having no effect
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| 44 | 2021-01-07 | pain in extremity | Sore arm, Joint pain, Fever, Fatigue, Back pain(muscles in back), Headache x 2 days so far |
| 44 | 2021-01-07 | pain in extremity | I had fever and arm was sore. I felt fatigue and very tired. |
| 44 | 2021-01-07 | pain in extremity |
I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning...
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I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning it was pounding, spread to the right half of my head, nausea, photo sensitivity, vertigo. It took 36 to 48 hours before I could function. 48 to 72 hours later I had another headache with vertigo. I had complete vision loss in my left eye.
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| 44 | 2021-01-07 | pain in extremity |
slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positiv...
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slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.
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| 44 | 2021-01-07 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at inject...
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Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at injection site and has not gone away, gets worse with some motions, has not been red or swollen Makes dressing, reaching, dishes, laundry, putting on a backpack, working with patients all painful (I am a physical therapist in the hospital) I have an old injury to the long head tendon of my biceps in the L arm and originally thought it just flared that up for some reason, but the pain is also more lateral by the injection site I have been resting it, trying not to aggravate it, using some tylenol as needed for sleeping as positioning is hard lately, and it's been hurting more towards the end of the day It is not getting better, and I feel like may be getting a little worse. I am going to start icing it this weekend too. It is starting to affect how I do my daily activities and my job - I am considering going to the doctor
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| 44 | 2021-01-07 | tingling |
shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in t...
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shoulder pain in the joint space causing paresthesia in the hand and arm with intermittent pain in the forearm. loss of full range of mobility in the shoulder. this has been ongoing x 1 week.
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| 44 | 2021-01-07 | tremor |
Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became ha...
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Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.
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| 44 | 2021-01-07 | tremor |
Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; m...
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Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; metallic taste in the mouth; burning in the eyes; chills; shaking; This is a spontaneous report from a contactable physician, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection on 24Dec2020 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020 at 07:00, the patient experienced sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking which lead to doctor or other healthcare professional office/clinic visit. Treatment was provided for the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking with NSAIDs. The outcome of the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking was not recovered. Since the vaccination, the patient has been tested for COVID-19 on 30Dec2020 via Nasal Swab and Antigen test and both were negative.
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| 44 | 2021-01-08 | facial pain |
I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and di...
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I exp pain in my cheek and swelling of my face. On 12/27 I went to urgent care with a rash and diagnosed with Shingles. I had blisters with redness scalping which fell off on 1/8.
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| 44 | 2021-01-08 | pain in extremity |
Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days...
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Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days Severe headache x 2 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Mild headache x 1 day (OTC Ibuprofen 400mg PRN) Dizziness x 2 days (Ensured proper hydration) Body aches x 3 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Malaise x 3 days
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| 44 | 2021-01-08 | tremor |
Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three...
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Shortly after vaccination I developed tachycardia which continues to persist. Also in the last three days I have started having violent shaking.
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| 44 | 2021-01-08 | tremor |
Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medic...
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Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medication for it and I informed her that it would still be recommended to get the vaccine. She was visibly anxious even after vaccine. Immediately after she began crying to her friend and said she "was just SO afraid of needles". I told her to take some deep breaths and after a minute or two she went to the observation room. Approximately 15 minutes later she rushed back into the room looking like she might hyperventilate or have hypoglycemia (shaking, cold sweats). She sat down and I tried to calm her down. I asked someone to get her orange juice. During the next couple minutes she did not seem to be getting any better and started shaking. I requested someone call 911. Another staff was helping so I moved to get and administer an epi-pen injection. By this time the patient was not responsive, but was still breathing. I instructed staff to help move her to the floor for monitoring and if needed, cpr. She regain partial consciousness. Her breath and pulse were always present, so there was no need to begin cpr. After a few minutes EMT arrived and transported patient to local hospital. During all of this, other employees at the facility were attempting to contact family members, which they were eventually able to do. About 30 minutes later the staff informed me they had spoken to family members who were at the hospital and that she was improving, but they had not seen her yet.
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| 44 | 2021-01-09 | feeling cold |
Pfizer-BioNTech COVID-19 Vaccine EUA Chills (low temp), fever (102), bad headache, overall body ache...
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Pfizer-BioNTech COVID-19 Vaccine EUA Chills (low temp), fever (102), bad headache, overall body aches, fatigue. Taking Tylenol and Aleve around the clock. Still ongoing.
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| 44 | 2021-01-09 | tingling, numbness, pain in extremity |
As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is s...
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As soon as 3 seconds after the shot my right hand was numb and tingling. The tingling sensation is still there and I have chronic pain in my elbow running down my arm into my ring and pinkie finger.
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| 44 | 2021-01-09 | tremor, inability to speak |
I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwis...
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I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwise, I am a very healthy physician, normal BMI, I have also been tested 5-6 times negative for COVID. I do get exposed in my job, but wear proper PPE. Viral infection in FEB that was like COVID-19 sx, I did AB test as soon as it was available, and negative. ---The Event: Monday morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx (could not get words out coherently), then fell into bed and started right wrist and right foot posturing. This lasted 10 min. I have non-memory of it, but my MD husband witnessed it. After 10 minutes, I was back to normal, except shaky and some word finding difficulties. After 30 min, totally back to normal.
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| 44 | 2021-01-10 | pain in extremity, night sweats, feeling hot |
Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on r...
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Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts. And I'm still having night sweats plus am extremely hot but not having a fever.
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| 44 | 2021-01-10 | pain in extremity | Achy, chills, arm pain |
| 44 | 2021-01-10 | tingling |
Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain fr...
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Sat. Jan. 9, 2021 Aches and swelling in left axilla, Sun. Jan 10, 2021 Woke up with left arm pain from shoulder to forearm, pain got better with regular daily movement. Enlargement of the injection site welt, increase firmness, redness and diameter, deep centrally located bruise. Shoulder begins to ache consistently worsening with movement or pressure to area. Mon. Jan 11, 2021 More noticeable swelling to left axilla and swelling appears to left upper outer pectoral area and below clavicle. Arm feels heavy and like fluid is traveling down arm and into hands/fingers. Fingers, wrist and forearm have brief periods tingling and pain. Swelling feeling in left extremity feels better when hand is held up over head.
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| 44 | 2021-01-10 | tingling |
Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tin...
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Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tingling on her face and then after 5 more minutes she said she felt her throat tingling. Our safety officer who is a DR was called ans ordered a dose of epinephrine 0.5 ml to be given and then call the EMS.
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| 44 | 2021-01-10 | tenderness |
1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore ar...
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1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore arm at injection site, left axilla pain and swollen left axillary lymph nodes 1/9 to- present: swollen axillary lymph nodes and tenderness left axilla
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| 44 | 2021-01-10 | tremor | chills, shakes, nausea, vomiting, lightheaded |
| 44 | 2021-01-11 | weakness, pain in extremity |
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild f...
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Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells. Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
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| 44 | 2021-01-11 | weakness |
Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset st...
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Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset stomach
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| 44 | 2021-01-11 | involuntary muscle movements |
received COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had atonic rea...
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received COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had atonic reaction: involuntary muscle movements and lasted for 3 days,
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| 44 | 2021-01-11 | involuntary muscle movements |
Received the COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had involu...
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Received the COVID-19 vaccine on 1/7/21 at 1:30pm, had diarrhea at 2:45pm, 12 hours later had involuntary muscle movements and lasted for 3 days
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| 44 | 2021-01-11 | feeling hot |
On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this ...
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On January 6,2021 when I woke up my face was red, swollen and extremely warm. My face was like this for at least 16 hours (very uncomfortable). Also, on January 6, 2021 at 1130pm I had horrible stomach pains, then started vomiting, after I was done vomiting I felt better. I did take 2 Benadryl and aleve to help When I got back injections and had surgeries I had the same reactions happen to me usually after 8-10 hours after I was out of surgery. I was given medicine to help with the discomfort either through IV or Benadryl.
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| 44 | 2021-01-11 | feeling hot |
About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rat...
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About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rate went to 140bpm. I alerted RN, gave me water, juice took about 20 minutes for HR to fo down to around 100. Did not go to ER. Went home, rested. HR returned to 80bpm around 3pm. Metoprolol taken two hours prior vaccine.
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| 44 | 2021-01-11 | feeling hot |
24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and...
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24 hours after vaccine injection I experienced swelling, heat, tenderness and nodules to my chin and cheeks where I had dermal filler injections in March 2020. This did not resolve with Benadryl 50mg. On 1/10/21 I was given a Rx for prednisone and the tenderness and swelling resolved with 40 mg of Prednisone.
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| 44 | 2021-01-11 | feeling hot | pt felt heart racing, warm ears and face. Pt monitored and given water. Symptoms resolved at 1721. |
| 44 | 2021-01-11 | flushing | Flushing, irregular heart beat, redness on chest |
| 44 | 2021-01-11 | flushing |
Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessmen...
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Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessment
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| 44 | 2021-01-11 | migraine |
I received the vaccine in the morning on 12/31/2020 and woke up on 01/01/2021 with a migraine, much ...
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I received the vaccine in the morning on 12/31/2020 and woke up on 01/01/2021 with a migraine, much worse than my usual migraines. It was gone by the morning of 1/2/21. I was advised to report this.
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| 44 | 2021-01-11 | pain in extremity, weakness |
Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and my throat felt a little tight. Then, I started to feel kind of lightheaded and my legs were weak. I let the staff know and they offered me benadryl but I declined. I waited about 35 minutes then I went home. I continued to feel lightheaded and weak for about 4 hours and I also began to fill nauseous. My arm continued to be sore for a few days and I ran a fever of around 100 from the following day 1/9 and I am still running a fever now on 1/12.
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| 44 | 2021-01-11 | pain in extremity, weakness |
1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a...
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1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home
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| 44 | 2021-01-11 | pain in extremity |
Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm follow...
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Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm followed by numbness and tingling (pins and needles), a few minutes later I experienced a dull headache. The arm sensation slowly subsided by the time my fifteen minutes was up. The dull headache lasted through the night Around 9 pm, I experienced chills, that lasted for 2 days with body aches and sore right and left arm. During the night, I had a hard time sleeping experiencing nightmares. Woke up at 2 am took a walk felt a little better. Chills continued throughout the night. Friday- chills continued with body aches and a general feeling of malaise. Temp was 98.7 at highest, bp 122/79, hr 80, and blood sugar 149, I have no hx of diabetes. Saturday- "hungover feeling" - headache that came in waves with a general feeling of malaise. Sunday- Pounding headache, extreme fatigue-slept until 1500 woke up and then went back to bed, body aches-worst I have felt in years. Monday shaky feeling somewhat better still malaise. Tuesday vomited all my breakfast, feeling of phlegm or something stuck in my throat. BP 120/77 hr 64 temp 98.4. Continued body aches.
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| 44 | 2021-01-11 | pain in extremity |
slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positi...
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slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positive COVID-19 test after first dose of vaccine; Fever; cold like symptoms; stuffy head; horrible headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient) from a Pfizer-sponsored program, Pfizer First Connect. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 16Dec2020 as a single dose (reported as 0.3 mL) (at the age of 44-years-old) for COVID-19 immunization. Medical history included ongoing hypothyroidism, one thyroid gland removed due to a nodule on an unspecified date (years ago), ongoing acid reflux, ongoing hypercholesteremia, ongoing fluid retention, and ongoing history of headaches. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism and for one thyroid gland removed due to a nodule from an unspecified date and ongoing, dexlansoprazole (DEXILANT) taken for acid reflux from an unspecified date and ongoing, atorvastatin (LIPITOR) taken for hypercholesterolemia from an unspecified date to an unspecified date, and hydrochlorothiazide (MANUFACTURER UNKNOWN) taken for fluid retention from an unspecified date and ongoing. Additional concomitant medications included unspecified vitamins. The patient had a positive COVID-19 test after first dose of vaccine on 01Jan2021; cold like symptoms, stuffy head, horrible headache, cough, and fever on 31Dec2020; slight chest congestion on 02Jan2021; and slight sore arm on an unspecified date. The events, stuffy head and horrible headache, were reported as medically significant. The events, cough, fever, and slight chest congestion, were reported as non-serious. The clinical course was reported as follows: It was reported that the patient was vaccinated on 16Dec2020, became symptomatic on 31Dec2020, and tested positive for COVID-19 on 01Jan2021. The patient stated that she became symptomatic one day prior to testing positive for COVID-19, on 31Dec2020. She initially had cold-like symptoms with a stuffy head, cough and a horrible headache; the worst headache she had ever had. These symptoms occurred earlier in the day on the 31Dec2020. Then later that night about 10:00 PM, she had a fever with a body temperature of 102 degrees Fahrenheit. Her body temperature had been normal at 98 degrees all day that day until that night. She also had slight chest congestion and then was fever free for over 48 hours. The patient stated that she had a history of headaches and can tolerate a headache. The headache started 31Dec2020 and was significant. It was reported that after the vaccine, she had no other symptoms other than a slight sore arm, which lasted a day; maybe 24 hours after she received the vaccine. The patient stated that she does not think any of the other symptoms, other than the sore arm, have anything to do with the vaccine. The clinical outcome of positive COVID-19 test after first dose of vaccine and slight sore arm was unknown; cold like symptoms, horrible headache, and cough was recovering; fever was recovered on 02Jan2021; and stuffy head and slight chest congestion was not recovered. The reporter assessed the causality assessment between the events, positive COVID-19 test after first dose of vaccine, cold symptoms, stuffy head, cough, horrible headache, fever, and slight chest congestion, as unrelated. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-11 | pain in extremity | body aches nausea, very sore arm 1 day after i2nd injection |
| 44 | 2021-01-11 | tingling, numbness |
I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was i...
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I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was in my arm and up into my chest and back. I felt like I was going to pass out. The numbness and tingling still hasn't gone away and my heart still races.
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| 44 | 2021-01-11 | tingling |
Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured fo...
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Patient reported tongue swelling that lasted for 3 minutes and then finger tingling which occured for 3 minutes.
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| 44 | 2021-01-12 | feeling hot, flushing |
10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was swea...
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10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was sweating and short of breath. My peripheral vision was cloudy. This lasted approx ten minutes.
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| 44 | 2021-01-12 | numbness, inability to speak |
numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word findi...
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numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word finding issues that progressively worsened, LLE weakness. ct brain neg. MRI/MRA head and neck neg. labs neg. MRI of c spine t spine l spine s spine neg. emg and eeg neg. discharged from hospital. symptoms fluctuating. slowly improving.
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| 44 | 2021-01-12 | migraine |
About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't...
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About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't feel right." No SOB. C/o 7/10 migraine headache. Nausea but no vomiting. Frontal lobe pain. Dizzy. Felt like she was drunk. BP 136/29, HR 79. Became slower to respond to questions and a rapid response was called. Transported to ED for observation where patient received acetaminophen 975mg po x 1 and metoclopramide 10mg po x 1. Patient declined NS 1L bolus. Per ED note, patient presented with likely vasovagal episode after receiving COVID-19 vaccination. Patient's symptoms improved and patient was discharged home.
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| 44 | 2021-01-12 | pain in extremity |
Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symp...
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Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symptoms. Still have left arm soreness on day 2 after injection . Body aches are better on the day 2 but not resolved yet, so his fatigue.
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| 44 | 2021-01-12 | tingling, numbness |
The day after my vaccine(1/8/21), I noticed pins and needles/tingling sensations in my left foot and...
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The day after my vaccine(1/8/21), I noticed pins and needles/tingling sensations in my left foot and left hand. I have never had this happen before. IT lasted for about 15 minutes that night. The day after that(1/9/21), it happened again in the evening and lasted about 10-15 minutes. The morning after that(1/10/21), I had the pins and needles/tingling and a bit of numbness in my left hand that lasted for a few hours. That evening(1/10/21), I had the sensations again in my left hand, as well as noticing a prickling/itching sensation on both of my shoulders. That lasted for about 30 minutes. That was the last time I experienced it and have not experienced it again in the last 2 days.
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| 44 | 2021-01-13 | weakness, flushing |
12 HOURS AFTER INJECTION, SEVERE JOINT PAIN, FLUSHING, LOW GRADE FEVER AND WEAKNESS. LASTED UNTIL 24...
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12 HOURS AFTER INJECTION, SEVERE JOINT PAIN, FLUSHING, LOW GRADE FEVER AND WEAKNESS. LASTED UNTIL 24 HOURS AFTER THE VACCINATION AND THEN JUST TIREDNESS AND SLIGHT MYALGIAS FOR FURTHER 12 HOURS.
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| 44 | 2021-01-13 | weakness |
THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,J...
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THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,SWELLING ON INJECTION SITE,NAUSEA,INFLAMATION OF NODES.
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| 44 | 2021-01-13 | cold sweat, difficulty speaking, flushing |
Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness imme...
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Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness immediately after getting her first dose of the Pfizer COVID-19 vaccine at 1030 this morning. 26 minutes later the symptoms are followed by cold sweats. She feels much better now, does not now, did not have shortness of breath, nausea, vomiting, wheezing, change in voice, difficulty swallowing. Patient reports the symptoms are similar to but much milder than the symptoms she gets during rituximab infusion for her myasthenia gravis. Patient notes that she took Zyrtec and acetaminophen at 9:00 as premedication. Prior to this patient had been well, no fevers, nausea, vomiting, diarrhea, chest pain, shortness of breath, cough, sore throat, urinary problems, or other problems. Patient did not receive any additional therapy in the ED. She was observed for 2 hours in the ED and was subsequently discharged home.
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| 44 | 2021-01-13 | cold sweat |
"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild ...
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"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild soreness to back of tongue. sent for obs. took zyrtec, tylenol prior to getting vaccine. eupneic, a/ox4, skin w/d. no distress" Blood pressur 160/91
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| 44 | 2021-01-13 | feeling hot, pain in extremity |
5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpita...
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5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough
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| 44 | 2021-01-13 | flushing |
With second COVID vaccine, patient experienced flushing, dizziness, lightheadedness, and diaphoresis...
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With second COVID vaccine, patient experienced flushing, dizziness, lightheadedness, and diaphoresis. Patient was given water/juice and was discharged in stable condition home.
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| 44 | 2021-01-13 | night sweats |
Approximately 28 hours post injection I developed profuse sweating that lasted all night (approximat...
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Approximately 28 hours post injection I developed profuse sweating that lasted all night (approximately 8 hours). I do not normally sweat in my sleep. I did not check my temperature. I had a brief moment of chills lasting <5 minutes at 10pm. I did not feel like I was febrile. I did not take any medication for any side effects.
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| 44 | 2021-01-13 | pain in extremity |
Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular ...
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Left arm soreness 24 hours post injection (minimal) that improved within 48 hours. Supraclavicular lymph node (left side- mildly tender), left sided neck pain, and left forearm tenderness that began almost 72 hours post vaccine. No fever. No other symptoms
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| 44 | 2021-01-14 | weakness, facial paralysis, numbness, tingling |
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c...
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Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-14 | weakness, flushing |
0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives...
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0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives to left side of neck 1005 another 50 mg of Benadryl PO taken and Tylenol 650 mg PO for chills and headache 1200 famotidine PO taken for burning to stomach 1400 diarrhea and weakness. Hives had subsided 1800 another round of Benadryl and Tylenol and famotidine. Saturday at 0200 woke up abruptly itching all over. Took more Benadryl. Saturday all day medicated every six hours with Tylenol, Benadryl and Pepcid. Diarrhea continued with abdominal cramps. Sunday continued same treatment for same symptoms. Hydration was aggressive and added Bentyl. Monday, Tuesday and Wednesday symptoms continued except for the itchiness. Continued Tylenol. Diarrhea persists as well as body aches, weakness and headaches. Friday, it is now a week and I still have diarrhea and chills and weakness.
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| 44 | 2021-01-14 | pain in extremity |
feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm...
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feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect. No further information was provided or obtained.
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| 44 | 2021-01-14 | pain in extremity |
Right arm pain; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnan...
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Right arm pain; This is a spontaneous report from a contactable physician. A 44-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Eh9899), via an unspecified route of administration in the left arm on19Dec2020 10:30 at a single dose for covid-19 immunization. The patient has no relevant medical history. Patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 19 December 2020, the patient experienced right arm pain. No treatment was given for the event. The outcome of the event was recovered. The vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Information on Lot/Batch has been requested.
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| 44 | 2021-01-15 | weakness |
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a hea...
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2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
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| 44 | 2021-01-15 | numbness, tingling |
Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe i...
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Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11
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| 44 | 2021-01-15 | pain in extremity | Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: missed work 1/8/2021 |
| 44 | 2021-01-16 | pain in extremity, numbness |
Severe muscle aches in both legs Left arm hurt to move Numbness in left arm to fingertips and both f...
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Severe muscle aches in both legs Left arm hurt to move Numbness in left arm to fingertips and both feet once muscle pain went away in extremities.
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| 44 | 2021-01-17 | numbness, tingling |
My face started to go numb and feel tingly. My ears also felt plugged, as if I were changing elevat...
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My face started to go numb and feel tingly. My ears also felt plugged, as if I were changing elevations. The effects lasted for a little over an hour.
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| 44 | 2021-01-17 | numbness |
30 minutes after I was given the vaccine I felt my left temple become warm and then numb. 40 minute...
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30 minutes after I was given the vaccine I felt my left temple become warm and then numb. 40 minutes after receiving the vaccine my left cheekbone and left jaw felt numb, like I had a Novocain shot from the dentist.
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| 44 | 2021-01-17 | migraine | Migraine started 2 days after first dose, came back worse 3 days after dose |
| 44 | 2021-01-17 | pain in extremity | Axilla on right side is swollen with enlarged lymph nodes, redness, warm to touch, and painful. |
| 44 | 2021-01-17 | tingling |
Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis ...
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Injection given at 10:39 AM. HR increased in 30 minutes, later to 120. At 11:40, she noted pruritis on arms and rash erupted - fine; erythema, warmth, HR 8, R 18, Pulse ox 97%, lungs clear. At 11:45, she noted tingling of the tongue, but no enlargement. Benadryl 25mg given PO at this time. At 12:00, she noted fingers tingling. At 12:20: HR 98, pulseox 97%. At 12:25: Rash, pruritis on right leg just below knees and behind the left knee.
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| 44 | 2021-01-18 | numbness, pain in extremity |
Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fev...
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Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing. Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-18 | muscle spasms | headache, fever, muscle pain, spasms. called in sick to work. |
| 44 | 2021-01-18 | tremor |
tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report f...
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tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Eh9899, expiry date: unknown, vaccine location: left arm, dose number: 1), via an unspecified route of administration on 21Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included dermatomyositis (not receiving any treatment). The patient had no known allergies. The patient's concomitant medications were not reported. Shortly after vaccination on 24Dec2020, the patient developed tachycardia which continues to persist. Also, on 24Dec2020, the patient developed intermittent violent shaking. Treatment was received for the adverse events. EKG and lab work were done. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The events did not result in death, were not life-threatening, did not cause or prolong hospitalization, were not disabling or incapacitating, and did not result to a congenital anomaly or birth defect. Outcome of the events was not recovered.
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| 44 | 2021-01-19 | migraine | migraine, fever, sweat, body aches, vomiting |
| 44 | 2021-01-19 | pain in extremity | Headache, pain in left arm, fever, chills, body aches, nauseous, fatigue |
| 44 | 2021-01-19 | seizure | Systemic: Anaphylaxis, Systemic: Seizure-Severe |
| 44 | 2021-01-20 | numbness |
facial numbness that started on her cheek, nose, and neck; This is a spontaneous report from a conta...
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facial numbness that started on her cheek, nose, and neck; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (pending clarification) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that within 10 minutes of administration, the patient experienced facial numbness that started on her cheek, nose, and neck. Three weeks later, she still has the numbness. The patient has reported improvement, but it has not been totally resolved. The patient described it as receiving a shot of Novocaine from the dentist but does not describe the sensation of paralysis or bell's palsy. The reporter asked whether or not the patient should receive the second dose of the vaccine after experiencing this side effect. Her 3-week mark was on Friday, in which she has missed her second dose (pending clarification). The patient received an unspecified treatment for the event. The outcome of event was recovering. Information on the lot/batch number has been requested.
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| 44 | 2021-01-20 | tremor |
body pain; rapid onset of fever (within 30 min 101.7); skin sensitivity; cough; itchy throat; violen...
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body pain; rapid onset of fever (within 30 min 101.7); skin sensitivity; cough; itchy throat; violent episodes of shaking and chills for 36 hours; violent episodes of shaking and chills for 36 hours; increased urination/diuresis; This is a spontaneous report received from a contactable nurse (who is also the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in left arm, on 09Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. The patient medical history was not reported. The patient is not pregnant. The patient had no other medications in two weeks. The patient did not have COVID-19 prior to vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in right arm, on 22Dec2020 12:00, at single dose, for COVID-19 immunization. The patient experienced body pain, rapid onset of fever (within 30 min. 101.7, as reported), skin sensitivity, cough, itchy throat, violent episodes of shaking and chills for 36 hours and increased urination/diuresis all on 09Jan2021 at 22:15. No treatment was received for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events body pain, rapid onset of fever (within 30 min 101.7), skin sensitivity, cough, itchy throat and increased urination/diuresis was recovered on unspecified dates; and the outcome of violent episodes of shaking and chills for 36 hours was recovered on 11Jan2021 at 08:15. Information on the lot/batch number has been requested.
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| 44 | 2021-01-21 | weakness |
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines...
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COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
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| 44 | 2021-01-21 | discomfort, pain in extremity |
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye...
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Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
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| 44 | 2021-01-21 | flushing |
Started with flushing. Recieved 25mg Bendaryl po, which did not seem to help. progressed to nausea, ...
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Started with flushing. Recieved 25mg Bendaryl po, which did not seem to help. progressed to nausea, some SOB, received epi, then started to break out. Prepare to take to BMC. Another dose of epi was given prior to transport. BP 176/106 HR 84 P 22
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| 44 | 2021-01-21 | grand mal seizure | Two grand mal seizures and went unconscious. Prior to seizures felt very lethargic. |
| 44 | 2021-01-21 | numbness, tingling |
Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "c...
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Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "code called" -- pt. given epi, oxygen, transferred to ED.
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| 44 | 2021-01-21 | pain in extremity |
I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my...
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I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my left arm all the way to the finger was swollen. I had pain in the wrist arm, joints and fingers. I determined it was due to the swelling. I had some lymph node enlargement, and was really fatigue and slept most of the day. (36 hours). I did not have a fever. I'm a doctor and did some evaluations on myself. I didn't have trouble breathing of swallowing. If I wasn't medically trained I would have gone into the doctor. I did see an ENT for hearing test to make sure there was no damage and there was not.
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| 44 | 2021-01-21 | seizure | I believe that I had a seizure lasting about 30 seconds or so |
| 44 | 2021-01-22 | flushing | Racing heart, dizzy, flushed face, headache |
| 44 | 2021-01-22 | pain in extremity | arm soreness then on 1/22 fever of 100.7 and headache. |
| 44 | 2021-01-23 | feeling cold | Fever, chills, muscle aches, fatigue, headache |
| 44 | 2021-01-24 | weakness |
Decreased range of motion and pain same day as administration. Pain resolves after 1 week. 3 weeks p...
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Decreased range of motion and pain same day as administration. Pain resolves after 1 week. 3 weeks post administration, range of motion is still decreased and weakness in that arm. Patient referred to specialized medicine.
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| 44 | 2021-01-24 | discomfort |
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur...
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Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
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| 44 | 2021-01-24 | slurring | Lower extremity weakness, dysarthria, presyncope |
| 44 | 2021-01-24 | flushing |
Patient stated "throat feels funny" and felt generalized flushing. Treated with benadryl 25 mg PO a...
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Patient stated "throat feels funny" and felt generalized flushing. Treated with benadryl 25 mg PO and observed 30 minutes with improvement of symptoms.
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| 44 | 2021-01-24 | night sweats |
Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold w...
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Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold with chills/ Was shivering; Fever; Sweating all night; This is a spontaneous report from a contactable nurse. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 31Dec2020 10:02 at a SINGLE DOSE for covid-19 immunisation. Medical history included tuberculosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BCG vaccine. The patient received Pfizer COVID Vaccine on 31Dec2020. On 04Jan2021, the patient got a couple of symptoms and started with a mild headache, not sharp pain and she took Tylenol. After she showered when she came home from work, she got chills. She took a couple more Tylenol, but doesn't know when. When she went to bed, she sweated all night and still feel cold with chills and was sweating all night. She didn't really check temperature, but knew she had a fever. On 05Jan2021, she woke up and felt like someone had hit her from her head to toes and every joint was aching, terrible body aches and couldn't walk. She went to emergency room on 05Jan2021 and thought she may have been exposed a couple of days before. She was working with patients who had COVID. She had a rapid COVID test that was negative and came home and symptoms continued. Today was the first day she was feeling a little better. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of mild, headache, cold with chills, cold with chills/ was shivering, fever, sweating all night , couldn't walk, terrible body aches, every joint was aching. The outcome of the events was unknown. Information was requested on Lot/ Batch number.
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| 44 | 2021-01-24 | pain in extremity |
very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; ...
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very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; This is a spontaneous report from a contactable nurse, reporting for herself. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the left arm on 17Dec2020 at single dose for COVID-19 vaccination. Vaccination was done in a hospital. Medical history included celiac disease from 2011 and ongoing (very well controlled, she eats gluten-free. This is an autoimmune disease, but she is not immunocompromised like they ask with the Pfizer COVID-19 Vaccine. She is typically very healthy) and irritable bowel syndrome from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that following the first dose, she just experienced arm pain and general fatigue, just the basics. Arm pain and general fatigue with first dose she described as she did not really have a negative effect from; just the basics what everyone was saying. She did not feel anything when the first dose was injected; she did not have any issues until about 3 hours later that day on 17Dec2020 when she had onset of arm pain and general fatigue where she just felt tired for a few days; nothing big; she was able to work after the first dose; she just took ibuprofen for the first 2 days and the arm pain went away. She also mentioned that before getting the second dose of the vaccine she had a very low grade fever; it was 99.5 degrees Fahrenheit but she felt fine. Her stomach she was kind of having a little issue with loose stools for a few days before the second dose of the vaccine. She had celiac disease and a history of irritable bowel syndrome; and her uncle died on 02Jan2021 so she blamed the symptoms going on stress due to that. She does not know if maybe she was getting a GI cold at that time, the symptoms were a little mild before getting the second dose of the vaccine, she never felt sick or anything like that. She told the doctor about these symptoms during her appointment on 06Jan2021. Seriousness criteria of very low grade fever and a little issue with loose stools unknown. The patient underwent lab tests and procedures which included body temperature: 99.5 degrees fahrenheit on an unspecified date and COVID-19 test: negative on 06Jan2021. The outcome of the events was unknown. The reporter assessed the events arm pain and general fatigue as related to BNT162B2.
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| 44 | 2021-01-24 | tingling |
After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later pa...
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After patient received vaccine she C/O tingling face was given Benadryl @1341 , 15 minutes later patient was C/O tight throat, Solumedrol 60mg IM administered to Rt buttocks by this nurse. Pt then escorted to ER for further evaluation. On 1/25/21 at 1359: Patient reported tingling of lips and throat felt tight. SPO2 via finger with a result of 99%. Emergency room provider's note: 44-year-old female patient presents ED after allergic reaction. Patient received her first COVID-19 vaccination and during the 15-minute observation period began to feel as if she had some tightness in her throat and difficulty swallowing. She has a scratchy sensation to her posterior pharynx. She denies specifically shortness of breath, nausea vomiting, dizziness or near syncope. She was medicated with 50 mg of Benadryl p.o. as well as 60 mg of Solu-Medrol IM prior to arrival. She states she has never previously had allergic reactions to vaccinations in the past
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| 44 | 2021-01-24 | tremor, pain in extremity |
1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue...
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1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue. 1am that night, awoke with chills, fever (102), generalized muscle aches. By midday Thursday, these symptoms began to dissipate slightly and she developed a h/a. Friday, fever, chills, h/a were gone & nausea and abdominal pain started. No vomiting or diarrhea occurred. By SAturday evening, nausea improved but upper legs became tremulous and weak. Weak, tremulous legs have continued and persist up until today (monday, 1/25).
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| 44 | 2021-01-25 | weakness |
I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; ...
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I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; feeling nausea; my legs were weak; my throat got tight; This is a spontaneous report from a contactable HCP. This 44-year-old female (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm at single dose for COVID-19 immunization on 08Jan2021 05:30 PM. Relevant medical history included osteoporosis and menopause. Known allergies included: soy, dairy, all nuts, sunflower, cottonwood, lentils, chickpeas, Vit E, cephalexin, Amoxicillin, sulfa, Bactrim, lisinopril , estrogen, moxifloxacin, Pseudoephedrine, paroxetine, trimethoprim, doxycycline, azithromycin, cipro, clindamycin, colestipol. The patient was not pregnant. Relevant concomitant drug included Vit D, calcium, ibuprofen. Five minutes after receiving the vaccine, her throat got tight then she started to feel lightheaded and her legs were weak. She notified the staff there who offered her Benadryl but she declined. She began feeling nausea about an hour later and she felt lightheaded and weak for about 4 hours. She started running a mild fever the next day and she still had a fever on 12Jan2021. The patient did not receive other vaccine in four weeks. The outcome of events was recovering. No treatment was received. The patient was not COVID infected prior vaccination. The patient did not have COVID tested post vaccination.
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| 44 | 2021-01-25 | weakness |
7pm-Dizziness, weakness, tiredness, chills. 1/26-530am - Chills, body aches, slight fever -101.0, he...
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7pm-Dizziness, weakness, tiredness, chills. 1/26-530am - Chills, body aches, slight fever -101.0, headaches, dizziness,
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| 44 | 2021-01-25 | cold sweat |
Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizzines...
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Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.
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| 44 | 2021-01-25 | cold sweat |
Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision....
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Approximately 20 minutes after receiving vaccination, patient reported dizziness and blurred vision. Patient almost fell while walking and was sat down. Patient was clammy and diaphoretic and blood pressure was elevated from her normal but O2 was normal. No swelling but patient reported drainage in her throat, a thick mucus like feeling. Ambulance was called and patient was taken away on stretcher, was not able to stand to get on stretcher.
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| 44 | 2021-01-25 | tingling |
Tingling sensation all over the body. Pins and needle sensation all over the body. Parestheshia of a...
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Tingling sensation all over the body. Pins and needle sensation all over the body. Parestheshia of all extremities . Abdominal pain, chills/rigors
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| 44 | 2021-01-25 | tingling |
Patient presented with possible allergic reaction described as feeling "tingles everywhere" and "wei...
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Patient presented with possible allergic reaction described as feeling "tingles everywhere" and "weird taste" in mouth. The symptoms began about 15 minutes ago after receiving the Pfizer COVID vaccine dose #1 Patient was treated with Benadryl, Solu-medrol and NS 1L bolus. Symptoms improved. Normal lung sounds. No signs of further reaction
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| 44 | 2021-01-26 | feeling hot, flushing |
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing...
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Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
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| 44 | 2021-01-26 | feeling hot, flushing |
Observed for 30 minutes. Flushing, arm heaviness reported, nausea, heat in thighs. Reports similar ...
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Observed for 30 minutes. Flushing, arm heaviness reported, nausea, heat in thighs. Reports similar reaction with first dose. Requested to rest on a stretcher. BP 140/71, HR 93. Nausea and arm heaviness reported at 1605. BP 150/81, 10015sats; HR 87. At 1610 Heat in thighs. BP 125/66, HR 82 100% sats on oxygen. 1628: No further symptoms. Released home.
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| 44 | 2021-01-26 | flushing |
Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat...
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Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after. Received Antihistamines, Albuterol treatment and steroid for treatment.
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| 44 | 2021-01-26 | numbness, feeling cold |
feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body n...
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feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body numbness/body started to feel numb; This is a spontaneous report from a contactable nurse reported for herself. A 44-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left deltoid on 13Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient historic vaccine included the first dose of BNT162B2 on 22Dec2020 for covid-19 immunization. The patient body started to feel numb on 13Jan2021, she was feeling cold/coldness on 14Jan2021, increased temperature on 14Jan2021 and she took her temperature and it was 100.2, stated that she knew that a fever is a side effect. She was only concerned with the body numbness and wanted to know if body numbness was anything to be concerned about. The reporter assessed events was related to Pfizer Covid vaccine and as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible temporal association, the Company considers the reported events of hypoesthesia, pyrexia and feeling cold are possibly related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-26 | pain in extremity |
Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial...
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Diarrhea, nauseated, headache, fever, arm pain, body aches, chills, joint pain, skin burning, facial redness, left chest wall swelling and tenderness. Seen Dr today
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| 44 | 2021-01-27 | inability to speak, numbness |
on the evening of 1/11/21 pt started to talk to her children and she "could not access the words." T...
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on the evening of 1/11/21 pt started to talk to her children and she "could not access the words." Then she tried to text and couldn't figure out the vocabulary. She went to the ER where she was transported to hospital, under stroke protocol. She also c/o right hand numbness at the er. She was admitted and test run. No evidence of a stroke.
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| 44 | 2021-01-27 | inability to speak, pain in extremity | body aches, sore arm, stomach ache, lost her voice. Symptoms lasted for 2 days. |
| 44 | 2021-01-27 | flushing, pain in extremity |
40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to ...
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40 sec after injection to left arm, flushed sensation to left side neck then to left ear, then to forehead, to right ear and to right side neck, followed by sudden throat dryness. BP 165/122, HR 120, Pts normal BP 90-100 systolic 80's diastolic, Hr usually 80's. about 1 hr later mild headache, left arm soreness. 2nd day after sensation of palpitations, day 3 sensation of palpitations, HR 108 on one measurement.
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| 44 | 2021-01-27 | muscle spasms |
her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; T...
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her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
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| 44 | 2021-01-27 | pain in extremity, feeling hot |
I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This i...
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I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure and diabetic. Concomitant medications included lisinopril for high blood pressure, metformin for diabetes, and amlodipine. Today (11Jan2021), the patient just got hot and her hands started hurting. She was just feeling kind of boozy. She really had a bad headache. The patient was thinking why the lady didn't ask her if she was taking any medication or anything, she just asked if the patient was allergic to anything. The patient was not allergic to anything but she was taking medications. The patient asked if she should go and take her medication for tonight or hold until her symptoms go away. No treatment was received for the adverse events. The patient just lied down and have been sleeping for two hours. Outcome of the events was unknown.
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| 44 | 2021-01-27 | pain in extremity |
Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Sy...
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Starting the day after the vaccine she had body aches, sore arm, stomach ache and lost her voice. Symptoms lasted 2 days.
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| 44 | 2021-01-27 | pain in extremity | Sore arm for a couple days |
| 44 | 2021-01-27 | tingling, numbness and pain in extremities | Arm neuropathy and tingling, warmth in the injection site |
| 44 | 2021-01-28 | weakness |
Had the common side effects: headaches, fevers up to 101.5, severe body aches, fatigue in the the mo...
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Had the common side effects: headaches, fevers up to 101.5, severe body aches, fatigue in the the morning after the shot, but also had concurrent severe vomiting and nausea. Vomited approximately 20 times day after the vaccine, starting about 18 hours after the vaccine. Other symptoms were present about 13-14 hours after the vaccine. Vomited continued for 14 hours. Severe nausea continued for 2-2.5 days. No diarrhea. No abdominal pain. Too weak to drive to the ER. Had Zofran at home and took 8 mg of Zofran ODT every 4-6 hours for 36 hours beginning with the onset of vomiting. Missed 3 days of work but was able to orally rehydrate.
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| 44 | 2021-01-28 | numbness |
Some numbness in left portion of face, namely forehead down to jaw along hairline. Lasted close to t...
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Some numbness in left portion of face, namely forehead down to jaw along hairline. Lasted close to three hours, and has not happened since.No treatment.
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| 44 | 2021-01-28 | pain in extremity, tenderness |
The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hou...
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The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hours of injection, could not touch my arm. The pain radiates from the shoulder to finger tips with sharp shooting, stabbing pains at times. A lot of pressure. There is a burning feeling from my shoulder to finger tips. By the end of day on 01/18/2021, I had decreased range of motion in my arm, it is difficult and very painful to try and extend my arm out to the side, which continues to today 01/29/2021.. My entire arm is still tender and sore, tricep, bicep, and shoulder. It is difficult to sleep and work due to the pain.
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| 44 | 2021-01-28 | pain in extremity |
This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient r...
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This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received first dose of bnt162b2 ( COVID-19 VACCINE; lot EK9231, expiration date unspecified), via an unspecified route of administration on 08Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included mild sleep apnea. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. On 09Jan2021, the patient experienced injection site pain and arm soreness on day 1 and day 2, patient was also very tired on day 1. Patient also had occasional sneezing and mild headache since day 1. On day 2, energy level was back to normal. However, on 11Jan2021, on day 3, the patient started to develop occasional shortness of breath and continued today, day 7. The shortness of breath comes and goes. On 14Jan2021, on day 6, the patient experienced occasional coughing and continued today, day 7. Since the patient was working in a pharmacy, she cannot rule out if symptoms were from vaccine or Covid exposure, so patient decided to get Covid test done today, day 7. The patient had no treatment received for the events. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Patient had no Covid prior vaccination and was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with pending results on 14Jan2021. Outcome of events was not recovered.
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| 44 | 2021-01-28 | tingling |
Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled ...
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Right after the shot I had itching, tingling, and red spots all down my arm, then my throat swelled a bit and I became sweaty. Nurse checked my blood pressure and it was very high for me (144/83) usually 117/78. Nurse administered one Benadryl tablet and I felt better within about 15 minutes. Now I just feel very tired.
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| 44 | 2021-01-29 | feeling cold |
At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid o...
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At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid on couch. Fell asleep, per family hallucinated. About 1 to 2 hours later I could not smell.
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| 44 | 2021-01-31 | numbness |
10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN ca...
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10am Pt c/o SOB, tightness in chest, left arm numbness, dizziness. BP 127/84 P-108 PO 100%. RN came to assist. 10:04am Benadryl 25 mg liquid given PO BP121/73 P 104 PO 97%. Left arm injection site asymptomatic. Pt states this is her 2nd Covid vaccine and did not react to the first one. Pt states she had anaphylactic reactions to PCN, ASA, Sulfa, Keflex and Codeine in the past. C/O blurred vision. 10:10am BP 132/81 p 112 PO 98% with same symptoms. RN present and we discussed going to ER, vs stable and patient declined going. 10:15am BP 133/82 P-114 PO 96%, pt states her breathing is better, thinks the Benadryl caused the dizziness, continued blurred/fuzzy vision, not double vision, A & O x3. 10:20am BP 127/83 P-108 PO98% denies SOB and chest tightness, states she feels better. Crackers, juice and water given. 10:25am BP 123/83 P 105 PO 98% pt states blurred vision has gone. 10:30am BP 129/70 P 105 PO 97% continue to feel better. Talking to her co-worker about getting a ride back to work with her after she receives her vaccine. 10:55am BP 120/72 P 105 Sat 99% went to restroom with another nurse and states she feels fine standing. 11am BP 126/75 P98 PO 98% denies arm numbness, blurred vision and SOB/chest tightness. Report off to 11am Volunteer RN for the monitor room.
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| 44 | 2021-01-31 | numbness |
diminished sensation on the lateral aspect of left leg from knee below and whole left foot/felt numb...
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diminished sensation on the lateral aspect of left leg from knee below and whole left foot/felt numbness on left leg; This is a spontaneous report from a contactable Other healthcare professional (patient). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 14Jan2021 10:30 at single dose in Left arm for COVID-19 immunization. Medical history included hypertension, covid prior to vaccination. Concomitant drug included unspecified products which the patient received in two weeks. There were no other vaccines received in four weeks. The patient previously took cefalexin monohydrate (KEFLEX) and experienced allergies. The patient did not have COVID tested post vaccination. Approximately 10 hours after the patient got the vaccine on 14Jan2021 21:00, she felt numbness on her left leg. It got worse this afternoon so she left work to go to urgent care. She had diminished sensation on the lateral aspect of her left leg from knee below and her whole left foot on 14Jan2021 21:00. The reported adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of events 'diminished sensation on the lateral aspect of left leg from knee below and whole left foot', 'felt numbness on left leg'. The patient underwent lab tests which included blood works with unknown result on an unspecified date. The outcome of the event was recovering.
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| 44 | 2021-01-31 | pain in extremity | Headache, Fevers , Body aches, Nausea, Arm Pain |
| 44 | 2021-01-31 | tremor |
Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling...
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Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling continued until Thursday (4 days later). Feeling ?off? or unwell without any other symptoms -3 hours after injection and lasted until 5:00pm next day when symptoms increased. Starting 5:45pm Lethargy, shaking all over, feeling of ?freezing ?, upset stomach, fever of 101- continued into the evening. Fever resolved with Advil and rest. Shaking and upset stomach stopped sometime overnight. Feeling very tired next day.
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| 44 | 2021-02-01 | feeling hot, facial paralysis |
right after the vaccine my whole arm got hot and traveled to the top half of body. I felt hot right...
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right after the vaccine my whole arm got hot and traveled to the top half of body. I felt hot right away , during the day I felt my left eye a bit droppy and pain to the injection site by the end of that day I had chills, next day chills , nauseated, tired, slight cough and still felt my left eye droppy , next day slight sorethroat and by the next day I was good.
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| 44 | 2021-02-01 | migraine |
Migraine that was so sever just moving my head would make me cry or cause me to throw up. Extreme n...
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Migraine that was so sever just moving my head would make me cry or cause me to throw up. Extreme nausea and chills Lasted for one day
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| 44 | 2021-02-01 | pain in extremity |
Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough...
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Report right arm pain, cough and chest tightness. Treatment: None. Outcome: Arm pain resolved, cough and chest tightness continues.
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| 44 | 2021-02-01 | tremor |
chills with shaking; chills with shaking; joint pain; muscle pain; fatigue; swelling at injection si...
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chills with shaking; chills with shaking; joint pain; muscle pain; fatigue; swelling at injection site; pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EA9899, via an unspecified route of administration on Arm Left from 19Jan2021 08:15 to 19Jan2021 08:15 as single dose for COVID-19 immunisation. The patient took first dose of the BNT162B2 vaccine on an unspecified date. Medical history included asthma, penicillin (PCN) allergy, environmental allergies, and major depression. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), and lamotrigine (LAMICTAL). On 19Jan2021 20:00, the patient experienced chills with shaking, joint pain, muscle pain, fatigue, swelling at injection site, and pain at injection site. The outcome of the events was recovering. Prior to vaccination and since the vaccination, was the patient was not diagnosed with COVID-19. No treatment was received for the events.
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| 44 | 2021-02-02 | migraine |
Migraine with nausea, sensitivity to light and sound for 10 days that is only minimally lessened wit...
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Migraine with nausea, sensitivity to light and sound for 10 days that is only minimally lessened with 12-16 Motrin daily. Had injection of Toradol and started imitrex this morning after going to my doctor, but still no change.
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| 44 | 2021-02-02 | migraine |
Migraine (two days), vomitting (one day), headache (three days), chills (one day), body aches (three...
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Migraine (two days), vomitting (one day), headache (three days), chills (one day), body aches (three days), and fatigue (three days).
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| 44 | 2021-02-02 | tingling |
Pt received Pfizer dose #1 and was stable/asymptomatic after 15min monitoring period. she reports on...
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Pt received Pfizer dose #1 and was stable/asymptomatic after 15min monitoring period. she reports on the way to her car she began to feel tingling on the left side of her neck that radiated to the jaw/cheek/lower eye on the left. VSS on check x2. Case discussed with doctor and Pt deemed stable to DC home
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| 44 | 2021-02-03 | feeling of body temperature change |
Light headache & injection area soreness at 2pm 10pm started to notice some aches. Midnight (14 ho...
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Light headache & injection area soreness at 2pm 10pm started to notice some aches. Midnight (14 hours post injection) awakened by intense headache, severe body aches, sweating, hot and cold. Extreme fatigue. In bed & slept all day. 8:30pm still have headache, fatigue & light body aches.
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| 44 | 2021-02-03 | numbness |
numbness on her temple, which moved down to her left cheek on her ear area. She also said that the s...
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numbness on her temple, which moved down to her left cheek on her ear area. She also said that the side of her face feels numb; This is a spontaneous report from a contactable consumer reporting for self. This 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249) on 18Jan2021 09:00 at single dose (Anatomical location: upper left arm) for COVID-19 immunisation. Medical history included penicillin allergic when she was a teenager, and allergic to cephlasporins. Ongoing concomitant medications included omeprazole, vitamin d nos (VITAMIN D) and birth control pills. No additional vaccines administered on same date of the BNT162B2. No prior vaccinations within 4 weeks. Patient said she had a reaction to the 1st dose of the vaccine. She said that she felt fine in first 15 minutes after the vaccine, about 30 minutes later, she experienced numbness on her temple, which moved down to her left cheek on her ear area. She also said that the side of her face felt numb, facial numbness on left side of her face but no paralysis. She stated she was able to move her face. The event onset time reported as 09:40 on 18Jan2021. Stated it felt like she went to the dentist and got a numbing shot like it was starting to wear off. Patient wanted to know if that is a typical reaction, and if it is related to Bell's palsy. Treatment was received for the event, patient just took Turmeri 1 table. No hospitalization involved, the event did not require a visit to emergency room or physician office. The outcome of event was recovering.
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| 44 | 2021-02-03 | pain in extremity |
Arm mildly sore evening after vax but no other symptoms. Following morning, started have mild muscle...
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Arm mildly sore evening after vax but no other symptoms. Following morning, started have mild muscle aches and fever. Tylenol kept fever down to around 100.5. By the evening, I had 103.2 temp even while taken tylenol and was advised by on-call RN to alternate tylenol and motrin for 3 hours until it decreased. Fever came down after 2-3 hours to 102.3. Fever down to 101.5 by next morning. Had mild headache, dizzyness and fever for next several days.
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| 44 | 2021-02-04 | weakness |
1/30 08:00 Severe chills, weakness, fever. Slept for approx. 10 hrs. Symptoms began to ease in the e...
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1/30 08:00 Severe chills, weakness, fever. Slept for approx. 10 hrs. Symptoms began to ease in the evening with full recovery to baseline 1/31. 2/1 05:00 Upon waking, I noticed I could feel cold sores beginning on my lips. I occasionally experience A SINGLE cold sore after extreme exposure to elements, but not usually after illness. This morning I could feel MANY cold sore forming on my lips (top and bottom) as well as insides of my cheeks and gums. I can count at least 15 different sores that all came on simultaneously. Treating sores as usual with frankincense and balm to reduce cracking and bleeding. Sores taking usual clinical course, not healed yet.
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| 44 | 2021-02-04 | feeling hot |
Immediate itching at site which spread to generalized body; Immediate itching at site which spread t...
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Immediate itching at site which spread to generalized body; Immediate itching at site which spread to generalized body; Red rash and warmth to entire upper arm; Red rash and warmth to entire upper arm; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284), via an unspecified route of administration on 02Jan2021 07:00 AM at single dose on left arm for COVID-19 immunization. COVID-19 vaccine was administered in the hospital. Patient is not pregnant. Medical history included hypothyroid. No other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included thyroid (ARMOUR THYROID), prednisone, famotidine (PEPCID) and fexofenadine hydrochloride (ALLEGRA). The patient previously took influenza vaccine, azithromycin and monistat, and experienced allergies to all. Patient was not diagnosed with COVID-19 prior vaccination. The patient experienced immediate itching at site which spread to generalized body. Patient also experienced red rash and warmth to entire upper arm. All events occurred on 02Jan2021 07:15 AM. No treatment was given for the events. Events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
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| 44 | 2021-02-04 | muscle spasms |
Nausea immediately after injection, joint and muscle pain, sharp back spasms shortly , site soreness...
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Nausea immediately after injection, joint and muscle pain, sharp back spasms shortly , site soreness, mild headache
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| 44 | 2021-02-04 | pain in extremity, weakness |
was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Jo...
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was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Joint pain; Muscle pain; she was severely sick for 11 days; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 0930 at a single dose on the right arm for COVID-19 immunization. Medical history included ongoing cholesterol problems from 2019 (manages without medication) and colitis. Concomitant medications were not reported. The patient previously took doxycycline from Aug2020 to 30Dec2020 for colitis. The patient experienced muscle pain, joint pain, sore arm and swollen arm on 31Dec2020. She experienced weakness, tired, chills on 01Jan2021, and was always in the bed not wanting to do anything on an unspecified date. The patient stated she was severely sick for 11 days and stated her covid and flu test came back negative. She said she could not work and was off work due to the side effects. She had to go to urgent care also. She wanted to know about taking the second dose. She was scheduled to get her second dose on 22Jan2021. She was sick with the first dose. She was weak, tired, had chills and was always in bed not wanting to do anything. She asked if these events will come back with the second dose and if it is possible to not get the second dose. She also reported that her arm was sore. She had joint and muscle pain. She tried to fight it. The weakness and chills continued off and on. She returned to work on 12Jan2021. She went to the urgent care and has also went to see her physician. She had lab work done. She also had a rapid Covid and flu test, both of which were negative. Outcome of weakness and chills was recovering; outcome of sore arm and swollen arm was recovered on 04Jan2021; outcome of joint pain and muscle pain was recovered on 12Jan2021; outcome of tired was not recovered; outcome of "she was severely sick for 11 days" was recovered on an unspecified date; outcome of "always in bed not wanting to do anything" was unknown. Information about batch/lot number has been requested.
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| 44 | 2021-02-04 | pain in extremity |
Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left should...
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Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left shoulder, arm pit and under rib cage. Itching and could not sleep. Can touch, turn or sleep on her left side.
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| 44 | 2021-02-04 | pain in extremity |
It began with right arm soreness and progressed to aches and low grade fever within the first 24 hou...
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It began with right arm soreness and progressed to aches and low grade fever within the first 24 hours. Then it moved on to mid-sternal chest pain that radiated to my back and I had shortness of breath that increased with deep breathing after about 48 hours.
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| 44 | 2021-02-04 | tingling |
2 weeks after vaccination, increasing tingling in right arm radiating to back and sometimes to lower...
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2 weeks after vaccination, increasing tingling in right arm radiating to back and sometimes to lower extremity. Intermittent dizziness. Symptoms are persistent, worsening and not relieved.
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| 44 | 2021-02-04 | unresponsive to stimuli |
15 min after vaccine administered patient stated she had a frontal headache radiating to her right s...
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15 min after vaccine administered patient stated she had a frontal headache radiating to her right side of head and tinglinig around her lips. She was instructed to stay for an additional 15 min for observation. She was placed on a stretcher to lie down. She was conversing and her S/S went unchanged. At approx 1 pm she became unresponsive, she did not wake with touch or verbal command Her eyelids were fluttering as if she was experiencing a seizure. A condition was called. Pulse ox 100 % blood sugar 90. Monitor NSR. She remained unresponsive and was taken to the ED. Upon arrival to the ED at approx 1:17 pm, the ED nurse stated she was awake. Evaluated by physician, labs and CT head ordered. Patient stated all lab work and CT scan was normal. Employee was discharged with a diagnosis of vasovagal near syncope.
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| 44 | 2021-02-05 | pain in extremity, numbness |
At 7pm, i experienced chills, shivering, head fuzziness, muscle aches and right arm pain. At 9pm, ex...
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At 7pm, i experienced chills, shivering, head fuzziness, muscle aches and right arm pain. At 9pm, experienced fever, headache and numbness in my finger tips. Took ibuprofen 600mg. Did not see any improvement for an hour. Went to bed at 12:30. Awoke at 3am with same symptoms. Took ibuprofen 600mg at 6am. Symptoms came back 1:30pm that day. Took another ibuprofen 600mg. The rest of the evening was good except for a headache.
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| 44 | 2021-02-05 | tingling |
Patient stated feeling lightheaded and tingling sensation on left leg after receiving second dose of...
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Patient stated feeling lightheaded and tingling sensation on left leg after receiving second dose of Pfizer Covid vaccine. Client was sitting on waiting area post vaccine for 15 minutes. EMT responded and alerted lead RN. Vitals taken at 1310: blood pressure 116/82, pulse 72, oxygen 99. Alert and oriented, stated symptoms began after vaccine. No prior history of tingling sensation in extremities. Stated tingling on left leg, mobility intact, no radiation or pain past leg. Allergies to amoxicillin and no current medications. Client given water and instructed to drink small sips. Per client no breakfast this morning and had two cups of coffee. Client denied chest pain, shortness of breath, palpitations, vision changes, headache. RN client asked to stay under observation longer and that EMT would recheck vitals prior to her leaving. EMT reassessed at 1325. Per client feeling better, was returning to work after leaving facility. Instructed to get food and rest. Last set of vitals: blood pressure 120/80, pulse 62, oxygen 99. Client left facility with a steady gait.
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| 44 | 2021-02-06 | numbness, tingling |
1408 Numbness and tingling of bilateral cheeks and swelling of fingers. Denies SOB, dysphagia,cough,...
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1408 Numbness and tingling of bilateral cheeks and swelling of fingers. Denies SOB, dysphagia,cough,diziness,syncope,Vital 120/82,82,96%. Given Benadryl 50mg po. 1419 Reports symptoms calming down less sensation of swelling and calming down. 1433 spoke with husband and notified of situation. 1515 Patient exited in stable condition. Agreed and understands of what to do if symptoms worsen or continue.
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| 44 | 2021-02-06 | tingling, numbness |
About a half hour after receiving my second vaccine shot I began to feel tingling and numbness on th...
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About a half hour after receiving my second vaccine shot I began to feel tingling and numbness on the right side of my face. The sensation was located under my cheekbone and expanded to my jaw. It gradually spread to my chin and lips. It lasted for approximately four hours. When I woke up the next morning it was gone. The day after the vaccine I had more common side effects.
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| 44 | 2021-02-07 | weakness, flushing |
Feeling ichy/unwell within 2-3 minutes post vaccination. Feeling dizzy and weak, flushed skin, overw...
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Feeling ichy/unwell within 2-3 minutes post vaccination. Feeling dizzy and weak, flushed skin, overwhelming fatigue, out of it. Administered lactated ringer and famotidine Potential vasovagal response. Felt improved within 2.5 hours 48 hours later began abdominal pain (7/10) and diarrhea lasting 36 hours, with diminishing severity of pain and volume of diarrhea; mild nausea without vomiting. Treatment includes Allegra every 12 hours and Naproxen Sodium.
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| 44 | 2021-02-07 | tingling |
Client reports tingling in arms, face, hands down to feet and felt lightheaded and dizzy. Client rep...
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Client reports tingling in arms, face, hands down to feet and felt lightheaded and dizzy. Client reports lasting about an hour, increased then plateaued and then decreased with taking Benadryl. Similar circumstances with first vaccination lasting approximately 1.5 hours. Increased heart rate and increase blood pressure during both circumstances.
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| 44 | 2021-02-07 | tremor, numbness |
Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, w...
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Friday 7:30 nausea- took zofran sublingual. 7:30-3pm headache , runny rose, body ache, shakiness, watery eyes. 3-6pm felt recovering. Friday 9pm-Sunday 4pm abd pain got added to the mix with bloating and abd distension. Friday?s symptoms lessen. Took meds and alkaline products to balanced things out. Ate bread crackers constantly to help with acid buildup and damage of mucosal lining. Protonix 40mdg only alleviate pain for 30 minutes. Could not sleep for over 24 hrs. Pale white stool. Axillary lymph nodes pain. Monday and pain better. Felt lethargy and numbness to hand and feet. Mild Headache still persist.
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| 44 | 2021-02-08 | breast pain |
Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle...
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Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle aches (whole body) Debilitating headache Pain and swelling at injection site (right arm) Painful joints *Safe dose range of OTC Tylenol ineffective Ongoing effects (onset approximately 24 hours after first vaccine): Painful lump right breast/armpit
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| 44 | 2021-02-08 | flushing |
Moderate to severe myalgias, arthralgias, & headache (HA) started 1/21/21 ~16hrs after 2nd vaccine d...
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Moderate to severe myalgias, arthralgias, & headache (HA) started 1/21/21 ~16hrs after 2nd vaccine dose. (Had mild-mod HA after 1st dose 12/30/20 which resolved after ~10days, with persistent neck/facial flushing & chills that decreased in frequency). Myalgias & arthralgias resolved ~4 - 5 days later, flushing/chills & HA continued, though severity lessened. Attempted return to work Wed 1/27 but severe HA w nausea began while driving. HA continued but decreased to mild ~1/31, and returned to work Wed 2/3 (reg sched is Wed-Fri, 3 x 12.5hrs). Mid morning Thurs 2/4 at work severe HA & nausea returned, had to leave work. Mod-sev HA continues 2/9/21, 20days after vaccine #2, and not cleared to return to work.
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| 44 | 2021-02-08 | numbness, electric shock sensation, weakness, tingling |
Started with headaches on 4th day out from vaccine. By that Sunday I was lethargic, had pains throug...
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Started with headaches on 4th day out from vaccine. By that Sunday I was lethargic, had pains throughout my body, zaps of pain, inflammed joints, anxiety, Stomach/acid reflux, Pains/aches in body - short temporary pains, Electrical like pulses of pain in head left front side mainly, also in right hand, felt weak - no energy, Legs felt a bit numb or tingly, hips and lower back feel tender, knees too
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| 44 | 2021-02-09 | feeling hot, pain in extremity |
warm sensation; anxiety; sore arm; This is a spontaneous report from a contactable consumer, reporti...
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warm sensation; anxiety; sore arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration at the right arm on 23Jan2021 17:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. On 23Jan2021 17:30, the patient experienced warm sensation, anxiety and sore arm. No treatment was received. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. Information on the batch/lot number has been requested.
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| 44 | 2021-02-09 | flushing |
fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. b...
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fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. bp 129/93 heart rate 115. Headache with flush face and arms and legs super heavy feeling on Sunday. Tuesday night experienced facial and head swelling, started in the middle of my forehead gradually filling up my entire head and face. Wednesday my whole face/eyes and head swollen, with tightness on my chest. My primary care provider prescribed methylprednisolone tablets USP Dosepak 4mg. I did take Benadryl and tylenol Tuesday. I also applied ice packs to my head and face. Headache still comes and goes with brain fog. Slight swelling remains on my forehead and eyes.
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| 44 | 2021-02-09 | pain in extremity, breast pain |
chills; headache; feeling sore in her arm; tiredness; she was also breastfeeding; she was also breas...
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chills; headache; feeling sore in her arm; tiredness; she was also breastfeeding; she was also breastfeeding; itching/itching was worse on her chest and back/allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; was breastfeeding; it was full of milk that also hurts very bad; allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; on her back as well; allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; on her back as well; feeling unwell; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on 21Jan2021 (lot number and expiry date unknown) at single dose for Covid-19 immunization. The patient stated "just to protect myself". Medical history included blood pressure high, lost weight because she was breastfeeding now (ongoing). Concomitant medication included labetalol from unspecified date for blood pressure high, and blood pressure medicine. Historical vaccine included first dose of BNT162B2 on 31Dec2020 for Covid-19 immunization and experienced allergy. The patient informed that she already reported to a pharmacist. The female patient received the second dose of the COVID vaccine on Thursday (21Jan2021). The patient informed that she was fine the same day she received the vaccine and had some itching (21Jan2021), but the next day (22Jan2021) she had a headache and was feeling sore in her arm. The patient experienced a little bit sore in her arm, bad sore on her arm; after she had the first one maybe after a day, but it was not that bad. The patient informed that she received the covid vaccine on Thursday (21Jan2021) and has been feeling unwell ever since (Jan2021). The first day it was okay, she meant a little bit sore in her arm, her sore arm. On Friday (22Jan2021), she started like having tiredness, headache, and sore like bad sore on her arm. Then now she has seen, she said it was okay then she knew because there was a side effect so she tried to take rest and drink water. What happened was, now (Jan2021) on her body it looked like some kind of allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area and she was a breastfeeding mom and on her back as well. The patient informed that after 3rd day (Jan2021) it got like especially on her breast area and her chest area got like itchy. Today (24Jan2021), the headache came back, and she was experiencing chills and her itching was worse on her chest and back. The patient informed that she was also breastfeeding. The patient wanted to know what she was supposed to do. The patient informed that she has headache, the headache was back today, now when she woke up, she has headache. The patient was asking for guidance if she was breastfeeding and has received the second dose of the COVID vaccine. The patient informed that she was to feed her son, because she didn't feed him yesterday, so it was full of milk that also hurts very bad. The patient was scared, because it was itchy area on her breast, so she was scared to breastfeed her son. The patient informed that it was like back and forth, but now this morning (Jan2021) the patient has headache, yesterday (Jan2021) she was okay. The patient informed that about her treatment, she didn't take even a painkiller; she just only took her blood pressure medicine. The outcome of the event headache was not recovered, while itching/itching was worse on her chest and back/allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area, feeling sore in her arm, feeling unwell, tiredness, allergy like a reddish thing, an itching thing was on her body, on her chest area, her breast area; on her back as well, chills, was breastfeeding; it was full of milk that also hurts very bad was unknown. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092765 baby case
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| 44 | 2021-02-09 | pain in extremity |
I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for abou...
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I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for about 24-36 hours. I was very tired for about 7 days all I did was sleep.
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| 44 | 2021-02-09 | tingling |
Systemic: Other- approx. 48 hrs. post 2nd vax on 2/1/21, patient exp in L (dominant) arm generalized...
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Systemic: Other- approx. 48 hrs. post 2nd vax on 2/1/21, patient exp in L (dominant) arm generalized hypothesia in L wrist & parathesia L hand & fingers. Moved to R hand on 2/4/21 less pronounced. Lasted 2 days
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| 44 | 2021-02-10 | bell's palsy |
Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't k...
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Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't keep mouth closed shut tight to swish after brushing teeth same night. Headache above right eye, right ear pain and right side neck pain all starting 2/6/21 morning. Had televisit on 2/8/21 who advised me to be further checked out. At the er they did an head ct without contrast which was normal did a neuro exam and determined I had bell's palsey. Prescribed prednisone 20 mg tid x 7 days and valacyclovir 1 gm tid x 7 days. They also advised to tape my eye shut when sleeping. My eye hurts when I drive or focus on pc or tv so I had to miss 2 days of work thus far.
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| 44 | 2021-02-10 | feeling hot, facial paralysis |
On 2/3, 2 hours after vaccine, I experienced extreme heat to my face. (The feeling I get when I?m g...
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On 2/3, 2 hours after vaccine, I experienced extreme heat to my face. (The feeling I get when I?m going into anaphylaxis) but anaphylaxis never came. It dissipated after a couple of minutes, but red face and ears all day. On the 7th, I started noticing partial paralysis on the right hand side of my face. It is still there. I have not been around anyone outside of my home since March 2019 nor have those who live with me. The only exception has been when I got my two vaccine doses.
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| 44 | 2021-02-10 | migraine, tremor |
Symptoms came on suddenly around 3:00 am on 02/09/2021 with migraine headache, shaking chills, extre...
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Symptoms came on suddenly around 3:00 am on 02/09/2021 with migraine headache, shaking chills, extreme body aches, fever as high as 102, nausea, abdominal cramps, and exhaustion lasting about 48 hrs. Then lesser symptoms and a lower temp another 12 hrs., with a normal temperature by 7:00 pm on 02/11/2021. Also, I'm not sure if this is related at all but thought it was worth mentioning, while washing my hair on 02/11/2021,a lot more hair than usual came out.
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| 44 | 2021-02-10 | pain in extremity | headache, sore arm, and swollen node(s) in the armpit of the same arm |
| 44 | 2021-02-10 | tingling |
Tingle to face started about 4 hours after dose, was ongoing a few hours then off and in for 1-2 day...
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Tingle to face started about 4 hours after dose, was ongoing a few hours then off and in for 1-2 days. Extremely tired with brain fog started evening of second shot and has been ongoing. Just starting to improve after 4 weeks.
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| 44 | 2021-02-14 | flushing, tingling |
Pt began to feel "hot, warm, and tingling through her mid section chest / stomach area, skin and che...
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Pt began to feel "hot, warm, and tingling through her mid section chest / stomach area, skin and chest and arms red and flushed. VS @1222 BP 176/80, HR 86, O2 99%. @ 1232, feels better, Vitals recheck @ 1238 BP 140/78, HR 92, O2 99%.
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| 44 | 2021-02-14 | pain in extremity |
Splitting headache, sinus pressure, 102.3 degree fever, body aches, chills, sore throat, runny nose,...
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Splitting headache, sinus pressure, 102.3 degree fever, body aches, chills, sore throat, runny nose, sore arm, fatigue. Took Advil at 7:00 PM on 2/14/21 because I couldn?t tolerate the pain anymore. It is 11:30 AM on 2/15/21 and still fatigued, aches, chills, and headache.
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| 44 | 2021-02-14 | pain in extremity |
Sore right underarm and right side of neck. Swollen lymph nodes right underarm, upper chest on righ...
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Sore right underarm and right side of neck. Swollen lymph nodes right underarm, upper chest on right side and right side of neck in front.
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| 44 | 2021-02-14 | pain in extremity |
Pain started slowly after shot and within a couple of hours the pain was in the entire arm, I could ...
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Pain started slowly after shot and within a couple of hours the pain was in the entire arm, I could not lift my arm up. I also felt very tired and sleepy. I took some acetaminophen twice (650mg) and was much better within 24h. The next day, the pain in the arm went away pretty quickly and I wasn't feeling so tired anymore.
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| 44 | 2021-02-15 | pain in extremity | NIGHT OF VACCINATION, DEVELOPED ARM PAIN, CHILLS, BODY ACHES, AND HEADACHE LASTING 24 HOURS. |
| 44 | 2021-02-16 | muscle twitching |
within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hou...
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within 15 minutes of Pfizer vaccine had itchy arms and facial twitching. She was observed for an hour and was told to take benadryl as needed after leaving. Noticed facial rash later that night. The next day patient was itchy in both arms and has some facial swelling, does not have any trouble breathing. was taking benadryl every 4 hours, seen by allergist next day for telemedicine visit and was advised to switch to cetirizine, max 2 tab bid.
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| 44 | 2021-02-17 | breast pain |
my left breast started draining clear/white fluid; there is associated pain radiating down towards t...
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my left breast started draining clear/white fluid; there is associated pain radiating down towards the nipple from the top of the breast and along the left side of the breast; This is a spontaneous report from a contactable nurse who reported for herself This 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# EL3247 in the left arm on 19Jan2021 at SINGLE DOSE for covid-19 immunization . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic.Age at vaccination 44 years.The patient received the first dose of the same vaccine from Lot # EL1284 on 29Dec2020 via intramuscular , on the Left arm .Tthe patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypothyroidism , gestational diabetes ,Allergies: Bees (anaphylaxis) , Allergy: shrimp (gastrointestinal) .Concomitant medication included levothyroxine , alprazolam , procaterol hydrochloride (PRO-AIR), chlorphenamine maleate (CHLOR) and vitamin d . The patient reported as follows :"On 22Jan2021 18:00 my left breast started draining clear/white fluid. Additionally there was associated pain radiating down towards the nipple from the top of the breast and along the left side of the breast that has lasted two weeks and continues".Lab data included mammogram (2021): unknown results .ultrasound left breast (2021): unknown results.The adverse event result in Doctor or other healthcare professional office/clinic visit.Events were treated (I have had to have a mammogram and ultrasound of left breast and am awaiting an MRI.Levaquin ).Events reported as non serious.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.Outcome of the events was not recovered.
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| 44 | 2021-02-17 | numbness | Arm burning, swelling of throat, facial numbness, dizziness, hives |
| 44 | 2021-02-18 | flushing, tingling |
Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine, ...
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Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine, developed palpitations, chest pressure, feeling flushed and anxious, nausea, tingling on left side of body and face, elevated blood pressure, and slight dizziness while driving home. Was seen at ER a few hours later; cardiac workup was done with CXR, bloodwork, EKG and heart monitoring and was treated with Benadryl IV. Was sent home for 2 days out of work and instructed to take Benadryl as needed.
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| 44 | 2021-02-18 | tingling | s/p injection c/o tingling left side of neck, jaw, and below eye. Resolved with no intervention |
| 44 | 2021-02-21 | face paralysis, inability to speak, facial paralysis |
I started feeling really tired (couldn't move type tired). I called off worked for few days. On the ...
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I started feeling really tired (couldn't move type tired). I called off worked for few days. On the 1/7 noticed right of my face was drooping about 10 days couldn't smile and wiggle both ears.For me to talk it was very difficult due to right side of my face being so weak. I went to walk in clinic was diagnosed with Bell's Palsy. As of today I still couldn't lift my eyebrow (right) and smile still slightly cooked.
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| 44 | 2021-02-21 | numbness |
About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that...
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About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.
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| 44 | 2021-02-21 | migraine, weakness |
Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migrai...
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Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain
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| 44 | 2021-02-21 | pain in extremity |
Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm...
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Day 1 - pain in arm where shot was administered. Day 2 - 4 - pain down arm concentrated in left arm-pit, area surrounding arm-pit and left wrist and top of hand.
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| 44 | 2021-02-21 | tenderness, pain in extremity |
Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed...
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Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size larger than a golf ball. Pain radiates down my inner arm to my forearm.
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| 44 | 2021-02-22 | weakness |
Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; Th...
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Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 44 | 2021-02-22 | pain in extremity |
I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facilit...
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I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facility for 15 minutes and did not have any issues at that time. My arm was a bit sore and I felt tired for a couple days following the 2nd vaccine. On 12 Feb early afternoon (around 1100am), I noticed I was dizzy and feeling a bit nauseated like I had motion sickness. I already had the following week off work, so I napped when I could. I have been tired as well. I have been experiencing waves of dizziness daily now since 12 Feb (today marks the 12th day). I spoke with my PCM's team at the Spokane VAMC and they recommended I try to take Meclizine at night to see if I improve. I was advised to have someone drive me to urgent care if my condition worsens where I lose consciousness, faint, or cannot stand up straight.
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| 44 | 2021-02-23 | feeling cold, tingling, numbness |
Patient complained of numbness/tingling of hands & feet, pale face and feeling cold with heart racin...
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Patient complained of numbness/tingling of hands & feet, pale face and feeling cold with heart racing.
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| 44 | 2021-02-23 | flushing |
Patient reported metallic taste in mouth feeling flushing in throat and chest. HR 113, 96% o2 RA was...
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Patient reported metallic taste in mouth feeling flushing in throat and chest. HR 113, 96% o2 RA was checked by paramedics and cleared refused treatment.
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| 44 | 2021-02-23 | numbness |
Per vaccine clinic recovery RN notes: "Patient was sent to ER (in front of vaccine clinic) for evalu...
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Per vaccine clinic recovery RN notes: "Patient was sent to ER (in front of vaccine clinic) for evaluation with c/o numbness of the right side of the face. States sudden onset and increasingly numb, and worse than after the first covid vaccination. States last time, numbness subsided within 1 hour and no further symptoms. Patient tolerated walking across parking lot to the ED, registration without problems."
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| 44 | 2021-02-23 | pain in extremity, feeling hot |
Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fati...
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Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fatigue, headache. My neck and underarm are still achy and enlarged. My body is still sore and I have not been able to continue with my daily activities. I have not felt like this since I had mono as a 19 year old. I have 5 children and have gone through natural childbirth 3 times. I?ve received all my vaccinations faithfully and have never in my life reacted this way. I am not getting the second dose until I have blood work done to see how my high my antibody levels are. I respect and am grateful for your work However I need to see data on my body?s reaction to even consider getting another dose.
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| 44 | 2021-02-23 | pain in extremity |
2/22 body aches, fever, rigors, fatigue 2/23 R axillary lymphadenopathy, pain in axilla, shoulder an...
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2/22 body aches, fever, rigors, fatigue 2/23 R axillary lymphadenopathy, pain in axilla, shoulder and arm, fever, fatigue, myalgias 2/24 low grade fever, otherwise same as 2/23
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| 44 | 2021-02-24 | weakness | Chills, Muscular pain, Fever, Headache, Weakness. |
| 44 | 2021-02-24 | numbness, tingling | Initial symptoms numbeness and tingleness in mouth anf face; hour after vaccine both hands dark blue |
| 44 | 2021-02-25 | migraine | Development of herpes zoster in T1 dermatome, migraine headache |
| 44 | 2021-02-25 | pain in extremity, feeling hot, tingling |
About an hour after the injection, it felt like someone was injecting the right side of my brain wit...
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About an hour after the injection, it felt like someone was injecting the right side of my brain with warm saline. Then I had a dull headache in that same area fir three days. Also, 18 hours after receiving the second dose, I experienced what felt like hot, electric bugs crawling throughout my hands and feet. My feet also felt very weak, like they couldn?t hold my body weight. This lasted for about 24 hours, and then resolved. I still occasionally experience the pins and needles sensation in my feet on and off. I also experienced the more common side effects, such as headache, extreme fatigue, muscle aches, and sore arm.
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| 44 | 2021-02-25 | pain in extremity |
Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contac...
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Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contactable 44-year-old female consumer (patient). A 44-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 14Jan2021 at 10:00 AM (at the age of 44 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included allergy to codeine, was diagnosed with COVID-19 prior to vaccination and had BNT162B2 vaccine dose 1 on unknown date, lot unknown. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications was not provided. The patient did not receive any other vaccines within 4 weeks or any medications within 2 weeks prior to the COVID vaccine. On 16Jan2021, at 08:00 AM, the patient experienced sore arm, sore neck and swollen lymph node under my left arm. No treatment was received for the events sore arm, sore neck and swollen lymph node under my left arm. The outcome of the events sore arm, sore neck and swollen lymph node under my left arm was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 44 | 2021-02-26 | feeling hot |
The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, ther...
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The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, there were halos on the lights, itchy eyes, itchy throat, and her body felt warmer. She had an increased blo0od pressure of 150/100mmHg.
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| 44 | 2021-02-26 | flushing, tremor | Palpitations, flushing, dizziness, shaky, chills, evaluated by EMS-cleared |
| 44 | 2021-02-27 | numbness, hot flush |
Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes ...
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Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes 10 minutes after injection Chest pain and tightness 15 minutes after injection Brain fog delayed movement thyroid meds left my system 20 minutes after injection
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| 44 | 2021-02-27 | pain in extremity |
Arm soreness - ensuing 36 hours Fatigue - ensuing 36 hours Vertigo (mild) - onset 4 days after the v...
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Arm soreness - ensuing 36 hours Fatigue - ensuing 36 hours Vertigo (mild) - onset 4 days after the vaccine, ongoing for 5 days
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| 44 | 2021-02-28 | cold sweat |
Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the...
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Severe body aches started at 4:00am, could not get comfortable. Only thing that helped aches was the bath tub. Didn?t take temperature until 9:00am 100.9. Husband gave me Advil & Tylenol. Stomach ache/nausea came next, didn?t feel like eating. Very painful back ache shortly after that. Temperature kept fluctuating all day (due to Tylenol use). The next day (today 3-1-2021), I felt better, so I went to work. I noticed all day I getting the cold sweats. I was clammy most of the day, but didn?t feel tired. Took temperature after someone noticed I looked pale at work. My temp was 99.7. At around 4:30 I noticed my left armpit was hurting. Went home at 5:30 and relaxed. I told my husband my armpit was hurting around 10:30pm, I decided to Take my temp at 11:15pm and it was 97.6. I will see if the adverse side affects go away after today.
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| 44 | 2021-02-28 | discomfort |
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin...
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Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
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| 44 | 2021-02-28 | feeling hot |
Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with ton...
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Sat 5pm eyeballs began to hurt. The entire eyeball was painfully sore. At night I woke up with tongue that felt thick or swollen. Then the next am woke up with aches, headache, chills, hot (suspected fever but did not get up and check) tiredness. Spit up yellow fluid (thought it might be from GERD) and laided around all day. Did not eat as stomach felt nauseated. At 3 pm I ate half a sandwich and at 4 ate half a banana and drank some water and 1/4 of cup of sweet tea. By 6pm I was really sick to my stomach got up and threw up sandwich and banana. I thought I saw some blood but was not sure. I continued to throw up and it became all blood (bright red) mixed with water. This occured twice and then I called doctors office and the dr on call advised me to go to ER since urgent cares were closed. I went to ER about 8:30pm with continued headache, nausea, lightheadedness. I tried to tell ER dr that I was there mainly for throwing up blood. I sat in waiting room. ER dr saw me at 3am and gave me Zofran for nausea as i thought I was going to be sick and gave me EKG, Blood panel and Blood Pressure readings. Told me I was mildly dehydrated. My BP was higher than I think I have ever seen it.
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| 44 | 2021-02-28 | muscle twitching |
01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching a...
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01.20.21-01.27.21: headache and fatigue daily 01.22.21: dizziness and right sided facial twitching along the mandibular branch of the facial nerve. This lasted ~ 4 hours 01.26.21: fever 99.2, nausea & dry heaving, left sided ear and throat pain, coughing, body aches, fatigue. These symptoms lasted ~ 12 hours
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| 44 | 2021-02-28 | tingling |
1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hour...
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1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hours. 30 minutes after receiving the vaccine I felt confused and in a fog. That lasted 2 days. The following morning I also had flu like symptoms. Those lasted 24 hours.
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| 44 | 2021-02-28 | tingling |
One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell....
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One minute after receiving the vaccine my face and tongue began to tingle. Then they began to swell. The swelling lasted for 4 hours. 16 hours after the vaccine I had a fever of 101 degrees Fahrenheit, chills, muscle aches, a headache, and I was vomiting. This lasted for 36 hours.
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| 44 | 2021-03-02 | burning sensation, weakness |
Within minutes, Xavier felt burning sensation but did not report it while she was in the observation...
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Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.
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| 44 | 2021-03-02 | numbness, one side paralysis |
Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double v...
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Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
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| 44 | 2021-03-02 | tingling, feeling hot |
Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP...
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Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
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| 44 | 2021-03-02 | seizure, tremor |
Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. ...
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Symptoms were: general allergic reaction with hives followed by a seizure and spontaneous recovery. Pt relates Seizure was consistent with her normal seizures but slightly worse. She had a seizure 1 week ago and has seizures in clusters, this was consistent with the waning period of the current cluster. Vital signs were (abnormal with tachycardia and hypertension on arrival to the ED). Exam was notable for neck pain. Patient was treated with Benadryl on scene and with Toradol and fluids in the ED and symptoms recovered but multiple shaking episodes characterized by patient as seizure. Patient was observed in the emergency department for an extended period.
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| 44 | 2021-03-04 | flushing |
Patient received the Covid-19 vaccine. She reports symptoms of flushing, swollen feeling in throat w...
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Patient received the Covid-19 vaccine. She reports symptoms of flushing, swollen feeling in throat with some difficulty swallowing. No difficulty breathing, no wheezing, etc. Symptoms quickly lessened in intensity with first set of vitals. Injection was given at 1443. I have observed patient from immunization given through 1605. Treatment/intervention 1500: BP 138/90 Pulse 94 SPO2 98% Respirations 20 Diphenhydramine 25 mg given - patient requests to receive. 1502: BP 128/90 Pulse 100 SPO2 96% 1506: BP 126/88 Pulse 96 SPO2 99% Respirations 16 Patient tolerated 8 oz water, swallowing Without difficulty, still feels strange feeling in throat but much improved. 1510: Patient states she is feeling "much better" and has called spouse for ride home. 1525: 2nd dose of Benadryl 25 mg given. Patient is feeling much better, throat swelling sensation decreased, face is pink, not flushed, swallowing well and tolerated second 8 oz water. Instructed to contact physician regarding reaction today. Instructed to call 911 if any symptoms recur, difficulties breathing, etc. 1605: Escorted to husbands car, states feels "good."
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| 44 | 2021-03-04 | numbness, tingling |
Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower l...
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Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
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| 44 | 2021-03-04 | migraine |
fever, muscles, joint, bone pains (severe), Vomiting x 1 day, with continuous gagging and vomiting d...
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fever, muscles, joint, bone pains (severe), Vomiting x 1 day, with continuous gagging and vomiting daily since then, migraine
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| 44 | 2021-03-04 | pain in extremity, involuntary muscle movements, numbness |
After two hours sore arm ... left side of face slightly numb proceeded by a sharp pain down leg foll...
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After two hours sore arm ... left side of face slightly numb proceeded by a sharp pain down leg following by an unnatural involuntary movement of toes for about 2 minutes sharp pain then stiffness and inability to move . Numbness followed by a release and weakness .
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| 44 | 2021-03-05 | tingling |
Pt @ 14 weeks pregnant, hx of seasme allergy (food ingestion) mild, no anaphylaxis now got first cov...
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Pt @ 14 weeks pregnant, hx of seasme allergy (food ingestion) mild, no anaphylaxis now got first covid vaccination and had mild hand tingling, no CP, no SOB or throat swelling
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| 44 | 2021-03-06 | feeling hot, weakness | Nausea, Weakness, Overheated, Lightheaded, Body Aches, Fever, Rash, Dizziness |
| 44 | 2021-03-06 | flushing, tingling |
nausea/ Dizziness with in 10 minutes of vaccine. Flushing and Tingling in face and upper extremities...
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nausea/ Dizziness with in 10 minutes of vaccine. Flushing and Tingling in face and upper extremities. Patient had Covid in November. She went home to rest after the vaccination.
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| 44 | 2021-03-07 | weakness |
After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I...
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After 10 minutes of my first dose vaccine, I began to experience chest pain and could not breathe. I felt nauseated. My BP went up to 150 and staff was monitoring me, my normal BP is 90/110. After two hours I started to feel dizzy, nauseated and i was in the ER room for four hours. I felt like passing out, my BP was 169/69 and my heart rate was also high. Then I started to feel cold and began to shivering while an EKG was performed. My BP never went down. After one week and for four days I had fever and weakness to my body also from my knees down felt weakness. Also one week after my vaccine, my lymph nodes got swollen, left ear. I communicated these symptoms to my PCP of my reactions.
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| 44 | 2021-03-07 | hot flush |
generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Si...
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generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Site pain persisted; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265 and expiry date: unknown), via an unspecified route of administration on the right arm, 04Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included HTN and Asthma. Patient was not pregnant at the time of administration. Concomitant medication included Olmesartan, bupropion hydrochloride (WELLBUTRIN), loratadine and vitamins. The patient previously took sulfur and morphine and experienced allergies. Events began with insomnia the night of injection on 04Feb2021 23:00. The following morning of 05Feb2021, patient woke with generalized aches and pains, fatigue, head fog, and hot & cold flashes. She had nausea and vomiting midday. Symptoms resolved by second day on 05Feb2021 but site pain persisted on Feb2021. TYLENOL and ibuprofen were given as treatments for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination.
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| 44 | 2021-03-07 | pain in extremity |
Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender...
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Extremely sore arm for 3 days Nauseous for 4 days Lymph nodes under left arm swollen and very tender for 5 days
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| 44 | 2021-03-08 | feeling hot |
Hives, took Benadryl they went away. Fever, chills then really hot, super achy. This happened on Sat...
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Hives, took Benadryl they went away. Fever, chills then really hot, super achy. This happened on Saturdat around 515 then Sunday super achy, very tired, couldnt function or move. Monday still very achy still had fever. Tuesday felt better
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| 44 | 2021-03-08 | flushing |
Felt an immediate flush on face, face reddened across cheeks and nose. Later, after work, noted rash...
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Felt an immediate flush on face, face reddened across cheeks and nose. Later, after work, noted rash on arms, back was dark with lighter rash on stomach and chest
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| 44 | 2021-03-09 | weakness, feeling hot, flushing |
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea...
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Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
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| 44 | 2021-03-09 | numbness | Tingling in throat, numbness of ankle and toes |
| 44 | 2021-03-09 | migraine |
Moderate headache for two days following, then a full blown migraine in the early evening on second ...
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Moderate headache for two days following, then a full blown migraine in the early evening on second day after vaccination. Sore arm muscle at vaccination site for a day and half.
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| 44 | 2021-03-09 | pain in extremity | persistent left arm pain. exam consistent with lateral epicondylitis |
| 44 | 2021-03-09 | tingling |
Pt. stated she started feeling tingling in her fingers 5 min. after getting vaccinated. The tinglin...
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Pt. stated she started feeling tingling in her fingers 5 min. after getting vaccinated. The tingling on her fingers went away but she started feeling tingling in her knees. Vital signs were taken. O2 sat 100%, BP 134/63, HR 86. Patient stated she was nervous when vaccinated, but the tingling was new. At 3:53 pm patient stated the tingling is going away on its own. At 4:01 pm she stated she was feeling ok and is ready to go home.
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| 44 | 2021-03-10 | weakness, tremor |
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ...
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Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
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| 44 | 2021-03-11 | breast pain |
Developed significant lymphadenopathy L axilla, L clavicle area, L breast with L breast swelling (3 ...
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Developed significant lymphadenopathy L axilla, L clavicle area, L breast with L breast swelling (3 inch increase in chest circumference). Pain and tenderness.
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| 44 | 2021-03-11 | flushing |
dizziness on the verge of passing out; welts all over midsection from upper legs through hips and on...
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dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-03-11 | tingling |
Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site....
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Fatigue, tingling in lips, face, neck, hands. Dryness in lips and hands. Soreness at injection site. Temperature 99.8
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| 44 | 2021-03-13 | numbness, flushing, tingling | flushing, tingling/numbness neck and face. Evaluated by EMS-Cleared |
| 44 | 2021-03-13 | pain in extremity, tenderness |
Woke up with sore upper right thigh Tuesday March 9. Very tender to the touch. Visited Dr. Wednesday...
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Woke up with sore upper right thigh Tuesday March 9. Very tender to the touch. Visited Dr. Wednesday March 10, ordered ultrasound which was completed on Thursday March 11 and diagnosed a superficial blood clot. Prescribed Xarelto 10mg.
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| 44 | 2021-03-14 | migraine |
migraine immediately after vaccine administration, pt self-medicated with home medicines, pt monitor...
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migraine immediately after vaccine administration, pt self-medicated with home medicines, pt monitored for 30 minutes with some resolution, pt would like to go home
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| 44 | 2021-03-14 | pain in extremity |
The day after receiving the vaccine I woke up with a lot of soreness in the arm of the injection sit...
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The day after receiving the vaccine I woke up with a lot of soreness in the arm of the injection site. I was tired and had some nausea that increased with activity. By early afternoon I was too tired to continue my daily activities and had to call out of work. Since receiving the vaccine, I have experienced fatigue and mild nausea daily that is only relieved by frequent rest.
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| 44 | 2021-03-14 | tingling |
PATIENT STATES HAS NAUSEA AND DIZZINESS ALONG WITH TINGLING SENSATION TO FACE AND LIPS. PULSE IS 100...
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PATIENT STATES HAS NAUSEA AND DIZZINESS ALONG WITH TINGLING SENSATION TO FACE AND LIPS. PULSE IS 100 AND REGULAR. PATIENT HAS NO SHORTNESS OF BREATH, NO RASH OR ITCHING. PATIENT WATCHED AND EXTRA 15 MINS BUT REFUSED TO GO FOR FURTHER TREATMENT.PATIENT INSTRUCTED TO FOLLOW UP WITH EMERGERGENY DEPARTMENT OR CLINIC IF HAD FURTHER NEDDS OR ISSUES DID NOT RESOLVE.
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| 44 | 2021-03-15 | breast pain |
Itching / Soreness of right breast. Started about 1 hour after vaccination and continued for approxi...
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Itching / Soreness of right breast. Started about 1 hour after vaccination and continued for approximately 48 hours.
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| 44 | 2021-03-15 | pain in extremity, tingling |
6 hours in - very sore arm. 12 hours in - sore arm that required tylenol. 12-24 hours headaches, fat...
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6 hours in - very sore arm. 12 hours in - sore arm that required tylenol. 12-24 hours headaches, fatigue. 24 hours later - itchy throat/roof of mouth (took benadryl). 36-48 hours itchy throat/roof of mouth continued but became itchy on arms and legs. 2-4 days post vaccine it progressed to itchy spots on my entire body. No hives - but a rash and redness. Feels like pin and needles.
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| 44 | 2021-03-15 | pain in extremity |
After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme so...
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After receiving my first dose I experienced the following adverse side effects: -Fatigue -Extreme soreness in my arm -The lymph nodes under my arm pit was swollen and tender -I broke out in hives on my hands and face -I had a rash on my tongue -A knot on the bottom of my right foot [in the area of the arch] -The skin on both of my hands have been peeling extremely bad
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| 44 | 2021-03-16 | pain in extremity |
Stomach upset, virus, and diarrhea. My right arm has a sharp pain from my neck down to my fingertips...
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Stomach upset, virus, and diarrhea. My right arm has a sharp pain from my neck down to my fingertips on a daily basis.
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| 44 | 2021-03-17 | bell's palsy, feeling hot |
Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red ...
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Bell's palsy on right hand side of my face; extreme heat in my face; Red face and ears all day; Red face and ears all day; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at single dose in right arm for covid-19 immunisation at the age of 44-year-old. Lot number was Ez9264. Medical history included asthma, interstitial cystitis, allergy to peanuts. The patient experienced anaphylactic reaction with GADAVIST. Concomitant medications were unknown. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 04:30 in right arm at the age of 44-year-old for Covid-19 immunisation (lot number was Gl3249). The patient was not pregnant. On 03Feb2021 at 07:15, the patient experienced extreme heat in face that lasted 2 minutes. Red face and ears all day but no more extreme heat. On 06Feb2021, Bell's palsy on right hand side of face occurred. The patient was not treated for the events. The patient did not recover from the events. Patient was not covid tested post vaccination; patient did not have covid prior vaccination.
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| 44 | 2021-03-17 | feeling hot |
Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to am...
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Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to ambulate to observation on her own and then signaled staff for help, felt hot, felt dizzy, felt nausea, staff immediately assisted to chair, RN @ side; inquired re food; had lunch; sips of beverage w sugar given able to eat cracker. She stated she felt better, was upright in her chair, no SOB, no complaints of swelling throat, itchy etc. After some initial sips of liquid, still feeling dizzy lowered to floor by staff w wedge cushion and legs and feet elevated above heart per protocol b/p 140/96 pulse 86. Stated she had been anxious re injection, but denied ever having this experience after injection. Additional information for Item 18: Reviewed the POD form questions again with her, denied any issues. She then stated she was feeling much better again, her warm feelings were going away from ice in a glove that we had used from her initial dizzy, warm/hot feeling. Around 3:30 she felt nausea again, so we sat her up and gave her a bucket to use to vomit if needed. She was unable to vomit. She wanted to sit up on floor. We sat with her and she sipped on clear beverage. She began to get cold. We put her legs back up took b/p 140/91 pulse 86. No change. We called nursing DON for District to make her aware and by that time patient experiencing chills. We called her husband to be on his way to drive her home after 30 minutes @ 3:45. She continued to tell us she felt better for a few minutes only to then tell us she was feeling nausea again. Rolled her to left side, helped her to prop us to vomit but she was unable to vomit anything. B/p readings 147/91, 150/90, 140/87,150/88She desired to sit upright again. So on floor with nurse holding and b/p cuff on sat her up to try to vomit, unable to do so. Lowered back to floor with legs upright where she remained local Paramedic on site and he came to assist, a portable recliner that allowed for legs to be elevated above heart was set up. Patient felt that she could transfer with paramedic and staff help and passed out while attempting briefly, chilling when she was alert, then passing out again; 911 was called and arrived by 3:55, patient and husband initially wanted to take patient home after hearing patient state she felt better once paramedics had evaluated her. However in front of husband, patient again passed out, and after she was conscious stated she could not feel her arms. and when he observed this he agreed it was best for her to be evaluated and then was transported to ER. Per phone conversation this morning, at 10:41 husband stating that patient still not able to stand without passing out on her own and they were continuing to evaluate her. No additional medication given on site at Mass vaccine site.
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| 44 | 2021-03-17 | flushing |
I received my first round of the Covid19 vaccine on Tuesday. They had us wait for 15 minutes to see ...
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I received my first round of the Covid19 vaccine on Tuesday. They had us wait for 15 minutes to see if there were issues. Sitting there I had no issues. By the time I got back to work maybe 15 minutes later I felt like I was foggy headed. It was like a was on a high dose of cold medication. I was also very flushed. I was okay sitting but movement brought it on. I was also pretty tired.
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| 44 | 2021-03-17 | pain in extremity, cold sweat |
Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and en...
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Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and enter my nasal cavity. At which time it seemed to dry up what ever nasal mucus I had. Almost immediately I felt dizzy and light headed. Then came the my heart beating faster. My breathing quickened cold sweats began with the palms of my hands. This continued for about 3-4 minutes. When my heart/ blood pressure seemed to go back to normal, I sat for an additional 15 minutes. I had 3 more incidents that day of dizzy and lightheadness throughout the day but not to the extent of the initial, almost passing out, spell. For 12 hours after injection, other than the typical reported symptoms of sore arm, fatigue which I did experience, i felt like I was in a haze, similar to when you have a fever for 11 hours. And oddly, almost immediately the haze and fatigue lifted. No other adverse reactions after that.
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| 44 | 2021-03-17 | pain in extremity |
Sore arm at the injection site which was very painful for 2 days. patient also complained of runny ...
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Sore arm at the injection site which was very painful for 2 days. patient also complained of runny nose on 3/4 which lasted for about 4 hours.
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| 44 | 2021-03-17 | pain in extremity |
Light headed and slight dizziness along with string metallic taste in mouth almost immediately follo...
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Light headed and slight dizziness along with string metallic taste in mouth almost immediately following injection. These symptoms dissipated after about 15 minutes and I was able to drive home. An hour later I started to have intense muscle and joint aches all over my body with slight dizziness. My left arm, regardless of continued movement, became increasingly sore. The next morning only slight aches and dizziness remained and I was able to go to work. By the end of the eight hour work day, the joint and muscle aches and fully returned accompanied with intense pain in my left arm, hand, and neck. Today I feel no symptoms at all.
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| 44 | 2021-03-17 | tingling |
Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the ...
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Right side of face, neck and chest broke out in hives. I had numbing in my lips and tingling on the right side of my body.
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| 44 | 2021-03-17 | tingling |
sharp ache sensation going up Right side of neck behind ear. Sensation decreased and turned to ting...
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sharp ache sensation going up Right side of neck behind ear. Sensation decreased and turned to tingling "all feelings are internal, feels like icy hot on my neck" no pain with palpation, injection site WNL, no redness, welling or warmth, no pain at injection site or arm, no los of ROM.
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| 44 | 2021-03-17 | tremor |
Waited the required 15 minutes after vaccine and done just fine. Started my drive back home and abou...
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Waited the required 15 minutes after vaccine and done just fine. Started my drive back home and about 15 minutes into my drive I began feeling very funny in my head, my heart rate went sky high, started shaking all over my body. Could barely drive called 911. Was advised to pull over and await for ambulance. Ended up at ER with elevated heart rate, chest pain and feeling winded. I could breath ok no swelling in throat but just felt like a elephant was on my chest
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| 44 | 2021-03-18 | flushing |
Hives/rash developed on chest and side of neck, as well as facial flushing, about 15/20 minutes afte...
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Hives/rash developed on chest and side of neck, as well as facial flushing, about 15/20 minutes after the injection. Blood pressure was taken repeatedly and high 150/100.
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| 44 | 2021-03-18 | migraine | Migraine headache almost continuously since vaccine. Had not had regular migraine in over 10 year. |
| 44 | 2021-03-18 | pain in extremity |
Left arm fatigued, sore, still painful after over a week. Pain radiates down arm. Issue is not getti...
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Left arm fatigued, sore, still painful after over a week. Pain radiates down arm. Issue is not getting worse just staying the same.
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| 44 | 2021-03-18 | pain in extremity |
Arm pain immediately following vaccination. 2 hours later, became extremely itchy all over body (no ...
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Arm pain immediately following vaccination. 2 hours later, became extremely itchy all over body (no rash.) One raised hive popped up on my stomach. I took Benadryl to reduce itchiness so I could sleep. Today I am dealing with a mild headache and bad diarrhea immediately after eating.
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| 44 | 2021-03-18 | pain in extremity |
Low grade fever (100.1F); Achy joints; headache; sore arm, especially at injection site; sore arm, e...
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Low grade fever (100.1F); Achy joints; headache; sore arm, especially at injection site; sore arm, especially at injection site; muscle aches; This is a spontaneous report from a contactable healthcare professional (the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 12Feb2021 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: vitamin C and ibuprofen (ADVIL), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 22Jan2021 13:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 06:00, the patient experienced low grade fever (100.1F), achy joints, headache, sore arm, especially at injection site, and muscle aches. The clinical course was as follows: Low grade fever (100.1 F), achy joints, headache and sore arm, especially at injection site, at 06:00 on 13Feb2021. Low grade fever lasted for about 10 hours, took ADVIL, which brought temperature to normal level (98.8 F). Slight headache still remained on 14Feb2021, but ADVIL relieved that. Fever and muscle aches dissipated by morning of 14Feb2021. No treatment was received for achy joints, sore arm, especially at injection site, and muscle aches. The clinical outcome of the events fever and muscle aches was recovered on 14Feb2021, and for other events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-03-18 | cold extremities, pain in extremity |
I had a slight headache prior to the vac one that lasted through the next day so I?m not sure if the...
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I had a slight headache prior to the vac one that lasted through the next day so I?m not sure if the vaccine contributed to it. Around 530 pm I started feeling fatigue and a slight wave of nausea. The nausea did not last long. By 6:30 pm I was exhausted and began having chills - my feet especially felt cold. I then crashed hard and slept for a few hours. The next morning my arm was slightly sore and by the evening I felt extra tired.
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| 44 | 2021-03-19 | pain in extremity |
Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I a...
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Approximately 3 hours after the shot, I got a horrible headache - the same one I had with COVID. I also felt tired and body aches. The next day I was exhausted, could hardly keep my eyes open and could not get enough water. My arm began to hurt, I had chills/fever, and my shoulders/back of my head hurt a LOT. I also was congested, coughing and sneezing, and my chest felt tight. My knuckles and toes hurt as well. Tylenol, day-quil, aspirin, - none of these worked. I had COVID back in June/July 2020 and the symptoms are all the same ones I had.
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| 44 | 2021-03-19 | pain in extremity | Arm is achy, running a high fever, chills, sweats |
| 44 | 2021-03-21 | feeling cold |
About 3 hours after the injection I began to feel tired and lethargic. 10 hours after the injection ...
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About 3 hours after the injection I began to feel tired and lethargic. 10 hours after the injection I began to feel more cold than normal. 12 hours after the injection I realized I had a fever and it took about 3 hours to break. By the next morning, today, I felt sore all over my body, like I had been non-stop throwing up. I had a raging headache in my right eye. Still feeling very lethargic. 27 hours later I still feel not myself.
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| 44 | 2021-03-21 | pain in extremity, breast pain, weakness |
Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in...
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Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in left arm) and by mid-afternoon headache. Overnight woke with fever, chills, headache and sore arm making sleep impossible. Ill all day Friday - fever, chills, fatigue, no appetite, headache, arm soreness. Friday evening awoke with intense pain in right arm pit, breast, upper ribs - extremely swollen lymph nodes (size of avocado). Extremely tender and sore. Pain continued throughout Saturday, Sunday, and now into Monday. Also still fatigued and feeling run down.
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| 44 | 2021-03-22 | numbness, pain in extremity, tingling, tremor, weakness |
Continued sensitivity & "nausea" in arms and chest similar to first dose, but more continuous. Abou...
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Continued sensitivity & "nausea" in arms and chest similar to first dose, but more continuous. About a week or so after, extreme fatigue and body weakness began and never stopped. Weakness/shakiness/tremorlike tingling body/arms/legs. It would come and go mainly in arms at first. Now it is constant all over body and it never goes away- 2 months. The muscle weakness is debilitating. First tingling/weakness/shakiness, followed by numbness in arms and legs, mainly right leg. Also arms started falling fully asleep and numb at night while sleeping. During day constant muscle and body weakness/tingling - is constant and almost unbearing. Feels like bugs are crawling under skin all over body, fatigue, numbness, (pins and needles come and go, very "elective" kind of surges through. Sometimes remains and fades). Newest symptom as of only a few days ago, pain in elbows, upper arms, knees, legs, shins, lower back, shoulders, back. Achy pain and burning pain. Pain is new, came before the Burning pain, which is the latest. I imagine these pains are my muscles dying. Muscle Atrophy per ER 3/21/21 visit.
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| 44 | 2021-03-22 | numbness, tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA 1. Left side of face was numb for a few minutes, got better, th...
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Pfizer-BioNTech COVID-19 Vaccine EUA 1. Left side of face was numb for a few minutes, got better, then got numb again. Numbness went away again. Over the last few days, left side of face has felt weird. Kind of tingly near cheek bone and under eye. 2. Sore shoulder for ~ 36 hrs. 3. Headache for ~ 48 hrs.
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| 44 | 2021-03-22 | pain in extremity | Sore arm 2 days, fatigue 1 day |
| 44 | 2021-03-22 | pain in extremity |
Significant headache, significant arm pain (hard to even move arm), significant right armpit pain, s...
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Significant headache, significant arm pain (hard to even move arm), significant right armpit pain, significant aches/pain all over mainly lower back and hips, exhaustion, neck pain
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| 44 | 2021-03-22 | tingling, feeling hot |
Shortly after vaccination patient reported feeling hot and dizzy with tingling in throat and legs. ...
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Shortly after vaccination patient reported feeling hot and dizzy with tingling in throat and legs. IV was started and patient was given Solumedrol and Benedryl before being taken to ER by EMS.
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| 44 | 2021-03-23 | feeling hot, flushing |
Felt flushed/hot about 30-60 minutes after shot. Muscle pain at site of injection and throughout upp...
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Felt flushed/hot about 30-60 minutes after shot. Muscle pain at site of injection and throughout upper arm - painful throughout the night. Pain dissipated somewhat 26-28 hours out from shot. Ran low-grade fever about 29 hours out from shot. Nausea, just general malaise throughout the day.
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| 44 | 2021-03-23 | flushing, feeling hot |
Patient came in to get her second COVID shot. informed me that she had reactions to the first (lymph...
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Patient came in to get her second COVID shot. informed me that she had reactions to the first (lymph node swelling, hives, bells palsy symptoms, and nausea). Her doctors and specialists discussed it with her and agreed they wanted her to have the second dose. She had pneumonia twice, had covid and has residual effects from it, and had mono. They were unsure if the symptoms were directly from the immunization or the fact that she had mono/pneumonia when she got it and didn't know. I Gave her the immunization and she said she felt warm after it. I sat with her for 30 minutes and she said she felt flushed and itchy, she was given 10 ml of Benadryl 12.5mg/5ml. She had no visible hives or swelling at the injection site or on her chest or arms. She felt nauseous and took her own phenergan. After sitting for 45 minutes together she said she wanted to go home. She went shopping for a few things and checked in before she left. I told her if there was any swelling at all in her throat/face or if she felt like she couldn't breathe to call 911 or get to the hospital immediately. She said she would and I will call tomorrow to follow up with how she is feeling.
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| 44 | 2021-03-23 | flushing |
After receiving 2nd dose of pfizer covid vaccine patient waited her 15 minutes and went to car to le...
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After receiving 2nd dose of pfizer covid vaccine patient waited her 15 minutes and went to car to leave but noted she was developing hives on her chest and flushing of face. She had no difficulty breathing. She waited in car for 5-10 minutes but it was not subsiding so she re-entered the facility and sought out EMS for evaluation. At that time she was noted to have confluent hives on chest and flushing of cheeks but no angioedema, throat or tongue swelling, sob, wheezing, difficulty breathing, or difficulty speaking. Hives remained localized to chest and flushing to cheeks. Vitals were stable and remained stable. She was observed x 20 minutes with no further progression of symptoms. She was offered benadryl but refused as she has a 1.5 hour drive home and has no one here with her. She was offered decadron but refused. She opted to drive to nearest gas station to get non drowsy antihistamine. She carries her own epi pen due to bee sting reactions and is well versed in how to use it. She was instructed to call 911 if getting worse or if she needs to use epi pen.
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| 44 | 2021-03-23 | pain in extremity |
She had previous reaction to Paclitaxel and was given vaccine in high risk COVID vaccine allergy cli...
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She had previous reaction to Paclitaxel and was given vaccine in high risk COVID vaccine allergy clinic. We pretreated her with cetirizine but did not test her to PEG. She developed significant distress, nausea and cough 2-3 minutes after receiving the vaccine. There was no hypotension, wheezing noted. She was treated promptly with epinephrine 0.3 mg. Within five minutes she started to feel better aside from adverse effects from Epi. Left arm and shoulder pain. No significant shortness of breath. She had a large amount of clothing on so were unable to fully see skin but no visible rash. She was transferred to the emergency department.
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| 44 | 2021-03-23 | pain in extremity |
I felt fine for the fors 24 hours. Limited arm soreness, no other symptoms. At 11:00Am Sunday I bega...
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I felt fine for the fors 24 hours. Limited arm soreness, no other symptoms. At 11:00Am Sunday I began to get achy at my joints. I was out on a 5 mile hike and unable to turn around. When I got home took Tylenol and rested. At 11Pm Sunday night I started feeling itchy and discovered a full body rash. They were raised patches and if i scratched myself the area would swell up like a hive. Took Benadryl and it was mostly gone by morning. At 11:00pm Tuesday night I started feeling itchy again and discovered the rash had returned again. Again took Benadryl and it was mostly gone by morning.
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| 44 | 2021-03-23 | pain in extremity |
Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left whe...
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Dizzy; Lost all the strength in her arms and legs; Passed out; Nauseous; She dropped to her left when she passed out and fell in shower; Ear completely clogged up only on the left side; Headache; Tired; Soreness on my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included underactive thyroid. Concomitant medication included unspecified thyroid medication. The patient was asking if her symptoms were normal following the vaccination. She got the second dose of the COVID vaccine yesterday, 07Mar2021 at around 11:00 (also reported as 10:00 to 10: 15 or 10:30). Throughout the day, she was fine and mentioned that she had soreness on her arm later. At around 22:00, she was driving home and started feeling a slight headache and reported that she didn't take anything. She was tired, so when she got home, the patient fell asleep. She woke up and did feel a slight headache and couldn't sleep on her left arm because it was killing her, but it was fine. At 5:30 this morning (08Mar2021), the headache was still there. She then stood and sat up, took her thyroid pill because she has an underactive thyroid and was on the highest dose of thyroid replacement. The patient stated that the events happened so fast, as soon as she got into the shower. She got out of bed and started walking, grabbed her stuff to shower and started feeling that her headache was building up more than it had all morning so far. She thought maybe it was just because she had just physically gotten up and started walking. She got into the shower, and for about 2-3 minutes into getting into the shower, she remembered she had started putting shampoo into her hands; grabbing the shampoo bottle; but she suddenly got so nauseous and the headache that came on was extreme. She did not have a lot of time to react. She thought she would throw up in the shower, she had no time to get out of the shower to the toilet to throw up; she suddenly felt dizzy, passed out in the shower and fell to her left side on the floor. All she could remember before she passed out was that she had the shampoo bottle in her hands and she said out loud, she heard herself say "What is happening to me". Then she lost all the strength in her arms and legs. She remembered for a split second she tried to hold on, she dropped the shampoo bottle on the floor and grabbed the rail or edge of the shower and tried to hold on because she felt herself when she went down. Her left ear was completely clogged up only on the left side. When she passed out, thankfully she thought by trying to hold on to the rail or edge of the shower that she kind of eased her fall down, so she did not fall hard or hit her head. She did not know if she passed out for seconds or minutes because she has no idea exactly when she went into the shower, maybe around 05:45; but when she woke up she realized she was on the floor, she was not flat on the floor but on her knees, having fallen to the left side with her head off to the side on the shower wall; the glass door to her shower was wide open and all the water was coming out of the shower; it scared her when she woke up. The outcome of the event passed out was recovered on 08Mar2021, not recovered for headache, and unknown for all other events. Information on the lot/batch number has been requested.
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| 44 | 2021-03-24 | numbness |
15:10 Patient verbalized feeling lightheadedness, sweating and left hand numb. Vital signs taken at:...
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15:10 Patient verbalized feeling lightheadedness, sweating and left hand numb. Vital signs taken at: 15:15 Bp 150/90 HR 80 Spo2 99 Temp: 97.1 F @ 15:20 Bp 147/93 HR 76 Spo2 99 @ 15:25 Bp 145/91 HR 82 Spo2 99 @ 15:30 BP 149/83 HR 71 Spo2 100 @ 15:35 BP 155/91 HR 72 Spo2 100 15:50 patient stated "feeling better" repeat vitals before releasing, BP 152/91 HR 78 Spo2 100 Patient was advised to follow up with PCP prior to recieving second dose of Covid vaccine. Patient left with daughter. (Initials) LVN
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| 44 | 2021-03-24 | muscle spasms |
My upper lip began to spasm and became numb. I also had some slight numbness on the tip of my tongue...
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My upper lip began to spasm and became numb. I also had some slight numbness on the tip of my tongue.
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| 44 | 2021-03-24 | tingling, tremor, numbness |
Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous...
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Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.
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| 44 | 2021-03-25 | migraine, pain in extremity |
After the first vaccine I got swelling and a hard lump at the site of injection. I couldn?t even lif...
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After the first vaccine I got swelling and a hard lump at the site of injection. I couldn?t even lift my arm for more than 24 hours and then the lump lasted over a week. Then after second dose I also got sore arm and a lump but developed a rash on my arm too. (Same day). Next day I had low grade fever and body aches and chills. 2 days after the vaccine I woke up with a migraine and still didn?t feel well but no more fever. I also had small blister like rash on my inner thigh that developed about 10 days after the first vaccine but thought they were unrelated. Today I saw a dermatologist and she said the rash on my leg was Shingles and was also caused from the vaccine.
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| 44 | 2021-03-25 | muscle spasms | Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm |
| 44 | 2021-03-25 | muscle twitching |
right sided facial twitching; severe soreness in the vaccine site; fatigue; body aches; gastrointest...
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right sided facial twitching; severe soreness in the vaccine site; fatigue; body aches; gastrointestinal pain; dizziness; heart palpitations; This is a spontaneous report from a contactable Other HCP (the patient). This non-pregnant 44-year-old female patient received her second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318 ), via an unspecified route of administration, in left arm on 20Feb2021 at 11:15 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included Grave's disease (treated with an ablation resulting in hypothyroidism). The patient had known allergies to raw egg whites, red food dye, and penicillin's. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine sodium (TIROSINT). The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN5318, on 30Jan2021, in the left arm COVID-19 immunization. On 20Feb2021, within 4 hours of receiving the vaccine at 4:15 PM, the patient experienced severe soreness in the vaccine site, fatigue, body aches, gastrointestinal pain. Starting at 48 hours after the vaccine she experienced dizziness, heart palpitations, and right sided facial twitching, No treatment was received. The clinical outcome of right sided facial twitching, severe soreness in the vaccine site, fatigue, body aches, gastrointestinal pain, dizziness, heart palpitations was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-03-25 | tingling, inability to speak |
I had long term Covid symptoms from early February 2020 to late February 2021 including, intense con...
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I had long term Covid symptoms from early February 2020 to late February 2021 including, intense concussion like brain fog for months, coughing for months, problems with my fingers seizing up and twitching uncontrollably, and extreme exhaustion for months. I had finally started to feel Covid free, except for some problems with my left hand, by end of February 2021. I got the first dose and about 45 minutes or so later the exhaustion came back suddenly - like someone removed all my batteries - and I started having trouble talking, thinking, remembering. Reading and writing work, but talking is difficult. My hands feel swollen and lacking dexterity and strength. I had an odd headache in the middle of the night (on day 2) with some sharp pain that kind of seeped around my scalp. I thought at first I had been stung by a bee and it went away as quickly as it came. But then the pain would suddenly appear on another part of my scalp. There was a tingling/seeping/spreading out feeling just before it would disappear. I woke up the next morning with a more normal headache, took IBU and CBD gummies, ate breakfast and it?s gone. I feel like all I can do is lay in bed and stare at the wall. This is exactly as I felt when I had Covid (though without finger seizures and coughing). I find myself coming to tears with a fear that it won?t ever go away or I?ve brought it on again by getting the vaccine.
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| 44 | 2021-03-25 | tingling |
I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had di...
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I had headaches at first but then I had heart palpitations that have lasted for 2 weeks. I've had difficulty breathing for 2 weeks. I have had eye twitching in my left eye for 3 days. I have had tightness in my chest and tingling in my chest.
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| 44 | 2021-03-25 | seizure |
On 3/24/21, almost a week after my second vaccine shot, I had a seizure while sleeping in bed. I had...
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On 3/24/21, almost a week after my second vaccine shot, I had a seizure while sleeping in bed. I hadn?t had a seizure in over 30 years, and then only with a fever (I had febrile seizures as a child). My husband got some of it on video after being unsuccessful waking me.
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| 44 | 2021-03-26 | bell's palsy | Bells Palsy |
| 44 | 2021-03-26 | difficulty speaking |
She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swel...
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She received the first dose of the Pfizer COVID-19 vaccine on 3/25, and had some lip and tongue swelling and vocal changes with wheezing within 15 minutes of receiving the vaccine. She was treated with benadryl and albuterol and sent home after improvement. After going home, continued to have some lip/throat swelling. She then presented to local hospital with worsened symptoms, treated with benadryl and steroids, given a script for prednisone, and sent home. She did not fill the prednisone script initially, but had some prednisone (unknown strength) at home and took a pill. The following morning (3/26), she continued to have throat and lip swelling and began to develop some dyspnea. Due to these worsening symptoms, she came to ED. She received a total of 5 doses of IM epinephrine (1734, 1938, 2010, 2320, 0017) along with IV pepcid and IV solumedrol for persistent subjective throat swelling, dyspnea, and difficulty tolerating secretions. She was admitted to the ICU for close monitoring of symptoms and consideration of an epinephrine drip, but did NOT require this. In the morning of 3/27, she noted substantial improvement in symptoms of tongue/lip swelling, improved wheezing, dyspnea, and dysphagia. Still with some mild hoarseness that she attributes to cough, also improving.
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| 44 | 2021-03-26 | feeling hot |
My arm became very hot later in the night and then my face got really hot and when I woke up my face...
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My arm became very hot later in the night and then my face got really hot and when I woke up my face was swollen like I had a mild reaction
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| 44 | 2021-03-28 | flushing |
Within the first hour after receiving the vaccine, I experienced a flushing warm sensation in my ski...
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Within the first hour after receiving the vaccine, I experienced a flushing warm sensation in my skin on my face and neck area. About 2-3 hours after receiving the vaccine, I broke out in a skin rash on my face, neck, and upper body. About 2 days later, the rash began to diminish. Now (6 days later) it has continued to recede (although it is still somewhat visible).
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| 44 | 2021-03-28 | seizure, burning sensation, muscle spasms |
3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she...
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3/25/2021-pt states that about 10-15 minutes after taking the covid vax her throat was tight and she was wasn't feeling right. About an one hour and ten minutes she went into anaphylaxis shock. Paramedics were called. Pt had a seizure while in transport to the Hospital ER. She was given an EKG in ambulance w/ abnormal results that showed tachycardia and abnormal ECG. Vent rate was 48 beats faster per minute, no spectral infarct detected. When came to she was having seizure like muscle spasms all her entire body. In the ER she was given meds and monitored for 4 hours before being released to home. 3/26/2021- Next day her skin, her eyes, and the inside of her body felt like it was boiling. She went back to the same ER. She was given another EKG which show possible left atrial enlargement and spectral infarct age undetermined - Abnormal ECG when compared to the ECG on 3/25/201. She blood work and Chest Ray. She was given more meds and told to FU w/ PCP. Her appt w/ PCP is on 3/29/21 and will be determined if she needs to see Cardiologist.
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| 44 | 2021-04-01 | numbness |
Purplish red spots on bottom of feet, lasted >day; headaches, fatigue, confusion, numbness in hands/...
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Purplish red spots on bottom of feet, lasted >day; headaches, fatigue, confusion, numbness in hands/ arms and feet. All but spots continue today. Nausea for 3 days, 3/29-3/31. Diminished sense of smell and taste, still.
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| 44 | 2021-04-04 | tremor | Visible tremors in extremities, difficulty walking, blurred vision, headaches |
| 44 | 2021-04-06 | pain in extremity |
Fatigue; sore lower left leg; sore arm; This is a spontaneous report received from a contactable con...
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Fatigue; sore lower left leg; sore arm; This is a spontaneous report received from a contactable consumer. A 44-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:15 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included calcium carbonate, colecalciferol (VITAMIN D 2000); linaclotide (LINZESS). The patient experienced fatigue and sore lower left leg and sore arm (pain in extremity) on 24Mar2021 at 07:00. Tylenol was taken as a result of fatigue, sore lower left leg, sore arm. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the event was recovering. Information on the lot/batch number has been requested.
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| 44 | 2021-04-09 | numbness, night sweats, pain in extremity, tingling |
About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went comple...
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About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine. My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.
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| 44 | 2021-04-09 | speech disorder |
Complete flare of Postural orthostatic tachycardia syndrome; Complete flare of Postural orthostatic ...
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Complete flare of Postural orthostatic tachycardia syndrome; Complete flare of Postural orthostatic tachycardia syndrome; Can't stand up, walk, talk without struggling to breath; Can't stand up, walk, talk without struggling to breath; Can't stand up, walk, talk without struggling to breath; This is a spontaneous report from a contactable nurse (patient herself). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733, Expiration date: Unknown), via an unspecified route of administration in left arm on 25Mar2021 at 14:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included just POTS (postural orthostatic tachycardia syndrome) from 2 1/2 years prior. Concomitant medication included nadolol received in two weeks. The patient previously took cefepime and experienced known allergies: Cefepime. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID priori vaccination. The patient did not undergo COVID test post vaccination. The patient experienced complete flare of postural orthostatic tachycardia syndrome (last flare was 2 1/2 years prior), can't stand up, walk, talk without struggling to breath on 25Mar2021 at 16:30. The events were considered as serious (disability or permanent damage) by nurse. No treatment medications were received for the adverse events. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the reportedly close drug-event temporal association, a possible contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the development of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-04-12 | muscle spasms |
Fever to 103.9; severe muscle cramping; joint swelling and pain. Joint swelling and pain has continu...
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Fever to 103.9; severe muscle cramping; joint swelling and pain. Joint swelling and pain has continued to this day; joint swelling and pain. Joint swelling and pain has continued to this day; This is a spontaneous report from a contactable other health care professional. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EK9231; Age at vaccination 44 Year), dose 2 via administered in Arm Left on 06Jan2021 17:00 as single dose for covid-19 immunisation. Medical history included Allergies to peanuts, tree nuts. Concomitant medications included famotidine. The patient previously took zithromax and experienced Allergies, bnt162b2 (Lot number: EK5730; 17Dec2020 17:00, Left arm, dose number=1). the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient received within 2 weeks of vaccination: Famotidine; Prior to vaccination, the patient not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. On 06Jan2021 22:30, Fever to 103.9, severe muscle cramping, joint swelling and pain. Joint swelling and pain has continued to this day. ae resulted in Disability or permanent damage; Recovered with lasting effects. The patient not received treatment AE. The outcome of the events was resolved with sequel. ~; Sender's Comments: A possible contributory effect of suspect BNT162B2 on the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-04-12 | seizure |
Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of c...
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Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of car, walked forward and passed out with a seizure then throwing up when I came to. Received concussion. Taken to ER and admitted for 5 days. Still experiencing vertigo and nausea
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| 44 | 2021-04-14 | numbness |
Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/thro...
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Immediate dizziness upon injection; Upon moving to observation (1-2 minutes), I again had chest/throat tightness and shortness of breath. Within 5-10 minutes, I began to experience facial numbness; All of these adverse reactions continued for a few hours post-vaccine
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| 44 | 2021-04-18 | grand mal seizure, seizure |
I had a seizure and fell out of bed between the night of March 12th and the morning of March 13, 202...
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I had a seizure and fell out of bed between the night of March 12th and the morning of March 13, 2021. I injured my face badly as well as my eye. I had to go to the Emergency room here on 3/16/21. I had a second seizure at the entrance to event on Saturday March 27, 2021 . It was a grand mal, clonic-tonic seizure. I was life flighted to Medical center on March 27, 2021 I was not discharged until 3/31/21.
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| 44 | 2021-04-19 | seizure |
Patient had a seizure 9 days after dose #1. First ever seizure. Was not initially recognized as a ...
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Patient had a seizure 9 days after dose #1. First ever seizure. Was not initially recognized as a seizure since she was post ictal and did not show up at ED until 36 hours later. Patient received dose #2 on 3/24/2021 and then a second seizure on 3/27/2021 and was hospitalized. Had MRI and EEG. Started on keppra.
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| 44 | 2021-04-20 | facial pain |
Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Int...
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Immediate left side (injection side) headache.; Intense headache, neck, facial and cranial pain; Intense headache, neck, facial and cranial pain; Extreme vertigo within 1 hour; loose stool; Nausea; vomiting; Swollen; itchy hives; itchy hives; Swollen left eye; This is a spontaneous report from a contactable HCP and a consumer (the patient). A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 (Batch/Lot Number: EW0150) as single dose for covid-19 immunisation . Medical history included migraine, demyelination , post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced immediate left side (injection side) headache. on 03Apr2021 11:45 with outcome of not recovered , intense headache, neck, facial and cranial pain on 03Apr2021 11:45 with outcome of not recovered , extreme vertigo within 1 hour on 03Apr2021 11:45 with outcome of not recovered , loose stool on 03Apr2021 11:45 with outcome of not recovered , nausea on 03Apr2021 11:45 with outcome of not recovered , vomiting on 03Apr2021 11:45 with outcome of not recovered , swollen on 03Apr2021 11:45 with outcome of not recovered , itchy hives on 03Apr2021 11:45 with outcome of not recovered , swollen left eye on 03Apr2021 11:45 with outcome of not recovered. All the reported events were considered Important Medical Events. Course of the event: Immediate left side (injection side) headache. Spread to entire head within 30 minutes. Intense headache, neck, facial and cranial pain persists at hour 53. Extreme vertigo within 1 hour, persisting now at hour 53. Nausea, vomiting and loose stool within 6 hours. Vomiting ceased at 48 hours post 1st shot vaccination. Nausea and diarrhea persists at hour 53. Swollen, itchy hives, injection side within 40 hours, spread to neck and face. Swollen left eye, within 24 hours, waning at hour 53. No follow-up attempts are needed. No further information is expected.
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| 44 | 2021-04-20 | feeling of body temperature change, tremor, discomfort, pain in extremity |
At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and...
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At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and Tylenol to sleep. Woke up next morning and took Tylenol at 8am so I could try to have a normal day. Held off on medicine but started to feel exhausted and got hot / shaking chills again at 3pm and could not get warm . Took a nap to try to avoid medication but then took Advil/Tylenol again at 5pm because my fever reached 103 and I was too uncomfortable. Fever broke an hour later and I was able to sleep all night. Felt 90% better in morning and pretty normal by 48 hours after shot though continued to have fatigue and some periodic nausea into following day and one instance of diarrhea. Also arm was sore.
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| 44 | 2021-04-21 | numbness |
On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and lan...
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On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and landed face first on the kitchen floor. When I came to, my nose was bleeding and my right arm was numb. My husband called my doctor (and spoke with the doctor on call) who told me to go to the ER. While at the ER, the doctor ran an EKG, CT, and labs. All tests came back fine. I have had a headache, neck pain, and have felt light headed ever since. I returned to the ER a week later with a severe headache. Another CT, EKG, and chest x-ray. All results were fine. I have also seen a neurologist and a cardiologists. All tests came back fine. I still have a constant headache and feel light headed.
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| 44 | 2021-04-24 | tingling, hypersensitivity of all senses |
PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't star...
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PMS symptoms; nipples became very hard and sore.; swollen breast tissue; Menses late and hasn't started; symmetrical lumps on the distal sides of my breasts; faint; slight injection site soreness; intense tingly whole body sensations; Sense of pressure and tingling on eyeballs; Increased sensitivity to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Mar2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Mild/moderate TBI in Oct1999 with herniated disk in lower lumbar region from auto accident (patient was a pedestrian and a car ran into her); fractured tibia/fibula from occurrence; low blood pressure which she had occasionally fainted from at blood draws (started after being active athletically during recovery from 1999 injury). Patient was not pregnant. There were no concomitant medications (no vaccine in 4 weeks and no other medication in two weeks). Patient did faint 15 minutes after receiving Pfizer Covid vaccine on 30Mar2021. Medical people at vaccination site made a vasovagal note on record. Patient reported that there were no body aches or fatigue or fever, only slight injection site soreness for a couple of days which was hard to notice through intense tingly whole body sensations that started after receiving vaccine on 30Mar2021 16:15. Still continuing to feel a week and a half later. It was very uncomfortable but not painful. Patient also experienced sense of pressure and tingling on eyeballs and increased sensitivity to touch. Menses were due one week after vaccination but 4.5 days after vaccination on 03Apr2021, nipples became very hard and sore. After a few days on nipples slightly sore still but mostly swollen breast tissue with soreness on Apr2021. Patient had not had this as PMS symptom since becoming pregnant almost 9 years ago and it never lasted 7.5 days with it still ongoing as of time of report. Her menses was late on Apr2021 and hasn't started but she was not pregnant. Patient's usual PMS symptoms have kind of started yesterday on 09Apr2021. It quickly formed bilaterally symmetrical lumps on the distal sides of her breasts which was also unusual on Apr2021. No treatment was received and events results in doctor's clinic visit. Outcome of the events was not recovered. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-04-26 | pain in extremity |
larger red and swollen itching injection spot; patient had larger red and swollen itching injection ...
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larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; tired; sore arm; nausea tired; Earache; headache; This is a spontaneous report from a contactable consumer (Patient) reported for himself. A 44-years-old female (Non-Pregnant) patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 24Feb2021 at 11:30 AM (at age of 44years) at single dose for COVID-19 immunization. Patient medical history included which was acid reflux. Patient had Known allergies to gluten, food sensitivity to dairy and tomatoes. Patient concomitant medications included esomeprazole (20mg) two times in daily, vitamin B12 (5000mcg). Patient did not receive any vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 24Feb2021 at 12:00 the patient experienced headache, nausea, earache and on 25Feb2021 second day patient had sore arm headache and tired, on 26Feb2021 (day 3) the patient had red, swollen, and itching at vaccination site also, tired, nausea. and on 27Feb2021 (day 4) the patient had larger red and swollen itching at vaccination spot nausea tired. Patient didn't take treatment for the events. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
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| 44 | 2021-04-27 | tenderness | Extremely swollen armpit lymph node, very tender. Tiredness, body muscle aches, headache |
| 44 | 2021-04-28 | numbness |
I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't wal...
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I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't walk; my immune system attacking the nerves; The shortness of breath is very bad; My pulse is high; My blood pressure is low; I have major neurological symptoms now.; My left eye is now affected too and blurry.; keep feeling my face and now my tongue and mouth go numb; keep feeling my face and now my tongue and mouth go numb; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the second dose. A 44-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the right arm via unspecified route on 03Apr2021 (at 44-years-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot unknown expiry information not provided) in the left arm on 13Mar2021 at 12:00 (at 44-years-old) and experienced face, head and ears started tingling, shortness of breath, numbness and weakness, severe burning all over her nerves of her body, and abnormal uterine bleeding. The patient denied any known allergies and being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and the patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 03Apr2021 she received her second shot and within four hours her left leg went completely numb and she could not walk. The patient reported that she went to the emergency room three times since that time. The patient reported that she was told it was her immune system attacking her nerves. The patient reported that the shortness of breath is very bad, her pulse is high, and her blood pressure is low. The patient explained that she has major neurological symptoms now. The patient stated that she has had two magnetic resonance imaging (MRI), on computerized tomogram (CT) and two x-rays though no results were provided. The patient explained that she has appointments with neurologist and immunologist. She is unable to work since she has to be on video with people and keep feeling my face and now her tongue and mouth go numb. The patient stated that she was scared to eat food, so she does not choke. The patient mentioned that her left eye is affected too and blurry. The patient exclaimed that she cannot function, it is scarring her little kids and has affected her entire family. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the events left leg went completely numb, could not walk, immune system attacking her nerves, shortness of breath, pulse is high, blood pressure is low, neurological symptoms, unable to work/ cannot function, feeling my face and now her tongue and mouth go numb, and left eye is affected too and blurry, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) :-PFIZER (Same reporter/patient/product, similar events with first dose)
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| 44 | 2021-04-29 | tingling |
Dizziness one hour after second vaccine on the next day sore arm at side of vaccine and drowsiness t...
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Dizziness one hour after second vaccine on the next day sore arm at side of vaccine and drowsiness tiredness. On Monday afternoon noticed lymph node in front of right ear opposite side of vaccine was swollen on Tuesday notice that there was fluid swelling directly under my right knee went to the doctor they said to monitor symptoms Thursday woke up to swelling in face on the left side between nose and cheek. Today feeling tinglingness in both legs hands and swelling continues in face right lymph node in front of ear is not as large.
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| 44 | 2021-04-30 | nerve pain, tingling, weakness, burning sensation, numbness |
Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; ...
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Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; Numbness; Weakness; Severe burning all over my nerves of my body; Severe burning all over my nerves of my body; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the first dose. A 44-year-old adult [non-pregnant] female received the first dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the left arm via unspecified route on 13Mar2021 at 12:00 (at 44-yeasr-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient denied any known allergies as well as being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and receiving any other vaccine within four weeks of this vaccine. The patient reported that on 13Mar2021 at 16:00 she experienced her face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body. On 14Mar2021, the day after the vaccine, the patient developed abnormal uterine bleeding. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the abnormal uterine bleeding was recovered on 21Mar2021 after seven days. The outcome of the events face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021413774 PFIZER (Same reporter/patient/product, similar events with second dose)
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| 44 | 2021-04-30 | tingling, pain in extremity, discomfort |
diagnosed with coronary vasospasm; chest pain for 10 minutes and it went down through her arm and sh...
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diagnosed with coronary vasospasm; chest pain for 10 minutes and it went down through her arm and she was nauseous and thought she could walk it off and she was fine and did that for 10 minutes and got sick and she had to go; it was a pressure, painful but pressure; arm a little sore; tired; weird taste in her mouth; got nauseous; tingling pins and needles in her bottom jaw; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Apr2021 11:30 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. She added it is to protect herself and she takes care of her mom next month and she had hers and she also works with the public at store and it is the right thing to do to not keep spreading the awfulness. No prior vaccinations within 4 weeks and no additional vaccines administered on the same date as the COVID-19 Vaccine. Medical history included ulcer, irritable bowel with constipation, tired a lot and just that her doctor said to take a multivitamin and knows B and D are good, sinus infection 2-3 weeks ago and he told her to do sulfer antibiotics, risk factors of high blood pressure, overweight, and a smoker. Concomitant medication included linaclotide (LINZESS) taken for irritable bowel with constipation from an unspecified start date (started taking over 5 years ago) and ongoing; hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for high blood pressure from an unspecified start date (started taking over 15 years ago) to 10Apr2021 (stopped taking on 10Apr2021, her last dose was 09Apr2021); colecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date (started taking about 1 year ago, after Covid came out and fiance, tested him and it was low and takes because going around) and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for supplementation therapy (reported as tired a lot and just that her doctor said to take a multivitamin and knows B and D are good) from an unspecified start date (started about 6months ago) and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA]) taken for as tired and heart healthy and she heard good things and thought she would try it from an unspecified start date (started about 6 months ago) and ongoing; vaccinium macrocarpon (CRANBERRY) taken for an unspecified indication from an unspecified start date (started 2-3 weeks ago) and ongoing. The patient also concomitantly took "Tantoprazole" (at 40mg once a day by mouth) started taking over 5 years ago and ongoing, states she took it that morning for ulcers; Dietary fiber (at 25 4 grams by mouth once a day) started taking over a year ago and ongoing after she lost her insurance and couldn't get the medication for her irritable bowel and was taking 2 a day and when she got insurance back and the medication back and still takes 1 a day and helps go to the bathroom; chewable immune support formula (by mouth daily) and ongoing and stated that it is like airborne, it has Vitamin C plus 13vitmains and she started taking this about 2 weeks ago VitC plus 13 vitamis started about 2 weeks ago; ongoing Culturelle Probiotic lactobacillus rhamnosus (40 mg) started over a year to a year and a half ago when she lost her insurance and had problems with irritable bowel with constipation and figured it can't hurt to keep taking. The patient added that she was not taking anything new, she has been on them a long time but will list in case the shot counteracts with a medication. The patient further added she was taking Lisinopril HCTZ for the last 15 years and has had high blood pressure for 20 years and was 1st on Capazoid and was changed to this. She states it is in a pharmacy filled see through bottle and the pill had BO3 on one side and LL on the other side. States she stopped taking it, her last dose was 09Apr2021 and the cardiologist switched her to 2 new medications. The Capazoid, she is not sure of spelling, was for about 5 years and it was Captopril and HCTZ and it was 15-20 years ago and she does not know the dose. It was also stated that she took her morning pills the day of the shot but didn't take her 3 afternoon pills. She went to the doctor for a sinus infection 2-3 weeks ago and he told her to do sulfer antibiotics and took that and she had problems going to the bathroom and the prescription for the UTI was too expensive so she got the over the counter and figured she would take Cranberry to keep it at bay. The patient does not know the name of the antibiotic, the dose, NDC, lot or expiry date states it was about 3 weeks ago. The pharmacist told her fiance that the over the counter was just as good as the AZO. It was also reported that the patient previously had prior vaccinations: sore arm with the flu shot, caller does not have name, dose, NDC, lot or expiry to provide. It was nowhere near the soreness from the Covid shot, it hurt to lift her arm. The patient can be heard asking if her fiance would like to make a report about being tired and having a sore arm after his shot. The patient and fiance decline to make a report. No further details provided. It was reported that the patient is calling to report the side effects she had with the 1st vaccine and what she went through after that and have it recorded and see if anyone else is having the same issue. She states if she can get answers that would be great. Her cardiologist can't confirm or deny if what she experienced was from the vaccine. States she had some immediately after and some happened a couple days later. States some of the stuff is on the sheet but not the severe stuff and if we have more information than when she got the sheet it would be great. The cardiologist she saw in the hospital that said he could neither confirm or deny that it is from the vaccine, states her primary is not aware of this. The patient states she didn't report right away as she didn't think it was a big deal and then she had big issues on Friday and she had the vaccine on Monday. The patient got the vaccine on Monday 05Apr2021, her appointment was at 10:35. The patient got the shot and right after the Band-Aid was placed a couple of minutes she got a weird taste in her mouth and she didn't say anything. She has donated plasma and knows there can be a metallic taste and it was just a shot and whatever it was a funny taste. She sat for the 15 minutes and was fine and got in her car and got nauseous and thought maybe she didn't eat so she started to drive and was calling her fiance to see what he wanted to eat. She started to get tingling pins and needles in her bottom jaw and that was weird to her and she told her fiance about it and got off the phone. She got to the place and ate and the nausea got a little better but she still had the tingling in her bottom jaw. She went home and laid down to take a nap. Shen she got up it was gone and everything was fine. The next day her arm was a little sore and she was tired but that is normal. Her fiance got his and he was tired and so she didn't think anything of it, she works 2 jobs, one at home and also at Target and her first day back was 09Apr2021. States most of the day she was fine but on her last break she was having chest pain for 10 minutes and it went down through her arm and she was nauseous and thought she could walk it off and she was fine and did that for 10 minutes and got sick and she had to go. Her manager and coworkers were worried about her so she went to the urgent care across the street and was told there that she was having signs of a heart attack with her risk factors of high blood pressure, overweight, and a smoker. They gave her 4 baby aspirin and did an EKG and that came back fine and was told she could go up to the ER if she wanted, she asked what that would do and was told they would run blood work. The patient states it was a pressure, painful but pressure. She asked him if this could have to do with the Covid vaccine she got Monday and he said he didn't know but probably not. She told him her symptoms she has listed, the taste, nausea, pins and needles in the jaw and he hung his head and shook it and told her that is another sign of heart issue. The patient went home and laid down for a nap and when she woke up the chest pain was still there and her fiance said she was going to the hospital since the aspirin didn't help and she could go by ambulance or by car. He took her to the ER Friday and they really thought she was having a heart attack and did tests like EKG and X-Ray and those were fine. It was stated that they did a T enzyme for your heart and it was .03 and they said they wanted it below that, that it wasn't bad. She had that test again and it went up so she had a catheter the next day and was told it was not clogged arteries. The patient stated she was diagnosed with coronary vasospasm. It was clarified the name of the test as Troponin and it was .03 and they wanted it below that and had her stay for observation and said it can go up and is a sign of heart damage and heart attack 6-24 hours after the initial pain. The patient stated they gave her nitroglycerin and that helped with the chest pain and it opened all the blood vessels. Throughout the night her Troponin levels went up. She had a cardio cath Saturday and the cardiologist was surprised he thought there was blockage and would place a stent and there was not blockage and nothing wrong. He explained that her blood vessels were so constricted that her heart spasmed as it was not getting enough oxygen and was causing the pain. She asked him if it could be from the Covid vaccine and he said he could not confirm or deny as she is overweight, has high blood pressure and smokes but she has never had issues before. The reason she is calling is because the tingling in the bottom jaw started within 30-45 minutes after the vaccine and she had never had that before and she is not saying it is related or not. This may help other people may be having issues and may help give information to say maybe you shouldn't smoke right after the vaccine or if you have high blood pressure or are overweight you should stay longer. For the next one her cardiologist thinks she should get the 2nd one and she will pay more attention to the signs. She has an appointment tomorrow with her cardiologist and will double check and ask him as they ask you to let them know before the vaccine if you are on a blood thinner and when her Troponin was up they have her blood thinner Warfarin through the night in the hospital and wants to double check to see if that is still in her system and if it's ok to get the 2nd dose. The physician also changed her blood pressure medication she has been on for over 15 years (No further details provided). The patient added she was hospitalized on 09Apr2021 evening and discharged 10Apr2021 around 5pm. For the investigation the patient states after the heart cath. she had an echocardiogram where you lay on your side and they do an ultrasound of your heart. The patient does not know the result of the echocardiogram, assumes it's fine but doesn't know. She took a week off at work as she was told not to bend her wrist from the procedure and has a weight restriction so she is doing her computer job. It was also reported the normal arm soreness and tired are expected but the severe, it helps to report and keep track of and it may be isolated and it may not be. The outcome of the events was unknown. The events required emergency room and physician office visit.
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| 44 | 2021-04-30 | cold extremities, feeling hot, discomfort |
passed out at work; abnormal (more than usual) vaginal bleeding; she felt uncomfortable on the morni...
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passed out at work; abnormal (more than usual) vaginal bleeding; she felt uncomfortable on the morning of 05Apr2021; her hands and feet were cold; she was kind of sweating; she felt sick on 05Apr2021; her body temperature went up; her body felt warm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 04Apr2021 15:45 (3:45 PM) (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. The patient medical history includes Shellfish Allergy (Reported she has had a shellfish allergy for a long time, approximately 7-8 years). She said as long as she had no shellfish, she was completely fine. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). There was no additional vaccine administered on the same date as the COVID-19 Vaccine. The patient previously took bnt162b2 for COVID-19 immunization on 14Mar2021 first dose intramuscular at the left arm (Lot Number: EN6208). It was reported that the patient has received both doses of the Pfizer Covid 19 Vaccine. Her second Pfizer Covid vaccine was received on 04Apr2021. Caller started her menstrual cycle on 07Apr2021. She experienced abnormal vaginal bleeding that night. The following day on 08Apr2021 she passed out at work and was transported to the ER via ambulance. She was advised by the ER provider that her symptom was not related to the Covid 19 vaccine. However, she spoke with her OBGYN and was advised they have heard that abnormal bleeding maybe caused by the Covid 19 vaccine. The patient asked if symptom has been reported? It was further reported that she had her first COVID-19 Vaccine shot on 14Mar2021, and her second COVID-19 Vaccine dose on 04Apr2021 at 3:45 PM (PST). She clarified later in the day on 04Apr2021, the COVID-19 Vaccine kicked in. She said she felt sick on 05Apr2021. She said she felt uncomfortable on the morning of 05Apr2021, but still went to work. She said she felt OK once she got to work, but then took time off from work (on 05Apr2021) because she felt uncomfortable. She said when she got home from work (on 05Apr2021), she took 2 Tylenol. She said she was cold, and her body temperature went up, and she was kind of sweating. She clarified her hands and feet were cold, and later in the day (05Apr2021) her body temperature went up. She said she was aware of the COVID-19 side effects because some of her friends had similar symptoms, so she was kind of expecting the symptoms. She said later in the evening on 05Apr2021, she took 2 Advil and went to bed. She said her body felt warm, but she thought her symptoms were to be expected. She said on 07Apr2021, her (menstrual) period started at 10:00 PM. She said she had abnormal (more than usual) vaginal bleeding for the whole night. She said on 08Apr2021, she felt uncomfortable in the morning when she was getting ready for work. She said she went to work (on 08Apr2021), and at 1:30 PM passed out while at work. She said from her work, she was sent by ambulance to the Emergency Room. She said she was not sure if her passing out had anything to do with the COVID-19 Vaccine, but she had never passed out at work before. She said she asked the Emergency Room doctor about the COVID-19 Vaccine and her passing out. She said the Emergency Room doctor said her passing out had nothing to do with her second COVID-19 Vaccine dose. She said she read more online about the COVID-19 Vaccine. She said she then asked the nurse at her OBGYN's office about abnormal bleeding after getting the COVID-19 Vaccine. She said the nurse had heard of some cases of abnormal bleeding after getting the COVID-19 Vaccine. She said her OBGYN's nurse told her to call to find out if her abnormal bleeding had anything to do with her second COVID-19 Vaccine. She said her OBGYN's nurse provided her with the number to get more information about the COVID-19 Vaccine. It was added that while she was at the Emergency Room, she had 7 vials of blood taken, 2 ultrasounds; an external one of her tummy (abdominal ultrasound), and an internal one where something was stuck in her (transvaginal ultrasound). She said she did not know the results of her testing, and was waiting for a copy of her medical records. The patient also weighed 165 lbs on an unspecified date. It was reported that for the treatment she had taken 2 Tylenol and 2 Advil at different times while at home, but was at work, and didn't have the Tylenol or Advil to provide the dosing, NDC, Lot, and Expiration Dates. For the Emergency Room treatment she reported an EKG was done, and she was given an IV drip. She said she was not sure what IV fluids were given to her. The patient required visit to Emergency Room and stated she was taken by ambulance on 08Apr2021 and discharged from the Emergency Room at 6:00 PM the same day. The patient also visited Physician Office and stated she went for a follow-up with her OBGYN doctor at between 9:00 AM-10:00 AM on 09Apr2021. She said the Emergency Room doctor had called her OBGYN doctor on 08Apr2021, while she was in the Emergency Room. The patient underwent laboratory tests which includes: EKG, Blood Test, Abdominal Ultrasound, Transvaginal Ultrasound (All tests were performed while at the Emergency Room on 08Apr2021. Patient stated she was waiting for a copy of her medical records with the test results). The outcome of the events was recovered on Apr2021.
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| 44 | 2021-05-03 | pain in extremity, weakness, tenderness |
Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me d...
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Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me down with ice on the back of my neck and I felt better. All day felt weak and woozy and brain fog. Lethargic and spacey the following two days. Three days after the shot, I had a pain in my hand and a blood vessel started popping out and hurting. It was quite painful for that evening and night and after ice and rest and ibuprofen, swelling was down the next morning and it's still just a little tender to the touch.
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| 44 | 2021-05-04 | migraine |
Migraine; extreme body aches; shaking chills; nausea; lower abdominal cramps; fever as high as 102; ...
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Migraine; extreme body aches; shaking chills; nausea; lower abdominal cramps; fever as high as 102; General malaise; when washing my hair much more than usual has come out since receiving vaccine; This is a spontaneous report from a contactable other HCP (Patient). A 44-year-old female patient received second dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot# EN5318), via an unspecified route of administration, administered in left arm on 08Feb2021 at 15:00 (at the age of 44-years) as single dose, dose 1 administered in left arm on 18Jan2021 at 02:45 (Lot# EL3246) as single dose for COVID-19 immunisation. Medical history included Lyme disease from 2017, treated with doxycycline. Patient had no known allergies. The patient concomitant medications were not reported. On 09Feb2021 at 03.00 (one day after vaccination), patient experienced migraine, extreme body aches, shaking chills, nausea, lower abdominal cramps, and fever as high as 102 lasting about 48hrs. Then lessening of symptoms over the next 12hrs and normal temp achieved by 60hrs, general malaise and when she was washing her hair much more than usual has come out since receiving vaccine. The patient underwent lab tests which included body temperature as 102 on 09Feb2021, and SARS-CoV-2 test, Nasal Swab: Negative on 09Feb2021 and pending on 12Feb2021. The patient did not receive any vaccine in four weeks nor received other medications in two weeks prior vaccination. The outcome of the events was recovering.
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| 44 | 2021-05-04 | seizure |
Seizure; This is a spontaneous report from a contactable consumer. A 44-year-old female patient rece...
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Seizure; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced seizure on 10Apr2021. The patient had no other vaccine in four weeks. The patient was tested for COVID post vaccination. The patient underwent lab tests and procedures which included nasal swab: negative. Therapeutic measures (medication and follow-up treatment) were taken as a result of seizure. The outcome of the event was not recovered. The event was reported as serious-hospitalized, disability, life-threatening.
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| 44 | 2021-05-05 | muscle spasms |
Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cra...
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Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cramps; Hydroxyzine HCL; Amoxicillin; Acetaminophen.
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| 44 | 2021-05-07 | migraine |
almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on ar...
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almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins. On 05Apr2021, the patient experienced the following events: almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that, it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.
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| 44 | 2021-05-09 | tingling |
Pt. developed a reaction to 1st dose COVID-19 vaccine. Pt. has symptoms of tingling and bilater arm...
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Pt. developed a reaction to 1st dose COVID-19 vaccine. Pt. has symptoms of tingling and bilater arms, no nausea. Pt. has history of Ischemic stroke 9 yrs. ago. No Rx of current medication. No hospital care provided. Pt verbalizes feeling better and recovered. Pt. VS: 107/74, 80 P, 99% O2Sat, Standing BP 117/73, 86 P, 97% O2Sat.
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| 44 | 2021-05-10 | grand mal seizure |
Within less than 36 hours after receiving the 1st dose pf the Pfizer Vaccine, I suffered a Grand Mal...
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Within less than 36 hours after receiving the 1st dose pf the Pfizer Vaccine, I suffered a Grand Mal Seizure . I was treated in the ER and followed up with my Neurologist. Dr. prescribed high dose of anti-seizure medication to take prior to Vaccine #2 on 5/16/2021
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| 44 | 2021-05-11 | speech disorder |
chest heaviness/very strong heaviness in her chest; restricted breathing; more breathless with any a...
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chest heaviness/very strong heaviness in her chest; restricted breathing; more breathless with any activity; breathing was difficult; difficult for his wife to talk and walk (because of her breathing).; difficult for his wife to talk and walk (because of her breathing).; allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband) A 44 year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), intramuscular, administered in Arm Left on 21Apr2021 at 13:30 (at the age of 44 years old)(Batch/Lot Number: EW0162; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. Historical Vaccine includes Dose 1 on 23Mar2021 administered left arm, Lot Number: ER8727 and Expiration Date: 01Jul2021 for covid-19 immunisation ('had no problem'). The patient medical history was not reported. Concomitant medication(s) included phenylephrine hcl (PHENYLEPHRINE HCL) CVS brand NDC Number: 59779-094-68, Lot Number: 0EE3081 Expiry: Jan2022, taken for nasal decongestion therapy from Apr2021 and ongoing.No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. On 22Apr2021, The patient experienced chest heaviness/very strong heaviness in her chest, restricted breathing, allergic reaction, difficult for his wife to talk and walk, more breathless with any activity, breathing was difficult. The patient underwent lab tests and procedures which included electrocardiogram normal: results normal on 24Apr2021. Therapeutic measures were taken as a result of chest heaviness/very strong heaviness in her chest, restricted breathing. The clinical course was reported as follows Husband Reported on behalf of his wife got her first COVID-19 Vaccine dose 1, and had no problem, and was fine. He said when his wife got her second COVID-19 Vaccine dose on Tuesday, 21Apr2021, the first day she was fine, but towards the second day (22Apr2021), she had a very strong heaviness in her chest, and her breathing was restricted. His wife thought she may be having a severe allergic reaction to the COVID-19 Vaccine. Reporter made a few calls to the doctor, and the doctor told him to continue to monitor his wife, and maybe in a day, or 2, her symptoms would go away. On Saturday, 24Apr2021, his wife still had the chest heaviness, and it was very difficult for his wife to talk and walk (because of her breathing). On Saturday, 24Apr2021, the patient went to an urgent care. The doctor (clarified as a PA-physician assistant) looked for other symptoms his wife might have, and told his wife she did not have the COVID-19 Virus. He said his wife was told there were reports that the Pfizer COVID-19 vaccine was known for thickening the blood and for causing inflammation of the heart, said that she had an allergic reaction so an EKG was done at the time, and the EKG was normal. The PA (physician assistant) prescribed Ibuprofen 600mg (Lot Number: DE2607, Expiration Date Feb2022) by mouth daily. Also reported as (' 3 Ibuprofen 200mg tablets a day (600mg total),', and told his wife to return in 3 days if her symptoms were not better. It was also Reported his wife's chest heaviness had gone away, but the came back. Chest heaviness was not worse, but it had not gone away. The caller stated the doctor (PA) concluded that the Pfizer COVID-19 Vaccine produced too many antibodies in his wife, and the antibodies made his wife's blood thick. He said the doctor (PA) prescribed the Ibuprofen to help with his wife's blood flow. Subsequently the patient's husband had called Pfizer to report his wife's experience, but to also to find out how long his wife needed to continue taking the Ibuprofen. Reporter's wife, entered the call. She said the doctor (PA) suggested the Ibuprofen for inflammation. She stated she was more breathless with any activity (if she spoke or moved around). She said if she sat still, her breathing was fine. She said she was not physically tired at all, but her breathing was difficult. She said her chest heaviness was OK yesterday (25Apr2021), but when she woke up this morning, she had the chest heaviness again. She said her chest heaviness was better, but persisting. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected
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| 45 | 2020-12-31 | numbness |
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a...
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Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
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| 45 | 2020-12-31 | pain in extremity |
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 d...
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12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
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| 45 | 2021-01-01 | feeling hot |
Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt...
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Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt hot, lips tingling/swollen and chest red. Denies any issues with breathing.
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| 45 | 2021-01-01 | tingling |
Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm ...
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Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm felt the same with slight improvement in my right arm. Later that day, I felt tingling in my left leg down to my toes. I have felt these symptoms every day since, but they have improved in severity, moving from one side to the other at times. This has not affected my activities of daily living, nor my work as a RN.
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| 45 | 2021-01-02 | feeling cold, weakness | Dizziness and Weakness, Headache, Aches, Cold feeling, Nausea, generally feeling unwell. |
| 45 | 2021-01-02 | flushing, cold sweat |
After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pul...
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After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pulse went night around 119 beats per minute and my blood pressure went high to 150 over 99 .. my sugar jumped to 149 and I got so clammy .. it lasted a good 25 minutes I kept checking my o2 and my pulse finally it went down and I was so tired.. I went home and I was fatigue for 5 days .. I don?t know if I should get the second dose after my heart raced
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| 45 | 2021-01-03 | weakness, tingling, pain in extremity, numbness |
After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm a...
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After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.
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| 45 | 2021-01-03 | burning sensation |
2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at t...
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2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at the front of my neck I had vaccine on 12/30/20 at 1:30 pm, and woke up on 01/01/21 at 7am with the red areas.
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| 45 | 2021-01-03 | numbness, feeling hot | right arm numbness, sensation of throat constriction and heat in her body |
| 45 | 2021-01-03 | pain in extremity, muscle spasms | 24hr extreme malaise (charley horse left calf) left arm pain 24hr temporal headache 24hr |
| 45 | 2021-01-03 | pain in extremity |
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headach...
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Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.
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| 45 | 2021-01-03 | tingling | Tingling of face for a couple hours, starting 2 hours after vaccine, gone by the next day |
| 45 | 2021-01-03 | throat numbness | Had an episode of tounge tingling and numb throat. Lasted 30 min, resolved without any treatment. |
| 45 | 2021-01-04 | feeling hot |
Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness ...
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Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection. Redness was spreading to left lateral neck and across upper chest. Took 50mg chewable Benadryl and 600mg motrin. All symptoms subsided approximately an hour later.
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| 45 | 2021-01-04 | flushing |
itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This...
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itchy flushed skin with a rash; itchy flushed skin with a rash; itchy flushed skin with a rash; This is a spontaneous report from a contactable healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2; reported as Pfizer-Bio-Tech COVID-19 Vaccine; lot number: EH9899; expiration date: unknown), intramuscular left arm on 16Dec2020 10:45 (also reported as 10:50 AM) at single dose for Covid-19 vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient has allergies to medications, food, or other products. It was reported that the patient was given vaccine at 10:50 am and 10 minutes after receiving the vaccine individual developed itchy flushed skin with a rash. She was given Benadryl 50 mg IM (intramuscular) in Right arm at 11:00 am. 11:37 am the itchy skin was less intensified, and vitals were stable. The patient went home with her husband. The event was considered as non-serious, was not life-threatening, did not caused/prolonged hospitalization, did not cause congenital anomaly/birth defect and did not resulted to death. The patient received the COVID-19 vaccine in the Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patent had any other medications the patient received within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and if the patient been tested for COVID-19 since the vaccination. The outcome of the event itchy skin was recovering while the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-01-04 | numbness, tingling |
Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle...
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Face started to tingle then went numb roughly 45-55 minutes after receiving.; Face started to tingle then went numb roughly 45-55 minutes after receiving.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received bnt162b2 (lot number: EL0140, Pfizer- BioNTech), intramuscularly at arm left, first dose on 23Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included environmental allergies, iron deficiency anemia, endometriosis, allergies to penicillin, and allergies to preservatives in flu vaccine from an unknown date. The patient is not Pregnant at the time of vaccination. Concomitant medication included ibuprofen, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), magnesium, all from an unspecified date, for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Age at vaccination is 45 Years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced face started to tingle then went numb roughly 45-55 minutes after receiving (reported as from 23Dec2020, 08:30 AM). Not sure if that is an actual reaction but it occurred. The event was reported as non-serious. Therapeutic measures were taken as a result of face started to tingle then went numb roughly 45-55 minutes after receiving, treatment included BENADRYL orally taken. The outcome of the event was recovered in Dec2020.
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| 45 | 2021-01-04 | pain in extremity |
had a severe pain in upper left hip; hurt to lift my left leg up (while taking a step forward); This...
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had a severe pain in upper left hip; hurt to lift my left leg up (while taking a step forward); This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular in the left arm on 24Dec2020 08:15AM at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included lyme disease from 2014. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive other vaccines in last four weeks. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 25Dec2020 07:30AM, the patient had a severe pain in upper left hip. It felt like an IT band issue she had before but this time it didn't radiate to her knee like it usually does. She did not have exercise since the morning of the 22nd when she did an upper body weight-lifting session. She took ibuprofen that took the edge off, and she was able to finish her day as a nurse in the Covid ICU. The following morning, she felt fine and went to her other job. She was fine in the morning during her usual drills practicing getting out of the helicopter while on the ground. She sat in one of the seats for about 15 minutes while having a discussion when she started to feel the pain again. She got out of the helicopter and tried to walk around, but it hurt to lift her left leg up (while taking a step forward) in Dec2020. She has never experienced this before. She limped back to the hanger, took ibuprofen 600mg and rested/stretched for an hour. The pain was reduced to a minor and tolerable ache. The outcome of the events was recovering. The report was considered non-serious.
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| 45 | 2021-01-04 | tingling |
Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and rin...
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Immediately after shot for 20 minutes was tasting metallic taste and tingling in right pinky and ring finger. Around 11 pm started having metallic taste and cannot get rid of it. Woke up in middle of the night having diarrhea which still having symptoms this morning.
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| 45 | 2021-01-04 | tingling |
Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring ...
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Immediately upon receiving vaccination had metallic taste and tingling in right hand pinky and ring finger. It went away in 20 plus minutes. Around 11 pm started having metallic taste again and woke up with diarrhea in the middle of the night. Symptoms have not subsided.
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| 45 | 2021-01-04 | cold extremities |
12 hours after the vaccine my right hand was really cold. There was a significant difference in the...
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12 hours after the vaccine my right hand was really cold. There was a significant difference in the temperature of the left hand.
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| 45 | 2021-01-04 | tenderness |
Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the tou...
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Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.
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| 45 | 2021-01-05 | inability to speak |
Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine...
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Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine clinic for her second-dose of the pfizer COVID-19 vaccine. Pharmacist then delivered vaccine. Almost immediately after administration, the patient started showing signs of distress including difficulty speaking, and going in an out of consciousness. Ice packs were placed on the back of patient's neck, and she was given water in order to hopes to stimulate consciousness. At this time, the pharmacist placed a pulse oximeter on her finger to monitor. Her oxygen stats dropped to 75% and heart rate dropped to a value slightly greater to slightly under 30 beats per minute as indicated by the pulse ox blinking at 30. Pharmacist timed the period of bradycardia, after 60 seconds an epinephrine pen 0.3mg was administered to the left lateral thigh. Rapid response code was called and team came 1.5 - 2 minutes after epinephrine administration. Oxygen was given to the patient at the scene where her recorded blood pressure was 94/54 mmHg. She was then transported into the emergency department via wheelchair. Patient stabilized and was discharged back to work approximately an hour after arrival.
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| 45 | 2021-01-05 | flushing |
[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative br...
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[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative breathing; believed it to be anxiety related until seeing CDC produced list of symptoms from vaccine. [2] Mild soreness, mild redness at injection site: started 4 hours after vaccine, lasted 24-36 hours. [3] Felt feverish and flushed, arthralgia: started approximately 18 hours after vaccine (12/31/2020). "Fever" initially managed with Tylenol 650 mg. Later that evening took naproxen 440 mg to address arthralgia, which lasted about 2 days. No medication taken on 1/1/2021.
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| 45 | 2021-01-06 | burning sensation |
Burning sensation. Started in left side of neck went to left shoulder then spread out all over body...
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Burning sensation. Started in left side of neck went to left shoulder then spread out all over body. Headache and fever
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| 45 | 2021-01-06 | cold sweat |
CLAMMY SKIN , LABORED BREATHING , DRY COUGH, TREATED WITH BENADRLT . SENT TO ER, PLACED ON DECADRON...
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CLAMMY SKIN , LABORED BREATHING , DRY COUGH, TREATED WITH BENADRLT . SENT TO ER, PLACED ON DECADRON.
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| 45 | 2021-01-06 | flushing, weakness | around 1500 Vomited x 1; HTN 190's/ 116-118; flush cheeks bilaterally; dizzy; weak; |
| 45 | 2021-01-06 | flushing |
felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue;...
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felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue; arms and legs feel heavy; This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek5730, expiration date: unknown), via an unspecified route of administration on the left arm on 30Dec2020 at 08:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included Hashimotos, Celiac, nonalcoholic fatty liver, and known allergies to gluten, eggs whites and eggs yolks, mustard seed, and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), thyroid (NATURE THROID), and an unspecified women's multivitamin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 08:15, also reported as within 10 minutes, the patient felt flushed and at 20 minutes, she started to itch and felt tightness in her throat. The patient left after 30 minutes to go home and take diphenhydramine (BENADRYL). The patient worked at night and slept most of the day except to take BENADRYL and call out from work. Also on 30Dec2020, she noticed fatigue when she woke in the afternoon and her arms and legs felt heavy. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of itch and felt tightness in her throat. She had been on BENADRYL 50 mg every 4-6 hours. The itching and throat tightness remained unchanged. She had used an albuterol inhaler 3 times. The patient did not receive treatment for the other events. The patient was not recovered from the events "felt flushed, itch and felt tightness in her throat, fatigue, and arms and legs feel heavy."
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| 45 | 2021-01-06 | hot flush |
nausea, hot flashes were noted, pt BP 162/98; Spo2 98%; HR 69. Pt given water and waited for extende...
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nausea, hot flashes were noted, pt BP 162/98; Spo2 98%; HR 69. Pt given water and waited for extended period. Pt stated she felt better and was able to ambulate independently. A/O x4
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| 45 | 2021-01-06 | nerve pain, pain in extremity |
Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but ...
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Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but now she is having nerve pain in her right thumb.
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| 45 | 2021-01-06 | tingling, facial paralysis |
Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, starte...
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Allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms, started approximately 10 minutes after receiving vaccine. Reaction resolved with no treatment. Patient developed Bell?s Palsy 2-3 days after vaccine. Currently being treated with high dose steroids and acyclovir.
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| 45 | 2021-01-06 | tingling, night sweats |
Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and ti...
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Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and tingling right hand.
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| 45 | 2021-01-06 | tingling |
I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. ...
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I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. My hands started to tingle and remained that way for three days. I developed a cough, sore throat, and fever. The fatigue was really bad for a few days.
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| 45 | 2021-01-06 | tremor |
At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my...
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At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my elbows but knees and hips as well. Then my neck started really hurting. I got a headache. Nausea and powerful chills that made my whole body violently shake. My core temperature Dropped to below 96, high 95s. Over a period of two hours I have stabilized my body temperature, the shaking has stopped. However the headache and muscle aches persist. No respiratory symptoms have developed. I feel as if I am recovering, over a period of about four hours.
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| 45 | 2021-01-07 | cold sweat, flushing |
I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitati...
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I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitations I was told my skin was clammy then I had another episode I was taken to ER and decardron was given. I was observed in ER for few hours . Since that day I have heart palpitations every day along with chest pain sometimes I am not able to wean off steroids I also had diarrhea on 1/3 that lasted few days . These side effects are very scary every day heart palpitations I feel my heart would stop
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| 45 | 2021-01-07 | discomfort, tremor | Fever, Headache, Shaking Chills, Discomfort in the body. I am taking Panadol every four hours. |
| 45 | 2021-01-07 | facial pain |
Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - a...
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Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; This is a spontaneous report from a contactable physician (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm left), on 19Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received facial filler Restylane, which was injected in Sep2019. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within two to four weeks prior to COVID vaccination. On 22Dec2020, approximately 3 days after vaccination, patient noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas. There was minimal erythema and tenderness only on palpation. The events resolved approximately 3-4 days later (unspecified date in Dec2020). The events did not require intervention/treatment. Outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-01-07 | flushing, discomfort |
After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by ...
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After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.
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| 45 | 2021-01-07 | hot flush |
typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting...
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typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
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| 45 | 2021-01-07 | muscle spasms | Headache, Diarrhea with cramping |
| 45 | 2021-01-07 | pain in extremity |
sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old ...
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sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as COVID-19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose, for Covid-19 immunisation. Medical history included rheumatoid arthritis and allergic reactions (unspecified). Concomitant medications were not reported. After receiving the first dose of the vaccination the patient experienced a sore arm on an unspecified date. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 45 | 2021-01-07 | pain in extremity |
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject...
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Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Rapid Response called @1721, patient monitored.
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| 45 | 2021-01-07 | pain in extremity |
I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain o...
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I got the vaccine on 12/18/20 on my left arm and on 12/28/20, 10 days after I started to have pain on my upper left arm and the next day the pain went to my armpit, back and forth from my upper left arm to my armpit and this went on for at least 5 days. On 01/02/21, 15 days after I notice red bumps on my upper left arm and as days went on red bumps show in my armpit, left back, and chest. The pain went from sharp to burning. On 01/06/21 I got the 2nd dose of the vaccine and I told the injection person about the red bumps. I told him that they look like hives. He spoke with the medical doctor about it and doctor said it was ok for me to get the 2nd dose of the vaccine. They think it was a delayed reaction. They have me monitored for 30 mins after the 2nd dose of the injection before I leave the site. I still have pain and red bumps so I went to see my primary doctor on 01/07/21. The doctor said that I have shingles. I told him that I never had shingles before and he said maybe the vaccine trigger it. He prescribed me some medications for the shingles. I don?t know if the vaccine trigger the shingles or just coincidence but I want to report this maybe someone might have the same experience. Thank you.
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| 45 | 2021-01-07 | pain in extremity |
Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse ...
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Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 3rd of 6 reports. A 45-year-old female patient received a single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) on 29Dec2020 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, on 29Dec2020, the patient had arm soreness and it lasted a few hours. The patient took Tylenol and was fine. She also developed diarrhea and headache, and her symptoms hit her all of a sudden late afternoon on 04Jan2021. No treatment was received. She woke up in the morning of 05Jan2021 and it was all gone. She had a COVID test on 05Jan2021 and it was negative. The patient recovered from the arm soreness on 29Dec2020 and recovered from diarrhea and vomiting on 05Jan2021. The events were considered related to the vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
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| 45 | 2021-01-07 | tingling |
minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, th...
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minutes after the injection the tip of my tongue and lips began tingling and my tongue went numb, the roof of my mouth began to tingle and go numb as. NO difficulty swallowing or breathing, No changes in the vitals and I was given benedryl by mouth and observed for 30 minutes with no further issues and all symptoms resolved. My right arm was tingling and weak also but to date all symptoms has resolved.
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| 45 | 2021-01-08 | bell's palsy |
Bell's Palsy started 12/24 or 12/25/2020 Narrative: Currently being treated by her Primary Care Pro...
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Bell's Palsy started 12/24 or 12/25/2020 Narrative: Currently being treated by her Primary Care Provider with prednisone
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| 45 | 2021-01-08 | flushing, numbness |
I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot adm...
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I waited 30 minutes after the vaccine. No issues and went back to work. At 70 minutes after shot administration, felt itchy on limbs, then trunk and neck, then ears, eyes and into scalp. Symptoms progressed over the next 2 hours (flushed neck and then lips felt tingly and numb). At 7:30 my soft palate started to feel numb and I started to have some difficulty swallowing. Went to ER. Symptoms continued. After IV meds given swallowing difficulty continued to worsen so I was given a low dose shot of Epi. Swallowing improved (not to normal but not as severe) over the next hour but itchiness returned. It is now 8:00pm on 1/9/2021 and I continue to have itchiness, my tongue and soft palate are still numb but I am able to swallow fairly well and my entire face has decreased sensation to touch.
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| 45 | 2021-01-08 | night sweats |
Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hour...
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Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol
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| 45 | 2021-01-08 | pain in extremity |
Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headach...
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Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headache. Took Aleve, headache gone. Day 2 at 1am, woke up with pretty bad arm pain ("why does my arm hurt so bad? Have I lifted too much weight at the gym?") and headache Did nothing; went back to sleep. Day 3, took Aleve again in the evening; headache gone. Day 4, mild headache. Day 5 and on, feeling fine. On Jan 5, for 4 days straight, I fell asleep at 6 and 7 pm. Normally I go to bed at 9am ( I get up at 4am). Felt fine enough to work, just tired at night more than usual. My 2nd dose is scheduled Jan 15 at noon.
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| 45 | 2021-01-09 | pain in extremity | slight headache fatigue sore arm |
| 45 | 2021-01-10 | burning sensation, muscle spasms |
Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms an...
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Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown. Information on lot/batch number for the product has been requested.
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| 45 | 2021-01-10 | slurring, facial paralysis, bell's palsy |
Patient reports having Bell's Palsy with photographic evidence that was noticed approximately 11 hou...
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Patient reports having Bell's Palsy with photographic evidence that was noticed approximately 11 hours (at 7:00pm) after vaccine administration. Patient reports having slurred speech and facial drop. Took muscle relaxant (Robaxin) and prednisone (5 days). Bell's Palsy resolved by 01:00am.
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| 45 | 2021-01-10 | facial paralysis, numbness, bell's palsy |
BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal ...
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BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal headache at night and took Tylenol 500 mg for headache relief. January 4, 2021- The slight numbness in tongue continued and my face started to feel a little different too. I had headaches on and off throughout the day and evening. January 5, 2021- Woke up to get ready for work and noticed that my right eyelid was a little swollen and the right side of my mouth looked different. I arrived at work and my right eye was not closing properly and I was having difficulty blinking. I left work an hour later and went to ER to seek treatment. I was prescribed Prednisone and Valacyclovir for a seven day course. The first time I had Bells Palsy was in 1997 when I was 22 years old.
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| 45 | 2021-01-10 | feeling hot |
Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improv...
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Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improving.
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| 45 | 2021-01-10 | flushing |
Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, di...
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Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, difficulty swallowing. Presented with elevated BP, pulse, normal O2. Symptoms came in waves with increasing frequency. Nausea also occurred as symptoms continued. Patient was monitored for ~15 minutes before Epi Pen (.03mg) was administered. Patient was transported to hospital by ambulance.
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| 45 | 2021-01-10 | numbness |
Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monda...
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Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monday 1/4/21- Started feeling some slight numbness on right side of face and front of tongue, headaches continued on and off throughout the day. Tuesday 1/5/21- Woke up to get ready for work and I noticed my right eyelid was a little swollen and right side of my mouth was numb and smile was slightly crooked. Arrived at work and my right eye was not blinking properly. I went to ER room to seek treatment and was prescribed Prednisone and Valacyclovir. Wednesday 1/6/21- Started with right ear pain that radiated down to right side of neck. This is the second time I've had Bells Palsy. First time was in 1997 when I was age 22.
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| 45 | 2021-01-10 | muscle spasms, weakness, discomfort |
Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling su...
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Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling super tired with no energy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the 45-year-old female patient who receive first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on Saturday (02Jan2021) at single dose (once by injection in the right arm) for covid-19 immunisation. Medical history included ongoing Hypothyroidism from 2008. Concomitant medications included levothyroxine at 75 ug ongoing from 2008 for Hypothyroidism. Medical Professional and told by her work that she could get it because contact with COVID patients. The consumer calls for information about if the side effects she is experiencing after the administration of the COVID-19 vaccine will last for more days. The consumer reported tiredness and other side effects to DSU. A Consumer calls for information about if it would be appropriate the second dose of the COVID-19 vaccine is not administered considering that she had adverse reactions. Consumer calls for information about if the second dose of the COVID-19 vaccine would cause her more side effects than the first one. Received the vaccine on Saturday, 02Jan2021. The day she got it she did not feel anything at all. She was completely fine. She did not even have pain at the injection site. The next day, on Sunday she started feeling super tired with no energy, had body aches, and cramping in legs from 03Jan2021. She has had these for the past 3 days now. She also had chills with no fever from 03Jan2021 to 05Jan2021. She took Tylenol for the first 2 days, but it did not help her at all. She is feeling a little better today, but not much. Her question is, how long will these side effects last? Tylenol: She says it did help a little bit. She think she would just sleep because she was uncomfortable. The Tylenol just did not make her symptoms go away completely. LOT/Batch: AA46487, EXP: Apr2022 UPC: The consumer says the number under the barcode is: 5187536. Feeling super tired and body aches: Has improved about 20%. She says these are all medically significant as she is not able to do what she was able to do before getting the vaccine. She is super tired with no energy and she is confined to her bed most of the time. The consumer confirms this is her first dose of the COVID Vaccine. She thinks she got the standard dose. Vaccine card does not have the expiration date or NDC written on it. Unknown causality. She said that she could be positive for COVID. She is unsure. The outcome of the event Chills with no fever was recovered. The outcome of the event Cramping in legs was not recovered. The outcome of the other events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-10 | pain in extremity |
arm soreness and pain with movement, "super sleepy" " I could not speak tomy daughter" headache, t...
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arm soreness and pain with movement, "super sleepy" " I could not speak tomy daughter" headache, throbbing arm pain
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| 45 | 2021-01-10 | pain in extremity |
About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after an...
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About 3 hours after vaccine severe arm pain in left arm which I expected was normal shortly after and still today intermittent vision(focus) issues and twitching of right eye with some slight right eye pain
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| 45 | 2021-01-11 | feeling hot, cold sweat |
Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the ...
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Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.
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| 45 | 2021-01-11 | feeling hot, feeling cold |
Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afterno...
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Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afternoon around 4 or 5 got really hot and then in the evening around 9 got really cold and face started to itch. chin was bumpy and face was itching, eyes were still hurting with slight headache. I did have vivid dreams at night and slept not well. in the am my face was itchy red eyelids and under eye, patch like rash on face and itch . Ankles hurt to walk (joints hurt) and arm site was painful and hurt. was cold on and off during day and monday it was hard to wake up, v ery drosy and exhausted. Later that day the face cleared up and i could walk fine and headache was gone . I did feel a little cold monday night. Tuesday everything gone except a slight itch here and there on my face. I feel fine and arm pain is gone as well.
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| 45 | 2021-01-11 | flushing |
Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for hersel...
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Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for herself. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EK9231), via an unspecified route of administration in left arm on 03Jan2021 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse. Patient was allergic to some chilis and animals. There were no concomitant medications. The patient experienced dizzy, flushed after injection on 03Jan2021. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, the patient been not been tested for COVID-19. Outcome of events was recovered in Jan2021.
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| 45 | 2021-01-11 | nerve pain, pain in extremity |
Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontan...
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Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek5730, expiry date: unknown), intramuscular on the right arm on 16Dec2020 11:00 to at a single dose for an COVID-19 immunization. Medical history included hypertension, obesity, lymphadenopathy, and migraines. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan, clonazepam (KLONOPIN), duloxetine hydrochloride (CYMBALTA), gabapentin (NEURONTIN), ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX), and zinc. The patient experienced right arm soreness, kinda like nerve pain and can't lift her arm up or reach the back on 16Dec2020. Outcome of the events was not recovered. No treatment was received for the events. The patient underwent lab test which included COVID test (nasal swab) on 19Dec2020 and 26Dec2020: both negative. The reporter considered the events non-serious.
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| 45 | 2021-01-11 | pain in extremity, feeling hot |
A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was ...
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A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was sleeping I had very vivid dreams. I was cold all night. When I woke up my arm was sore to touch , to move and both ankles hurt to walk and I started itching on my face. Started Saturday in the evening( chin, nose) Eyelid and underneath was red and I also had a headache. I had blotches on my cheek. Next day I woke up and no change but I was extremely fatigued.. Monday 10am it started going away. By evening majority of pain was gone. About 98% recovered. I still have some itching and chills.
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| 45 | 2021-01-11 | tingling, hypersensitivity of all senses |
Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility ...
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Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
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| 45 | 2021-01-12 | discomfort, cold sweat |
pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 13...
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pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 130's, BP 134/78. c/o feeling pressure in throat. Rapid response called and patient assisted to stretcher and transported to ED.
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| 45 | 2021-01-12 | discomfort |
Swelling, redness, itching and burning radiating out from injection site starting two days after, in...
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Swelling, redness, itching and burning radiating out from injection site starting two days after, increasing in severity over time, got to the size of an orange, went to urgent care, treated with steroids and antihistamines. All localized, no other symptoms. Medication started 1/13/2021 but the initial antihistamine helped with discomfort.
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| 45 | 2021-01-12 | feeling cold | Chills, joint pain, redness/swelling/itching at injection site |
| 45 | 2021-01-12 | feeling hot, weakness |
after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrin...
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after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrine injection and 911. patient waited around for about an hour after vaccination - patient BP went up, felt weak, signs of weakness, tongue big and throat closing - patient refused epinephrine again, called on call doctor who suggested Benadryl 25mg. Facility gave patient 25mg Benadryl IM. Patient to be monitored at facility
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| 45 | 2021-01-12 | feeling hot |
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck....
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At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
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| 45 | 2021-01-12 | feeling hot | HOT, HARD RED AREA, BLISTERING, PAINFUL |
| 45 | 2021-01-12 | flushing |
Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:2...
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Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:28: Pt c/o dizzy & chest tightness, appeared pale, monitoring; 08:34: Pt c/o increased chest tightness 130, 144/81, 22, 100% monitoring 08:36: Epinephrine .3mg given IM to R thigh, pt. reported flushing, pounding heart, 911 called; 08:40: Pt flushed.
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| 45 | 2021-01-12 | numbness, flushing |
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ...
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Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider made aware at 09:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 BP 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 09:56 BP 164/89, heart rate 72, oxygen saturation 100% on room air, temperature 97.7, vitals checked again at 10:00 BP 158/95, heart rate 75, oxygen saturation 100% on room air, and temp 97.7. Heart palpitations resolved. Provider prescribed Diphenhydramine 25mg x2capsules to be taken at home. Provider referred patient to urgent care and follow up with PCP.
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| 45 | 2021-01-12 | numbness, flushing |
Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on ...
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Pt received vaccine on left deltoid at 8:56am. Checked on pt at 9:05 pt stated she had itchiness on her back, heart palpitations and right handed numbness, and felt flushed. Provider notified at9:05. Vitals taken at 9:15 temp 98.8, heart rate 83, blood pressure 150/91, and oxygen saturation 96% on room air, at 9:26 bp 151/88, heart rate 73, and oxygen saturation 99% on room air, blood pressure rechecked at 9:32 and was 151/88. Vitals rechecked at 9:56am temp 97.7, BP 164/89, HR 72, oxygen sat 100% on room air. Vitals at 10:00am BP 158/95, HR 75, oxygen sat 100% on room air, temp 97.7. Provider prescribed Diphenhydramine 25mg x2 capsules to be taken at home, and referred patient to urgent care and follow up with primary care provider.
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| 45 | 2021-01-12 | pain in extremity |
In the first 12 hours after the vaccine I developed left arm pain. Approximately 12 up to 36 hours a...
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In the first 12 hours after the vaccine I developed left arm pain. Approximately 12 up to 36 hours after the initial vaccine was given, I developed low-grade fevers. headaches, myalgia, chills, and severe fatigue. It?s now about 48 hours later and I still experience mild fevers occasionally.
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| 45 | 2021-01-12 | pain in extremity |
The day after the second vaccine I had significant arm soreness and some fatigue and malaise. On Sat...
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The day after the second vaccine I had significant arm soreness and some fatigue and malaise. On Saturday two days after the second dose I had significant dizziness which might be considered vertigo. I am now six days past the second vaccine and continue to have dizziness.
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| 45 | 2021-01-12 | pain in extremity | Fever 100.9 for 5 days. Muscle aches, chills, headache. Arm pain entire left arm. |
| 45 | 2021-01-12 | tingling |
12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow a...
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12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow and shoulder intermittently 12/26/2021-vomiting and constant severe burning pain in left arm. Applied ice pack 12/27/2021-went to ER for the constant severe pain. Given prescriptions for prednisone 60mg orally x two days and norco. Later that night left arm between elbow and shoulder was bright red and hot to the touch. Took Benadryl liquid and the redness/heat went away in 4 hours. Shoulder, tricep, and bicep have continued to hurt with tingling in fingers. Have seen primary care physician at clinic and Dr. with another facility. Have orders for an MRI and follow up with the other facility
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| 45 | 2021-01-13 | feeling cold |
FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJEC...
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FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJECTION SITE, FEELING BAD.
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| 45 | 2021-01-13 | flushing |
Flushed; This is a spontaneous report from a contactable other healthcare professional (patient). A ...
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Flushed; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 20:00 at a single dose for COVID-19 immunization. Medical history included HTN and pericarditis. Concomitant medication included valsartan, spironolactone, amlodipine, desvenlafaxine succinate (PRISTIQ) and ascorbic acid (C 1000). The patient experienced flushed on 08Jan2021 at 19:00. No treatment was received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. No allergies to medications, food, or other products. Outcome of the event was not recovered. Information about batch/lot number has been requested.
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| 45 | 2021-01-13 | hot flush, pain in extremity |
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau...
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shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
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| 45 | 2021-01-13 | night sweats |
Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it...
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Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it did help.
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| 45 | 2021-01-13 | tingling, facial paralysis |
Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red ra...
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Allergic reaction to vaccine; tingling to upper lip and face; tingling to upper lip and face; red rash on bilateral forearms; Patient developed Bell's Palsy 2-3 days later; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 23Dec2020 at 14:30 at single dose in left arm for covid-19 immunization. Medical history included mitral valve prolapse from an unknown date, and allergies: Cephalosporins and nut (peanut derived). Concomitant medication included epinephrine (EPIPEN) 0.3MG/0.3ML, fluticasone propionate 50MCG/ACT nasal spray. On 23Dec2020 at 14:45, the patient experienced allergic reaction to vaccine, tingling to upper lip and face, red rash on bilateral forearms. Reactions resolved with no treatment. The patient developed Bell's Palsy 2-3 days later in Dec2020. Currently being treated with high dose steroids and acyclovir. All events required emergency room visit and physician office visit. All events were reported as non-serious by reporter. The outcome of event Bell's Palsy was not resolved, outcome of other events was resolved on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if the patient has been tested for COVID-19 since the vaccination.
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| 45 | 2021-01-14 | weakness |
Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fat...
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Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination. Information on the lot/batch number has been requested.
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| 45 | 2021-01-14 | feeling hot |
Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extrem...
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Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1686) via an unspecified route of administration on 06Jan2021 11:00 AM at a single dose in the left arm for Covid vaccine. Medical history included GERD. Concomitant medication included omeprazole (received within 2 weeks of vaccination). The patient had known allergies to erythromycin and hydrocodone bitartrate/paracetamol (VICODIN). The patient was not pregnant at the time of vaccination. She was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine. On 06Jan2021 16:00 (04:00 PM), the patient experienced extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours), it started 5 hours after injection and lasted 48 hours. Treatment was not received for the events. The events were non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 since the vaccination (post vaccination). The outcome of the events was recovered on 08Jan2021 16:00.
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| 45 | 2021-01-14 | flushing |
Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 H...
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Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 HR 97 RR 16 Temp 36.5 No SOB or throat tightness. Patient sat for 15 minutes after vital signs. Given water. Felt much better. BP 145/94 HR 87 RR 14. No more shaking of hands. Discharged from clinic and recommend to report for next shot and let them know to monitor for 30 minutes.
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| 45 | 2021-01-14 | hot flush |
Hot flush feeling felt like she was going to pass out started getting wizzy and raspy breathing hasn...
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Hot flush feeling felt like she was going to pass out started getting wizzy and raspy breathing hasn't been great
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| 45 | 2021-01-14 | hot flush | wheezing tight chest headache had to use a breathing treatment hot flush sensation |
| 45 | 2021-01-14 | hot flush |
Approximately a minute after receiving it I felt a wave of heat start at my feet and go to my head. ...
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Approximately a minute after receiving it I felt a wave of heat start at my feet and go to my head. I then felt my heart rate increase. I took my heart rate from my apple watch and it was 145. Spoke to the nurse on site and she took my BP which was 185/140 (I am normally 120/80). Within a few minutes the heart rate started to drop but I was taken to the ED to be monitored. remained slightly tachicardic, but it was much better and BP dropped but was still elevated upon release -
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| 45 | 2021-01-14 | numbness, sensory loss, tingling |
Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and f...
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Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and fingertips.
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| 45 | 2021-01-14 | numbness |
After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then...
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After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then she couldn't remember her name and date of birth for 5 minutes. She then felt her throat was swelling. 911 was called and paramedics checked her blood pressure and vitals were within range. She was monitored at the hospital and was doing fine.
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| 45 | 2021-01-14 | pain in extremity, hot flush |
wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feel...
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wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feels tight, almost like she is congested
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| 45 | 2021-01-14 | pain in extremity |
Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with feve...
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Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with fever 101.0, body aches, dizziness, fatigue enlarged lymph node at left axilla, same side as shot, mild nausea, and a sore left arm. Felt sick for about 12 hours with these symptoms, fever resolved slowly with ibuprofen. Symptoms mostly resolved in 24 hours, except I still have an enlarged lymph node - left axilla with throbbing pain. No fever.
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| 45 | 2021-01-14 | pain in extremity |
Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared ...
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Severe pain in both arms few hrs after injection given in left arm. Now, right arm swollen compared to left. Carpal tunnel pain at wrist. Worse at night and when holding arm in downward position. Have not had carpal tunnel before. No injury to arms. No recent trauma or heavy lifting
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| 45 | 2021-01-14 | tingling |
About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal an...
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About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal and upper arm. Vital signs within normal limits. Improved
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| 45 | 2021-01-15 | weakness |
On 1/11/2020 I got my second dose and the same night I started feeling sick it felt tired, I felt fe...
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On 1/11/2020 I got my second dose and the same night I started feeling sick it felt tired, I felt feverish but no fever, achy, headache, weak it felt like I had the flu it lasted 3 days. Telehealth appointment with my doctor 1/12/2020
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| 45 | 2021-01-16 | feeling cold, weakness, pain in extremity |
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul...
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2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
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| 45 | 2021-01-16 | muscle spasms | Fever, muscle spasms to the point of difficulty walking, severe nausea |
| 45 | 2021-01-17 | night sweats |
4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen a...
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4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen and Aspirin helped somewhat. 9pm severe fatigue, followed by worsened fever, worsened headache, throat tightness, nausea, myalgia, and waking hourly until 8am. Oral temp at 9am (1/17) was 100.6. Acetaminophen plus aspirin helped. 1/17 all day headache, malaise, poor appetite, and crying. 1/18 woke every 3rd hour to change clothes from night sweats. By 9 am had abdominal cramps, low grade headache, still malaise, and still low appetite. Still not recovered fully.
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| 45 | 2021-01-17 | tingling, numbness |
Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) af...
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Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.
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| 45 | 2021-01-18 | flushing |
Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels...
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Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels wierd." Feeling anxious. At 3:10pm, BP 165/74 HR=78 O2 sat=99%. At:3:30pm, BP=155/72. Symptoms improving. Patient released from clinic at 3:32pm.
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| 45 | 2021-01-18 | flushing |
Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but...
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Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but cough and a feeling of pressure in face worsened. Cough persisted and she was unable to sleep that night. Took Benadryl, Pepcid and pushed fluids. No further airway prolbems, but did not work the next day. Was back at work and back to normal on Jan 15.
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| 45 | 2021-01-18 | pain in extremity |
Left arm was sore all day Sunday and Monday. Monday night I noticed a lump in my armpit. It is painf...
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Left arm was sore all day Sunday and Monday. Monday night I noticed a lump in my armpit. It is painful and still there.
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| 45 | 2021-01-18 | pain in extremity |
Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore,...
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Night of 2nd dose had chills/body aches. Developed diarrhea next day. Arm became swollen and sore, red and itchy. Continued to get progressively more red, sore, itchy and swollen. On day 5 post vaccination, seeing by primary care doctor and diagnosed with cellulitis. Placed on antibiotics.
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| 45 | 2021-01-18 | tingling | tingling in arm, progressive tingling and paresthesia in back and legs |
| 45 | 2021-01-18 | tenderness |
on Jan 13, 2021 I developed a rash on my back. It was a little tender. Then on 1/14th I developed a...
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on Jan 13, 2021 I developed a rash on my back. It was a little tender. Then on 1/14th I developed a little more rash on my left side and under my left breast. The rash is painful. Diagnosed with Shingles!!
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| 45 | 2021-01-19 | weakness |
Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 11...
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Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 112, RR 28 ,Pox 100% RA (at 1700) Repeat vitals at 1710 BP 217/110, HR 103, RR 32, Pox 97% RA. Symptoms became progressively worse. She was given water. She reports she takes Metoprolol and Nefedipine ( last dose 1/20/21) and HCTZ (last dose 1/19/21. She also began to report feeling weakness as well. Due to persistent symptoms she was transported to the ER at 1715 via wheelchair.
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| 45 | 2021-01-19 | weakness | Hives around the waist, weakness/ tired at 0500 1/20 |
| 45 | 2021-01-19 | breast pain |
1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (...
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1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (both not as severe as 1st dose), two days post injection = painful and swollen right axilla lymphadenopathy and right breast pain...used right deltoid for injection site. Also, noted fatigue and chills w/o known fever.
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| 45 | 2021-01-19 | burning sensation, tingling |
1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itchin...
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1/15 starting with burning tingling hands that become itchy and tingling, burning, hives, and itching all through body that comes and goes. Could this be delayed reaction to vaccine? highly concerned about getting 2nd vaccine.
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| 45 | 2021-01-19 | numbness, flushing |
Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the ...
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Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the dose. Symptoms completely resolved after diphenhydramine within 75 minutes. Patient signed out against medical advice.
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| 45 | 2021-01-19 | numbness, tingling |
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh...
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3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
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| 45 | 2021-01-19 | numbness, cold extremities, tingling |
pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue are...
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pt c/o tingling on left facial area with numbness. Also; c/o tingling of lips, facial and tongue area. C/o LA hand coldness.
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| 45 | 2021-01-19 | pain in extremity |
12/29/20 , left arm soreness, sinus issue, throat issue, which by 12/30/20 sinus/chest congestion w...
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12/29/20 , left arm soreness, sinus issue, throat issue, which by 12/30/20 sinus/chest congestion with cough. HD tested for Covid 19 (negative on 1/1/21) Started aka seltzer cold and flu medicine, seen in respiratory clinic on 12/31 - started new meds codeine with guaifanesin cough syrup, Flovent inhaler, and Mucinex Max strength cold and flu. 1/8/21, felt more fatigued and cough felt more violent. Seen again in respiratory clinic 1/11/21 negative chest X-ray and Covid 19 test, continue same regimen - rest, OTC, inhalers. 1/20/21, first day of feeling overall improvement, still ongoing cough.
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| 45 | 2021-01-19 | seizure like phenomena, weakness, numbness, tremor |
Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had n...
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Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had numbness loss of feeling to leg leg. Was admitted to Hospital for 5days. Had intermittnet seizure type episodes. Has had labs and imaging tests that have been neg Under the care of the A Neuro Group. MRI scheduled for 1/20/21. As of 1/20/21 feeling better but still weak.
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| 45 | 2021-01-19 | sensory loss |
a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, thro...
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a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, throbbing headaches, difficulty operating a vehicle. The dizziness has now gotten bad enough that it is causing nausea.
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| 45 | 2021-01-20 | weakness |
High temperature starting at 3:00 am (101.84, 38.8 Celsius), severe headache, pain all over the bo...
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High temperature starting at 3:00 am (101.84, 38.8 Celsius), severe headache, pain all over the body and shortness of breath, as soon as I tried to drink water I threw up, extreme tiredness and weakness. Slept basically the whole Sunday (1/17). Around late afternoon it started getting better and I was able to eat some soup. But still tiredness and weakness and shortness of breath. I took Ibuprofen 600 3 times that day but it didn't help. On Monday 1/18 headache got better but still extreme shortness of breath and weakness and back pain. Today 1/21 I'm still having shortness of breath and back pain.
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| 45 | 2021-01-20 | numbness | Pain and numbness on the left side of the body from head to toes, lump on L side of throat |
| 45 | 2021-01-20 | numbness |
Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was cl...
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Hives, shortness of breath, dizziness, chest pain, numbness of lip and face, felt like throat was closing. Was rushed to the hospital.
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| 45 | 2021-01-20 | migraine | Migraine, exhaustion x 48hrs, nausea |
| 45 | 2021-01-20 | migraine | Migraine with nausea and vomiting, extreme fatigue x 48hrs |
| 45 | 2021-01-20 | pain in extremity, burning sensation |
Since the 1/14/2021 Pfizer COVID vaccine, I had L 2nd MTP and R 3rd MTP burning sensation on 1/15/20...
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Since the 1/14/2021 Pfizer COVID vaccine, I had L 2nd MTP and R 3rd MTP burning sensation on 1/15/2021 (like I had foot blister or stubbed a toe). Then, I had petechiae with discoloration on 1/16/2021 and 1/17/2021. With my preexisting Raynaud, I believe the COVID toes again (pictures attached) are a COVID vaccine immunogenic response rather than COVID infection itself given my serial negative COVID PCR, absence of other symptoms, and only home/work social bubbles for > 7 days. I have reported to Pfizer for vaccine adverse events.
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| 45 | 2021-01-20 | pain in extremity |
Site soreness,body ache,headache,chilling12/28/21 Tylenol around-the-clock, ice for site soreness 1...
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Site soreness,body ache,headache,chilling12/28/21 Tylenol around-the-clock, ice for site soreness 12/30/20 vomitted
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| 45 | 2021-01-20 | tingling, cold sweat |
approx 15 minutes after receiving the vaccine, client started c/o tingling in hands and arms bilater...
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approx 15 minutes after receiving the vaccine, client started c/o tingling in hands and arms bilaterally, as well as clammy hands and light headedness. She also said her eyes were foggy. Vital signs monitored and o2 given per mask. She c/o frontal area head pain, resolved after being on O2 for 5 minutes. 4:05pm says clamminess in hands and light headedness improved. She was release to drive home and told to report to ER if she has any more problems. client does report today of having daily headaches since she received her shot.
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| 45 | 2021-01-20 | tingling, numbness | Numbness, tingling, itching of left arm, whereas vaccine was administered to the right arm |
| 45 | 2021-01-20 | tingling |
Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, di...
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Body aches, tingling in lip/tongue, tongue swelling, fever, tingling in left arm above the elbow, diarrhea, rash, sore throat, headache
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| 45 | 2021-01-21 | weakness, pain in extremity | Arm sore, Tired, weak, fever 100.3 |
| 45 | 2021-01-21 | feeling cold | Injection site pain, muscle aches, chills |
| 45 | 2021-01-21 | muscle spasms |
Muscle cramps, fever, nausea, chills, headache , Pain in armpit Treated with Tylenol, ibuprofen ,...
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Muscle cramps, fever, nausea, chills, headache , Pain in armpit Treated with Tylenol, ibuprofen , and mucinex cold and flu
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| 45 | 2021-01-21 | night sweats |
Headache, muscle pain (extensive), joint pain (extensive), chills and then night sweats. Generalized...
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Headache, muscle pain (extensive), joint pain (extensive), chills and then night sweats. Generalized malaise
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| 45 | 2021-01-21 | pain in extremity, migraine |
2 hours post vaccine I was at observation at the ER due to reaction I had with the 1st dose. By 11:3...
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2 hours post vaccine I was at observation at the ER due to reaction I had with the 1st dose. By 11:30AM I had a slight headache that progressed to a migraine, around 8PM I started feeling flu like symptoms and chills. At the ER my temp was 99.7F the symptoms lasted for 24 hours but the soreness of the arm that lasted around 2 days.
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| 45 | 2021-01-21 | pain in extremity |
R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Foll...
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R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Following day, r arm sore, fatigue sinus pressure continued. After second day, no more fatigue, sinus pressure but developed vertigo with nausea, vomiting and diarrhea.
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| 45 | 2021-01-21 | pain in extremity | Mild headache Woke up to really sore arm Chills Low grade fever of 100.5 F Had covid 3 months ago |
| 45 | 2021-01-21 | pain in extremity | Fever , severe chills , body aches , abdominal pain , arm pain |
| 45 | 2021-01-21 | tenderness |
Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injectio...
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Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injection site. Woke up around 1:30am on 1/19/21 and could not go back to sleep with overall malaise and pain in my right axilla (ipsilateral to vaccine); upon palpation of this area, I could feel enlarged lymph nodes, very sensitive to the touch (never had this from a vaccine, and I take usual flu shots and others occasionally recommended). Malaise slowly went away during the day, pain in right axilla persisted, although not as bothersome for about 2 days. On 1/19/21, I also had myalgia, which were still present on 1/20/19, but slowly subsided. Today 1/22 the enlarged right axillary adenopathy is still palpable, mild to no pain.. No additional symptoms.
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| 45 | 2021-01-23 | numbness |
Immediate funny taste in back of nose, back of throat. Tingly tongue. In about 15 minutes, cheeks nu...
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Immediate funny taste in back of nose, back of throat. Tingly tongue. In about 15 minutes, cheeks numb and swollen feeling.
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| 45 | 2021-01-24 | discomfort, tingling |
About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and m...
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About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and my face felt heavy. I looked myself in the mirror, my face, cheeks and neck became very red like beet red and warm to the touch. I returned to the vaccine site and they observed me but the symptoms worsened, my eyes started getting puffy/ my cheeks started getting purple instead of red, and they sent me to the ER. At the ER they continued to monitor me and gave me IV Benadryl and IV Pepcid and IV steroids and said I had a delayed case of hives. Once I had all the IV medication the swelling went down and the hives on my arms and my back went away, the redness in my face and neck stayed until next day and I noticed after taking a warm shower the next day the redness returned on other parts of my body. I took a Benadryl. About after 2 days it was all resolved.
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| 45 | 2021-01-24 | flushing | HA/CP/Flushed/SOB/Dizziness after 20minutes-- > was taken to ER |
| 45 | 2021-01-24 | numbness, numbness |
She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had bod...
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She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.
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| 45 | 2021-01-24 | pain in extremity |
About 13 hours after the vaccine she began having body aches and chills, headache and arm pain, extr...
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About 13 hours after the vaccine she began having body aches and chills, headache and arm pain, extreme thirst, temperature of 100.1. The next morning she had a temperature of 101.2 with improvement of the chills but ongoing headache and body aches.
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| 45 | 2021-01-24 | pain in extremity |
Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours...
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Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours and woke with a fever 100.3 treated with Tylenol. Saturday, fever 100.0 most the day and was tired. Sunday felt better. Today better.
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| 45 | 2021-01-24 | pain in extremity |
Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she...
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Soreness in her Left arm on 1/18. Congestion at 2am on 1/19 then when she went into work on 1/19 she lost her voice and she had face and neck/throat swelling
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| 45 | 2021-01-24 | tingling, pain in extremity, weakness |
I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm,...
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I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
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| 45 | 2021-01-25 | feeling cold |
Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out...
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Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out. Felt better minutes later. Reports rash to body 2 weeks after 1st injection.
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| 45 | 2021-01-25 | pain in extremity, weakness, feeling hot |
I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating a...
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I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating and getting really hot. I felt like I might need to use the restroom (soon) and I was at the grocery store. So, I immediately left. My house is 5-7 minutes from the store. During this time, I experienced terrible pains in my stomach and lower abdomen. I barely made it through my door and had to run to my bathroom. I experienced diarrhea like I?ve never experienced in my life. It was painful and explosive. This lasted about 30 minutes on and off. Mostly on. Once I cleaned myself up, I was very tired and weak. I felt nauseous this entire night but have not had any other episodes. I also have not invested anything except water since this happened.
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| 45 | 2021-01-25 | tremor, hot flush |
Rapid Response Team called to vaccination observation room. Arrived to find patient sitting in chair...
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Rapid Response Team called to vaccination observation room. Arrived to find patient sitting in chair, reports immediately after receiving vaccine feeling flushed and shaky, BP checked 172/95 MAP 115. Denies PMH of HTN, reports baseline BP 120s-130s/60s-70s. Denies CP/SOB or throat scratchy/swelling but does report jaw pain. Reports only allergy is to PCN, last meal was a protein shake ~1 hour prior. Symptoms did not resolve when placed in supine position, reported the feeling of ?flushed? worsening. Decision made to transfer patient to ED for further evaluation. ED work-up negative. Was observed for one additional hour in ED and discharged to home. No further symptoms documented in ED.
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| 45 | 2021-01-26 | weakness | Fever ranging from 102-104, headache, fatigued, weak, body aches |
| 45 | 2021-01-26 | discomfort |
lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on ...
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lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on the injection side and it's painful; This is a spontaneous report from a contactable nurse and other hcp (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: EL1283, expiry date: unknown), via an unspecified route of administration on 11Jan2021 09:00 at single dose (left deltoid) for COVID-19 immunization. There were no medical history and concomitant medications. On 12Jan2021, patient had lymph node swelling on the same arm as the injection site. It got worse on the 13th. She described her experience as uncomfortable. She was asking how long it is expected to last. It was further reported that the patient received first Covid-19 vaccine on 11Jan2021 and is doing well, but had lymph node swelling in axillary area on the injection side and it's painful on 12Jan2021. She wanted to know how long it will be like that and if it doesn't go away when should she seek medical attention. Received the vaccine on the 11th and a couple days later had the lymph node swelling. She then clarified lymph node swelling started the 12th. Mentioned it got worse yesterday and it's staying about the same today with the swelling and is very uncomfortable (Jan2021) and is persisting. Causality not provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in the past. Vaccination Facility Type was Clinic. The outcome of the events was not recovered. Events reported as medically significant.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events swollen lymph nodes and lymph node pain. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | flushing |
Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of recei...
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Mouth and tongue tingling progressed to increased heart rate and flushing within 10 minutes of receiving vaccine. Transported to ER. Still has rash as of 1/27/2021 face, behind knees, and torso.
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| 45 | 2021-01-26 | hot flush |
intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; p...
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intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | migraine, weakness |
I'd heard about these side effects, was more than I expected, couldn't go to work that day since I w...
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I'd heard about these side effects, was more than I expected, couldn't go to work that day since I was in bed with side effects. Felt like more than any vaccine I'd received in my life, so decided to report just since this is a new vaccine. About 10 hours after vaccine, chills and fever started, fever up to 101, body weakness, lack of appetite, headache/migraine. Insomnia that night, up all night due to symptoms. . All symptoms except migraine resolved over the next 24 hours. Migraine continued so I took 50 mg imitrex x 3 over the course of the next 36 hours until that finally resolved . So all symptoms gone after around 2.5=3 days.
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| 45 | 2021-01-26 | pain in extremity, numbness |
Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in a...
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Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in arm. Pt still having Anxiety.
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| 45 | 2021-01-26 | pain in extremity |
mild arm soreness that lasted a few days; headache; This is a spontaneous report from a contactable ...
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mild arm soreness that lasted a few days; headache; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 22Dec2020 09:30 at single dose on the right arm for COVID-19 immunization. The patient's medical history included hypertension, anxiety, degenerative arthritis and allergies: sulfa. The patient's concomitant medications were none. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After first shot given at 09:30 by 12:00, patient had a headache and mild arm soreness that lasted a few days. No treatment received. Outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-01-26 | tenderness, burning sensation |
Injection was given firmly and arm bled. Arm was hurting immediately. Two days after injection, pain...
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Injection was given firmly and arm bled. Arm was hurting immediately. Two days after injection, pain at injection site was gone but left pectoral muscle and anterior left rotator cuff began to ache. Six days post injection pain intensified and burning sensation began in left pectoral muscle, left clavicle, and left anterior rotator cuff. Arm was placed in a sling to reduce movement and anti-inflammatory meds and Tylenol were taken for the pain. Twelve days post injection pain subsided and I was able to stop using sling and meds. Currently only tenderness remains with certain movements.
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| 45 | 2021-01-26 | tenderness, burning sensation |
Injection was given with some force, arm bleed at injection site, arm started hurting immediately an...
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Injection was given with some force, arm bleed at injection site, arm started hurting immediately and continued for 2 day. Two days after injection left pectoral muscle and left anterior rotator cuff became achy. Six days post injection moderate to severe pain with burning sensation occurred in left pectoral muscle, around left clavicle, and left anterior rotator cuff. Pain continued for 5 days. I placed arm in sling to reduce movement and took anti-inflammatory meds with Tylenol for the pain. 13 days post injection, pain subsided. I am currently able to move arm without pain, only tenderness around anterior rotator cuff remains. No accidents occurred.
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| 45 | 2021-01-27 | weakness, pain in extremity |
Body aches (muscles and joints); Body aches (muscles and joints); tiredness; weakness; left arm very...
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Body aches (muscles and joints); Body aches (muscles and joints); tiredness; weakness; left arm very sore; left earache; back and neck pain; back and neck pain; Fever 102; Chills; Body aches (muscles and joints); This is a spontaneous report from a contactable consumer (patient herself). This 45-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL33029), via an unknown route, on 16Jan2021 (at 09:45) at single dose administered on the left arm for COVID-19 immunisation, administered at hospital. Relevant medical history included high blood pressure, asthma and COVID-19 (prior to vaccination). The patient was receiving concomitant medications (unspecified). On 17Jan2021 (at 08:00 AM), the patient developed fever 102, chills, body aches (muscles and joints), tiredness, weakness, left arm very sore, left earache, back and neck pain. It was unknown if the patient received treatments for the events. The patient was recovering from the events.
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| 45 | 2021-01-27 | weakness | Chills, body aches, weakness, fatigue |
| 45 | 2021-01-27 | feeling hot | Felt suddenly hot, sweaty, dizzy. H20 given, resolved on own stayed 30 min |
| 45 | 2021-01-27 | feeling hot |
Patient with a PMH significant for allergic rhinitis and cyclic neutropenia, as well a pre-syncope w...
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Patient with a PMH significant for allergic rhinitis and cyclic neutropenia, as well a pre-syncope with previous blood donations received COVID-19 vaccine at 0645 and approximately 1 hour later developed a generalized feeling of warmth, followed by lightheadedness/dizziness. She denies frank LOC. She also reports palpitations and a rapid heart rate. She denied any rash, pruritis, dyspnea or chest pain, or N/V/D. Patient works in hospital and was transported to ED and upon arrival vitals were stable with HR of 79, BP 151/84, SaO2 of 100% on RA. Additional information for Item 18: Patient treated with IVF and released. Patient discharged to home and by 1:00pm that day was no longer symptomatic. She does endorse pre-syncope with previous blood draws.
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| 45 | 2021-01-27 | feeling of body temperature change, night sweats |
Fatigue, Hot and cold body temperature, chills, dizziness, flighty-light headed, night sweats, stoma...
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Fatigue, Hot and cold body temperature, chills, dizziness, flighty-light headed, night sweats, stomach and back pain
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| 45 | 2021-01-27 | flushing |
Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contacta...
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Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El01Y0, expiration date not reported), intramuscular on the left arm, on 08Jan2021 at 10:30, single dose for Covid-19 immunization. The patient has no medical history and no concomitant medications. The patient previously took the first dose of bnt162b2 (Lot number: EJ1685), intramuscular on the right arm, on 18Dec2020 at 10:00 AM for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, at 10:35, the patient experienced flushing feeling with tachycardia 5 minutes post vaccine. On 15Jan2021, she is day 7 post vaccine and experiencing panic/anxiety, tachycardia, and vertigo type feelings. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment (prescription/monitoring) for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 45 | 2021-01-27 | flushing | Rosacea, flushing |
| 45 | 2021-01-27 | numbness, feeling hot |
1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 ...
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1/6/21 Received Pfizer COVID vaccine part 2. 1/12/21 Went to urgent care for mild swelling and numbness on left side of face, scalp, ear. Also very dry flaky skin. Given desnoide cream, and instructed to take Claritin 1/13/21-1/15/21 Took Claritin, and all symptoms resolved except for dry skin 1/16/21-1/17/21 Did NOT take Claritin 1/18/21 Mild facial numbness, on left. Took Zyrtec-D, symptoms improved 1/19/21 No apparent numbness. Took Claritin 1/20/21 Possibly hint of numbness. Extremely dry skin and scalp. Took Claritin. Used desonide. Only skin around eyes slightly swollen. 1/21/21 Mild-mod numbness on left side of face. Extremely dry skin and scalp. Face feels warm. Took Claritin
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| 45 | 2021-01-27 | pain in extremity |
Sore L arm; body aches; chills; diarrhea; headache; This is a spontaneous report from a contactable ...
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Sore L arm; body aches; chills; diarrhea; headache; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982, expiration date unspecified), intramuscular on 14Jan2021 15:30 at single dose (left arm) for Covid-19 immunization. Medical history included vitamin d deficiency (def), Beta Thalassemia, some shellfish allergy, Sulfa allergy and COVID-19, which was prior to vaccination. Concomitant medication included vitamin D3. The patient received vitamin D3 within 2 weeks of vaccination. On 15Jan2021 at 06:45, the patient experienced sore left (L) arm, body aches, chills, diarrhea, and headache. The patient did not received treatment for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for Covid-19 since the vaccination. Outcome of events was recovering.
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| 45 | 2021-01-27 | pain in extremity |
moderate headache; body ache; tender arm; diarrhea; chills; nausea; vomiting; This is a spontaneous ...
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moderate headache; body ache; tender arm; diarrhea; chills; nausea; vomiting; This is a spontaneous report from a contactable Other Health Professional reporting for herself. A 45-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), via an unspecified route of administration on 15Jan2021 09:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 45 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. She received unspecified concomitant medications. On 16Jan2021 at 23:45 the patient experienced moderate headache, body ache, and tender arm and 40 hours after the dose, she developed diarrhea, chills, nausea & vomiting lasting 4 hours. All the events were considered non serious. No treatment was received for the events. The events had resolved on an unspecified date in Jan2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 45 | 2021-01-28 | weakness |
Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spike...
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Reported had severe headache the same night. Worse the next day. Tongue and lip swelling. BP spiked, severe headache, severe abd pain, seen at Urgent Care and sent to ER. Given meds and sent home. Next day seem at clinic and again sent to ER. . Given IV fluids, IV meds and after four hrs sent home. Experienced extreme weakness. Could barely get out of chair or walk. ED visit 1/15/2021 for acute nonintractable headache, epigastric pain, adverse effect of vaccine. Presents to the ER with epigastric abdominal pain, nausea, and headache after receiving second dose of Pfizer COVID-19 vaccination yesterday at 6 AM. Patient states symptoms started last night. Treated with IV fluids, Reglan, Benadryl, Toradol, and Floricet. Abdominal pain totally resolved and headache pain improved. Discharged to home with prescription for Reglan 10mg PRN. She does have a history of chronic migraines and already has Maxalt at home and was given a prescription for Floricet today which she is already filled.
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| 45 | 2021-01-28 | burning sensation |
petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensatio...
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petechiae with discoloration; petechiae with discoloration; L 2nd MTP and R 3rd MTP burning sensation; foot blister; stubbed a toe; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284) at Left arm, intramuscular on 14Jan2021 16:45 at single dose for covid-19 immunisation. Medical history included Sjogren's, Raynaud, s/p Total abdominal hysterectomy (TAH)/Bilateral salpingo-oophorectomy (BSO) sex cord sclerosing stromal tumor, and known allergies: Sulfa. Patient did not have Covid prior vaccination. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), leflunomide, ciclosporin (RESTASIS), pilocarpine, colecalciferol (VITAMIN D), fish oil (OMEGA 3). Since the 14Jan2021 Pfizer COVID vaccine, the patient had left (L) 2nd Metatarsophalangeal (MTP) and right (R) 3rd MTP burning sensation on 15Jan2021 10:00 (like she had foot blister or stubbed a toe). Then, she had petechiae with discoloration on 16Jan2021 and 17Jan2021. No treatment was received for the events. The patient lab data included Covid PCR Test (Nasal Swab): negative on 15Jan2021. The outcome of events was recovering.
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| 45 | 2021-01-28 | hypersensitivity of all senses |
Fever (as high as 103.1 after Motrin); Headache; Chills; Joint pain; Inj site pain; Skin sentivity; ...
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Fever (as high as 103.1 after Motrin); Headache; Chills; Joint pain; Inj site pain; Skin sentivity; General feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249) via an unspecified route of administration in right arm on 15Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history included hypertension, vertigo. The patient's concomitant medications were not reported. The patient was allergic to PCN, Sulfa, Keflex, Solodyn (Tetracycline). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 04:30 AM, the patient experienced fever (as high as 103.1 after Motrin), headache, chills, joint pain, injection site pain, skin sensitivity, general feeling unwell. No treatment was received for other adverse events. The patient did not pregnant at the time of vaccination. Events outcome was recovered.
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| 45 | 2021-01-28 | numbness, tingling, tremor |
Pt waited her 15 minute waiting period without issue. Pt then left the clinic & reports that she did...
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Pt waited her 15 minute waiting period without issue. Pt then left the clinic & reports that she did not feel right so she came back to the clinic. Pt reported some numbness & tingling in her arms & hands, nausea, increased anxiety, & shaking. 1mL dexamethasone 4mg/mL given IM to right buttock. Pt placed on 2LPM 02 via NC for comfort. Pt tolerated well.
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| 45 | 2021-01-28 | tremor |
severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report f...
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severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself. A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-29 | feeling hot, cold extremities |
Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour...
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Pretreatment with prednisone 50 mg q6 x 3 doses starting 13 hours prior plus Benadryl 50mg po 1 hour prior. 20-25 minutes after injection began itching, rash on upper body, redness to body, lightheaded when stood up. Sought treatment from nurse & paramedic on site. Vital signs about 30 minutes after injection 187/107, hr 135, sats 98%. Given Benadryl 25 mg IM . Over next 30 minutes symptoms improved & bp came down to 145/80 and hr around 100. That evening whole body was red & rash on upper body- took Benadryl 50 mg. A week out remain with mild rash on chest, arms, neck & itching that comes & goes. Have been treating with Claritin during the day & Benadryl at night for 6 nights. Days 2& 3 after injection feet felt very cold, but face felt very hot when wearing a mask.
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| 45 | 2021-01-29 | flushing, feeling hot |
About 5-10minutes after vaccine I felt flushed/warm. Reported to nurse who took my vitals. Elevated...
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About 5-10minutes after vaccine I felt flushed/warm. Reported to nurse who took my vitals. Elevated blood pressure and heart rate. Also felt slightly dizzy. Symptoms lasted about 45 minutes. At no time did I experience itching/swelling or rash. Also did not experience wheezing or difficulty breathing. Only treatment needed was vital sign monitoring. Vitals improved and no intervention was needed. I have had no further complications.
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| 45 | 2021-01-29 | flushing |
15 minutes after receiving shot, I started feeling itchy in many places. My face flushed red and my ...
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15 minutes after receiving shot, I started feeling itchy in many places. My face flushed red and my skin has red splotches on my upper chest. I had just been released from the vaccination observation area, and I returned for additional guidance. They told me since I drove out of observation, they could not do anything and I had to go to an urgent care center. I phoned my regular doctor and the triage nurse in the office instructed me to take 2 Benadryl immediately. I drive to a pharmacy and took the Benadryl. The Benadryl relieved the symptoms for about 2.5 hours and then they returned. I took 2 Benadryl every 4 hours until the itchiness stopped approximately 12 hours after receiving the shot.
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| 45 | 2021-01-29 | flushing | Tachycardia, high blood pressure, flushing Given Benadryl and observed in the ER |
| 45 | 2021-01-30 | numbness, feeling cold |
After 2nd shot within an hour I started to feel a cold sensation flow through my body and my right a...
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After 2nd shot within an hour I started to feel a cold sensation flow through my body and my right arm and hand felt numb.
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| 45 | 2021-01-31 | breast pain, pain in extremity |
nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling an...
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nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; headache; body aches at the slightest touch; fever; loss of appetite lasting 4 days; left upper arm/underarm/breast swelling and pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiration date not provided), intramuscular in the left arm on 14Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and hypothyroidism. The patient is not pregnant. The patient has no know allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 02:45, the patient experienced nausea, left upper arm/underarm/breast swelling and pain, headache nothing would take away, body aches at the slightest touch, fever, loss of appetite lasting 4 days and still with nausea, loss of appetite and headache. Treatment was not provided in response to the events. The outcome of the events was recovered with sequelae on an unspecified date in Jan2021. The patient has not been tested for COVID post vaccination.
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| 45 | 2021-01-31 | facial paralysis |
Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different ...
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Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different and the continues of HA and numbness sensation during the day/ evening. She was unable to close her R eyelid and R side drooping. The HA increased with time after two weeks the R side of the face different mouth and R side was swollen. She then seek medical treatment at the ER where she received prednisone and valacyclovir for one week treatment.
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| 45 | 2021-01-31 | flushing |
DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT...
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DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.
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| 45 | 2021-01-31 | hot flush |
Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swol...
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Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swollen lymph under jaw on neck.
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| 45 | 2021-01-31 | numbness | Left hand numbness |
| 45 | 2021-01-31 | migraine, feeling of body temperature change |
Later that night she felt like she had the flu, nausea, vomiting, later that day diarrhea, and a mig...
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Later that night she felt like she had the flu, nausea, vomiting, later that day diarrhea, and a migraine at Left temple area, sweating, hot and cold chills, after she was able to eat she felt better
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| 45 | 2021-01-31 | pain in extremity |
Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fev...
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Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fever of 101-103 for the next two days. She experienced headache and nausea for the next week. On 1/22/21 she developed pain and swelling in the right middle finger at the MCP and PIP joints, and then on 1/24/21 developed pain and swelling in the L fourth finger MCP and PIP joints. She also started her period after the vaccine was given and has continued to have daily vaginal bleeding since. Her hand pain is improved slightly as of today.
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| 45 | 2021-01-31 | tingling, discomfort, feeling hot, tremor, numbness |
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h...
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1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 200/110, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to 160/92 within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 and blood pressure was elevated for 12 hours before returning to my usual results.
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| 45 | 2021-01-31 | tingling, feeling hot, discomfort |
Got vaccine at 930am. Woke up morning after the vaccine about 930am with tingling/severe pain should...
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Got vaccine at 930am. Woke up morning after the vaccine about 930am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then tylenol mid day. That evening had fatigue and pain all over, slight head ache, chills and then turned to temp 99.9, very warm/uncomfortable. Tylenol again. Woke on Sunday better just fatigue and achy.
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| 45 | 2021-01-31 | tingling |
stiffness in lower back; warm tingling, sensation down her leg on the left side down toward her foot...
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stiffness in lower back; warm tingling, sensation down her leg on the left side down toward her foot area; left side of her body was completely sore; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 13Jan2021 12:27 at single dose on the left upper arm for COVID-19 immunization. Medical history included ongoing asthma and ongoing sinus issues. The patient's concomitant medications were not reported. The patient had no history of all previous immunization and no additional vaccines administered on same date of the Pfizer suspect. The caller reported that she took the Pfizer COVID vaccine and had some things going on afterward but she wasn't sure if the symptoms were side effects. She works in a doctor's office, this is how she was able to get the shot. The caller explained she stayed for the 15 minutes and immediately she started feeling stiffness in lower back on 13Jan2021. A couple days later (in Jan2021) she started having a tingling, warm tingling, sensation down her leg on the left side down toward her foot area. She got the shot on the left upper arm and so everything happening was on her left side. Her left side of her body was completely sore. She reported stiffness in the buttocks area, everything was sore on the left side. She had been using a heating pad on lower back and hip area and things are getting better. The tingling was still there but gotten better. The events did not require a visit to emergency room or physician office. No relevant tests were done. The outcome of the events was recovering.
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| 45 | 2021-01-31 | tremor, discomfort, numbness, tingling, feeling hot |
1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt h...
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1 minute after injection felt a very uncomfortable sensation of heat come over entire body, I felt heart palpitations and a sensation that my heart was racing. I then became lightheaded and dizzy and my hands and lips/cheeks became numb and tingling and I got very shaky. I summoned paramedics who came and took vitals and my heart rate was in 130s with blood pressure of 190/100, I have no prior history of high blood pressure or high resting heart rate. Blood pressure came down to normal level within 30 minutes, other symptoms improved and I was cleared to leave vaccination site. Intermittent numbness in face and hands and general shakiness persisted through the next 12 hours and heart rate stayed 100-120 for 12 hours before returning to my normal rate of 60.
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| 45 | 2021-02-01 | burning sensation, discomfort |
Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per fami...
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Following dose #2, had body aches and fever on day two (T 102.7) and felt better next day. Per family report starting complaining about L ear pain on Friday 1/29, On Sunday 1/31, started to experience dizziness and some L ear discomfort, Had cellulitis last summer after "new earrings" in left ear and assumed this might have been it, had NP check ear on Monday at work, some fluid on R ear. Monday evening pain increased, heaviness and muffled sound increased, pain increased, started to "burn" and "itch". Tuesday AM contacted three MDs, concerns of shingles. Diagnosis later that day, vesicles in L outer ear, started on antiviral and antibiotics. Pain and dizziness at work Tuesday morning however its only Tuesday night. Pain/burning still very intense.
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| 45 | 2021-02-01 | facial pain |
over left cheek bone feel sore, left side of neck sore as well; massaging to see if it goes away; no...
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over left cheek bone feel sore, left side of neck sore as well; massaging to see if it goes away; no dizziness, no vision changes, no HA, no change in speech
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| 45 | 2021-02-01 | numbness, tingling |
1ST INJECTION WAS 1/28/21 THE EVENING AFTER 1ST INJECTION (1/29/21).. FEVER 102 MUSCLE AND JOINT ACH...
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1ST INJECTION WAS 1/28/21 THE EVENING AFTER 1ST INJECTION (1/29/21).. FEVER 102 MUSCLE AND JOINT ACHES, HEADACHE AND SWOLLEN AXILLARY NODES IN LEFT ARM LASTING ABOUT 24-36 HOURS. 4 200ML ADVIL TAKEN SWOLLEN NODES REMAINED SUNDAY MORNING AND I WOKE WITH LEFT SIDE OF MY FACE NUMB BUT FUNCTIONING WHICH CONTINUED FOR ABOUT 48 HOURS. TODAY (2/2/21) IS DAY 5 POST INJECTION, SWOLLEN NODES REMAIN AND PINS AND NEEDLES FEELING ON LEFT SIDE OF FACE
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| 45 | 2021-02-01 | migraine | Headache, unspecified after vaccination, migraneous. |
| 45 | 2021-02-01 | tingling, feeling hot |
Patient received COVID vaccine Pfizer first dose in vaccine clinic. Her symptoms started 5 min afte...
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Patient received COVID vaccine Pfizer first dose in vaccine clinic. Her symptoms started 5 min after injection, lasted 10-15 min and resolved. She started feeling tingly in her arms, then noticed a red, raised, blotchy rash on her arms. She felt hot and a little weak in the legs. No oral swelling, throat tightening, shortness of breath, nausea, vomiting, diarrhea. Symptoms onset 5 min after vaccine, symptoms resolved spontaneously within 15 min. Patient transferred to ED. No symptoms in ED. Patient given Benadryl in ED. Observed, no further symptoms. Dc home with Epi pen
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| 45 | 2021-02-02 | weakness, electric shock sensation, tingling |
Severe muscle pain to the point of tears for about 8-10 hours even after extra strength tylenol. Te...
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Severe muscle pain to the point of tears for about 8-10 hours even after extra strength tylenol. Temp 101.6 after extra strength tylenol. Severe fatigue, muscle weakness-could not get out of the bed or even sit upright in the bed for nearly 72 hours. Once the pain subsided, body aches, weakness and tingling began, mostly located in lower extremities and gluteal muscles. Yesterday, day, 4, weakness/tingling/feeling of electrical impulses throughout lower extremities which was intermittent. I am currently on day 5 now and still experiencing fatigue, aches/feeling of impulses throughout lower extremities intermittently. I have a Dr. appointment scheduled for tomorrow 2/4/2021
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| 45 | 2021-02-02 | weakness |
Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in...
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Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in the morning at 4:30 am. Headache, low grade fever of 99.7, achy all over, a bit of nausea.
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| 45 | 2021-02-02 | involuntary muscle movements |
Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minute...
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Mild allergic reaction (tingling in mouth, splotchy red chest, itchy eyes) approximately 5-10 minutes after receiving the vaccine; itchy eyes and puffiness in face on and off from time of vaccine to present (7 days later); vaccine and/or subsequent mild allergic reaction triggered Functional Neurological Disorder symptoms (involuntary muscle activations in legs, face and neck, dystonic posturing of feet)
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| 45 | 2021-02-02 | numbness, tingling |
Extreme numbness and tingling in left hand, beginning 15 minutes after vaccination. Numbness was sev...
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Extreme numbness and tingling in left hand, beginning 15 minutes after vaccination. Numbness was severe enough to interfere with normal activities such as typing, texting, dialing phone. Patient became nauseated and very dizzy (unable to walk unaided) within 1 hour of vaccination. Numbness improved after 24 hours, and was back to normal after 72 hours. Nausea and dizziness lasted for 24 hours. No previous reactions to vaccines of any kind.
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| 45 | 2021-02-02 | pain in extremity |
Chills, body aches, painful/heavy arm, and worst headache. Took tylenol and ibuprofen with no relief...
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Chills, body aches, painful/heavy arm, and worst headache. Took tylenol and ibuprofen with no relief.
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| 45 | 2021-02-02 | pain in extremity | Extreme swelling, redness, and soreness in left arm, can barely lift. |
| 45 | 2021-02-02 | tingling, weakness |
Since the vaccine I have experienced tingling of lips and face. The past few days I have started exp...
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Since the vaccine I have experienced tingling of lips and face. The past few days I have started experiencing more tingling/twisting sensations on left side of body and some weakness of left side of body as well as twitching of left eye.
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| 45 | 2021-02-03 | burning sensation |
Skin redness/hands were red/red patches; hands were red and itchy; hands were red and itchy, burning...
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Skin redness/hands were red/red patches; hands were red and itchy; hands were red and itchy, burning.; extensive hives starting over dorsal hand surface, then wrists,eventually covering entire arms and patches over knees and lower legs; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date unknown), via an unspecified route of administration on 19Jan2021 09:15 at a single dose on the left arm for COVID-19 immunization. Medical history included COVID-19 and allergies: PCN. Concomitant medication included colecalciferol (VITAMIN D). The patient received no other vaccine in four weeks. Patient is not pregnant. On 20Jan2021 08:30, the patient developed skin redness, her hands were red, itchy, and burning. This was followed by extensive hives starting over dorsal hand surface, then wrists, and eventually covering entire arms. The patient also had patches over knees and lower legs. The events resolved with 20 mg prednisone and Allegra after a couple hours, except for the flat red patches which remained over the knees and surrounding skin. The patient has not been tested for COVID-19 post-vaccination. Outcome of the event "skin redness/hands were red/red patches" was not recovered and of the other events was recovered on an unspecified date.
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| 45 | 2021-02-03 | discomfort, tingling |
Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. ...
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Approximately 20 min after vaccine I felt my left lower arm between wrist and elbow get very tight. I began to feel lightheaded and hot in chest. Vitals were take , BP was very high and HR was very high. My checks got tingly as well. I began to get the chills. This lasted approximately 2 hours.
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| 45 | 2021-02-03 | feeling cold |
Fever chills body aches and headache started about 7 hours after shot. Symptoms continued throughout...
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Fever chills body aches and headache started about 7 hours after shot. Symptoms continued throughout night. Fever resolved next day. Fatigue and brain fog all day until 7 pm when symptoms resolved very quickly. Tylenol and one dose of advil
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| 45 | 2021-02-03 | migraine |
I started to have aches, joint pain and a migraine with slight nausea on 2/1/21 @ 1700 after having ...
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I started to have aches, joint pain and a migraine with slight nausea on 2/1/21 @ 1700 after having the 2nd vaccine earlier that morning. The migraine persisted till 2/3/2021 at 0930. I called employee heath and was suggested to take some Tylenol and coffee. I continue to have mild joint pain, a mild headache, and no nausea.
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| 45 | 2021-02-03 | pain in extremity |
Left arm remained sore and warm to touch for several days. On 1/31/21 started having extreme pain wi...
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Left arm remained sore and warm to touch for several days. On 1/31/21 started having extreme pain with ROM of left should. Went for evaluation on 2/1/21, was diagnosed with left shoulder deltoid myositis after injection.
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| 45 | 2021-02-03 | pain in extremity | sore arm, fatigue, body aches Narrative: |
| 45 | 2021-02-04 | feeling hot |
Chills; It's kind of warm; I am really tired; This is a spontaneous report from a contactable consum...
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Chills; It's kind of warm; I am really tired; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization , paracetamol (TYLENOL) , via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history included diabetes. The patient's concomitant medications were not reported. The patient experienced chills, it's kind of warm and she was really tired. It was reported that the patient had side effects that wasn't bad, she took some paracetamol and today she noticed she need to take a few more. Consumer stated that she was just curious to know, how long can side effects last. She was not in any pain or anything but the chills and it's kind of warm. And she was just wondering how long was that supposed to last. The patient was really tired. The start date of events was reported on 21Jan2021. Paracetamol was reported as co-suspect. The action taken in response to the event for paracetamol was unknown. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 45 | 2021-02-04 | numbness, tingling |
Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingli...
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Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingling, itching (vaccine administered on right-arm).; Left-arm numbness, tingling, itching (vaccine administered on right-arm).; This is a spontaneous report from a contactable Pharmacist. A 45-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), intramuscular on 17Jan2021 at single dose for covid-19 immunisation . Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced left-arm numbness, tingling, itching on 17Jan2021. vaccine administered on right-arm. The outcome of events was recovering.
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| 45 | 2021-02-04 | seizure like phenomena |
In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicate...
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In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some "pressure in her head" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.
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| 45 | 2021-02-04 | tremor, tingling |
On January 27, 2021 at around noon I received the first dose of the Pfizer/BioNTech Covid-19 vaccine...
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On January 27, 2021 at around noon I received the first dose of the Pfizer/BioNTech Covid-19 vaccine. After approximately 10-15 minutes I noticed a reaction. I was really lightheaded , short of breath, and shaking. It felt like I was going to pass out. I was given water and a bar to eat, and eventually I got to a place where I felt that I could drive. I went for a walk with a couple of friends, but was having a hard time walking because of shortness of breath, and was still lightheaded plus I had skin tingling on both sides of my face. I ate something afterward the walk and felt better within an hour. The next day I seemed to be fine, but then Friday (two days after the shot) I became increasingly lightheaded/dizzy and nauseous. Additionally, I had issues on Friday and Saturday with anxiety and trying to hold off mild panic attacks plus depression and nausea. I was still lightheaded/dizzy and had shortness of breath for a week after the shot. which has extend to today (February 5, 2021), over a week after the shot.
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| 45 | 2021-02-05 | weakness |
15 minutes after the injection I started getting a scratchy throat.. which lead to my throat, tongue...
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15 minutes after the injection I started getting a scratchy throat.. which lead to my throat, tongue, lips tingling and burning. After a couple hours my nose felt numb and tingly inside and stayed like that until the day after. The day after i had the vaccine if I try to eat it flairs the burning fizzing feeling in my mouth and lips again. Feel week and tired, headaches and body pain. Im concerned with the mouth stuff though before getting the second dose.
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| 45 | 2021-02-05 | feeling hot |
Patient felt nauseated and hot. Laid down and given water. About 10 minutes later, patient had cl...
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Patient felt nauseated and hot. Laid down and given water. About 10 minutes later, patient had clear emesis (small amount). Patient sat up and cool cloth applied to face and neck. Felt cooler and said she has a hx of cyclic nausea/vomiting. She was resting and cool cloth applied again to face. Sipped some water. After total of 40 minutes of observation, patient felt better and declined further evaluation in the ED.
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| 45 | 2021-02-05 | pain in extremity | L arm pain. L sided lymphadenopathy anterior cervical, supraclavicular |
| 45 | 2021-02-06 | flushing |
1640 Red palms, flushed, arms itch hx sensitive skin feels throat full. denies, dysphagia or dyspnea...
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1640 Red palms, flushed, arms itch hx sensitive skin feels throat full. denies, dysphagia or dyspnea. Benadryl 25mg po. 1645 Vital signs 160/100,97%,76. 1655 D/C amb. without problems.
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| 45 | 2021-02-07 | feeling hot |
fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near le...
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fatigue; chills; fever (about 99-100F); the site of injection is sore; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch!; This is a spontaneous report from a contactable other health professional reported for herself. This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9031) via an unspecified route of administration on 19Jan2021 at 09:15 AM at single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history and concomitant medications were reported as none. Allergies to medications, food, or other products was reported as none. The patient previously received the first dose of BNT162B2 (Lot number EH9899) on 30Dec2020 at 11:15 AM at single dose in left arm for COVID-19 immunisation and had no symptoms; Influenza vaccine on 10Dec2020 for immunization. The patient experienced fatigue, chills followed by fever (about 99-100F) lasted for about one and half days. The site of injection is sore even after 3 days. The patient observed a moving painful lump near left shoulder blade (may be supraclavicular lymph nodes), which is warm to touch. The events onset date was reported as 21Jan2021. The events were reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination and not tested for COVID-19 since the vaccination. The patient received no treatment. The outcome of the events was not resolved.
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| 45 | 2021-02-07 | feeling jittery |
Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swoll...
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Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swollen Day 3: brain fog, feeling jittery, chills, fever 100.2
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| 45 | 2021-02-07 | migraine |
Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Cl...
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Client reports had tingling in back of throat and tongue, took a Benadryl and symptoms subsided. Client reports taking Benadryl all evening long. Client reports 3 days later having migraines, nausea, head ache and not feeling well. Day 3 pulse dropped in the 40's which is abnormal. Denies trouble breathing. Client reports had similar symptoms of migraines but not additional symptoms.
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| 45 | 2021-02-07 | pain in extremity, weakness |
Tired; Feel bad; Weak; Sore arm; Fever 100.3; This is a spontaneous report from a contactable consum...
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Tired; Feel bad; Weak; Sore arm; Fever 100.3; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: unknown; reason why batch/lot was unknown: misplaced/discarded) via an unspecified route of administration at left arm on 21Jan2021 09:45 AM at a single dose for COVID-19 immunization. Medical history included anxiety, high blood pressure (HBP). Since Covid - short of breath still racing heart. Allergies to medications, food, or other products included penicillin and apple juice. Prior to vaccination, the patient was diagnosed with COVID-19 (short of breath still racing heart). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included niacin, lisinopril, venlafaxine and montluskat for allergy. Facility where the most recent COVID-19 vaccine was administered was at public health clinic/veterans administration facility. The patient was not pregnant at the time of vaccination. The patient experienced adverse events included tired, feel bad/weak, sore arm, fever 100.3; with start date on 22Jan2021 at 03:00 PM. The events were reported as non-serious. The outcome of events was resolving. Treatment Tylenol received for fever. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 45 | 2021-02-07 | tingling |
swelling on the left side of her jaw and throat began to swell/swelling on left side of face and thr...
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swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.
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| 45 | 2021-02-08 | migraine |
Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues wit...
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Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues with dizziness. 19 days since and improving but memory and focusing occasionally an issue. Dizziness stopped on day 16. Had one of the worst migraines on about day 10.
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| 45 | 2021-02-09 | weakness |
fever; chills; weakness; rash all over the body; sob; This is a spontaneous report from a contactabl...
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fever; chills; weakness; rash all over the body; sob; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm left on 04Jan2021 08:45 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included asthma, obesity. Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), macrogol 3350 (MIRALAX), montelukast sodium (SINGULAIR). The patient previously took cefalexin (KEFLEX) and experienced Known allergies: Keflex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 01:30 PM Intramuscular in right arm for COVID-19 immunization. The patient experienced fever, chills, weakness, rash all over the body, sob all on 04Jan2021 12:00 with outcome of recovered in Jan2021. No treatment was received. Information on the Batch/Lot number has been requested.
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| 45 | 2021-02-09 | numbness |
Numbness to face, and left arm; headache; This is a spontaneous report from a contactable nurse (pat...
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Numbness to face, and left arm; headache; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm,on 24Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included sulfa drug allergy, artificial heart valve (replacement) and HTN (hypertension). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included warfarin sodium (COUMADIN), lisinopril and metoprolol. The patient previously took omnicef [cefdinir] and experienced allergies. On 24Jan2021 11:15, the patient experienced headache and numbness to face and left arm. The outcome of events was recovering. Therapeutic measures taken as result of the events includes Benadryl. Follow-up attempts are completed. The following information on the batch number has been requested.
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| 45 | 2021-02-09 | tingling, numbness |
Dizziness; tingling up neck and right-side of face; numbness sensation on right brow, eyelids and ch...
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Dizziness; tingling up neck and right-side of face; numbness sensation on right brow, eyelids and cheek/intermittent numbness; headache; This is a spontaneous report from a contactable Other HCP. A 45-year-old female no pregnant patient received , at hospital , the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL8982 on 21Jan2021 15:15 at SINGLE DOSE for covid-19 immunisation . Medical history included diabetes .Concomitant medication included metformin (METFORMIN), glyburide (GLYBURIDE), sitagliptin phosphate (JANUVIA ).The patient previously took codeine and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity, cortisone and experienced adverse reaction. On 21Jan2021 at 15:30 the patient experienced Dizziness, tingling up neck and rightside of face, numbness sensation on right brow, eyelids and cheek. 2 hours later teeth chattering for hour and half, headache for 4 days, intermittent numbness for 3 days.Outcome of the events was reported as recovered with sequel. No COVID prior vaccination, No COVID tested post vaccination
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| 45 | 2021-02-09 | tremor, weakness | tremors temp of 104.9 rash pain all over and little zings weak shaking immune system issues |
| 45 | 2021-02-10 | pain in extremity |
Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind...
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Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind me eye, moderate chills, mild nausea maybe due to the pain. Symptoms started 2/10/21 at 6pm and progressively got worse to the point of being unable to sleep. Took Tylenol at 1:30am and the pain decreased and was able to sleep some, 4 hrs later symptoms returned. Took more Tylenol. 2/11/21 5:57pm still have mild sore arm, mild headache off and on and mild chills.
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| 45 | 2021-02-10 | tingling | Pain at injection site, muscle/body aches, chills, prickly skin, headache, nausea & fatigue. |
| 45 | 2021-02-10 | tenderness |
Left arm felt heavy a couple hours after second COVID vaccine. By evening she had tenderness to left...
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Left arm felt heavy a couple hours after second COVID vaccine. By evening she had tenderness to left axilla. In am on 2/10/21 she could not move left arm due to swelling and pain in lymph nodes. Woke up 2/11/21 and still couldn't move arm due to discomfort. Also developed a runny nose, slight upper abdominal pain, and slight headache.
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| 45 | 2021-02-12 | pain in extremity |
Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profoun...
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Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profound deafness on audio gram.
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| 45 | 2021-02-14 | flushing, feeling hot |
Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advise...
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Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advised to wait 30 minutes while being supervised. Reaction noted to start at 1736. Patient reported "Fire feeling" and "Tingling on my tongue." Blood pressure in right arm 190/78. Heart rate 85-90's, oxygen saturation level 98% on room air, and respirations 20 breaths per minute. Patient reported dry mouth and hot sensation. Cheeks and chest flush. Patient denied shortness of breath and swelling of the mouth and tongue. Patient reported "Could be a panic attack." Educated on importance of deep breathing. Exercise completed. Bottle of water provided. Benadryl offered and patient declined at this time. 1742: "Fire feeling" began to resolve. 1756: Blood pressure in right arm 160/80. Heart rate 81 and oxygen saturation level 97% on room air. Respirations 16 breaths per minute. Temporal temperature 98.6 degrees F. Patient reports headache in frontal region.
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| 45 | 2021-02-14 | numbness |
I exp headaches, shoulder aches and really bad nausea. The headache from dose 2 was worse than first...
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I exp headaches, shoulder aches and really bad nausea. The headache from dose 2 was worse than first dose. I also exp numbness(limp feeling) bilateral arms. I was unable to cook had to be in bed for 2 days.
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| 45 | 2021-02-14 | tingling, pain in extremity, discomfort |
passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of ba...
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passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-02-14 | tingling, pain in extremity |
stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like n...
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stomach was a little upset; very tired; her heart rate is a little higher, like 95; she feels like nausea; tongue was tingling a little bit; whole body was tingling; headache; her tongue feels like it is tingling and dry; has pain in her right hand since she got the vaccine dose in her right upper arm; feeling a little bit febrile, her temperature was 99 degrees Fahrenheit; This is a spontaneous report from contactable consumers. A 45-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EC1283, via an unspecified route of administration in the right arm, on 24Jan2021 17:00 at SINGLE DOSE for covid-19 immunization. Medical history included blood pressure, and on birth control. She recently started taking the blood pressure medication (lisinopril) three months ago her blood pressure was due to a lot of stress, and she was not feeling good she had her doctor to see her blood pressure her doctor then put her on this (lisinopril). She stated that she took Lisinopril 5mg at night last night as well as took her birth control pill. Concomitant medication included lisinopril for blood pressure; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), pantoprazole and an unspecified flu shot injection to arm in October (year not specified; she takes the flu shot every year). The patient received BNT162B2 on an unspecified date for covid-19 immunization; on the first dose of COVID-19 vaccine, she felt nothing, just a little tired and she had pain in her left hand. However, it was different for the second dose. Fifteen (15) minutes after getting her second dose of vaccine, the patient was fine. Then after 30 minutes, she came home and felt like her whole body was tingling, and her tongue was tingling a little bit. She says she did drink some water. She did no treatment other than drink some water and take and hold breath in and out, holding her breath a little bit. She says her body was tingling for just a second, that is gone, her tongue feels like it is tingling and dry, kind of like when you taste something spicy a little bit, that kind of experience. She says that it lasted like 1- 2 hours yesterday and it is not going, she still feels it a little bit on her tongue, the rest of her body is not tingling. She also experienced headache and has pain in her right hand since she got the vaccine dose in her right upper arm. Today(25Jan2021), she was feeling very tired, her heart rate was a little higher, like 95, and she was feeling something like nausea, her stomach was a little upset today, and she was feeling a little bit febrile, her temperature was 99 degrees Fahrenheit when she took it. Outcome of events was reported as 'unknown'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
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| 45 | 2021-02-14 | tingling |
0930 R arm tingling. BP 142/88, HR 83, lung clear equal, )2 99, HR 83 RR 14. 0940 had some water, ...
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0930 R arm tingling. BP 142/88, HR 83, lung clear equal, )2 99, HR 83 RR 14. 0940 had some water, 0945 had some snacks. Pt c/o sleeping deprived. No Health Hx, no medications, last physical on 10/20, no surgeries. Pt was prescribed Norvasc but currently not taking. Pt was advised to call PCP to follow up and if the symptoms worsen to call 911. 1005 HR 75, good pulse RR 18, lungs clear & equal. BP 140/90. 1010 Pt feeling better, called the ride. 1016 Pt stated she is going home and eat. 1020 Pt's ride got to the building to pick her up. This RN walked the pt. The pt stated she was feeling much better and was going to call PCP asap.
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| 45 | 2021-02-15 | pain in extremity | Sore arm, chills, fever, muscle aches, headache, fatigue for 48 + hours |
| 45 | 2021-02-16 | weakness, numbness |
developed left side facial numbness and weakness, head pressure, neck pain near base of skull, chill...
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developed left side facial numbness and weakness, head pressure, neck pain near base of skull, chills, and aches
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| 45 | 2021-02-16 | slurring |
shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling...
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shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling, difficulty swallowing and speaking, nausea, numbness of lips
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| 45 | 2021-02-16 | migraine |
Pt completed 2 dose of COVID 19 (Pfizer) vaccine. She did not develop any side effects after her fir...
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Pt completed 2 dose of COVID 19 (Pfizer) vaccine. She did not develop any side effects after her first dose, but developed acute on chronic migraine HA, nausea, low grade fever, and back pain after her 2nd shot. On the day of the 2nd shot (01/29/21), she did not have any symptoms, but woke up the next day (1/30/21) with symptoms. Her symptoms persisted after more than one week.
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| 45 | 2021-02-16 | muscle spasms |
Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a co...
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Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-16 | pain in extremity |
12 hours after vaccination, i experienced chills, fever, headache and very sore arm. My teeth were c...
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12 hours after vaccination, i experienced chills, fever, headache and very sore arm. My teeth were chattering and I was shivering. Symptoms last for next 72 hours but were on and off. This happened too when I got my 1st dose.
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| 45 | 2021-02-16 | tingling, numbness |
Patient had numbness and tingling in left hand and fingers. Held patient for an additional 15 minute...
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Patient had numbness and tingling in left hand and fingers. Held patient for an additional 15 minutes and symptoms got worse. Staff took vitals BP: 152/107 and pulse: 75. Patient taken to ER for examination via wheelchair. At ER, pt stated that after receiving her first dose of the COVID vaccine, she the fingers of her left hand became tingly and then blood pressure became elevated while at the clinic. Patient stated she does have a history of anxiety and that taking shots does make her nervous and upset. She does have Xanax at home that she can take but she has not taken any today. She also does have a history of high blood pressure and does have high blood pressure medicine which she did take today. Pt discharged home, with instructions to follow up with primary care provider, return to clinic in 4 days if no better, or return sooner to clinic/ER if worsening symptoms. 1/29/21: Pt received the 2nd dose of vaccine with no issue.
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| 45 | 2021-02-16 | tenderness, discomfort |
After receiving the vaccine, I experienced moderate arm pain at the site of injection within 2 minut...
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After receiving the vaccine, I experienced moderate arm pain at the site of injection within 2 minutes. Almost 7 hours later and the pain has increased to the surrounding area in an approximate 2" radius around the site of injection. I am also experiencing a lymphatic response, mostly felt in my neck, and also have some muscle soreness in my neck. I also experienced a few PVCs...I was diagnosed 4 years ago with heart arrhythmia that was mitigated through reduction of stress and caffeine. So, I don't consider it to be a "chronic" condition and it is not something I normally experience, but I have felt a few PVCs happen since being vaccinated today along with some very mild heart pain that is just beginning. For treatment of muscle soreness at injection site, I am just applying a bit of ice. For lymph nodes, I've been doing some lymphatic exercises and trying to not to sit too much. I also have a little bit of headache that is just developing. These symptoms are mildly uncomfortable over all. The arm tenderness does give me a general feeling of discomfort and limits my desire for movement, but does not seem to impede my ability to move. For headache, I would normally take a 400 mg of ibuprofen, but I'm not going to take any kind of NSAID at this time. I will monitor my heart but am not concerned. I cannot be certain the vaccine is the cause of any of these symptoms, except for the arm tenderness and probably the lymphatic response as well. Headache and PVCs can be caused by a lack of sleep and possible dehydration, and I've had a bit more caffeine than I normally might.
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| 45 | 2021-02-17 | numbness, night sweats |
Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection;...
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Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection; itching on body on the side on injection; dizziness; insomnia; night sweats; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown, unable to locate or read details), via an unspecified route of administration on 23Jan2021 16:15 (04:15 PM) at single dose on right arm for COVID-19 immunization. Patient was not pregnant at the time of report. The patient medical history was not reported. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included fluticasone, salmeterol, montelukast and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The most recent COVID-19 vaccine was administered in School or Student Health Clinic The patient experienced abdominal pain, severe nausea, headache, numbness in hand, itching on body on the side on injection, dizziness, insomnia, night sweats, low grade fever, all on 24Jan2021 02:00. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovering. Patient has not been tested with COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 45 | 2021-02-18 | difficulty speaking, inability to speak |
Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlyi...
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Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.
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| 45 | 2021-02-18 | numbness |
at the time of initial assessment, patient does not have hives and is 98 to 99% on room air. She do...
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at the time of initial assessment, patient does not have hives and is 98 to 99% on room air. She does report a sensation of feeling like difficulty breathing or swallowing and is initially treated with Solu-Medrol and Benadryl as well as IV fluids. She reports that symptoms are improving almost immediately after meds are pushed. As result epinephrine is initially deferred for continued monitoring. However upon reassessment approximately 1 hour after reported reaction, the numbness in the hands and feet have resolved, but she is complaining that she feels as though the back of her tongue is swollen and still making it difficult to swallow though she no longer feels short of breath. As a result, we have discussed the possibility of treatment with epinephrine in order to fully resolve symptoms, and she is agreeable to proceed. ,
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| 45 | 2021-02-18 | pain in extremity |
Wednesday, day of vaccine, soreness in arm, started out feeling bruised then progressed to stiffness...
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Wednesday, day of vaccine, soreness in arm, started out feeling bruised then progressed to stiffness and pain in my shoulder joint. Thursday my whole body ached, especially my knees and hips, I felt feverish. Thursday night a severe headache developed and persisted through Saturday morning. ibuprophen and acetemetiphine did nothing to relieve any of the symptoms.
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| 45 | 2021-02-21 | feeling hot |
Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), ...
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Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), sweating and heat episodes (heat feels like it's emanating from from my neck/shoulder area). Additional SE's: pain at injection site, fatigue. Quasi-dissociative feeling resolved after fever stopped. At this writing, still having sweating episodes, pain diminished considerably, fatigue waxing and waning.
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| 45 | 2021-02-21 | pain in extremity |
Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-da...
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Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-day 3. Chills-day 4.
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| 45 | 2021-02-23 | burning sensation |
burning sensation in her right arm (not where she received the shot); This is a spontaneous report f...
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burning sensation in her right arm (not where she received the shot); This is a spontaneous report from a contactable consumer reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3247/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 10:15 (at the age of 45 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control pills. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021 at 23:30, the patient experienced burning sensation in her right arm (not where she received the shot) late at night, lasting for about 20minutes. The patient did not receive any treatment for these events. The event did not require hospitalization. The outcome of the event burning sensation in her right arm (not where she received the shot) was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had not been tested for COVID-19.
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| 45 | 2021-02-23 | flushing |
headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with stron...
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headache, flushing, nausea , vomiting and chest pain after 2nd dose. vitals were stable with strong pulses pt took zofran that she brought home. encouraged rest, and fluids. provided cold compress and reassurance pt laid down in a stretcher and rested for about an hour before getting discharged home.
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| 45 | 2021-02-23 | hot flush |
hot flash sensation on right side body under her arms down side of her body; This is a spontaneous r...
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hot flash sensation on right side body under her arms down side of her body; This is a spontaneous report from a contactable pharmacist (patient). This 45-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3302; dose 1) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced hot flash sensation on the right side of her body. The patient stated she got the vaccine "today" (26Jan2021) and wanted to find out if the kind of side effect she was having would resolve or if she needed to contact her physician. She had been experiencing a hot flash sensation on the right side of her body under her arms and down the side of her body on 26Jan2021. The outcome of hot flash sensation on the right side of her body was not recovered. No follow-up attempts are needed. No further information is expected.
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| 45 | 2021-02-23 | tingling |
Tingling sensation in extremities followed by an itchy rash, redness, and hives in arms, neck, face,...
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Tingling sensation in extremities followed by an itchy rash, redness, and hives in arms, neck, face, and chest.
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| 45 | 2021-02-23 | tremor |
Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated bloo...
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Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature. Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-02-25 | weakness, migraine |
Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runn...
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Diarrhea, vomiting , Fever , chills, Extreme body each , Migraine, light sensitivity, weakness, Runny noise, lose of apatite . Extreme sweating. Extreme sweating of the under arm is still and issue. No fever now.
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| 45 | 2021-02-25 | weakness | pain on vaccination site , unable to move arm, body aches, fever, weakness for 48 hours |
| 45 | 2021-02-25 | breast pain |
Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. ...
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Severe swelling and pain in right arm pit, swelling in left arm pit, neck and pain in Lymph glands. Pain under left side of breast bone and shoulder blade.
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| 45 | 2021-02-25 | flushing, tingling |
Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of fa...
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Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of face) and behind ears, lips stinging (this started first) tongue tingling, felt lightheaded or unsteady (pulse was up), and headache
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| 45 | 2021-02-25 | muscle spasms |
Other than mild pain at the injection site on the night of 2/19/21, things were fine until Tuesday, ...
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Other than mild pain at the injection site on the night of 2/19/21, things were fine until Tuesday, 2/22/21 when my tongue began twitching. It is now 2/26/21 and it continues to twitch. I can eat and drink and swallow fine.
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| 45 | 2021-02-25 | tingling | Tingling/Pins & Needles in hands and feet. |
| 45 | 2021-02-26 | pain in extremity | pt with dizziness and painful left arm, redness to nose and face. Benadryl 50 mg given |
| 45 | 2021-02-28 | weakness |
Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction di...
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Constricted throat. I was given Zyrtec. Observed for an hour. Got discharged. Throat constriction didn't go away until 2 hours afterwards. Puffy, itchy eyes (both eyes) with rash came and lasted about two weeks. Monday or Tuesday, I noticed a rash all over my body - red and blotchy. That went away in a day. I got chills, fever, weakness, nausea, vomiting, diarrhea and that lasted 48 hours (16th in pm-17th and got better evening of 18th). When I had the rash was all over the body, I took a Zyrtec. The weekend I was really sick I didn't take any medication. Phone visit with Doctor - January 15th - allergist - I followed up with him about the throat constriction. He just was monitoring symptoms. After the weekend that I was really sick, I told him and he ordered bloodwork.
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| 45 | 2021-02-28 | flushing, difficulty speaking |
Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear he...
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Immediately after receiving Pfizer Covid vaccine, patient developed hoarseness and tried to clear her throat. She had mild flushing as well. The hoarseness was on and off for a few minutes. Pulse ox was 97-98% on room air and was given PO Pepcid 40mg and PO Benadryl 50mg while in vaccine clinic. She was transported to the ED (chief complaint recorded as "hoarseness, chest tightness, SOB, throat swelling") where she was given IV Pepcid 20mg, IV Benadryl 50mg and IV SoluMedrol 125mg. She remained on room air and vital signs remained within normal limits. The patient was monitored for 2h before discharged home. Patient was given an outpatient prescription for Medrol DosePak and Pepcid.
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| 45 | 2021-03-01 | weakness |
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to s...
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Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
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| 45 | 2021-03-01 | tingling |
pt with sensation of tingling of the right lower leg 10 min after first covid vaccination. pt denies...
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pt with sensation of tingling of the right lower leg 10 min after first covid vaccination. pt denies, rash, flushing, hives, chest pain, palpitation, shortness of breath, wheezing , stridor or altered mental status. symptoms resolved 40 min without intervention except observation and reassurance. pt instructed to follow up with pcp
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| 45 | 2021-03-02 | pain in extremity |
Severe headache and fatigue, lasted about 6 hours. Have had several headaches throughout the followi...
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Severe headache and fatigue, lasted about 6 hours. Have had several headaches throughout the following days but not a severe as first one. Sore arm and elbow
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| 45 | 2021-03-02 | seizure, grand mal seizure |
Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousnes...
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Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousness lasting <15 seconds with eyes "rolling back" and skin color change from normal for age/race to pale followed by bilateral upper extremity convulsions. Witnessed by monitoring area Registered Nurse. Hx: Seizures, last seizure secondary to codeine ingestion >1 y ago. Anxiety related to injections. Timeline: 1759- Vaccinated with Pfizer Lot # EN6199 1st dose 1805- adverse reaction occurred 1806- mental status: slow to respond, skin: pale/diaphoretic, VS: HR 51 (regular at the radial site), BP 80/palp, RR: 12, T: 36.8, Spo2 100% on RA 1807- 911 activated, placed in position of comfort. 1815- EMS arrived, EKG consistent with sinus bradycardia, HR 58, BP 150/130, RR 15, Spo2 100% on RA 1820- EMS placed patient on gurney. 1825- Departed via EMS gurney
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| 45 | 2021-03-02 | tenderness | increased swelling and redness and neck tenderness and pain |
| 45 | 2021-03-03 | flushing |
Tingling and numbness in the face particularly around the mouth. Started 15 minutes after vaccinati...
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Tingling and numbness in the face particularly around the mouth. Started 15 minutes after vaccination and continues now 6 days later. Does not seem to have abated at all. Face feels flushed all the time.
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| 45 | 2021-03-03 | migraine, pain in extremity | I had a sore arm, migraine headache and extreme fatigue. |
| 45 | 2021-03-03 | muscle spasms |
extreme muscle cramps in both legs; This is a spontaneous report from a contactable consumer (patien...
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extreme muscle cramps in both legs; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at the left arm on 21Jan2021 15:00 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included magnesium, cannabidiol, and docusate sodium (COLACE). The patient experienced extreme muscle cramps in both legs on an unspecified date after the first shot. The patient underwent lab tests and procedures which included nasal swab: negative both on 15Feb2021 and 16Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event was recovering.
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| 45 | 2021-03-04 | burning sensation, night sweats |
Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats a...
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Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats and burning; All night woke up with sweats and burning; All night woke up with sweats and burning; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Feb2021 08:30 at single dose for covid-19 immunization. Medical history included Vasovagal synchope, allergy to Sulfa drugs. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), metoprolol. The patient previously allergy to cipro and levaquin. The patient previously received the first dose of bnt162b2 (Lot number unknown), at the age of 45-year-old, via an unspecified route of administration in left arm on 28Jan2021 15:30 at single dose for covid-19 immunization. About 11 hours after 2nd dose (20Feb2021 19: 30), the patient got extreme chills and fever, headache and body aches. All night woke up with sweats and burning. Fainted around 21Feb2021 06:00 (patient had vasovagal synchope so maybe aggravated it). No treatment received. The patient was no pregnant. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 45 | 2021-03-04 | burning sensation |
rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This ...
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rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 25Jan2021 at 15:30 (at the age of 45-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib), tachycardia, and allergy to proton pump inhibitors. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included metoprolol tartrate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 04Jan2021 at 11:00 (at the age of 45-years-old) in the left arm for COVID-19 immunization. The patient experienced body aches and fever of 102.7 on 26Jan2021, left ear pain in Jan2021, intense burning and intense dizziness on 01Feb2021, and rash and shingles on 02Feb2021. The events were reported as non-serious. The clinical course was reported as follows: The day after the vaccination, 26Jan2021, the patient had body aches intermittently (reported as: not bad) and then spiked a fever of 102.7 the evening of 26Jan2021. The pain (per family recollection: complains of left ear pain) started about 28Jan2021 or 29Jan2021, but intense burning, pain, and intense dizziness started on 01Feb2021 with diagnosis of rash and shingles on 02Feb2021. Therapeutic measures were taken as a result of all of the events, which included valacyclovir (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of body aches, fever, left ear pain, intense burning, intense dizziness, rash, and shingles was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 45 | 2021-03-04 | pain in extremity |
Initial soreness in left arm deltoid muscle lasted about 2 days. Then a few days after that there wa...
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Initial soreness in left arm deltoid muscle lasted about 2 days. Then a few days after that there was muscle weakness and soreness when I tried to use my left deltoid muscle. Pain and weakness has yet to go away and it?s been 2 months.
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| 45 | 2021-03-04 | pain in extremity |
Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. The...
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Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. Then the next day I had a headache, upset stomach, chills and a was achy.
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| 45 | 2021-03-04 | tenderness |
Swollen and very tender/sensitive knuckles in fingers. Painful. Excessive swelling to the point that...
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Swollen and very tender/sensitive knuckles in fingers. Painful. Excessive swelling to the point that wedding band doesn?t even come close to fitting on finger (which has been worn for 15 years).
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| 45 | 2021-03-05 | flushing |
While in observation period, pt reported feeling lightheaded and flushing, 12 minutes post-vaccinati...
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While in observation period, pt reported feeling lightheaded and flushing, 12 minutes post-vaccination. Assessed by on-site EMS. Patient reported palpitations and chest-tightness. Vital signs taken by EMS. At 1815 BP 141/88 HR 104. At 1817, BP 160/101 HR 150. HR 168 per EMS. Based on tachycardia and symptoms, decision was made to transport to ER. Patient denied any significant health history or previous vaccine adverse events. Patient transported via ambulance.
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| 45 | 2021-03-05 | migraine | Migraine; nausea; vomiting; low grade fever; tired; chills. |
| 45 | 2021-03-06 | feeling hot |
Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started...
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Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started to feel lightheaded and just weird. I was taken to lay down. My blood pressure was taken and it was elevated. I don't recall the exact numbers. I then began to develop hives on my chest and neck and a few minutes later I began coughing. An ambulance was already on site. They took me in the ambulance and gave me 25 mg of Benadryl and a dose of epi. The coughing subsided for about 10 minutes then began again. I was given another 25 mg of Benadryl. At the hospital I was observed. At approximately 5:30 I began to cough again. It was decided that I needed steroids and was given steroids in my IV. Once I stopped coughing I was discharged and sent home with a prescription for steroids and an Epi-pen
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| 45 | 2021-03-07 | involuntary muscle movements |
Less than two hours after the shot was administered, I started to feel nauseous and overall not well...
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Less than two hours after the shot was administered, I started to feel nauseous and overall not well, along with fatigue. I had chills and remained cold for the next 14 or so hours. The worst part was the uncontrollable movements of my entire body, which started as almost a feeling of crawling inside then quickly progressed to moving. This began about 6:30 pm and lasted until almost midnight. At times, it felt like my muscles were tightening up so much that they were going to spasm. I have never experienced this and it was quite worrisome. It was what I imagine people with Parkinson's feel. I had a reaction to the first shot on 2/14/21 about 26 hours after. Severe fatigue, body aches and headache. All were terrible. Only lasted about 12 hours.
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| 45 | 2021-03-07 | difficulty speaking |
thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; S...
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thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown.
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| 45 | 2021-03-07 | flushing |
Became flushed , rapid HR, nausea and syncope. Employee taken to ED where she was stable and receive...
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Became flushed , rapid HR, nausea and syncope. Employee taken to ED where she was stable and received IV fluids and Zofran, monitored and discharged to home.
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| 45 | 2021-03-07 | numbness |
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have verti...
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groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
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| 45 | 2021-03-07 | muscle twitching | Involuntary twitching of right arm that lasted for 48 hours. |
| 45 | 2021-03-07 | pain in extremity |
within hours after vaccine - noted left arm pain and reduced range of motion, reduced ability to pus...
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within hours after vaccine - noted left arm pain and reduced range of motion, reduced ability to push/pull with left arm - sxs still present 2 months later
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| 45 | 2021-03-07 | pain in extremity |
arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is ...
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arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 02Feb2021 10:30, at single dose, for COVID-19 immunization, at a school or student health clinic. Medical history included COVID-19 (prior to vaccination) and arm hurt, both on an unknown date. The patient was not pregnant at the time of vaccination and has no allergy to medications, food, or other products. Concomitant medication included ibuprofen and vitamins. It was reported that on 02Feb2021 at 14:30, about 4 hours after getting the vaccine, the patient's arm hurt worse than ever and she was extremely exhausted. On 02Feb2021, in the middle of the night, the patient experienced headache, controllable chills and had a fever of 101. No treatment was given for the events. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was not resolved. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 45 | 2021-03-08 | hot flush, muscle spasms, feeling cold, flushing |
On March 8th, I started my period 11 days early. I have 94 cycles tracked on my tracking application...
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On March 8th, I started my period 11 days early. I have 94 cycles tracked on my tracking application and my cycle does not deviate from 27-29 days. I had cramps and pain the 9th. the symptoms that started on 2/28 were normal: site of injection soreness, fatigue, some face flushing and flashes of hot and cold.
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| 45 | 2021-03-08 | tenderness | Two large red blotches on upper arm. One on bicep and one on back of arm. Both sore to the touch. |
| 45 | 2021-03-09 | flushing |
I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my che...
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I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my cheeks were VERY flushed. I took my temperature. Though it was 98.5, that is higher than my personal 'normal' temp. I am typically 97.3-7. Checked again on my flushed cheeks to see that my face was swollen. I ran into a neighbor, though wearing a mask, she didn't see/say anything, and I felt okay enough not to bring it up. By the end of the day, swelling in my cheeks was less noticeable so I went to bed thinking I wasn't having more than a typical vaccine reaction. I woke up the next day with swollen eyelids. I've only become concerned after googling the general side effects and saw 'swelling of the face' and/or 'swollen eyelids' listed as both "common" and "when to call a doctor". My (non)fever is up and down over the past few days though I still feel flushed with more pink in my cheeks.
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| 45 | 2021-03-09 | tingling |
Client had a vasovagal reaction x 3 seconds within 5 minutes post vaccination. Hx of fainting with b...
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Client had a vasovagal reaction x 3 seconds within 5 minutes post vaccination. Hx of fainting with blood draws and vaccination during her college years. client stated tingly on left upper chest for just a few seconds. denies chest pain, shortness of breath or dizziness. Client vitals were take at 15:26 with spo2 97, pr 54, BP 147/62, vital #2 at 15:31 spo2 98, pr 67, BP 140/85, vitals #3 15:48 spo2 98, pr 71, bp 150/88. Client was advised to go to an urgent care/ emergency room for further monitoring. Client's son will be transporting.
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| 45 | 2021-03-10 | weakness, paralysis |
(3/10-3/11) Fatigue, headache & body aches on day of vaccine and overnight (3/11) 12:00pm lighthead...
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(3/10-3/11) Fatigue, headache & body aches on day of vaccine and overnight (3/11) 12:00pm lightheadedness and fatigue (took nap) (3/11) 3:10pm overall weakness (took 99mg Potassium tablet) and sudden onset of paralysis that lasted for 1 1/2 hrs (3/11) 6:05pm still feeling fatigued and a little weak, but strong enough to get out of bed on own
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| 45 | 2021-03-10 | feeling hot | While waiting, my left hand became hot. At the moment, I have pain in the shot area and below it. |
| 45 | 2021-03-10 | muscle spasms |
I set my timer on my phone for the 15 minuets. I had no problems or reactions what's so ever. Till...
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I set my timer on my phone for the 15 minuets. I had no problems or reactions what's so ever. Till I got back home. I started to walk and noticed that my left leg started to what felt like a leg cramp. It started to be mostly on my thigh and moved slightly down my left leg. It doesn't hurt, just a little bother some.
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| 45 | 2021-03-11 | flushing |
Hives with facial flushing. No airway concerns. Received Benadryl, observed for 30 min and was disch...
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Hives with facial flushing. No airway concerns. Received Benadryl, observed for 30 min and was discharged home in a stable condition. BP 139/91, O2 sat 97 % RA, HR 68.
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| 45 | 2021-03-11 | pain in extremity |
The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from...
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The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from the vaccine, a really bad headache, muscle aches, temperature of 100.2F, chills, nausea and I noticed my arm hurt and then my noticed my lymph nodes under my right armpit swollen (painful - lasted about a week) all other symptoms about 2 days. I had the vaccine on a Thursday, on Friday I could not even finish my work day. The overall symptoms lasted about2 or 3 days. Consulted with PCP on the phone who suggested hot and cold compresses.
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| 45 | 2021-03-11 | pain in extremity | Arm soreness, headache, dizzy. Signed refusal went home. |
| 45 | 2021-03-12 | numbness | Numbness to right side of face, arm, leg |
| 45 | 2021-03-12 | pain in extremity |
Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other co...
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Sore left arm, bruise. Very sore, swollen lymph node. Sore upper left arm. No fewer and no other concerns. As of 3/13/21 still slight soreness.
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| 45 | 2021-03-14 | breast pain, tenderness |
I had no side effects until several hours later when I went to bed and woke up at 3:00am with pain i...
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I had no side effects until several hours later when I went to bed and woke up at 3:00am with pain in my breast on the right side. It feels like a pulled muscle but is also in the same area as a breast tumor that was removed decades ago. My right arm and right breast are tender to the touch and I have occasional sharp pain I the breast. No feeling of lumps though.
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| 45 | 2021-03-14 | migraine, hot flush |
In the evening I became very dizzy and vomited. In the morning at 5:00am I woke up with a severe mig...
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In the evening I became very dizzy and vomited. In the morning at 5:00am I woke up with a severe migraine and vomited 2 more times. Around 10:30am I ate a small amount of cereal so I could take an aspirin. I had excruciating pain, nauseous, hot flashes, chills, and sweats throughout the day and only could lie in bed in the dark and quiet. I slept on and off for almost 36 hours. The following day my migraine was gone but I was very dizzy and nauseous and did not want to eat. The third day I am finally feeling fine.
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| 45 | 2021-03-14 | nerve pain |
diagnosed with Shingles. March 4th, thought I had a pulled muscle, over the next few days, decided ...
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diagnosed with Shingles. March 4th, thought I had a pulled muscle, over the next few days, decided it was nerve pain and started looking into massage therapy for sciatica. A few days later hive developed and considered if it could be shingles. The next day I consulted a doctor and shingles was confirmed.
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| 45 | 2021-03-15 | numbness |
"Patient with palpitations and numbness to both hands (fingertips) that lasted 10min after PFIZER co...
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"Patient with palpitations and numbness to both hands (fingertips) that lasted 10min after PFIZER covid-19 vaccine, self limited BP 110/83 O2Sat 100% pulse 80, feeling better, refused ER ,HX anxiety disorder"
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| 45 | 2021-03-15 | migraine |
No taste; Migraine; Fever; This is a spontaneous report from a non-contactable consumer (patient her...
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No taste; Migraine; Fever; This is a spontaneous report from a non-contactable consumer (patient herself). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration on 30Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation in hospital. The patient's medical history was unknown. It was unknown whether the patient had allergies to medications, food, or other products or not. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), on 09Jan2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation and felt tired, lethargic all weekend. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination or not. On 30Jan2021, the patient experienced no taste, fever and migraine. The patient underwent lab tests and procedures included body temperature: Fever on an unspecified date. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 45 | 2021-03-15 | pain in extremity |
Exactly one week after shot, I experienced pain at the injection site. Pain spread from injection si...
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Exactly one week after shot, I experienced pain at the injection site. Pain spread from injection site to middle of arm. Left index finger joint pain. Friday, the joint was just sore. Saturday it was swollen and very painful. Attempted compression and heat therapy unsuccessfully. Sunday pain reduced to soreness. Today pain and soreness from arm and joint have ceased. Index finger joint affected is the one above palm of hand.
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| 45 | 2021-03-15 | tingling, tremor |
Dizziness, tremors, fast heartbeat, strong tingling in fingers. Symptoms onset 30 minutes after vac...
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Dizziness, tremors, fast heartbeat, strong tingling in fingers. Symptoms onset 30 minutes after vaccine was administered and subsided about 2 hours later. Primary care physician suggested that skipping breakfast may have been a contributing factor (I sometimes skip breakfast; I had not eaten for about 14.5 hours at the time the vaccine was administered).
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| 45 | 2021-03-15 | tremor |
Extreme fatigue, followed by approx. 5-6 hours of Tachycardia (heart rate was continuously around 11...
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Extreme fatigue, followed by approx. 5-6 hours of Tachycardia (heart rate was continuously around 113/116), extreme chills with shaking ( 4 blankets on me), followed by extreme sweating for 1 hr. After that I was fine as had no other symptoms.
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| 45 | 2021-03-16 | feeling jittery |
Pt developed trouble swallowing/dry throat approx 15-20 minutes after vaccination. Denies SOB or tro...
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Pt developed trouble swallowing/dry throat approx 15-20 minutes after vaccination. Denies SOB or trouble breathing. Benadryl 25mg PO x 1 given, pt also took 1 puff of albuterol, throat symptoms resolved, then pt developed dizziness/jitteriness. Pt monitored and symptoms resolved. Pt discharged home with family under stable condition. Respirations unlabored and even. SpO2 100% RA BP 126/61 HR 85
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| 45 | 2021-03-16 | numbness |
This is a continuation from Dose 1 and 2 worsening symptoms pain in PIP,both elbows.I have more pai...
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This is a continuation from Dose 1 and 2 worsening symptoms pain in PIP,both elbows.I have more pain late at night causing me to not be able to sleep. Im exp stiffness and in the last month both hands little numb.The past week exp neck/back pain. I have had bloodwork which is has been normal. Before the vaccine I haven't had any of the symptoms.
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| 45 | 2021-03-16 | pain in extremity |
Sore arm left site started at 8 PM 3/16. Then after midnight had chills and fever and nausea, temp 1...
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Sore arm left site started at 8 PM 3/16. Then after midnight had chills and fever and nausea, temp 101.6 shivering, body aches, dizziness when sat up. Took Advil, slept some more Hard time sleeping. 7:45 AM 3/17 had fever 102.1 F this AM, and took Tylenol. Now temp 101.1 F.
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| 45 | 2021-03-16 | tingling | Tingling back of throat and tip of nose. Dizzy on standing. |
| 45 | 2021-03-17 | flushing | Face was bright red and flushed off and on fir a few hours. |
| 45 | 2021-03-17 | pain in extremity |
Development of DVT of right leg and PE of right lung. Leg pain started on Friday 01/15/21. Care so...
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Development of DVT of right leg and PE of right lung. Leg pain started on Friday 01/15/21. Care sought at Urgent Care on 01/18/21. Started on Eliquis 01/18/2021.
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| 45 | 2021-03-17 | tremor |
Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vac...
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Patient presented to the ED on 3/14 11:30PM with difficulty swallowing. Patient received Pfizer vaccine on 3/13 at 4:30pm. Immediately afterward she had sensation of lip and tongue swelling. She was given Zyrtec and monitored by the vaccination clinic for 30 minutes. She was discharged from the clinic after improvement of systems. Lip swelling presented on 3/14 at 2:00pm and she took Zyrtec. At 10pm, patient felt sensation of swelling in throat and presented to ED. EMS gave patient 50 mg IV Benadryl. Patient discharged on prednisone. Patient re-presented to ED on 3/16. Allergic symptoms subsided, but patient complained of atypical chest pain with paliptations, tremulousness. Suspect adverse reaction prednisone. She was given cardiology referral for follow up if her symptoms persisted. She remained in normal sinus rhythm with initial sinus tachycardia. Was discharged home in stable condition and counseled to return to ED for any concerns.
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| 45 | 2021-03-18 | burning sensation |
Burning almost immediately after injection while waiting during the 15 minute observation. No immedi...
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Burning almost immediately after injection while waiting during the 15 minute observation. No immediate swelling. Pinching sensation at site of injection throughout evening. Due to lack of visual change within an hour or two of injection, area not further observed. Next morning, observed injection site. It was/is swollen and with a small raised, white area at the immediate injection site. Red area surrounding pinpoint injection is approximately 2 inches in diameter and the area is firm with the firmness additionally extending beyond the red area. Would not describe this as a rash. Reporting due to lack of information reported about "Covid arm" relating to Pfizer as compared to Moderna reports of same reaction.
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| 45 | 2021-03-18 | pain in extremity, flushing |
I waited at the clinic for 30 minutes, but when I left I realized that I was a bit dizzy, itchy (wit...
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I waited at the clinic for 30 minutes, but when I left I realized that I was a bit dizzy, itchy (without hives), and flushed. I took 50mg of Benadryl and waited in my car until I felt safe to drive again (about ten minutes). By evening, I felt like I had been punched in the left bicep. I also had some minor flu-like symptoms (muscle and join pain) that resolved with Tylenol. Today is two days after receiving the vaccine and I feel perfectly fine.
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| 45 | 2021-03-18 | pain in extremity |
Soreness in arm. 2 hours after mild headache fatigue. Starting at 24 hours after injection through ...
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Soreness in arm. 2 hours after mild headache fatigue. Starting at 24 hours after injection through 40 hours after Injection headache body aches muscle tenderness exhaustion nausea.
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| 45 | 2021-03-19 | flushing, hot flush |
1605-Pt c/o fast heart rate. Interpreter immediately with pt and nurse to translate. Husband broug...
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1605-Pt c/o fast heart rate. Interpreter immediately with pt and nurse to translate. Husband brought to pt. BP-142/90 with heart rate 132. Chest and face flush. Received 25 mg benadryl po. Pt stated she was feeling better. 1610-BP-124/82 with heart rate 117. 1615-Pt started c/o of heart racing again. Heart rate 130 and pt now c/o sob and headache. BP-140/84.
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| 45 | 2021-03-19 | pain in extremity | chest pain, fatigue, headaches, chills, arms soreness, insomnia |
| 45 | 2021-03-20 | numbness |
Numb feeling on left side of face like 3 hours after the shot , and a little after left ear and left...
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Numb feeling on left side of face like 3 hours after the shot , and a little after left ear and left part of head . Got better on the Next morning
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| 45 | 2021-03-20 | nerve pain |
Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injecti...
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Chest discomfort (30 min after injection), Upper lip swelling (6 to 6 and a half hours after injection till 14 days after injection, sometimes subsiding with Benadryl), Feeling of right side of throat closing in (20 hours after injection, but improved with Benadryl), Red spots on upper lip together with swelling (1 day after injection till 11 days after injection, at times disappearing with Benadryl), Both lips swelling (1 to 2 weeks after injection, on and off), Headaches (most days from 2 days after injection till now, 16 days after injection), Stiffening of the back of the tongue (20 hours after injection, cured with Benadryl), Nausea (2 days after injection, every few days till 16 days after injection), Low fever (5 times, every 3 days since 3 days after injection, till 15 days after injection), Diarrhea (around every 5 days since 4 days injection), Joint pain (from 2 days after injection, continued around 6 days), Nerve pain (continuing two weeks since a few days after injection), Chills (on and off, from around 3 days after injection till 1 week after injection), Fatigue (going on 16 days since an hour after injection).
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| 45 | 2021-03-20 | pain in extremity |
VACCINE WAS NOT DILUTED CORRECTLY (WAS <1.8ML OF DILUANT) AND PT GOT CONCENTRATED DOSE OF PFIZER COV...
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VACCINE WAS NOT DILUTED CORRECTLY (WAS <1.8ML OF DILUANT) AND PT GOT CONCENTRATED DOSE OF PFIZER COVID VACCINE. PT HAD NO AEs 30 MIN AFTER VACCINE WAS ADMINISTERED. 2 DAYS LATER, ONLY AEs WAS SORE ARM.
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| 45 | 2021-03-21 | feeling hot, flushing |
Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in...
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Within minutes of the COVID injection my heart was racing and fluttering with flushing and warmth in my face. Resting heart rate was as high as 140 (measured by my Apple watch) prior to seeking medical assistance. After sitting in the waiting area for 20 minutes my pulse had slowed down to 100 (my resting heart rate is typically lower-mid 60s); however, my pulse was still high and I did not feel well and had started clearing my throat with mild tightness in my throat and chest. A doctor took my blood pressure reading was 140/78, typically my blood pressure is 105/65. My throat was not visibly swollen. At about 40min the EMT hooked me up to monitor my blood pressure, oxygen, pulse. At the same time I was being hooked to the monitor, my lower lip began itching and visibly showing minor swelling as well as minor swelling and red splotches in my cheeks and forehead. My heart was initially showing PVC but returned to normal. After being monitored for about 30 minutes my adverse reactions had slowed and stabilized to be released to go home. I took antihistamines and ibuprofen.
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| 45 | 2021-03-21 | numbness, tingling | numbness/ tingling in left foot |
| 45 | 2021-03-21 | numbness |
With in 15 minutes my fingers on my left hand started going numb. I had the shot in my Right arm. B...
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With in 15 minutes my fingers on my left hand started going numb. I had the shot in my Right arm. By the next morning I was numb from the neck down and my vision went in my left ye and very blurry in the right eye.
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| 45 | 2021-03-21 | pain in extremity, muscle spasms, tremor |
I had leg weakness, feeling like both legs going to give out about 15 minutes after vaccine, later f...
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I had leg weakness, feeling like both legs going to give out about 15 minutes after vaccine, later feeling of fatigue and unwellness. Couple of days later had dysphagia, food getting stuck in throat, throat tightness, feeling of phlegm, severe leg spasms in both legs, I could see spasms/jerking through pants, then had arm and hand tremors/spasms and leg weakness/feeling of legs going to give out. I had to go to ER and then had relapse of same symptoms week later. I still have dysphagia, unable to swallow solids, food and pills stuck in throat, throat tightness, weight loss of 12lbs, leg weakness and pain, excessive fatigue.
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| 45 | 2021-03-21 | tingling, face paralysis, weakness, numbness |
Symptoms: Tingling, numbness, and weakness beginning in the lower extremities and spreading upwards ...
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Symptoms: Tingling, numbness, and weakness beginning in the lower extremities and spreading upwards up to and including the face. Extreme muscle weakness, difficulty walking. Symptoms similar to those previously experienced with severe allergic reaction to insect stings, for which the patient has allergies documented by bloodwork. Time course: symptoms emerged in the first 5-10 min after the injection. Sensation to the face and upper torso began to fade in one hour, however symptoms persisted until several hours into administration of prescription antihistamines. Treatment: approximately 1 hour and 15 min after the injection, the patient self-administered 25 mg hydroxyzine, every 12 hours for 3 days.
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| 45 | 2021-03-21 | tingling, migraine |
soreness at injection site, massive headache that subsequently turned into a migraine and lasted for...
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soreness at injection site, massive headache that subsequently turned into a migraine and lasted for 3 days, extreme fatigue that lasted for 3 days, sore throat, facial tingling and sensitivity.
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| 45 | 2021-03-21 | tingling |
after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips st...
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after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips started to tingling, then my cheeks, then my tongue. My cheeks started to get red and a bit swollen, then my breathing was getting weird, my blood pressure rise. At that moment I agreed to go in the rescue.
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| 45 | 2021-03-22 | breast pain |
lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sor...
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lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sore throat
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| 45 | 2021-03-22 | discomfort, numbness |
My resting bpm went over a 100 for about 4-5 hours. It is usually at 68-72. drinking more water help...
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My resting bpm went over a 100 for about 4-5 hours. It is usually at 68-72. drinking more water helped get it to the 80-90 range. When first receiving the shot I started feeling numbness in left hand. Tingling in mouth. Altogether my left side felt weird the first hour at least.
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| 45 | 2021-03-22 | feeling cold, feeling hot |
On the day after my vaccine I was sweating all day but did not think anything of it. By the end of ...
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On the day after my vaccine I was sweating all day but did not think anything of it. By the end of the day I was not feeling myself, I went home and felt like I needed to rip my clothes off because I was so hot. I was sweating but freezing at the same time. I changed my clothes and went to bed. I then began freezing where I my teeth were chattering and could not get warm. I had on 3 blankets and was shaking. I fell asleep and was having hallucinations and talking to my grandparents that are deceased. I woke up not know anything but what I was told by my husband and daughter. I took my temperature and it was 104.1. I then continued to alternate between tylenol and ibuprofen for the rest of the night. I slept from 6:00 pm the night of the 12th to 10:00 am on the 13th. I still had a fever but developed a headache that nothing was helping. my fever was 101.4. I was told to go to the doctors to get checked by my job which I did, they examined me and the next day I went back for a COVID swab. I was in bed for the next 12 days and everyday I was developing various symptoms. By day 4 I had no taste and impaired smell and day 5-12 I had body aches, congestion and a cough that would not go away. I was our of work from 01/12/21-01/25/21.
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| 45 | 2021-03-22 | feeling of body temperature change, tremor |
5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, he...
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5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, heart raced, shaking and sweating, hands trembled, light headed, felt both hot and cold at same time. Patient alerted pharmacist and sat down in chair. 23 minutes after vaccine patient not 100% but better, feel fuzzy in head, shaky and feel sweaty but not sweating, carpet looks weird (patient states has hallucinations from other drugs). 25 minutes after vaccine patient light headed, vision not perfect. 28 minutes after vaccine patient's body feels warmer 32 minutes after vaccine patient feels unbalanced, body warm, legs heavy. 36 minutes after vaccine patient's feet feel heavy, feel more normal, temperature difference, sweating stopped, feel more like herself. 39 minutes after vaccine patient's feet feel smidge heavy, feel like herself. 41 minutes after vaccine patient left observation.
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| 45 | 2021-03-22 | migraine | Migraine tiredness muscle pain. Chills fever |
| 45 | 2021-03-22 | speech disorder, tremor |
Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy ...
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Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy rash to chest, abdomen, back and bilateral arms. I was wheelchaired over to the Urgent care section of the building with a Dr following along. By the time I reached the Urgent Care room I was feeling the same strange feeling in my mouth tongue and throat that I had felt with the first vaccine. I felt as if my tongue and possibly lips may be swelling a little though I don?t think they were. It was hard to swallow but I have a mitochondrial disorder which causes trouble swallowing at times too so it may have been a little worse than what I usually feel with that. I seemed to be having trouble pronouncing words as my tongue seemed to be in the way and my voice weaker. By blood pressure was elevated as it was after the first vaccine. I was given a subcutaneous shot of epinephrine and the symptoms started to improve within approximately 15-20 minutes though I was very shaky and anxious from the epi. I was then given an IM injection of Benadryl. After possibly an hour and a half I was sent home with my husband an epi pen and a script for prednisone. I continued to have a strange feeling in my mouth and throat on and off for a couple of days but less severe and I did not use the epi pen for
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| 45 | 2021-03-23 | weakness |
I woke up with severe chills from 4am-10am and then had fever of 103 plus that afternoon, could bare...
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I woke up with severe chills from 4am-10am and then had fever of 103 plus that afternoon, could barely get up out of bed, nausea, weakness, dizziness. Aches all over my body and joints especially, intense headache, pain at injection site. The next night, same thing, woke up at 5am with chills and fever of 103 plus and all the other symptoms the second day. I was in so much pain I considered going to the doctor but could barely move. Tylenol did not touch it. I was delirious. The third night/day the fever finally had broken but I was still super weak and tired. The next day I was better. Anyway, if I had the option I would not take the vaccine again because of these side effects.
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| 45 | 2021-03-23 | breast pain |
About 30 minutes after the shot I got really tired. 30 - 45 minutes later I got really happy and sta...
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About 30 minutes after the shot I got really tired. 30 - 45 minutes later I got really happy and started to laugh a lot. It got worse with movement and was containable if I was sitting still. I was unsteady on my feet as well. I kept losing my balance. I would describe it as euphoria or intoxicated. Lasted until about 10:30 pm when I got really tired and fell asleep pretty quickly. This morning I am just tired and sore with a headache.
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| 45 | 2021-03-23 | difficulty speaking | Patient received dose 1 of Pfizer vaccine - developed hoarse voice and increased SOB |
| 45 | 2021-03-23 | difficulty speaking |
15 min. after administration, pt became short of breath and hoarse. Hospital Rapid Response called,...
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15 min. after administration, pt became short of breath and hoarse. Hospital Rapid Response called, pt took Benadryl 50mg PO and then transported immediately to the ED for further evaluation. ED administered Solumedrol and epinephrine.
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| 45 | 2021-03-23 | flushing, migraine |
Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain M...
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Redness/Flush Face within minutes, Minor itching Migraine headache within hours including Jaw pain Muscle tightness in neck and shoulders Soreness at injection site
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| 45 | 2021-03-24 | weakness |
Guest patient, reported feeling dizzy, complained of being very weak after receiving her first dose ...
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Guest patient, reported feeling dizzy, complained of being very weak after receiving her first dose of Pfizer Vaccine - (Lot #ER8712), administered in the LD at 14:37 hours. Guest complained of feeling ? ?the loss of strength?, to the upper part of her body and that she ?just wanted to close her eyes and sleep.? EMS activated to the Observation Area. Vital Signs assessed: B/P-110/60, P-74 (reg), R-18, T-98.5, 100%, and blood glucose reading of 94. EMS completed further evaluation and guest was released at 14:53 hours reporting that she was no longer experiencing the above complaints/or symptoms. She was offered and accepted water and more observation time. Client reported ?I am back to normal.? Client observed sitting talking on a cellphone and appears to be no apparent distress.
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| 45 | 2021-03-24 | weakness |
Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being...
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Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being itchy without any rash on various parts of the body" about a week after injection. Also reported no appetite and a dry mouth along with being weak and tired. Denied any dyspnea, rash, or other s/s allergic reaction or anaphylaxis. States s/s resolved after 1-1.5 weeks. Did not seek medical care. States "she thinks it may have been pre- or post- menstrual issues and/or supplements". Also states she had had rash in December 2020 of unknown cause. Reports she used "allergy cream then and was sick to her stomach" and was resolved before first dose.
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| 45 | 2021-03-24 | difficulty speaking |
I started with a cough and that got progressively worse until I started throwing up. After throwing ...
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I started with a cough and that got progressively worse until I started throwing up. After throwing up I felt like I could not get enough air for about 40 mins. I had a Abuteral inhaler left from fighting bronchitis so I took a few puffs of that and started to feel a little better. Through the night I continued to throw up a few times and having a lot of coughing. The next day mt throat was on fire and could not really talk. I am assuming this was from all the coughing and throwing up.
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| 45 | 2021-03-24 | facial pain |
Fevers for several days, nausea, diarrhea, myalgias/arthralgias., headaches, sweating, worsening R s...
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Fevers for several days, nausea, diarrhea, myalgias/arthralgias., headaches, sweating, worsening R sided facial pain; these have been persistent for 1 week now
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| 45 | 2021-03-24 | feeling hot |
Patient stated her face was feeling itching and was hot. Patients face was red and warm to touch. Pa...
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Patient stated her face was feeling itching and was hot. Patients face was red and warm to touch. Patient was given 10mg of oral cetirizine. Patient observed for 30 minutes in observation area. Patient went home with spouse, stated she was feeling better. Redness in face resolved.
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| 45 | 2021-03-24 | numbness, tingling | tingling, slight numbness in pinky and left side of ring finger |
| 45 | 2021-03-24 | pain in extremity, weakness |
1. Felt arm soreness after shot and tried to move around around a lot and flex muscle to reduce sor...
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1. Felt arm soreness after shot and tried to move around around a lot and flex muscle to reduce soreness. 2. Started feeling chills, muscle aches, headache and nausea around 9:00PM. 3. Began vomiting around 11:00PM, with other symptoms remaining. Vomited about 3 separate times that evening. 4. The following day, felt chills, muscle ache, joint ache, skin pain, nausea, headache and arm pain, along with sore throat (probably caused by previous night's vomiting). I had very low energy and did not want to eat or drink anything. I began taking Tylenol every 6-8 hours and taking Pepto Bismol as needed to address the nausea. 5. The symptoms continued, but lessened each day over the course of the next 5 days. I anticipate symptoms will continue to reduce over the next 1-2 days, and no treatment will be needed.
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| 45 | 2021-03-24 | pain in extremity |
Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine...
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Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.
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| 45 | 2021-03-24 | pain in extremity | Soreness in arm; Rash covering neck, chin, scalp, ears, arm (non-shot arm) |
| 45 | 2021-03-24 | pain in extremity |
10 days after my first dose of Pfizer, I still have pain in the injection arm. It has been almost a...
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10 days after my first dose of Pfizer, I still have pain in the injection arm. It has been almost a month since I have gotten the 1st shot.
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| 45 | 2021-03-24 | tingling |
Face tingling, lightheadedness. History of childhood anaphylaxis with nuts, carries epi pen and bena...
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Face tingling, lightheadedness. History of childhood anaphylaxis with nuts, carries epi pen and benadryl. Sx onset within 15 minutes of first dose of pfizer vaccine administration. Tx: recline in car seat, lower extremety elevation. Pt given 25mg PO diphenhydramine upon pt request. Approximately ten minutes later pt states facial tingling and lightheadedness subsiding. Pt then had son (vaccinated at same time) drive them home.
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| 45 | 2021-03-24 | tremor |
At first my eyes , mouth, and throat started to burn, then I started to shake uncontrollably for sev...
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At first my eyes , mouth, and throat started to burn, then I started to shake uncontrollably for several hours. I went straight to the ER when it started. Every day since then I have had several shaking episodes lasting in length from 30min to 2 hours. After I get a horrible headache and feel exhausted.
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| 45 | 2021-03-25 | weakness, pain in extremity |
congestion; Fever; headache; weakness; arm pain; armpit pain; This is a spontaneous report from a co...
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congestion; Fever; headache; weakness; arm pain; armpit pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN5918) via an unspecified route of administration in the Left arm (at the age of 45-year-old) On 18Feb2021 at 10:45 as a single dose for COVID-19 immunisation. The patient medical history included Hypoglycaemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included buspirone hydrochloride (BUSPAR), (sertraline hydrochloride) ZOLOFT, simvastatin (ZOCOR), amitriptyline, clonazepam (KLONOPIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Flonase and experienced allergies and also took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 28Jan2021 at 13:45 in the left arm (at the age of 45-year-old) for COVID-19 immunisation. On 18Feb2021, at 17:00 the patient experienced Fever, headache, weakness, congestion, arm pain, armpit pain. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Information about Lot/batch has been requested.
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| 45 | 2021-03-25 | weakness | Dizziness, weakness, reduced appetite and fatigue |
| 45 | 2021-03-25 | flushing |
Nurse notified at approximately 2:30 Client taken to private recovery area RN also present in priva...
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Nurse notified at approximately 2:30 Client taken to private recovery area RN also present in private recovery area Client initially stated that it felt like she had swelling in her jaw area and neck Client reports no difficulty breathing At 2:35 After further questions the client states that a better word would be tightness. No swelling noted Client reports left sided jaw tightness and tightness and stiffness in the neck (just below her left ear) Vitals taken : BP 138/99, Pulse 106, O Sat 98 Client states that it feels like when she has TMJ Client reports feeling a flushed sensation go up her arm towards her jaw and neck after the injection At 2:40 Client reports that the pain/ tightness in her jaw has lessened and no longer feels like its building Client was previously given water Client reports no difficulty breathing and No sensation of her throat closing At 2:42 Client states that when she has issues with TMJ she normally takes Benadryl which helps One 25mg tablet of Benadryl was given with a sip of water Client is not driving and came with her husband. Her husband will drive Client reports feeling like its calming down I let her know that she didn?t have to leave immediately and could still sit At 2:49 Client reports feeling better than when she arrived in the private recovery area Vitals taken: BP 134/105, Pulse 105, O Sat 99 A few minutes later her husband arrived At 2:57 Client reports feeling well enough to leave Client was driven today by her husband Client was advised to seek further care via call 911 if symptoms worsen or difficulty breathing Client able to ambulate to the car unassisted
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| 45 | 2021-03-25 | pain in extremity, numbness |
3/26/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ...
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3/26/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Numbness to left fingers,left arm aches, . Assessment : Time of assessment 1040am Alert and oriented. No redness or swelling, able to move fingers, reports pain 3?10. Actions taken: VS @1040am BP- 149/100, P- 81, O2- 99%, recheck at 1049 BP- 152/87, recheck @ 1131- 147/79, P- 77, O2-100%. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/26/2021 10:46 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
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| 45 | 2021-03-25 | pain in extremity |
Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours la...
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Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen. I started on benedryl. 2x a day. The redness, welts and hives traveled down my face, onto my neck, then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC. I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen, bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today, March 26, it is starting to calm down.
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| 45 | 2021-03-26 | migraine | fever, severe chills, tachycardia, diaphoresis, nausea, migraine |
| 45 | 2021-03-26 | pain in extremity, tingling | Severe , aching pain in arm, underarm, back. Tingling in fingers. Tired, sluggish |
| 45 | 2021-03-26 | tingling, pain in extremity |
Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from rig...
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Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from right forearm to elbow.
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| 45 | 2021-03-28 | weakness |
20 minutes after the vaccine I felt very faint and weak. My blood pressure went up. My throat starte...
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20 minutes after the vaccine I felt very faint and weak. My blood pressure went up. My throat started to swell. This is a typical mast cell reaction for me. I took 20 mg of Fomatadine a few minutes later. I had already had 50mg Bendryl on board. About 20 minutes after the Fomatadine the swelling in the throat started to improve slightly. I left the facility where I had the shot after about an hour and my condition did not worsen. I fulle recovered in about 48 hours.
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| 45 | 2021-03-28 | migraine | Migraine headache for 2 days |
| 45 | 2021-03-28 | pain in extremity, feeling of body temperature change, weakness | Sore arm, chills, body aches, hot and cold spells, and weakness. |
| 45 | 2021-03-28 | pain in extremity | Very sore arm lasting about 24 hours |
| 45 | 2021-03-30 | weakness |
I have experienced Headache; chills; felt weak the first day; This is a spontaneous report received ...
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I have experienced Headache; chills; felt weak the first day; This is a spontaneous report received from a contactable other health Care Professional (patient herself). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified route of administration, in right arm on 03Feb2021 16:00 at single dose for COVID-19 immunization. Medical history included Allergies: Penicillin and Allergies: Sulfa. The patient concomitant medications were not reported. Patient previously took first dose BNT162B2 on 13Jan2021 16:00 for COVID-19 immunization. On 04Feb2021 06:00, the patient experienced chills, first day felt weak, the second day felt better and Third- and fourth-days experienced headache. Treatment received was reported as no. The event considered non serious. The outcome of the events was recovering. Batch/lot number has been requested.
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| 45 | 2021-03-30 | pain in extremity |
lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft ti...
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lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft tissue disorders.; leg bumps/or swelling; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:30 (Batch/Lot number was not reported), at the age of 45-year-old at vaccination, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took NSAIDS and experienced drug hypersensitivity. The patient did not have COVID prior vaccination. On 09Mar2021 06:00, the patient woke up with her right knee swollen and had difficulty walking. She went to the Hospital in the afternoon and was told that her lymphatic nodes were swollen, and the diagnosis is Leg pain and swelling and other specified soft tissue disorders. The still have a swollen knee and cannot walk yet, 6 days after the vaccine. The patient still have leg bumps/or swelling in her leg. The patient was hospitalized for lymphatic nodes were swollen. It was also reported that patient has physician and ER visit. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events which includes Codeine/paracetamol, RICE routine care for injury. Information about Batch/Lot number has been requested.
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| 45 | 2021-04-01 | involuntary muscle movements, tingling |
it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her...
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it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her head and last night aching on left side of her head; Eyelids with poking sensation; lip is jerking, jerking of eyes; pain on left side of her neck; I feel my gland is swollen with a lump on left side; I have had tingling and a needle pain sensation all over my body./Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head; Has to work through the pain/Pain ran down along left side of neck a couple of nights ago also;; Left top of head aching sensation; It is effecting her work and daily life.; This is a spontaneous report from a contactable pharmacist. A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205, Expiration date: not reported via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 14:25 (at the age of 45-years-old) as single dose for COVID-19 immunization. Medical history included ongoing hepatitis B, Kidney stone from 2019 and ongoing. Concomitant medication(s) included tenofovir disoproxil fumarate (Dosage text : 300mg Tablet once daily at night) taken for hepatitis b. The patient's father has high blood pressure and heart problems and mother is fine as stated. The patient experienced tingling and a needle pain sensation all over my body/tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head on 07Mar2021, had to take benadryl to sleep on an unspecified date with, eye lid tingling on an, on 16Mar2021 lip is jerking, pain on left side of her neck, feel the gland is swollen with a lump on left side, also reports pain on the top of her head and last night aching on left side of her head, eyelids with poking sensation, jerking of eyes, left top of head aching sensation, it is effecting her work and daily life, has to work through the pain/pain ran down along left side of neck a couple of nights ago. Therapeutic measures were taken as a result of insomnia. The outcome of event Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head, Lips Jerk, Jerking of Eyes, Left side of neck lump like a swollen lymph is Not Recovered, Left top of head aching sensation, Pain ran along left side of neck is Recovered. Follow up (17Mar2021): New information included clinical information and description of product complaint: Is there a Product Complaint: Taking benadryl last two nights to sleep, did not help last night. Product strength and count size dispensed: 25mg. Additional lot numbers: P117225. Is a sample of the product available to be returned, if requested: No No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal association, a causal relation between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-04-01 | numbness |
Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient ...
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Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient stated she has high BP and a history of stroke. BP was158/114. 911 was called and ambulance arrived in 10 -15min. EMT assessed patient and asked her to smile. Patient's left face was not responding normally, Patient asked to lift both arms. Patient could not fully lift both arms. Patient transported to hospital.
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| 45 | 2021-04-09 | facial paralysis, pain in extremity |
lip area looked a little droop; numbness around her mouth area that spread to the left cheek area; s...
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lip area looked a little droop; numbness around her mouth area that spread to the left cheek area; soreness/pain in the arm after the injection; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 05Mar2021 (received at 45-years-old) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid 19 vaccine at noon on 05Mar2021. She stated that 18 hours later, when she woke up the next morning on 06Mar2021, she had numbness around her mouth area that spread to the left cheek area. She said it was like going to the dentist and getting local anesthesia for a filling. Her lip area looked a little droopy, but she wasn't sure. It continued the whole day and reduced the next day (07Mar2021). She also had soreness/pain in the arm after the injection (05Mar2021) and the next morning (06Mar2021). She further stated that her doctor wasn't sure if this was a one-time issue or related to the vaccine. Outcome of Her lip area looked a little droopy was recovering, while outcome of the other events was unknown. Information about batch/lot number has been requested.
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| 45 | 2021-04-15 | breast pain |
I had my first dose of Covid vaccine, Pfizer 30ug at 3:40pm on 4/8/21. 1 day after my first dose I s...
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I had my first dose of Covid vaccine, Pfizer 30ug at 3:40pm on 4/8/21. 1 day after my first dose I started have low fever(98.8-99.2f). 2 days after my first dose of Covid vaccine my left breast start being painful and start whole body ache. 4 days after first dose my left breast start having an half egg size painful touchable lump with red, warm and swelling. I started taking Acetaminophen 10 mg bid. 4 days on 4/11 till today after first dose for both pain control and reducing body temperature. I used to have granulomatous mastitis on my right breast which is self limited and I had not have this problem for one year. Although the mechanism is still unclear but some theory of this disease is more like an autoimmune problem. I doubt somehow this vaccine has too strong immunogenicity, or at least which is too strong for me. I was getting Pfizer which is 30ug I think. Possibility: 1 Too large dose for my body size (120 lb) 2 Some adjuvant in this Pfizer vaccine induces too strong cellular immune response which may initiate or help for some none Covid specific antibody production, unfortunately for some patients who have autoimmune disease are triggered by this vaccine then they may start producing autoimmune antibody which start self attacking.
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| 45 | 2021-04-15 | slurring |
From ED Physician's Note 4/16/2021: 45 yr female presents to ER complaining of left arm and leg fee...
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From ED Physician's Note 4/16/2021: 45 yr female presents to ER complaining of left arm and leg feeling heavy since yesterday (4/15/2021) morning. Patient states she got the Pfizer first vaccine on Wednesday (4/14/2021) morning, felt fine throughout the day, went to bed without any problems or symptoms. Patient states she awoke yesterday morning feeling as if she was" drunk". Patient states she feels like her left arm and leg are heavy and at times is having slurred speech. Patient states she feels like her walking is off and that she is dragging her left leg. Patient denies any numbness and tingling in the upper or lower extremities. Patient denies any headache or dizziness, vision changes, fever, chills, body ache, infectious respiratory symptoms, chest pain or shortness of breath.
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| 45 | 2021-04-21 | tingling, speech disorder, pain in extremity, numbness |
arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist....
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arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist. immediately that area swelled up and turned red. today (4/22) it is still significantly swollen, though swelling has decreased. also immediately felt "spacey" and feet and forehead felt tingly. within 30 minutes it felt odd to walk because legs/feet felt a bit numb. the spacey feeling stayed for 6 full days during which i felt exactly the same as i had when i had a concussion about 6 years ago. i could think but i couldn't multi-task, communicate well, focus well, speak normally. it's hard to explain but it felt like i had a concussion and it was really scary. i tried to drive at day 6 and realized i could not do it. by day 7, my head started to clear up and i felt better mentally.
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| 45 | 2021-04-24 | feeling hot, electric shock sensation |
is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not d...
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is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not dizzy, she just feels like yuck; Patient states she has pain; she felt like she couldn't breathe; she felt like, not herself, like un-well. Patient states she is feeling unwell since; zapping, basically like a electric shock; nausea and vomiting; nausea and vomiting; extreme fatigue/that night she was exhausted, she couldn't pick up her head; head just doesn't feel right/she couldn't pick up her head; fever; closing of her throat; heat coursing through her body, felt heat in her vessels/she was a bloody, hot mess; chills; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Patient states she had chronic strep throat, she was sick four times a year for the first 12 years of her life. Patient stated she has no allergies, she was a healthy woman. Concomitant medication included simvastatin taken for an unspecified indication from 2020 and ongoing. On 26Mar2021, the patient experienced nausea/vomiting happened almost immediately, soon after the injection. The patient stated she wasn't feeling well, she had to go home from work, but the symptoms started that day almost immediately and persisted for a few days later. She has this zapping. The patient stated it was actually a term, it's basically like an electric shock that she was feeling throughout her body, like from head to toe on 08Apr2021. The patient stated and her head just doesn't feel right, just like dizziness. The patient stated she has pain and was uncomfortable. Patient stated she was concerned about what to do moving forward. Patient stated the day she got the shot, within three minutes, she felt like she couldn't breathe. Patient stated it was not emotional, she's very self aware, she was a psychologist. Patient stated it was a closing of her throat, but that has turned on and off as well. Patient stated then she had heat coursing through her body, felt heat in her vessels, down the center of her throat down in to her throat into the center chest and down into legs. Patient stated that night she was exhausted, she couldn't pick up her head. Patient stated she threw up and had chills, she felt like, not herself, like un-well. Patient states she was feeling unwell since. Patient states she did travel that Monday after, which she doesn't know if it made it worse, but was gone only for an hour, then got sick again that night with fever and throwing up. Patient states then yesterday, she started getting these zaps in her body, it felt like someone had put a taser to her all over her body. Patient stated she was just not herself, she wasn't at her normal. Patient stated she passed out at 7PM at night. Patient verified she was not dizzy, she just felt like yuck. Patient stated she also experienced chills and fever, that happened later that day on 26Mar2021. Patient stated she came back to work and she just felt like she needed to go home. She was instantly not well. Patient stated she has had two antibody tests and she's been negative. Patient stated she checked after that, she made sure she had no antibodies. Patient clarified she checked her antibodies twice before getting the vaccine. Patient stated her resting heart rate was at 55, she was in athletic shape, she was healthy. Patient stated when she had the both, she was on the toilet and throwing up at the same time, she was a bloody, hot mess. Patient states she ripped her clothes off, she was hot. The outcome of the event nausea, vomiting, fatigue, "head just doesn't feel right" was recovered with sequel on 03Apr2021l; fever was recovered with sequel on 07Apr2021; chill was recovered on 03Apr2021; electric shock was not recovered and unknown for the other events. The patient did not received any recent vaccines for SARS-COV2 other than Pfizer- BioNtech COVID-19 Vaccine prior to the event being report and has not received any other vaccines around the time of Pfizer- BioNTech Vaccine Vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-04-26 | tremor, tingling, numbness, cold sweat, inability to speak, muscle spasms |
Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness...
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Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue Onset at time of vaccine administration Labeled NOT anaphylaxis
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| 45 | 2021-04-27 | weakness, muscle spasms, muscle twitching |
I started to get muscle twitching in my left arm, it moved to my breast bone and around to the upper...
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I started to get muscle twitching in my left arm, it moved to my breast bone and around to the upper portion of my rib cage. I also experienced quite a bit of deep muscle pain around the injection site and extreme tiredness. I spoke to my doctor and he prescribed cyclobenzaprine for the twitching
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| 45 | 2021-04-29 | feeling hot |
Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side o...
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Within seconds/ less than a minute of receiving the vaccine, I felt heat rush up through left side of neck... Then underneath my eye / crawl / felt strange like swelling. Then within 5-10 min my skin on left side of head crawl .... But ok within an hour. Only on left side. Also, no pain at all didn't even feel needle go in but had lump at injection site and painful when touched until Day 12.
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| 45 | 2021-04-30 | numbness and pain in extremities, pain in extremity |
Arm weakness/leg weakness; Little irritation at the injection site; Minor headache off and on; Leg p...
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Arm weakness/leg weakness; Little irritation at the injection site; Minor headache off and on; Leg pain/really bad arm pain in the left arm with lifting and movement/arm pain; Itching on chest and arms; Tenderness in injection site; Neuropathy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955; Expiration date was not reported) on the left arm on 27Mar2021 (19:55) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). The patient had no relevant medical history. Concomitant medications included cetirizine hydrochloride (ZYRTEC). On an unspecified date in 2021, the patient had neuropathy. On 27Mar2021, the patient had minor headache that was off and on; leg pain and really bad arm pain (left arm) with lifting and movement; itching on the chest and arms; and a little irritation at the injection site. On 28Mar2021, the patient had arm and leg weakness. In Mar2021, the patient had tenderness at the injection site. The patient had received diphenhydramine (BENADRYL) as treatment for the itching on the chest and arms. The patient's x-ray was normal on an unspecified date in 2021. The outcome of the events was not recovered for 'arm and leg weakness'; recovered on 27Mar2021 for 'itching on the chest and arms'; and was unknown for all the other events. The patient was scheduled to receive the second dose of vaccination, but did not want to risk having the same effects in the right arm.
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| 45 | 2021-04-30 | pain in extremity |
Pain on left foot - feels like a small bump; Pain on left foot - feels like a small bump; This is a ...
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Pain on left foot - feels like a small bump; Pain on left foot - feels like a small bump; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pain on left foot - feels like a small bump on 31Mar2021. The event was reported as non-serious. The patient did not receive any treatment as a result of the event. The clinical outcome of pain on left foot - feels like a small bump was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 45 | 2021-04-30 | seizure, pain in extremity |
it could have been a seizure; Unconscious/Collapsed/ diagnosed her as having a Syncopal Episode; Uri...
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it could have been a seizure; Unconscious/Collapsed/ diagnosed her as having a Syncopal Episode; Urinated on self/Wet her pants; Headaches; Feeling light headed; Felt her heart beat faster; Sore arm; This is a spontaneous report from a contactable nurse (patient mother). A 45-year-old female patient received bnt162b2 (BNT162B2, lot number EW0150 and expiration date was not provided), via an unspecified route of administration first dose on 05Apr2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included ongoing Hypertension (Patient diagnosed in her late 30's), ongoing Hypothyroid (Patient diagnosed when she was around 20 years old), ongoing Allergies, ongoing Gastrooesophageal reflux disease (The patient was exposed to a chemical in her 20's that caused this condition), ongoing Birth control, ongoing Allergic to eggs (States patient has never received the flu vaccine due to her egg allergy), and ongoing Allergic to shellfish. The patient's concomitant medications included ongoing levothyroxine at 150 ug, 1x/day for Hypothyroid, ongoing Hydrochlorothiazide at 12.5 mg, 1x/day for hypertension, ongoing omeprazole at 20 mg, 1x/day for gastrooesophageal reflux disease, ongoing losartan at 100 mg, 1x/day for hypertension, ongoing norethisterone (SHAROBEL) for Birth control. On 06Apr2021 13:00, the reporter stated that her daughter fainted at work, lost her urine, and was unconscious and was taken to the Emergency Room. Primary Care Physician told her daughter she should have no problem getting the second vaccine. States that she was not certain if her daughter should get the second shot. It was scheduled for next week. Also, reported that after lunch reporter stated that her daughter fainted in her office at work. She had urinated on herself and was unconscious. Caller was concerned it could have been a seizure. Her daughter was taken to the Emergency Room and they diagnosed her as having a Syncopal Episode. On 06Apr2021, the patient had headaches that continue since these events. The reporter stated that her daughter's doctor told her daughter that the blood work and electrocardiogram done at the Emergency Room were normal. The Emergency Room and her daughter's doctor acted like her symptoms were not serious. The reporter looked at the Vaccine Adverse Event Reporting System website and it said that a syncopal episode is a reportable event. Says that her daughter's doctors did not report this event. Says doctors need to have training on the importance of reporting events. The reporter called the Food and Drug Administration last week but she hasn't heard anything from them. States they told her it could take 5-7 business days. Says she called Pfizer today to see if there was any further information or guidance she could get as she is concerned about her daughter. She says her daughter has her own office so she was in there alone when she collapsed. Someone found her on the floor. The reporter was asking for guidance on administration of the second vaccine dose following a syncopal episode after the first. The patient received her first vaccine dose on 05Apr2021 15:00 and she was fine, she had a sore arm, but went to work the next day (06Apr2021) and after lunch she reported feeling light headed and felt her heart beat faster and went to get up and a colleague later found her on the floor and she had wet her pants. They took her to the ER around 1 pm the day after her vaccination and diagnosed her with a syncopal episode stating that they didn't think it was from the shot. The events syncope, urinary incontinence, seizure, and headache were considered as serious (medically significant) by the reporter. The events syncope, and urinary incontinence caused emergency room visit and physician office visit. The outcome of the events syncope, urinary incontinence was recovered on 06Apr2021. The outcome of the event Headache was not recovered. The outcome of the remaining events was unknown.; Sender's Comments: Based on the information currently available, a causal association between the reported events and bnt162b2 cannot be fully excluded.Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 45 | 2021-05-04 | bell's palsy, numbness |
Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on ha...
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Bells Palsy on right side of face; Severe rash on hands, trunk, neck; large blister like bumps on hands, trunk and head: itching; itching; facial swelling/ swelling in face; hand swelling/ swelling in hands; tingling in lips; some mild difficulty swallowing; throat swelling; mild difficulty breathing; numbness; swelling in mouth; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 06Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Feb2021 15:00 (lot: EN6201) and second dose on 25Feb2021 15:00 (lot: EN6205); both via an unspecified route of administration in left arm (at the age of 45-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included known allergies Sulfa, bee stings, shellfish and Ceclor. Concomitant medications included armodafinil; clonazepam; vortioxetine hydrobromide (TRINTELLIX), also Tooo Max and an unspecified vit. The patient experienced Bells Palsy on right side of face; throat swelling; itching; mild difficulty breathing; severe rash on hands, trunk, neck; numbness; swelling in mouth; large blister like bumps on hands, trunk and head: itching; facial swelling/ swelling in face; hand swelling/swelling in hands; tingling in lips; some mild difficulty swallowing on 02Mar2021 at 15:00. The patient considered the case as non-serious, did not result in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and non-congenital anomaly/birth defect. The events resulted doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received prednisone, cetirizine hydrochloride (ZYRTEC), omeprazole (PRILOSEC), methylprednisolone sodium succinate (SOLU-MEDRO) IV at ER as treatment. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-05-04 | depressed level of consciousness, numbness |
Rapid heart rate of 120 - 160 BPM (while sitting down) for over an hour. Difficulty remaining consc...
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Rapid heart rate of 120 - 160 BPM (while sitting down) for over an hour. Difficulty remaining conscious and numbness in my face.
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| 45 | 2021-05-05 | pain in extremity |
Immediate chest pain (tightening) , then arm pain while in store/pharmacy Next Day began spotting (m...
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Immediate chest pain (tightening) , then arm pain while in store/pharmacy Next Day began spotting (menstrual bleeding) and lasted for 2.5 days Chest pain continued and has not stopped for last 10 days, intermittent throughout the day - tigheting of left side and right side of chest, radiates to theback Sunday following Monday vaccination (6 days later) got a blood clot on palm of hand, lasted for 4 days that started bleeding out and blood spread to front of hand like a birthmark as it bleed out
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| 45 | 2021-05-07 | burning sensation |
Severe allergic reaction; Fainting; Hives; Itching; Burning; Shortage of breath; This is a spontaneo...
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Severe allergic reaction; Fainting; Hives; Itching; Burning; Shortage of breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Apr2021 08:45 as single dose for COVID-19 immunization in an hospital. Medical history included known allergy from an unknown date. There were no concomitant medications. No other vaccines taken in four weeks. No COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. On 10Apr2021 13:00, the patient experienced severe allergic reaction - hives, itching, burning, shortage of breath, fainting. She was unable to stand or sit, and had to call ambulance and go to emergency. The events resulted in emergency and physician's office visit and required hospitalization. The patient was given a steroid and unspecified allergy medications as treatment. The outcome of the events was reported as recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-05-07 | tremor, numbness |
Allergic swelling of young and throat; Allergic swelling of young and throat; Shakes; Numbness on ri...
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Allergic swelling of young and throat; Allergic swelling of young and throat; Shakes; Numbness on right side of face; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergies to gluten and dairy, covid prior vaccination and Mthfr. There were no concomitant medications. The patient has no other vaccine in four weeks and no other medications in two weeks. The patient experienced shakes, numbness on right side of face and allergic swelling of "young" (as reported) and throat on 20Apr2021 at 22:00. The events were treated with Benadryl. The patient was not tested for covid-19 post vaccination. The outcome of the events was recovered with sequel on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 45 | 2021-05-09 | pain in extremity |
Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nau...
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Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nausea and vomiting. EKG showed T-wave inversion on V2 and pt was sent to the ED for further evaluation. At the ED, bloodwork showed a significantly elevated troponin level. Pt was admitted for a possible NSTEMI and placed on a heparin gtt, diagnosis changed to myocardial injury within the setting of myo/pericarditis.
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| 45 | 2021-05-12 | paralysis |
complete paralysis/paralyzed/can't move anywhere/can't move her arms and legs; muscle weakness; This...
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complete paralysis/paralyzed/can't move anywhere/can't move her arms and legs; muscle weakness; This is a spontaneous report from two contactable consumers (patient herself and her husband). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered in the right arm (also reported as right shoulder), on 13Apr2021, as 1st dose, single, for COVID-19 immunization, at a pharmacy/drug store. Medical history included allergies to latex, bulimia, depression, and COVID-19 (prior to vaccination). The patient previously took codeine and experienced allergies. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 since the vaccination. Concomitant medications were unspecified (taking other medications). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 16Apr2021, the patient experienced complete paralysis which started with muscle weakness 3 days after the vaccine. The events resulted in emergency room visit, hospitalization (also reported as prolonged hospitalization, pending clarification), disability or permanent damage. The patient was still in the hospital at the time of the report. Treatment for the events included spinal tap, IV fluids, and potassium intake treatment. On 29Apr2021, it was reported that the patient was having a really bad reaction (unspecified), was paralyzed, could not move anywhere and in the hospital from 25Apr2021 and ongoing. The patient underwent lab tests in Apr2021 with unknown results. On 08May201, it was reported that the patient could not move her arms and legs and is "nursing home" (pending clarification). The reporter assessed the events as serious (hospitalization and disability). The outcome of the events was not recovered.
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| 46 | 2020-12-31 | numbness |
Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated b...
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Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck Â
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| 46 | 2021-01-01 | weakness |
Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driv...
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Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).
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| 46 | 2021-01-02 | difficulty speaking, tenderness, pain in extremity |
Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for obs...
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Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for observation, left on my own. Noticed face was swollen and red after showering- took photo. Cough and clearing throat like when I eat something I?m allergic to. Took another benedryl four hours later as well as Tylenol for headache. Ate dinner went back to sleep notice arm hurts a bit. Next morning 9 am face no longer swollen but arm hurting to the slightest touch. 4:30 pm still resting arm very painful . Headache and facial swelling under control. At no time did I have trouble breathing, slight itching
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| 46 | 2021-01-02 | hot flush, numbness, tingling |
Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/20...
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Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/2021, peripheral tingling or numbness on 1/2/2021. Took 800 mg Ibuprofen BID to help with symptoms,
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| 46 | 2021-01-03 | flushing |
Turned red and flushed within 5 minutes of vaccine administration. Lasted for about 60 minutes. N...
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Turned red and flushed within 5 minutes of vaccine administration. Lasted for about 60 minutes. No issues breathing.
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| 46 | 2021-01-03 | tingling, numbness |
After the 15 min monitoring, I went back to work 15 min later. the left side of my face started ting...
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After the 15 min monitoring, I went back to work 15 min later. the left side of my face started tingling which went to a numbing feeling down the left side of my body affecting my neck, shoulder, arm, elbow and up the upper left torso. My face and neck was numb for about 48 hrs and the rest came back to sensation within 24 hrs. D/T the numbness I was admitted into the hospital for a 24hr observation.
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| 46 | 2021-01-04 | weakness |
Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no brea...
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Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no breathing difficulties, and weakness. Tylenol helped.
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| 46 | 2021-01-04 | weakness |
tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-lik...
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tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included polycystic ovarian diseases from an unknown date. Concomitant medication included metformin, omeprazole, apremilast (OTEZLA). Patient stated she got the vaccine on the 18th. She took the vaccine on 20Dec2020. Yesterday (25Dec2020) she started to feeling sick and today (26Dec2020) patient got tested and she have Covid. She reported to have tested positive for COVID today (26Dec2020) with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms yesterday at around 4:00pm. This was the first time she has taken the Covid test. The physician stated she didn't know the causality between the event and vaccine. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive test for COVID based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 46 | 2021-01-04 | feeling cold, breast pain, burning sensation |
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an...
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At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
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| 46 | 2021-01-04 | feeling cold |
chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report...
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chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 46-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), intramuscular in arm right, on 28Dec2020 morning, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from the end of May2020 to unknown date in 2020 (not ongoing) and ongoing hypertension. Concomitant medication included losartan (LOSARTAN) from an unspecified date and ongoing, for hypertension. On 28Dec2020 evening, around 08:00 or 09:00 PM, the patient experienced chills with outcome of recovering, bad headache with outcome of not recovered, body aches with outcome of recovering, she felt cold with outcome of recovering, her arm felt so heavy with outcome of recovered in Dec2020. Therapeutic measures were taken as a result of bad headache and included laying down, ice on her back and neck. The second dose is scheduled on 18Jan2020.
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| 46 | 2021-01-04 | flushing |
flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (pa...
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flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female (not pregnant) patient received BNT162B2 (lot number EH 9899) first dose intramuscularly on right arm on 30Dec2020 09:30 AM at single dose for COVID-19 immunization. Medical history included HTN/GERD, allergies to pineapple and sulfa. Concomitant medications in two weeks included diltiazem (CARDIZEM), valsartan (DIOVAN), omeprazole (PROTONIX), meloxicam (MOBIC), docusate and bupropion hydrochloride (WELLBUTRIN). No other vaccine in four weeks. Patient experienced flushing, chest pressure and lightheadedness on 30Dec2020 09:30 AM, resulted in: Emergency room/department or urgent care and received treatment as ER evaluation. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered in Dec2020. The seriousness was reported as no.
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| 46 | 2021-01-04 | flushing |
Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day);...
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Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event"Patient had SVT" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-04 | pain in extremity, burning sensation |
Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burni...
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Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via an unspecified route of administration on 25Dec2020 at 03:00 PM (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history included anemia. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 25Dec2020 at 08:00PM, a fine rash developed on arms and legs. Red, itchy patches on abdomen, back, neck and chin. Hot, burning sensation to palms of hands and soles of feet. The patient did not receive any treatment for the events. The clinical outcome of the events rash on legs & arms, Red, itchy patches on abdomen, back, neck and chin, and Hot, burning sensation to palms of hands and soles of feet was recovered on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. There were no other vaccines the patient received within 4 weeks of the vaccination.
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| 46 | 2021-01-04 | pain in extremity |
3 WEEKS POST VACCINE AND ARM MUSCLE/SHOULDER HAS PRETTY SEVERE PAIN. IT HURTS TO RAISE MY ARM ABOVE...
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3 WEEKS POST VACCINE AND ARM MUSCLE/SHOULDER HAS PRETTY SEVERE PAIN. IT HURTS TO RAISE MY ARM ABOVE MY HEAD, SHAMPOO/BRUSH MY HAIR, ETC....
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| 46 | 2021-01-04 | tingling |
Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; Thi...
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Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 46 | 2021-01-05 | burning sensation, feeling hot |
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever a...
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About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
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| 46 | 2021-01-05 | facial pain |
3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of...
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3 days after injection (Thursday 12/24/20)noticed pain and pressure from jaw to ears on left side of face. Saturday morning (12/26/20) noticed left lymph node was swollen. Sought medical care-DX anterior cervical lymphadenopathy.
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| 46 | 2021-01-05 | feeling cold |
c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to even...
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c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to event. 0900 - bp 126/70, hr 107, rr 20, sats 100 0905 - bp 122/67, hr 90, rr, 18, sats 100 0910 - bp 113/66, hr 81, rr 20, sats 100 - lightedness no longer present, she c/o of being cold, 0915 - dry throat that water helped. denied throat itching, states breathing wnl. 0915 - bp 120/80, hr 88, rr 20, sats 100 Pt reports that she feels better. She is off work today, but she will stay in the rt office with staff for 30 minutes before going home.
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| 46 | 2021-01-05 | flushing | Dizziness, flushing |
| 46 | 2021-01-05 | numbness, weakness, tingling |
muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; he...
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muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus. Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
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| 46 | 2021-01-05 | numbness, tingling |
states 40 minutes after her vaccine she developed facial parasthesias and numbness that eventually ...
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states 40 minutes after her vaccine she developed facial parasthesias and numbness that eventually resulted in an "ache". No muscle weakness. This has since improved.
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| 46 | 2021-01-05 | numbness |
Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of ...
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Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.
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| 46 | 2021-01-05 | muscle twitching, tingling, numbness |
Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/20...
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Received the vaccine in morning: Started developing itching on torso throughout the day. On 1/6/2021 starting at 0500, the opposite arm (Right) developed tingling and numbness. Thumb is twitching.
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| 46 | 2021-01-05 | tingling | Left arm heaviness with tingling. |
| 46 | 2021-01-05 | tremor, feeling jittery |
Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms...
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Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms earlier and worse than usual. EKG showed PVCs.
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| 46 | 2021-01-06 | weakness |
12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to inj...
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12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.
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| 46 | 2021-01-06 | discomfort |
Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right ar...
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Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right arm) limiting the use of this arm and causing excruciating pain and discomfort.
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| 46 | 2021-01-06 | feeling hot, muscle spasms, numbness |
jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around he...
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jaw tightening; muscle spasms; entire face and around her mouth went numb; entire face and around her mouth went numb; heart palpitations; I had hives on my chest; a wave of heat rush up her back; This is a spontaneous report from a contactable nurse (patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 22Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included ectopic pregnancy, hay fever. Concomitant medication received within 2 weeks included: loratadine, colecalciferol (vitamin D), olly womens multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. About 15 minutes after the vaccine the patient experienced jaw tightening and muscle spasms. The patient was given oral Benadryl 50 mg. About 5 minutes after taking the Benadryl, her entire face and around her mouth went numb. The patient began having heart palpitations and felt a wave of heat rush up her back. She had hives on her chest. The patient received 1 dose of epinephrine from an Epi-Pen and transported to the emergency room for further treatment. Adverse event start date: 22Dec2020 11:00 AM. Events were considered as non-serious. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event included: Benadryl, Epinephrine, Solumedrol, Pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Test Name: SARS-CoV-2 by PCR (Nasal Swab) on 30Dec2020: Negative. Outcome of the events was not recovered.; Sender's Comments: The temporal relationship is suggestive of an acute anaphylactic reaction. Based on the temporal relationship and the known pattern of response, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-06 | muscle twitching | Lower lip twitching |
| 46 | 2021-01-06 | pain in extremity |
Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had...
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Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had to use my inhaler, take cold/cough medicine to help me stop coughing. By Wednesday Had a bad cough, tightness in the chest, and lots of congestion. Left arm was very sore. Called work who told me to go to the ER for covid test. Tried to get into my doctor's office who would not see me and told me to get a covid test. Tried to get into Facility who told me I would require two appointments. One to see a doctor and another to get a Covid test. Also, it would be a three to four-hour wait. Felt so sick that I took myself to an ER in order to be seen. Mysaturation was good in the ER but HR was in the 120s. They did an EKG, gave me an albuterol inhaler, IV fluids, IV steroids, and a chest X-ray. They did a Covid test which was negative as well as other bloodwork. Then sent me home. My husband also started with a cold the Sunday night before my vaccine so I do not know if that might have been where I got sick?
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| 46 | 2021-01-06 | pain in extremity | Sore arm- lasted 3 days. Moderate intensity Fatigue- 24 hours Nausea and dizziness-2 hours |
| 46 | 2021-01-06 | pain in extremity |
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on...
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I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
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| 46 | 2021-01-06 | tingling, weakness, slurring |
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body a...
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Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.
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| 46 | 2021-01-06 | tingling |
Having pins and needles in left hand, today having it in right hand as well, no treatment at this ti...
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Having pins and needles in left hand, today having it in right hand as well, no treatment at this time still having symptoms this morning at time of report
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| 46 | 2021-01-06 | tingling | Dizziness Left leg tingling intermittingly, BP163/107 HR 75, BP110/119 HR79 O2 98% |
| 46 | 2021-01-07 | difficulty speaking |
she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratc...
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she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratchy throat, swelling sensation of the throat, hoarse voice, difficulty breathing. Presented to the ED. Received IM Epi, IV Benadryl and Solumedrol.
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| 46 | 2021-01-07 | facial paralysis | Headache, Fatigue- on day 2 Bels Palsy- Day 4 |
| 46 | 2021-01-07 | feeling jittery |
Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feelin...
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Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feeling jittery and shaky. Oxygen saturation remained normal. Vital signs normal.
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| 46 | 2021-01-07 | flushing |
Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Fa...
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Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Facial flushing accompanying rash Severe body and joint aches appeared 18 hrs post-injection - responsive to ibuprofen-still present Severe headache appeared 16 hrs post-injection - responsive to Excedrin/Tylenol - still present Low-grade fever 100.1F (taken 3 hrs post ibuprofen)
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| 46 | 2021-01-07 | pain in extremity, feeling cold |
With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I co...
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With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I couldn't get warm, I felt very tired. About the next thirty hours I had body ache and head ache my arm got very heavy and hurt, I did not run a fever but felt very restless and achy. I was very tired and didn't work the following day, didn't have much of an appetite. I had some mild itching on my arm.
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| 46 | 2021-01-07 | pain in extremity |
left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, sli...
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left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, slight fatigue started 12 hours after my second Pfizer dose, better with ibuprofen.
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| 46 | 2021-01-07 | tingling, numbness |
The next day after receiving the Covid vaccine injection in my left arm, I had the typical muscle pa...
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The next day after receiving the Covid vaccine injection in my left arm, I had the typical muscle pain. That subsided within a day or two. But I am experiencing numbness and tingling throughout the entire length of my arm. It is not severe and I am still able to conduct my work and daily chores, but it is very concerning to me. It is now 5 days later, and the numbness is not any better. My left pinky finger is the worst out of all of my digits. I'm not sure if they somehow hit a nerve during the injection or if this is a side effect of the shot.
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| 46 | 2021-01-08 | numbness |
Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating ...
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Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating joint pain, chills leading to rigors. No fever. Incapacitating.
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| 46 | 2021-01-08 | night sweats | Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache |
| 46 | 2021-01-08 | pain in extremity | 1st Day- Arm Neck Pain 12/31/2020 Loss of Appetite, Dizzy-current |
| 46 | 2021-01-08 | pain in extremity |
Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizzi...
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Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizziness and nausea about 2 hours after the vaccine. Her right arm is slightly sore. 12/30 - symptoms have improved and are very slight today. 12/21 resolution of all symptoms.
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| 46 | 2021-01-08 | pain in extremity |
Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids,...
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Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids, Tylenol and Motrin at home
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| 46 | 2021-01-08 | tremor |
01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marath...
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01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marathon in bed) Temp 99.5 9:30PM-Temp of 101 then it went to 102 within an hour. Headache. 10:30 took Tylenol 11:30 Temp 101.5 stopped shaking but still have a temp and muscle aches- probably from the shaking. 12:30 (01/08/2021) Temp 101. Fell asleep 4:30 Temp 100 8:30 Temp 99.5 Still have a headache and muscle pain, and upper back pain Tired, but probably just from roller coaster ride. 01/08/2021 Most of the day and night had low grade fever 99.5-100.7 , headache and sweats 01/09/2021 No Fever, but still have the occasional seats and dizziness
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| 46 | 2021-01-09 | difficulty speaking, feeling hot |
15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could fe...
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15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .
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| 46 | 2021-01-09 | feeling hot |
Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway con...
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Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.
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| 46 | 2021-01-09 | nerve pain, pain in extremity |
Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injectio...
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Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injection), radiates to the right neck and fingertips. Neuropathic, worse at night. Improves to a 3/10 with ibuprofen. No weakness/sensory loss.
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| 46 | 2021-01-09 | pain in extremity | Arm soreness, myalgia, fever, fatigue |
| 46 | 2021-01-09 | tingling |
14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, ...
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14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, occasionally trunk
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| 46 | 2021-01-10 | weakness, hot flush | Headache, malaise, fatigue, dizziness, weakness, chills and hot flashes |
| 46 | 2021-01-10 | flushing |
Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of brea...
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Erytema with facial flushing on neck and face, Nauseas, no vomit, No dyspness, no shortness of breath. treatment Benadryl IV = Solumedrol + Famatidine IV
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| 46 | 2021-01-10 | hot flush, migraine, weakness | Migraines, body ache, malaise, fatigue, weakness, chills, hot flashes |
| 46 | 2021-01-10 | migraine, weakness, pain in extremity |
Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the v...
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Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the vaccine arm, headache, and feeling ache. Day 1 post vaccination patient experienced sore arm, headache, low grade fever, feeling ache, and GI symptoms with diarrhea. Day 2 post vaccination patient experienced sore arm, Migraine, and diarrhea. Day 3 post vaccine patient woke up with chest pain that radiated into her left arm and some weakness. Patient's blood sugar was >500 and was admitted to hospital for DKA.
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| 46 | 2021-01-10 | pain in extremity, cold sweat |
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik...
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About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
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| 46 | 2021-01-10 | pain in extremity, tenderness |
About 6 hrs after receiving the Pfizer-BioTech COVID-19 Vaccine my left arm was sore and my left leg...
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About 6 hrs after receiving the Pfizer-BioTech COVID-19 Vaccine my left arm was sore and my left leg, from the knee down was very achy, along with some swelling behind my knee. The next morning my leg did not ache but was very tender to touch, swollen and as of today (3 days later) it is still tender and swollen.
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| 46 | 2021-01-10 | pain in extremity |
Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain...
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Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain. Patient now knows she was exposed before receiving vaccine.
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| 46 | 2021-01-10 | pain in extremity |
01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vacci...
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01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vaccine 01/09 body aches, headache couldn?t move neck due to stiffness; 01/10 left arm soreness, armpit pulsation, fever range 102 F,; 01/11 vomiting. seasonal allergy eye drops for right eye swelling (went away), Benadryl 50 mg.; ibuprofen and Tylenol around the clock starting 01/09 to present day, 01/11/2021
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| 46 | 2021-01-10 | tingling, feeling cold |
Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on...
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Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on Saturday 1/9 after receiving dose#2 of the Pfizer COVID Vaccine on 1/8 24 hours prior. Her temp went up to 100.4. She took Tylenol and motrin with subsequent resolution of symptoms except some slight body aches and the onset yesterday of bilateral stocking like paresthesia in LE's. As the body aches improved, she noticed the paresthesias more although they have lessened somewhat today. No prior history of COVID. Allgergies: NKA Meds: as above SH: Tob: none. ASSESSMENT Vaccine Reaction to COVID. PLAN Follow up with OMS tomorrow or prn.
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| 46 | 2021-01-10 | tingling | Golf ball size lymph node in left axilla, mild tingling in left arm |
| 46 | 2021-01-10 | tingling |
One week after administration, I had sudden onset inability to move left arm. I was transported to E...
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One week after administration, I had sudden onset inability to move left arm. I was transported to ER immediately. Treated, scanned with CT of brain, MRI of brain, c-spine and brachioplexus. In hospital for 2 days and no answers. Still no answers to left arm paresthesia and proprioreceptor deficits. Spreading into left leg and mild systemic symptoms. I have been to the ER, seen by primary physician, Physiatrist and Neurology and Occupational Therapy. I am scheduled for many more appointments and trying to find and answer.
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| 46 | 2021-01-10 | tingling |
The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID...
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The patient began to experience heart palpitations about 10 minutes after receiving the Pfizer COVID vaccine (first dose). The HR was checked and marked to be 110bpm. The pt then began to experience tingling at the injection site as well as in the lower bilateral extremities. The pt was escorted to the holding area to lie down on the stretcher. VS checked (139/89 BP, HR 95, Temp 98.4, O2Sat 100%.). Dr in the ACC was called to assess and observe the patient. No further recommendation for treatment was given. Patient was observed for a total of thirty minutes. HR remained within normal limits and pt was cleared to be discharged to home safely. Pt ambulated to personal vehicle with nurse escort.
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| 46 | 2021-01-11 | weakness |
Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse e...
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Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse event from COVID 10 Vaccine Dec 21, received COVID-19 Vaccine #1 in right arm lot #EH9899 Dec 23- mild pain in left shoulder, did not do anything that I could pinpoint as the cause of this, no injuries, falls or accidents Dec 24, pain intensified Dec 28, 2020- went to primary MD for exam, gave several medications and ordered an MRI of C-spine which was completed on this day. Dec 29- pain has continued to intensify, now shoulder, and entire left arm. Fingers on left hand intermittently numb except for pointer finger that stays numb, and hand is colder than right hand Dec 29, 2020- results of C-Spine showed no significant issues. Small herniation in one of the disks. Per MD, ?more suspicious of a muscular issue or something external to spine pinching that nerve?. Pain has continued despite medications ordered. Dec 30, 2020 MD referred me to a Neuroversion for pain control. I did not want to go here yet, I wanted to know what was causing the issue, not just treat the pain, decided to wait to make this appointment and instead get an appointment with a Neurologist on Monday due to offices being closed on New Year?s Eve. January 4, 2021 pain, numbness and now weakness have persisted all weekend, appointment with Neurologist scheduled for Tuesday January 5, 2021. January 5, 2021, appointment with Neurologist, suspecting Parsonage-Turner Syndrome. Parsonage Turner syndrome (PTS) is characterized by the sudden onset of shoulder and upper arm pain followed by progressive (worsening over time) weakness and/or atrophy of the affected area. The pain is felt along the path of one or more nerves and often has no obvious physical cause. The network of nerves involved in this syndrome is called the brachial plexus and it controls movement and sensation in the shoulders and arms. The cause is still unknown (idiopathic). However, researchers believe that most cases are due to an autoimmune response following exposure to an illness or environmental factor. Suspected triggers include viral and bacterial infections, surgery, vaccinations, injury, childbirth, strenuous exercise, certain medical procedures, and various health conditions. Treatment is symptomatic and may include pain relievers, corticosteroids and physical therapy.[1][2] January 6, 2021- MRI of left shoulder completed January 8 2021- Follow up of MRI with neurologist. No abnormalities seen on MRI, ruled out any other tumors, or anatomical issues causing pain. Diagnosis Parsonage-Turner Syndrome. Increased dosages of current medications and added another to control nerve pain. January 9, 2021- pain seems to be lessening, numbness and weakness continues January 10, 2021- significant pain returned, numbness and weakness continues. I did get the 2nd dose of the COVID-19 lot # EJ1685 in R arm vaccine today, as MD did not advice against it and I still believe that the vaccine is important.
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| 46 | 2021-01-11 | feeling hot, flushing |
Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brai...
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Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brain fog, chest red 1425 - bp 95/64, hr 82, rr 20, t 97.7, sats 98 1428 50 mg po Benadryl given 1432 - bp 118/68, 1440 - pt reports I am feeling better but it does come in waves. chest remains red 1445 - bp 112/74, hr 70, rr 16, sats 98. Pt reports fine to go home. does not live alone.
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| 46 | 2021-01-11 | migraine |
Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headach...
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Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headache that worsened to a severe migraine throughout the day. Also that afternoon, developed sores/ulcers inside of mouth. Next day developed worsening sores in mouth and then my tongue began to swell and then noted sores on my tongue as well. This improved with Benadryl over the next 36 hrs.
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| 46 | 2021-01-11 | pain in extremity, numbness, numbness and pain in extremities, tingling, burning sensation |
#2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue,...
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#2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue, scratchy throat. Over next 2 days pain back of legs, which then evolved into burning and then numbness of palms of hands, soles of feet. Reported to me on 1/8. Over last 3 days, she has had slow improvement with slight tingling and numbness fingers. Over weekend, I had her get tested for COVID - both rapid and PCR neg. She went to ED for testing, and they also ran CT head and labs -- negative. She made appt with neurologist today and will follow up with her PCP. Testing for COVID was to rule out as cause for peripheral neuropathy. Might be due to vaccine vs some other undiagnosed condition including autoimmune. Due to the unique nature of this complaint, may be considered Adverse Reaction
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| 46 | 2021-01-11 | pain in extremity, numbness | Pain and numbness in her arm, fever |
| 46 | 2021-01-11 | pain in extremity, tingling |
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t...
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1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
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| 46 | 2021-01-11 | pain in extremity |
Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizzin...
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Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 31Dec2020 at 15:30 as a single dose for COVID-19 immunization. Medical history included allergy to tomatoes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 21:00, the patient experienced soreness in my arm, dizziness, tiredness and overall not feeling well. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness in my arm, dizziness, tiredness and overall not feeling well were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 46 | 2021-01-11 | pain in extremity |
Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right...
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Red, swollen, slightly warm, slightly tender to pressure, small lump about three fingers below right deltoid injection of 2nd dose noticed on 1/12/21 at 05:30 which is 4 days post dose. No advert issues or need for medication treatment.
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| 46 | 2021-01-11 | pain in extremity |
Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral ...
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Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral foot pain. Day three moderate bilateral foot pain, all joints have pain, hands and feet the worst. Day four: fatigue (decreased), all over joint pain mild to moderate (went home from work) fatigue. Day Five (today) continued bilateral feet and hand joints mild pain that increases with pressure (walking holding or opening anything causes increase in pain from mild to moderate.
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| 46 | 2021-01-11 | tingling, feeling cold |
Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is...
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Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is really cold; Caller is continuously coughing during the call.; Fever; Headache; joint and muscle achiness all over; joint and muscle achiness all over; Tiredness; joint and muscle achiness all over, it started in her right arm where she received the injection; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscularly in right arm on 05Jan2021 around 1315-1320 at single dose for covid-19 prophylaxis in hospital and vaccine was not administered at Military Facility. Medical history included ongoing asthma diagnosed as a child, leaky valve closed up in her heart from 2020 to an unknown date. Family medical history included her mother had Covid over around May2020 and the mother was positive for quite sometime and had to take 3-4 tests, her son had tested positive for Covid and the patient had been around him a little bit. Prior Vaccinations (within 4 weeks) were none and adverse events following prior vaccinations were none. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BRIO INHALER) at 200/25 once a day by inhalation, nebulizer by inhalation every 4 hours as needed, salbutamol sulfate (PROAIR) at 2 puffs every 4 hours when needed, montelukast at 10mg every evening by mouth, all ongoing for asthma. The patient received the Covid-19 vaccine yesterday 05Jan2021 and reported that on 05Jan2021 she has had tiredness, headache, joint and muscle achiness all over. On 06Jan2021, she had fever and chills. She said that she was really cold. She also had a little tingling under her lip and chin area, but it is resolved. She stated that this was this morning 06Jan2021. She said that she did not have the physician details to provide at this time. She said that she had only seen this doctor once on a virtual appointment. She said that tiredness started around 1830-1900 05Jan2021. Headache started 05Jan2021 around when she got off of work at 1500. For event fever, she took her temperature 3 different times, it was at 101.2, then she had a temperature of 102. She last checked it about a half an hour ago on 06Jan2020. For event joint and muscle achiness all over, it was noticed the achiness around 9-10 pm 05Jan2021, she said that it started in her right arm where she received the injection, then moved down to her legs and her back. She stated that it was worse and when she went outside. For chills it started this morning on 06Jan2020 when she was still in bed before she got up at about 0500. She said that she called out of work. This was her first dose of the vaccine. Her next dose is supposed to be on 26Jan2021. The patient was continuously coughing during the call on 06Jan2020. The fever, joint and muscle achiness all over were worsened. The adverse events did not require a visit to emergency room or physician office. The outcome of tiredness, headache, fever, chill, joint and muscle achiness all over, it started in her right arm where she received the injection, were not resolved, outcome of the tingling under her lip and chin area were resolved on 06Jan2021, outcome of she was really cold and cough were unknown.
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| 46 | 2021-01-12 | electric shock sensation |
Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a sho...
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Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a shocking sensation around my throat then I had some palpitation.I better about 20 minutes latter. I had prednisone at home, so I took 40mg and Benadryl and PepciI felt I had some sensation of throat tightness the day after that but it went away after few hours.
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| 46 | 2021-01-12 | feeling hot |
Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very wa...
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Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very warm). At about 1:45am on 1/13/2021, was feeling very achy and uncomfortable, so I went downstairs to get some Tylenol. Rapid heart rate and sweating, so much I had to sit down in the kitchen for a few minutes. Eventually took the Tylenol, and as I was heading back upstairs, I passed out (I don't remember going down to the floor) and dropped the cup of water I was taking with me. Was out for less than 30 seconds. A couple episodes of heaving/vomiting small amounts of liquid while on the floor. Made it back to bed and was starting to feel improved around 4:00am.
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| 46 | 2021-01-12 | pain in extremity |
Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for ...
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Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for 3 days. Fatigue day after for 5 days all other sxs started day 5 and still continue
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| 46 | 2021-01-12 | pain in extremity |
Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was fee...
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Right arm is sore the following day. When i got home from work (1/13/21) took a shower and i was feeling the area where i got the shot and when i raise my right arm i notice under my armpit is swollen.
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| 46 | 2021-01-12 | tingling |
Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tin...
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Swollen and painful lymph nodes in jaw and neck. Myalgia in neck. Right side greater than left. Tingling around area of right ear and hearing changes on right side. Numbness in arms/fingers. Symptoms presented about 6 days after 1st vaccine , worsened. Persisted for about 5 days.
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| 46 | 2021-01-13 | discomfort |
following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflamm...
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following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflammation, overall discomfort, back pain which radiated to the front of the chest lasting x3 days, took Tylenol. now resolved
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| 46 | 2021-01-13 | flushing |
flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, thr...
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flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, throat itchiness and was given Benadryl 25mg IM and took 20 -30 minutes to relieves the itching and hives subsided gradually
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| 46 | 2021-01-13 | flushing |
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all ...
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Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted 0 days
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| 46 | 2021-01-13 | numbness, pain in extremity |
Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or poppin...
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Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or popping on an airplane; Severe arm pain; This is a spontaneous report from a contactable consumer reporting for self. This 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 06Jan2021 at 13:20 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. Concomitant medications included ascorbic acid (VITAMIN C) and ibuprofen. The patient got the flu shot every year for immunisation, and got arm pain with the flu shot. No prior vaccinations within 4 weeks. The patient received Pfizer COVID-19 Vaccine on 06Jan2021, at 13:20. By 15:30-15:45, the right side of her face was numb. Had tingling in her lips. Stated the experience was similar to the feeling of receiving procaine hydrochloride (NOVOCAIN) or similar to the feeling when procaine hydrochloride begins to wear off. Her ear was plugged like she was on an airplane. Sated feels like she has water in her ear or like her ear is popping on an airplane. The whole right side of her face was doing something funny. Her lips began to tingle first, then face went numb, then her ear clogged. She talked to an ER physician who advised her to take a diphenhydramine hydrochloride (BENADRYL). ER physician stated these side effects are being seen. No further details provided. Clarified did not require ER Visit, just talked to an Emergency Physician and explained symptoms. She took diphenhydramine hydrochloride at home and the numbness and tingling went away after a couple hours. Her ear is still plugged today. Everything was echoing in her head and it was driving her crazy. Stated she also experienced severe arm pain happened evening of 06Jan2021. Arm pain in only in injection arm. Outcome of right side of her face was numb and tingling in her lips was recovered, outcome of ear feels plugged was not recovered, outcome of other event was unknown.
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| 46 | 2021-01-13 | migraine |
Severe, intractable daily migraine headaches that escalate throughout the day; This is a spontaneous...
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Severe, intractable daily migraine headaches that escalate throughout the day; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received bnt162b2 (BNT162B2) lot no: RH 9899, via an unspecified route of administration in left arm on 16Dec2020 at a single dose for Covid-19 immunization in hospital. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included vilazodone hydrochloride (VIIBRYD), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lamotrigine (LAMICTAL), trazodone, and lorazepam (ATIVAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 17Dec2020 06:00, the patient experienced severe, intractable daily migraine headaches that escalate throughout the day and do not respond to any treatment, medicinal or non medicinal (unspecified). The event was reported as non-serious. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not recovered from the event. The patient received another bnt162b2 dose (lot no: EK 4176) on 06Jan2021 in left arm. Information on the batch number has been requested.
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| 46 | 2021-01-13 | pain in extremity, migraine |
Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever...
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Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever of 101.6. My right arm is very sore/tender. I have generalized aches.
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| 46 | 2021-01-13 | pain in extremity |
Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contac...
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Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on her left arm on 28Dec2020 at 12:45 at a single dose for COVID-19 immunization. Medical history included hypertension, migraine, polycystic ovaries (PCOS) and allergies to wasp venom and dust mites. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 28Dec2020 at 15:45, the patient experienced mild left arm pain near injection site that lasted a few hours, severe fatigue which started 3 hours post injection and lasted for 4 hours; and moderate headache which started on 29Dec2020 (duration 3 days). The patient did not receive treatment for the adverse events. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-01-13 | pain in extremity |
On January 4th i was sitting down eating my lunch and when I was done and went to get up I couldn't ...
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On January 4th i was sitting down eating my lunch and when I was done and went to get up I couldn't put weight on my left foot. Felt like i sprained it. The pain was there for two and a half days and suddenly it went away and i was ok. Now this past sunday January 10th my period came, 15 days earlier, and is really bad. I have to change pads like every two hours because of the amount of blood coming down and is still going on today. It has never lasted this long and I have not bleed this much for this long either.
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| 46 | 2021-01-13 | tingling |
Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday ar...
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Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday around 1130am- went home from work and took ibuprofen. stayed home from work Wednesday- started to taper off pre immunization medication of benedryl, Pepcid, and prednisone on Wednesday afternoon. Wednesday night noticed using my inhaler. Little more- I took Half dose of prednisone. Had to do nebulizer treatment later that night. Thursday morning woke up wheezing took another prednisone and used rescue inhaler. Went to work and wheezing didn?t get any better, but didn?t get any worse. Took another prednisone and sent home to do nebulizer. Continued to rest and monitor asthma- Notified PCP of what was going on- advised to continue Pepcid, benedryl and prednisone for a few more days and advise of any issues.
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| 46 | 2021-01-13 | tingling |
paresthesia of the left arm and hand; heaviness of the left arm.; This is a spontaneous report from ...
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paresthesia of the left arm and hand; heaviness of the left arm.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 46-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231, expiry date 30Apr2021) via an unspecified route of administration in the left arm on 08Jan2021 at 15:30 for COVID-19 immunization. Medical history included migraine (she occasionally had migraines and treated it with ibuprofen). The patient's concomitant medication included ibuprofen for migraine (the last dose of Ibuprofen was two or three days ago before 08Jan2021). The patient had received the first single dose of BNT162B2 on 18Dec2020 for COVID-19 immunization and experienced soreness in the left arm which lasted for a day and a half. No other vaccine received within 4 weeks. The patient experienced paresthesia of the left arm and hand on 08Jan2021. She received the first dose of the vaccine on 18Dec2020 in her left arm and had some soreness in the left arm at that time, which was resolved on 20Dec2020 (event reported in AER 2021019477). On 08Jan2021, she received the second dose also in her left arm and within five minutes she had this strange paresthesia of the left arm and hand. She also described it as strange heaviness of the left arm. No limited range of motion of the left arm. She didn't know if it was serious. She didn't visit emergency room or physician office. After two hours (the time of reporting) she still had the same sensation. The event was not resolved. The reporter considered the event paresthesia of the left arm and hand was related to the vaccine.
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| 46 | 2021-01-14 | weakness, numbness |
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ...
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Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
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| 46 | 2021-01-14 | weakness | Body ache , feeling weak |
| 46 | 2021-01-14 | weakness | Temature, body aches, headache, weak and vomiting |
| 46 | 2021-01-14 | weakness |
Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird meta...
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Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird metal taste; very thirsty at times; throat seemed swollen; Still feeling tired and weak; Still feeling tired and weak; running nose and draining in the back of my throat; running nose and draining in the back of my throat; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received first dose of BNT162B2 (Lot# EK9231), via an unspecified route of administration, in left arm, on 07Jan2021 14:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Medical history included migraines, depression and allergy: latex. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced flu symptoms, fever, chills, achy body, dry mouth with weird metal taste, very thirsty at times, throat seemed swollen, all symptoms started Thursday, the evening of getting the vaccine and lasting until Saturday morning. Still feeling tired and weak. Now have running nose and draining in the back of my throat. The start date of all the events was 07Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
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| 46 | 2021-01-14 | difficulty speaking, flushing |
severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; i...
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severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; it took a minute for her to catch her breath; flushed; itchy; muscle aches; something that look like hives on the arm/hives on the lower right arm; skin felt really hot to touch; fire engine red on the right upper arm; pain at the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 06Jan2021 11:00 in deltoid left at single dose for covid-19 immunization. There were no medical history and concomitant medications. Family medical history relevant to event was none. Relevant tests were none. Patient reported she received the Pfizer COVID-19 vaccine on 06Jan2021 and had pain at the injection site. On 07Jan21 she started having muscle aches and got something that look like hives on the arm and her skin felt really hot to touch, it was fire engine red on the right upper arm. On 08Jan2021, she woke up and felt like she got hit by a tractor trailer, has severe aches, voice very raspy, and very wiped out with headaches. Patient mentioned injection site arm was bright red and warm to touch after injection, but has improved. When waking up this morning on 08Jan2021 even walking this morning from the bedroom to the bathroom she was fatigued and it has gotten better with her walking around, but she still felt wiped out. The muscle aches was very short lived. She went to do something at work and it took a minute for her to catch her breath and that and the muscle aches went away and that was it. An hour later she felt very flushed and itchy and coworkers joked with her about what she ate for lunch, which was nothing different. On the opposite arm from injection arm she had hives on the lower right arm. They were there about 15-20 minutes and it turned completely fire engine red and that lasted about half an hour. She showed the doctor she worked with and they recommended diphenhydramine hydrochloride (BENADRYL), which she didn't take, it was weird. All this subsided and she felt fine afterwards. Last night she felt very fatigued when walking around the house. This morning when she woke up she felt very, very, very fatigued. Walking took a lot of effort out of her. It is hard to explain, but people say this was how they felt when they had Covid. She felt very lethargic and very tired. Patient still had a lingering headache, but nothing like she felt earlier this morning. It's not terrible, but it wasn't pleasant for a couple of hours. Patient was unable to provide seriousness for today's events (08Jan2021), and stated it wasn't really life threatening, but more significant than yesterday. Patient denied having any other vaccines the same day or 4 weeks prior. No history of problems or adverse events with vaccines in past. Pfizer Covid-19 vaccine with events were reported as related. Events did not require a visit to emergency room or physician office. Outcome of severe aches, voice very raspy, headache/lingering headache, wiped out /fatigued/tired were not recovered; outcome of lethargic, it took a minute for her to catch her breath, flushed and itchy was unknown, and outcome of other events were recovering.
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| 46 | 2021-01-14 | feeling hot, tremor, flushing |
I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by ...
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I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by a truck. Later that evening my temp went to 102F, after that I was sleeping 10 hours a day, no appetite, nausea, vomiting, diarrhea, 9lbs in 9 days, back was killing me, alternated hot and cold compress. One morning I woke up and my tongue was like a rock, I was so dehydrated. Fever for 5 days, took Tylenol and it would just break it down to 100F. Went to COVID and flu on the 12/29 got positive for COVID on 12/31/20. Yesterday I felt hot and flushed and was sweating profusely, other than that no other symptoms. ( I received the second dose on 01/13/21)
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| 46 | 2021-01-14 | feeling of body temperature change, pain in extremity |
arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold ...
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arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at 13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water. They kept her for 30 minutes on observation. She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00. She took Motrin 600mg and it helped out. The outcome of the events was recovered. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.
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| 46 | 2021-01-14 | pain in extremity |
sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a s...
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sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the left arm on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 (reported as three weeks ago from 07Jan2021) for COVID-19 immunization and she was fine. The patient got the second COVID vaccine on 07Jan2021 afternoon. The pain at the injection site to left arm started on 07Jan2021 20:00. On 07Jan2021, in the middle of the night, the fever, headache, and legs hurting started. She has been sleeping all day on 08Jan2021 and she does not do this normally. Outcome of the sleeping all day was unknown, of the headache was recovering, of the pain at the injection site to left arm was recovered on 07Jan2021, of the legs hurting and fever was recovered on 08Jan2021.
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| 46 | 2021-01-14 | tingling |
A few minutes after receiving the vaccine patient developed tingling in her extremities and stated t...
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A few minutes after receiving the vaccine patient developed tingling in her extremities and stated that her lips felt funny.
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| 46 | 2021-01-14 | tingling |
A few minutes after receiving the vaccine patient developed tingling in all four extremities and st...
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A few minutes after receiving the vaccine patient developed tingling in all four extremities and stated that her lips felt weird
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| 46 | 2021-01-15 | feeling cold, tremor |
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. ...
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12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. 2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog. 2:30 thru evening Face and neck puffy, red, hives & fatigue.
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| 46 | 2021-01-15 | flushing |
Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and f...
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Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and facial flushing , mild facial swelling, and feeling of heart racing. Initial vital signs: blood pressure 117/58 mmHg, pulse 91 beats per minute, and oxygen saturation 97% on room air. Patient administered oral diphenhydramine 50 mg once and observed for a total of one hour from vaccine administration during which symptoms improved. Vital signs were checked every five minutes and remained within normal ranges during entire observation period. Patient given water and juice and left in stable condition.
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| 46 | 2021-01-15 | muscle spasms |
Unexpected menstrual period - I am currently on Lo Loestren Fe for birth control. I have not had a p...
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Unexpected menstrual period - I am currently on Lo Loestren Fe for birth control. I have not had a period in 15 months since I started using this pill. 11 days after receiving the vaccine, I had cramps and a heavy period which lasted 7 days.
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| 46 | 2021-01-15 | pain in extremity |
Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred ...
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Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred since then: extremely itchy blotchy rash that attacked underarms, under bra area, stomach, lower back, legs. Skin was hot to the touch, felt like a mild sunburn, sensitive to the touch, difficulty wearing clothes. Pain in muscles/joints in hands, and knees .
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| 46 | 2021-01-15 | tremor, numbness |
Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swo...
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Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swollen, developed minor tightness in throat and feeling tongue swollen along with tremors and lightheadedness. BP 140/102, HR low 100s. Took Benadryl 50mg with bottle of water. Symptoms resolved over next 30 minutes. Developed numbness in left 4th and 5th digit which resolved at approximately 1 hour. About 1 1/2 hours after injection some abdominal cramping and 1 episode of diarrhea. BP and HR back to normal at about 1 hour after event.
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| 46 | 2021-01-16 | numbness |
Besides soreness on the injection site on both times, a day after received the second dose of Covid-...
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Besides soreness on the injection site on both times, a day after received the second dose of Covid-19 vaccine I have experienced left-arm site soreness, aches all over my body i.e back pain and muscle pain, malaise, chills, and numbness on the fingers on my left arm.
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| 46 | 2021-01-16 | numbness | Rapid onset facial & neck numbness, headache |
| 46 | 2021-01-16 | pain in extremity |
24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The h...
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24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The highest I recorded was 104 at resting. My normal is 74. I felt tired but wired and started recording it on my smart watch. After 48 hours it returned to more of a normal rate but still continues to be more elevated than before. I will follow up with my PCP this week. I had other symptoms that seemed normal-headache, chills, exhausted, sore arm, etc.
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| 46 | 2021-01-16 | tingling, numbness |
This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (if was fir...
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This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (if was first dose of the Pfizer vaccine). Other than some muscle soreness, which I expected, I started experiencing numbness and tingling in the arm that received the shot (my left arm). It is now 4 days later, and the numbness/tingling is not any better. I don't know if this is a frequent side effect that will go away in time, but it is very concerning to me.
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| 46 | 2021-01-16 | tremor |
Began with chills - shaking in bed for 2 hours, 11 hours after getting vaccine. Woke in middle of n...
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Began with chills - shaking in bed for 2 hours, 11 hours after getting vaccine. Woke in middle of night with 103 fever which lasted 36 hours. SEVERE headache began on Day 2 which I wondered if I should go to urgent care. Unable to tolerate walking or being "up" for more than 3-5 minutes at a time. Notable fatigue. A week later now, still having daily headaches which are moderate in nature.
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| 46 | 2021-01-17 | numbness, tingling |
1. Runny nose/sore throat and extreme fatigue started about 4pm. 2. By 8pm I had extreme body chills...
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1. Runny nose/sore throat and extreme fatigue started about 4pm. 2. By 8pm I had extreme body chills/dizziness with a temperature of 101. That is when the muscle weakness went into overdrive. I was unable to sleep more than an hour overnight due to the chills and muscle pain. Early in the morning of 1/12 I messaged my supervisor and called the main pharmacy that I was unable to be there for my 9-5:30pm and would be out for the day. 3. Around noon on 1/12 the temperature went below 100 degrees and around 4pm on 1/12 I was finally able to eat something and start moving around. 4. On Saturday 1/16 I started having right arm weakness and my fingers tingling/numbness that hasn?t resolved. This is the arm that I received both injections in.
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| 46 | 2021-01-17 | pain in extremity |
arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contact...
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arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contactable Nurse anesthetist reporting for herself via Pfizer employee (friend). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 08:00 at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) received via an unspecified route of administration on 18Dec2020 at 08:00 at single dose. The patient was taking COVID-19 vaccine since is front line healthcare worker. The patient was vaccinated at hospital. Age at vaccination was 46 years. The patient's medical history and concomitant medications were not reported. The patient reported she had no problems with the first dose but after the second dose that night (08Jan2021) her arm really hurted and she had stomach cramping. She didn't feel well at all. The patient took two Advil and the next day (09Jan2021) she was fine and is still fine. The Pfizer employee stated her friend looked fine as she was exercising. Onset date of the events was also reported as 09Jan2021 with recovery date 10Jan2021. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
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| 46 | 2021-01-17 | pain in extremity |
Pt developed left arm pain, shooting pain down the left arm and up in the the shoulder/ neck. Severe...
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Pt developed left arm pain, shooting pain down the left arm and up in the the shoulder/ neck. Severe pain and did to to urgent care for pain management on 1/16/21. 1/17/21, did develop a rash and is consistent with shingles.
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| 46 | 2021-01-17 | tingling, weakness |
I noticed that my arm started itching, tingling and my whole arm and hand became weak. I started bur...
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I noticed that my arm started itching, tingling and my whole arm and hand became weak. I started burning under my armpits. Then, I started having issues swallowing. I felt a general feeling of weakness all over. I went to the ER because I was scared I was having a stroke.
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| 46 | 2021-01-17 | tingling |
Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe h...
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Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe headache, no breathing difficulty, no rash, no swelling of tongue or throat, was able to walk, now feeling much better- after 2 days.
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| 46 | 2021-01-18 | weakness |
On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/20...
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On my second does the same night on 1/13/2021 I started feeling nauseas. The next morning on 1/14/2021 I felt horrible, my stomach was hurting, my left arm was swollen, felt really weak & tired, I had a lot of fatigue & I felt very nauseas. It last 24 hrs.
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| 46 | 2021-01-18 | weakness |
I received the 2nd dose of Covid vaccine at 12:40 pm on Tuesday 1/12/2021, around 6:30 pm I started ...
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I received the 2nd dose of Covid vaccine at 12:40 pm on Tuesday 1/12/2021, around 6:30 pm I started with cough and the need to keep clearing my throat. By 9 pm, I felt like my lymph nodes in my neck were swollen, my throat was getting sore, and my head was starting to throb. I took 2 tylenol and went to bed. I woke up at 3 am with a 101.6 temp and body aches. By 8 am on 1/13/2021, I could not lift my own body out of bed or roll over. The fever and body aches continued around the clock for 55 hrs. The headaches are debilitating and continue. I have tried Tylenol, Ibuprofen, Excedrin, and Imitrex and none of these have helped. I missed 3 days of work and 2 weekend days trying to recover and i am still not back to normal. Headaches are still happening everyday. At one point in the middle of this, i felt like I should go to the hospital, but I was too sick to get out of bed and shower and make myself go.
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| 46 | 2021-01-18 | flushing |
1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sen...
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1/12: Immediately after receiving vaccine felt pressure and flushing in face which progressed to sensation of tightness in chest and throat but no dyspnea, able to talk, no change in MS. Evaluated by PA - Code Green called. VS stable, transferred to ICU> In ICU labs completed, monitoring continued - all stable. Ate sandwich without difficulty or N/V. discharged to home 1/13: Had continued sensation of numbness and tingling in tongue that night and metallic taste in mouth with fatigue and headache. Aprox 11am 1/13 developed racing heart , increased numbness and tingling in tongue and metallic taste in mouth. Called 911 - transferred to different hospital. Evaluation including EKG completed without finding. Symptoms gradually resolved - discharged how with instruction to f/u with PCP. 1/14 - Home/stable, mild change in sensation in mouth and tongue persist otherwise tolerating all activity, working from home without difficulty.
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| 46 | 2021-01-18 | numbness, pain in extremity | Pain and numbness on L forearm near the injection site Mild hypertension and tachycardia |
| 46 | 2021-01-18 | numbness |
Facial numbness to left side of face (same side as injection). Stated reaction stronger and faster t...
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Facial numbness to left side of face (same side as injection). Stated reaction stronger and faster than previous reaction with first dose. EE sent to the ED for evaluation.
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| 46 | 2021-01-18 | migraine, pain in extremity | Chills, Fever 100.5, Arm and Leg muscle pain, fatigue, Migraine, Nausea |
| 46 | 2021-01-18 | tingling | HEADACHE DIZZINESS TINGLING IN LOWER EXTREMITIES |
| 46 | 2021-01-18 | unresponsive to stimuli |
Patient received vaccine around 1pm and during the 15 minute observation period she became nonrespon...
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Patient received vaccine around 1pm and during the 15 minute observation period she became nonresponsive. She did not fall, but slumped in her chair and would not answer questions. Glazed look. Removal of mask showed swollen lips and neck and an epi-pen was administered at 1:14 and 911 called immediately. During the next 5 minutes the patient began to answer questions. EMTs arrived 1:25 and by then the patient was speaking, and did not want to go to the emergency room. EMTs loaded her onto the stretcher and transported her at 1:35.
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| 46 | 2021-01-19 | flushing |
A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. ...
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A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. Right ear was flushed red. No symtoms in left ear. No tongue swelling. Symptoms eventually resolved after approximately 1 hour.
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| 46 | 2021-01-19 | flushing |
About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of ch...
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About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of chest, and continuous cough. Was administered one dose of epi-pen injection, steroid injection, and oral benedryl by doctor on site. 20 minutes later flushing, headache, and extreme nausea. Was given second dose of epi-pen and sent to the hospital in an ambulance for monitoring.
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| 46 | 2021-01-19 | muscle spasms, difficulty speaking |
I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visibl...
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I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visible muscle spasms, and my teeth began to chatter uncontrollably.
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| 46 | 2021-01-19 | pain in extremity |
the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen...
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the day following the vaccine this patient had lots of arm pain, swelling of the neck, and a swollen lymph node near her collar bone
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| 46 | 2021-01-19 | tingling, feeling of body temperature change, pain in extremity |
Hello, When I received my second Covid vaccine, I was asked to report my side effects to this emai...
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Hello, When I received my second Covid vaccine, I was asked to report my side effects to this email address. They are as follows: After Vaccine 1 (12/22/20): I had the vaccine at around 1:30pm. I only had arm-stiffness at first. Approx. 24 hours after however (1:30pm the next day), I started having chills and feeling like I had a fever. My entire body ached but I did not have a headache. These side effects lasted through the night for approx. 14 hours. The following day I woke up with a surge of energy and felt very much like I had been given a shot of adrenalin. I?m not sure that I have ever felt as good. After Vaccine 2 (01/11/21): I had much more severe side effects after the second vaccine. I had this vaccine at approx. 1:30 pm and within a couple of hours I started to feel a bit tired. At approx. midnight that night, I started having body aches and a headache that woke me up. I had chills and was oscillating between feeling very cold and feeling very hot. Through the night I had to change my clothing several times due to sweating. These symptoms lasted for the entire following day. The second day after the vaccine I felt much better but still a little tired. Of greatest concern is that I have a lingering pain deep within my left arm (the arm into which the shots were given). Having a hard time extending my arm and doesn;t seems to be going away. Sometimes it feels tingly and I sometimes have loss of grip and/or weakness in the entire arm. Hope this helps you in compiling the side effects. Thank you.
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| 46 | 2021-01-19 | tingling |
suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; ...
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suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events " lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-19 | tingling |
Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 min...
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Itching face/back-5 minutes after. tightness in throat-10 minutes after. fullness in ears- 30 minutes after. Taken to ER approximately 25-30 after injection for evaluation. Symptoms not escalating, eventually treated with Benadryl, steroids and Pepcid, held briefly for observation, released with Claritin and steroid prescription to take for the next few days. I was instructed to premedicate for the 2nd dose. Approximately 5-6 hours after dose developed tightness in chest, tingling face/lips/mouth/fingers. Symptoms persist still, self medicating with Benadryl and klonapin.
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| 46 | 2021-01-20 | weakness |
Fever; In morning my temperature was 100.4; Headache; Felt tired from weak; Felt tired from weak; Fe...
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Fever; In morning my temperature was 100.4; Headache; Felt tired from weak; Felt tired from weak; Feels bad; Chills/shivering; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration in the left arm on 09Jan2021 as single dose for COVID-19 immunization. Medical history included covid-19 in Oct2020. The patient's concomitant medications were not reported. The patient experienced fever; in morning my temperature was 100.4 on 10Jan2021 with outcome of unknown; headache on 10Jan2021 with outcome of unknown; felt tired from weak in Jan2021 with outcome of unknown; chills/shivering in Jan2021 with outcome of recovered in Jan2021, feels bad in Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included fever at 100.4 in Jan2021. Details were as follows: patient received the first dose of the Covid-19 vaccination and woke up with a fever and a bad headache in the morning. As it related to casualty, the reporting nurse indicated yes and commented that she was fine the day prior and then when she woke up this morning, she had fever and a bad headache. She indicated that she felt like a little; she got it in the morning around the 11 O'clock. And then by the evening she felt tired. She thought that she was just tired from the week. And when she woke up on this morning, or in middle of the nigh, she was shivering a little bit. She fell asleep and woke up the next morning, with a temperature of 100.4. She said that she did not feel really that bad; she had a headache; she did not have shivering or chills then. Therapeutic measures were taken as a result of fever; in morning my temperature was 100.4, headache, felt tired from weak, shivering, feels bad, chills and felt tired from weak ; she took ibuprofen. The chills/shivering recovered in Jan2021; the outcome of the other events was not reported
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| 46 | 2021-01-20 | numbness, tingling |
numbness and mild pins and needles in my right thumb, index and middle finger, Right side of mouth a...
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numbness and mild pins and needles in my right thumb, index and middle finger, Right side of mouth and right cheek, and Headache. all except fro headache Resolved by 0630. Numbness lower lip and chin started at 0831 1/21/21, headache persists. No muscular deviation.
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| 46 | 2021-01-21 | breast pain, pain in extremity |
8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlar...
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8 1/2 hrs. after receiving 2nd dose, right arm became very painful, right axillary lymph nodes enlarged, and right breast pain and swelling started. Symptoms impeded function of arm. Seen by a provider on 1/19/2021
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| 46 | 2021-01-21 | burning sensation, feeling hot |
Shortly after the vaccination I got a burning warming sensation up and down my left leg which still ...
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Shortly after the vaccination I got a burning warming sensation up and down my left leg which still presist today. I had a fever for one day but had diarrhea for about a week.
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| 46 | 2021-01-21 | burning sensation, numbness |
Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered set...
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Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; This is a spontaneous report from a contactable Other HCP. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscularly on 28Dec2020 10:30 at single dose for covid-19 immunisation. Vaccine location: Left arm, dose number: 1, facility type vaccine: hospital. Medical history included viral asthma, hypertension, mild depression, anaphylaxis to Bee Stings, vertebral artery dissection with brainstem injury and covid-19 (If covid prior vaccination: Yes). Concomitant medication included acetylsalicylic acid (ASPRIN), metoprolol (METOPROLOL), omeprazole (PROTONIX [OMEPRAZOLE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity and fentanyl and experienced drug hypersensitivity. On 11Jan2021 02:00 the patient developed "full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting up". The patient was taken to emergency room (ER) /department or urgent care. In the ER all labs and CT with and without contrast clear, but was unable to find any other reason for the event. No treatment received. The events outcome is recovering. The action taken was not applicable.
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| 46 | 2021-01-21 | cold sweat, hot flush |
Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but ...
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Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but felt intermittently clammy/sweaty started on the 20th and resolved midday on the 21st until the morning of the 22nd, the dizzy/nausea returned and occasional sweaty/clammy feeling. Called OHS and they recommended calling pcp. PCP called in script for zofran and instructed me to take that and dramamine and call if not improved by Monday the 25th
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| 46 | 2021-01-21 | flushing |
allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well ...
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allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-21 | numbness |
Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of f...
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Nausea and vomiting within 45 minutes of vaccine. Left side facial numbness, allergic swelling of face within 1 hour of vaccine, lasting 24 hours with Benadryl & Pepcid given as treatment. Numbness of face occurring 1 week post vaccine. Benadryl given as treatment.
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| 46 | 2021-01-21 | numbness |
1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well ...
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1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well she could leave. Patient stated she had had some left lateral hand numbness since just after the injection that now is feeling more like tightness than numbness, a new tickle in the throat and tongue which felt "puffy" like "taking up some more space than normal. Denied any other symptoms. 1400: VS 135/90, pO2 98-99%, HT regular at 84, stated throat tickle dissipating, tongue puffiness resolving and left had less tight. 1410: Patient asked to go to BR and returned without complaint. 1420: Patient drank small bottle of water without difficulty, "felt normal to swallow." Patient stated her symptoms had resolved and there were no new symptoms. Patient stated she felt normal and comfortable to drive home.
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| 46 | 2021-01-21 | pain in extremity |
I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to...
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I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to ward off arm soreness. I had quite a bit of pain at the injection site with this vaccine, more severe than the initial dose. I felt the same mild fatigue and headache as with the first dose, but yesterday (Thursday (01/20/21) afternoon, around 3-4pm), I noticed soreness in my right axillary area, and found lymphadenopathy with palpation. I took additional ibuprofen and tylenol, and the pain has lessened somewhat today (Friday 01/22/21, noon)
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| 46 | 2021-01-21 | pain in extremity |
My left arm has been constantly sore non stop since I woke up yesterday more than 2 weeks after gett...
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My left arm has been constantly sore non stop since I woke up yesterday more than 2 weeks after getting the vaccine. There was initial soreness that I expected but its more than 2 weeks past now and now I do not want to receive my 2nd dose on 1-26
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| 46 | 2021-01-21 | tenderness |
On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side ...
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On 01/19/2021 afternoon client noticed left parotid gland swelling on left side of neck. Left side wit ear and base of neck was tender and painful to touch. Client has been taking tylenol, lemon candy lozenges, hot packs, and herbal tea. These have provided short periods of relief.
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| 46 | 2021-01-22 | flushing |
patient went back to the procedure center after receiving vaccine after 15 min observation and compl...
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patient went back to the procedure center after receiving vaccine after 15 min observation and complained of N, abdominal pain and out of body experience with inability to talk or describe what happened. Palpitations. No CP, SOB, wheezing or visual changes. HR 140's w occ PVCs, SBP 160-170's SpO2 100% with pt appearing flushed and drowsy. O2 NC, NS 1 liter IV, zofran 4mg IVP x1 given. Admitted to procedure center at 1500 and discharged at 2359.
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| 46 | 2021-01-22 | pain in extremity |
Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right ...
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Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right leg shooting pain
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| 46 | 2021-01-23 | weakness | Tired/weak. Sore Throat |
| 46 | 2021-01-23 | weakness | Feeling sick , body aches , weakness and visible blood in urine , headaches |
| 46 | 2021-01-24 | weakness | Headache, body aches, fatigue, weakness. |
| 46 | 2021-01-24 | feeling hot, flushing |
Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25m...
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Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25mg orally and chest tightness and heaviness received 2nd dose Benadryl 25mg . EMS /cardiac monitored and was transferred to a Hospital.
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| 46 | 2021-01-24 | feeling jittery | Shortly after the vaccination the patient complained of nausea and jitters. |
| 46 | 2021-01-24 | feeling of body temperature change, tremor, muscle spasms |
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he...
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fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
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| 46 | 2021-01-24 | pain in extremity, breast pain |
Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank...
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Injection site was on left deltoid. Within hours experienced significant soreness on arm, left flank and left breast. Severe swelling and joint pain at left knee and hives down left leg calf. Significant rash and swelling of both eyelids and allover body soreness.
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| 46 | 2021-01-24 | pain in extremity, facial paralysis |
Had soreness in the arm for two days. On the 26th, evening, I went to take drink of water and some o...
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Had soreness in the arm for two days. On the 26th, evening, I went to take drink of water and some of spilled down my face and I thought I just had a fat lip. 27th, I went to work and went to lunch at noon, I went to eat food and I noticed that my mouth -right side was numb. I thought something might be wrong and someone told me that my right side of my face looked slack. Saw on Dec 28, Dr. - had already scheduled an appt for follow up for diabetes - and I told her about my symptoms and she looked at my face and had me smile and crinkle my face. She sent me to my doctor downstairs (she had the nurse call downstairs and told them I needed to be seen that day). I went downstairs and I saw my doctor and my doctor scheduled an MRI on 28th at 7 PM and also ordered for me to take Prednisone and Valtrex. MRI result came back fine. I responded well to both of these meds - I started to get muscle control back into my face. It shot my sugar numbers up but solved the other problem in about 15 days I could shut my eyes without delay and I feel like I have muscle control in my face. January 22, I got the second dose and so far I don't notice anything different.
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| 46 | 2021-01-24 | tremor |
I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes we...
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I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes were hurting and burning really bad.
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| 46 | 2021-01-25 | weakness |
Fever Cough Fatigue Malaise Headache Dizzy Weak Tight chest/short of breath Generalized discomfort J...
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Fever Cough Fatigue Malaise Headache Dizzy Weak Tight chest/short of breath Generalized discomfort Joint discomfort
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| 46 | 2021-01-25 | flushing, feeling hot | Felt warm and flushed with elevated Blood Pressure |
| 46 | 2021-01-25 | muscle spasms |
cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a cont...
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cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient) and another consumer. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: 30Apr2021), intramuscular (right arm) on 11Jan2021 (around 1:10-1:30pm) at single dose for Covid-19 immunization. The patient received the first dose of COVID Vaccine (BNT162B2, lot number: EK5730, expiration date: 31Mar2021) on 21Dec2020, intramuscular (right arm) for Covid-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021, the patient experienced nausea, some vomiting which has subsided, diarrhea, headache and body aches. The patient also stated that she woke up at 3 a.m. this morning (12Jan2021) vomiting. She vomited for about an hour and half. The vomiting has subsided and now she is just nauseated. The diarrhea initially began about 7:30 a.m. She had 3 bowel movements and she hasn't had a movement since about 8:30. She still has cramping but nothing else. The body aches started within last half hour or so. The headache has been the entire time since 3 a.m., starting when the vomiting occurred. The vomiting was more important at that moment, but she knows her head hurting at the time. The patient verified it was her second COVID vaccine. She received the vaccine yesterday (11Jan2021), between 1:10-1:30p.m. The patient reported that she did have bloodwork, but not in regard to the COVID vaccine. She had bloodwork done Monday, 04Jan2021. The outcome of vomiting was recovering; outcome of event cramping was unknown; while the outcome of other events was not recovered.
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| 46 | 2021-01-25 | night sweats, weakness, cold sweat, pain in extremity |
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i...
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Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
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| 46 | 2021-01-25 | pain in extremity | Arm soreness, frontal headache |
| 46 | 2021-01-25 | pain in extremity |
Received 2nd vaccine 1/22/21. The next day I had fatigue, chills, low-grade temp, mild nausea, body ...
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Received 2nd vaccine 1/22/21. The next day I had fatigue, chills, low-grade temp, mild nausea, body aches, and arm was more sore than 1st vaccine. Symptoms were pretty much resolved by Sunday afternoon.
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| 46 | 2021-01-25 | tremor, weakness |
Fever; Chills; Aches and Pains; Lethargic; shaking; weakness; Sweats; joint pain; headache; pain in ...
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Fever; Chills; Aches and Pains; Lethargic; shaking; weakness; Sweats; joint pain; headache; pain in the armpit of the injection arm; severe sore throat; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown), intramuscular in the left arm on 08Jan2021 at 08:30, at a single dose, for COVID-19 immunisation. Medical history included autoimmune disease. The patient has no know allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown), intramuscular in the left arm on 18Dec2020 at 08:00 AM for COVID-19 immunisation. On 08Jan2021, at 15:00, the patient experienced fever, chills, aches and pains, lethargic, shaking, weakness, sweats, joint pain, headache, pain in the armpit of the injection arm, severe sore throat, and generally feeling ill. The patient did not receive treatment for the events. Outcome of the events was recovered. The patient underwent nasal swab on 10Jan2021 with a negative result.
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| 46 | 2021-01-25 | tremor, tingling, numbness |
day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3...
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day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3 hrs. nausea. rt axilla swollen and severe pain. 18/ bilateral hand numbness and tingling up to elbow. temp normal, nausea better. no axilla or neck swelling. reports tremors (that aren't visible) when tries to write "feels not right". 1/11 all sxs resolved. ok to work.
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| 46 | 2021-01-25 | tremor |
Employee had first Covid-19 on 01/19/2021. On the night of 01/20/2021, she began to experience uncon...
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Employee had first Covid-19 on 01/19/2021. On the night of 01/20/2021, she began to experience uncontrollable shaking and chills. The next day, 01/21/2021, employee developed a total body rash and wen to urgent care where she received intramuscular steroids, oral steroids, and oral anti-pruritic medication.
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| 46 | 2021-01-26 | weakness, pain in extremity | Chills, body aches, headache, weak, tired sore arm |
| 46 | 2021-01-26 | weakness |
Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing i...
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Chest tightness/ heaviness ( like an elephant sitting on my chest ), severe headache , and ringing in ears began about 1 hour after vaccine given. Fever greater than 102 / chills began about 2 hours after vaccine given. Severe body aches, nausea, and extreme fatigue, extreme weakness, dizziness, and chest pain when taking a deep breath began within 4 hours after vaccine.
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| 46 | 2021-01-26 | hot flush, tingling, numbness |
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; ...
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the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
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| 46 | 2021-01-26 | night sweats, tingling | Severe muscle aches and fatigue, chills, night sweats, hypersensitivity of skin (prickly sensation0 |
| 46 | 2021-01-26 | tremor |
Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day ...
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Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day of 1/19, only took 1g dose of Tylenol that evening mostly due to headache. I woke up feeling fine on 1/20 but then developed some shakiness that evening. On 1/21, I had fatigue/tiredness, and other than food/bathroom, stayed in bed resting. On 1/22 continued to feel fatigued and dizzy, finally checked my BP, the readings were 93/67 (did not write down HR - heart rate) and 89/68, HR87. I videoconferenced the Methodist urgent line, spoke to NP, recommended continued check BP and increase fluid intake. Still feeling slightly dizzy and tired, but better overall, just feel slightly "off", especially with exertion. BP: 1/23 - 98/76 HR84 , 104/83, HR77; 1/24 - 102/82, HR87; 1/25 - 109/75, HR68, 104/67, HR58, 98/79,HR104, 96/74, HR93; 1/26 - 94/69, HR81, 95/72, HR74, 98/64, HR80; 1/27 - 121/84, HR81 (during MD video visit), 114/80, HR75, 96/74, HR82. Spoke to my doctor today. She asked if I'd filled out this form so decided to fill out. She recommended I continue to monitor BP, increase fluid intake, restart vitamins, add electrolyte drink, add caffeinated drink (for intermittent headache) and follow-up next week if not resolved.
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| 46 | 2021-01-27 | weakness | High Fever bones hurt sores under tongue and inside throat Weak |
| 46 | 2021-01-27 | pain in extremity |
Headache, Myalgia, C/O body aches and fatigue, and sore arm Narrative: Employee endorsed symptoms ...
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Headache, Myalgia, C/O body aches and fatigue, and sore arm Narrative: Employee endorsed symptoms started 1/12/21 between hours of 2-5A.
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| 46 | 2021-01-27 | tingling |
25th Jan-body aches, fatigue, HA, nausea 26th Jan 2021-Body aches, fatigue, HA, N/V, Chills, severe ...
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25th Jan-body aches, fatigue, HA, nausea 26th Jan 2021-Body aches, fatigue, HA, N/V, Chills, severe low back pain, bilateral arm tingling 27th Jan 2021-Body aches, HA, fatigue 28th Jan 2021-Fatigue
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| 46 | 2021-01-28 | discomfort |
The pressure like midsternal pain started on 1/28/2021 around 10:00, I was standing. It came on and ...
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The pressure like midsternal pain started on 1/28/2021 around 10:00, I was standing. It came on and went away throughout the day. I woke up on 1/29/2021 and about 11:00 I started having the same pain again. I am more tired today. I have problems with acid reflux in the past usually after eating too much or during my menstrual cycle. I have been seen in hospital recently prior to covid vaccine and my heart is very great. I don't smoke or drink alcohol, no illicit drugs. I took Prevacid, it didn't help. The pain comes and goes with no aggravating or relieving factor.
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| 46 | 2021-01-28 | feeling hot, tingling |
pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff ...
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pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3. It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown. No follow-up attempts are possible, No further information expected.
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| 46 | 2021-01-28 | muscle twitching | facial twitching within 24 hours after receiving vaccine, sent to neurology |
| 46 | 2021-01-29 | flushing |
Patient reported experiencing itchiness in her throat 6 mins after receivng the vaccine. No redness ...
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Patient reported experiencing itchiness in her throat 6 mins after receivng the vaccine. No redness or swelling at the injection site. Pt verbalized that she experienced this same reaction 4 yrs ago after recieving the Flu vaccine. Pt administered Benadryl 50mg IM to the L Deltoid area at 1710HR. Pt resting and being monitered. Pt is now reporting dizziness at 1730HR, face is flush, B/P 188/88, HR- 122. Pt reported that she has POTTS. Pt consumed sips of water and is continuing to rest. Pt moved to the sitting position @ 1755HR and HR is 98. At 1600HR pt is able to get up and walk without difficulty and reported feeling better. Pt encouraged to report to the hospital if symptoms worsen and to report incident to her PCP. Pt assisted out by her husband.
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| 46 | 2021-01-29 | tingling, pain in extremity |
4 hours after the administration of her COVID-19 vaccine, she developed the onset of twitching of he...
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4 hours after the administration of her COVID-19 vaccine, she developed the onset of twitching of her left eyelid, some left-sided jaw pain, a cotton mouth sensation, and migratory left-sided facial paresthesias described as a tingling sensation that could involve the eyelid, nostril, scalp, cheek, or forehead. These sensory symptoms feels somewhat like a Christmas tree with lights going on and off in different spots but always restricted to the left side of her face. In addition she experience a mild headache but without associated scotoma, nausea, vomiting, or vertigo. Upon looking in the mirror she thought that perhaps there is some slight facial asymmetry on the left side. In addition she reports feeling that her neck is weak on the left side and that she has to support her head in order to keep it from flopping further to the left. The symptoms have been also associated with some pain in the left arm which has since improved as well as discomfort and achy sensation involving her left leg extending from the hip laterally down to the level of the knee. She was evaluated the next day by a neurologist. Her neurological examination demonstrates some subjective decrease in sensation involving the left V1 and V2 distribution but is otherwise normal. Difficult to know to what extent the prior Botox injections could be contributing to her worsening left-sided neck weakness. We are aware that the vaccine does induce a inflammatory cytokine response and it is conceivable that this is contributing to some of her symptoms. MRI was obtained to exclude any underlying CNS pathology that could be conceivably exacerbated in the setting of an inflammatory micro environment induced by the vaccine. There was no clear evidence of a new CNS lesion based upon the examination.
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| 46 | 2021-01-29 | tenderness |
Patient claims axillary and supraclavicular pain, after 48h of 2nd dose vaccination with Pfizer vac...
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Patient claims axillary and supraclavicular pain, after 48h of 2nd dose vaccination with Pfizer vaccine. That has recovered in 75% since onset of symptoms. Pt claims tenderness in the right neck area, with a non visible but palpable lump the size of a quarter. Patient took a dose of tylenol 1g which subdued most of the symptoms, and reports today 1/30/2021 only local tenderness, with no other side effects to report. Pt also claims feeling of chills, and flu like symptoms 24 hours after the vaccination which subdued with a dose of Tylenol 1g.
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| 46 | 2021-01-30 | numbness, tingling | Headache / Nausea / Vomiting / Fever / Numb tingly feeling on face |
| 46 | 2021-01-30 | numbness | Pt states she felt woozy and had numbness radiating across shoulder blades |
| 46 | 2021-01-31 | weakness |
Patient called to report that after receiving her vaccine on Friday: during the middle of the night ...
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Patient called to report that after receiving her vaccine on Friday: during the middle of the night she starting feeling chills and had a temp of 101. She took some ibuprofen and her fever broke around 9030 or 1000 on Saturday because she became very diaphoretic. She reports that she slept approx 19 hours on Sat and she had chills and sweats off on during this time period. She just felt weak and tired. On Sunday she felt better, just tired. Today, Monday 2/1 she did not come to work due to being tired and feels dehydrated due to the fever and being weak and sweating spells she had. She also states that her Right arm pit is swollen
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| 46 | 2021-01-31 | weakness |
malaise; weakness; nausea; This is a spontaneous report from a contactable healthcare professional (...
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malaise; weakness; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Dec2020 08:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant at time of vaccination. Concomitant medication included linaclotide (LINZESS), omeprazole, ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient previously took erythromycin and DEMEROL and experienced allergy. The day after first injection, patient had extreme malaise, weekness and nausea on 20Dec2020 06:00. Outcome of the event was recovered. No treatment was received for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 46 | 2021-01-31 | burning sensation |
This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old fe...
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This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 16 Jan 2021 at 12:45 PM at a single dose for COVID-19 immunization in a hospital. Medical history included high cholesterol, GERD, Barrets esophagus, IBS-C, brain aneurysms, and known allergies to penicillin. The patient also received first dose of other vaccine in left (arm). Concomitant medications included clopidogrel bisulfate (PLAVIX), pravastatin, amitriptyline, famotidine, and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient has known allergies to Topamax. The patient experienced burning feeling from chest down to feet, tachycardia, high blood pressure, and chest pain on 16 Jan 2021 at 12:45 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. No treatment received for the events. The patient is recovering from the events. Information on the batch/lot number has been requested.
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| 46 | 2021-01-31 | pain in extremity, burning sensation |
severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; blee...
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severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.
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| 46 | 2021-02-01 | muscle spasms |
About two hours after the receiving the vaccine, I started getting a headache. I was rotating betwee...
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About two hours after the receiving the vaccine, I started getting a headache. I was rotating between Tylenol and Ibuprofen every 8 hours. The muscle spasms started Friday neck and shoulder. On Sunday I couldn't even turn my head. Today I noticed I broke out in hives arms, legs, back and stomach. Today I had a temperature 102 this morning, I just checked it again and it was down to 100. Today I went to my Doctor. She prescribed you Methylprednisolone dose pack and Cyclobenzaprine hydrochloride for muscle spasms.
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| 46 | 2021-02-01 | pain in extremity |
I had blood drawn yesterday in left arm annual health exam and the blood draw site hurt yesterday ...
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I had blood drawn yesterday in left arm annual health exam and the blood draw site hurt yesterday no big deal but it was more than usual Next day left arm and muscle upper arm aches.
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| 46 | 2021-02-02 | muscle spasms, numbness, tingling |
felt like a cramp in face on one side of her cheek and it felt like her face was not working right; ...
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felt like a cramp in face on one side of her cheek and it felt like her face was not working right; arm and legs were tired; tingling in her forehead and in nose/tingling in arms and in legs and her feet felt the worst; numbness; Muscle weakness; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient reported that she had some things happened just after receiving the COVID-19 vaccine on Tuesday morning (12Jan2021). The patient later on experienced tingling in her forehead and in nose on 13Jan2021. The next day (14Jan2021), it started like tingling in arms and in legs and her feet felt the worst. On 14Jan2021, two days after (Thursday), she felt like her arm and legs were tired. On Friday (15Jan2021), she woke up and felt like a cramp in face on one side of her cheek and it felt like her face was not working right. Three days later (Friday), she still feels that it is better than it was. The patient also experienced numbness and muscle weakness (both in Jan2021). She don't know what she should do or if she should get the next shot, she almost felt like it was the worst and need to go to the hospital but her body was not so fatigued, she felt her muscle worked hard, described as weak. The patient haven't seen by her doctor or visited in emergency room. The patient did not receive treatment for the events. Outcome of the events was unknown. The events were assessed as non-serious.
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| 46 | 2021-02-02 | pain in extremity | fever, body aches, sore arm, arm red and warm to touch |
| 46 | 2021-02-02 | pain in extremity | left upper inner thigh rash, left leg pain |
| 46 | 2021-02-03 | weakness |
Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, chills, HA, muscle aches, weakness and some dizziness. ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, chills, HA, muscle aches, weakness and some dizziness. The Nausea started around 05:00 Am on 2/3/21 some dry heaving. Other symptoms have been progressively worsening throughout the morning. No Temp.
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| 46 | 2021-02-03 | difficulty speaking |
Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report fr...
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Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse. A 46-year-old nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose in the Left arm on 15Jan2021 at 11:30 am for COVID-19 immunization.Medical history included allergy to latex. The patient's concomitant medications were not reported. On 15Jan2021 at 12:00 am the patient experienced lip and mouth numbness, hoarseness, chest pressure and lightheadedness. Since the vaccination, the patient has not been tested for COVID. No treatment was received. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-03 | feeling jittery | Metallic taste, eyes watering, feeling jittery, eyes itching, needs to take deep breathe |
| 46 | 2021-02-03 | flushing |
On day 1 post immunization @ 14 hours, I started to feel nauseated then developed chills, flushing ...
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On day 1 post immunization @ 14 hours, I started to feel nauseated then developed chills, flushing of face, body aches. On about 24 hours post immunization, I developed temp. 100.9 , chills and with wet cough , headache. Post 24 hours, fevers, sweats, wet cough and continued headache. On day 3 post immunization, no more fevers, wet cough, and chills with sweats, head ache , body ache and pain at sight subsided. As of date of reporting experiencing, sweats, chills and wet cough. Starting taking Tylenol and Ibuprofen for symptom management.
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| 46 | 2021-02-03 | migraine |
WOKE UP WITH TERRIBLE MIGRAINE THAT MADE ME NAUSEOUS AND BODY ACHES WITH EXTREME FATIGUE. MIGRAINE ...
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WOKE UP WITH TERRIBLE MIGRAINE THAT MADE ME NAUSEOUS AND BODY ACHES WITH EXTREME FATIGUE. MIGRAINE LASTED CLOSE TO 10 HOURS. BODY ACHES AND FATIGUE LASTED 2 DAYS.
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| 46 | 2021-02-03 | muscle spasms |
Mild to moderate pain behind left ear; spasms in left ocular area; This is a spontaneous report from...
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Mild to moderate pain behind left ear; spasms in left ocular area; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), via an unspecified route of administration in the right arm on 19Jan2021, at 11:15 as single dose for covid-19 immunization. Medical history included Raynaud's from an unknown date, but otherwise healthy. No allergies to medications, food, or other products were noted. Concomitant medication included acetaminophen (MANUFACTURER UNKNOWN), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN), both on unspecified dates within 2 weeks of vaccination. The patient previously received BNT162B2 on 29Dec2020 for covid-19 immunization in the left arm, when the patient was 46 years old. The patient experienced mild to moderate pain behind left ear on 19Jan2021, at 18:00 with outcome of recovering; spasms in left ocular area on 19Jan2021, at 18:00 with outcome of recovering. The events were non-serious and described as mild to moderate pain behind left ear and spasms in left ocular area beginning approximately 6-8 hours post injection. Continuing, but lessening frequency and intensity. No therapeutic measures were taken as results of the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The outcome of mild to moderate pain behind left ear was recovering.
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| 46 | 2021-02-03 | pain in extremity |
really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm...
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really swollen and sore underneath her arm in her armpit; really swollen and sore underneath her arm in her armpit/Incredibly sore arm; Fever and chills; Red at injection site; Very tired; Bad headache; This is a spontaneous report from a contactable other health professional reported for herself. A 46-year-old female patient received the first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer, lot number: EL9262,) via unspecified route of administration at age of 46 years old on 21Jan2021 10:15 AM at single dose and vaccine location at left arm, for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included: prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications reported as there had other medications the patient received within 2 weeks of vaccination. The patient past drugs included: allergies to prochlorperazine (COMPAZINE) and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported really swollen and sore underneath her arm in her armpit. Patient presented fever and chills. Red at injection site. Incredibly sore arm. Patient was very tired and bad headache, the adverse events reported started on 21Jan2021. It was reported the non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. There was no treatment received for the adverse event. Outcome of events were not recovered.
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| 46 | 2021-02-03 | pain in extremity | Sore arm for two days, headache and body aches for 7 days |
| 46 | 2021-02-03 | tingling, burning sensation |
Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site te...
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Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site tenderness, sinus pressure, sore throat, eye pain (R), burning sensation and tingling. Seen at ED on 1/12/21.
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| 46 | 2021-02-03 | tingling, numbness |
numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a ...
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numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a neuropathy type of feeling"; tingling fingertips/gets bouts of tingling or being numb/neuropathy type, numb tingling sensation; like a traveling sensation; her joints, later clarified that she has to keep opening and closing her left hand; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 15Jan2021 10:00 at SINGLE DOSE, for covid-19 immunization. The patient is right-handed which is why she got the vaccine in her left arm. Medical history included ongoing high blood pressure since an unknown date in 2011 (diagnosed about 10 years ago). There were no concomitant medications used. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient was experiencing numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a neuropathy type of feeling"; tingling at her fingertips, her joints, later clarified that she has to keep opening and closing her left hand. All of these has been continuous, and it seems like it was getting worse not better. It was uncomfortable and hard to explain, it was weird. She describes that it was like "a pain that travels from her elbow to wrist but its numb at the same time". Her left hand gets bouts of tingling or being numb. She has to open and close her hand. Her left arm feels essentially numb from her wrist to the elbow region. She knew there was something going on the day of the injection like a traveling sensation, but she started to really notice the neuropathy type, numb tingling sensation on Saturday (16Jan2021). She clarified that she was not in pain. She did not have any of these symptoms prior to getting the vaccine She was hoping it will go away because it was concerning since it has been about a week since the vaccination. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 46 | 2021-02-03 | tingling |
I have been having body aches but they have all but disappeared but the tingling through out...
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I have been having body aches but they have all but disappeared but the tingling through out body still continues
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| 46 | 2021-02-03 | tingling | -Palpitations -Rash -Tingling of Hands and Feet |
| 46 | 2021-02-04 | muscle spasms, tingling, tremor |
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att...
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Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
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| 46 | 2021-02-04 | pain in extremity |
I got shot at 7 am Thursday morning. I had sore arm around 130 pm. And was all day. At 130 am Frid...
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I got shot at 7 am Thursday morning. I had sore arm around 130 pm. And was all day. At 130 am Friday morning. I woke with chills. I took my temp. It was 100.8. And he lot as high as 101.2. Between 130-430. I woke up again at 630 and it was 100.3. I have been warm all day now. I do not feel I need attention o am sweating it out.
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| 46 | 2021-02-04 | pain in extremity |
symptoms began 02/02/21 that night and lasted about 24 hours. headache, muscle aches, nausea, fever...
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symptoms began 02/02/21 that night and lasted about 24 hours. headache, muscle aches, nausea, fever, chills, right arm soreness
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| 46 | 2021-02-04 | pain in extremity |
Chills began about 1/2 hour later. The chills got continuously worst as the day went on.; Immediatel...
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Chills began about 1/2 hour later. The chills got continuously worst as the day went on.; Immediately after the shot I felt nauseated; lethargic; ache and pain in my arm is tremendous; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 vaccine; unknown lot number and expiration date), intramuscular left arm on 21Jan2021 11:30 at a single dose for covid-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the most recent COVID-19 vaccine in nursing home/senior living facility. The patient reported that she has never had an adverse effect to this degree from any injections or vaccinations. She mentioned that immediately after the shot (21Jan2021 11:30 AM), she felt nauseated then chills began about 1/2 hour later. The chills got continuously worst as the day went on. It has only been about 4 hours since the shot and she was very lethargic and the ache and pain in her arm was tremendous. She was an extremely active athlete and she has not been sick in over 2 years. The patient did not receive treatment for the adverse events. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event chill was not recovered while the outcome of the other events was unknown. The following information on the batch/lot number has been requested.
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| 46 | 2021-02-04 | pain in extremity |
sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female p...
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sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3247) on left arm on 21Jan2021 10:00 AM at a single dose for COVID-19 immunization. Medical history included Penicillin allergy. Patient was not pregnant. Concomitant medications were not reported. No other vaccine administered in four weeks. No other medications administered in two weeks. Patient experienced sore arm on 21Jan2021 10:30 AM with outcome not recovered. No treatment was received. No COVID prior vaccination. No COVID tested post vaccination.
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| 46 | 2021-02-05 | bell's palsy | Started with Bell's Palsy on 02/04/2021 |
| 46 | 2021-02-05 | pain in extremity, tingling |
pain and tingling in left arm and hand within 1 week of first dose, tingling/paresthesias in both ha...
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pain and tingling in left arm and hand within 1 week of first dose, tingling/paresthesias in both hands and feet/lower legs 1 week after 2nd dose, daily, worse at night when trying to sleep
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| 46 | 2021-02-07 | feeling hot | Feeling warm, dizzy, light-headed, hypotensive |
| 46 | 2021-02-07 | pain in extremity |
Symptoms began 2/2/21 that night and lasted about 24 hours, HA, muscle aches, nausea, fever, chills ...
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Symptoms began 2/2/21 that night and lasted about 24 hours, HA, muscle aches, nausea, fever, chills & right arm soreness
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| 46 | 2021-02-07 | tingling | pt verbalized tingling in hands and swelling in hands post vaccination. |
| 46 | 2021-02-07 | tingling |
Within three months, left arm which is the injection site, was struggling to lift up much at all, le...
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Within three months, left arm which is the injection site, was struggling to lift up much at all, left hand went tingly, once Nurse came saw that I had an increased pulse. When medics came through as increased pulse and increased blood pressure. Was cleared after about 15 minutes. The next day was decently sleepy with a decent headache. Then was fine.
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| 46 | 2021-02-07 | tremor |
Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and ch...
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Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and chest within 10 minutes of shot. Feeling of nausea after 25 minutes Selling of tongue with a fuzzy feeling 35 minutes after test.
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| 46 | 2021-02-08 | inability to speak |
One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and w...
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One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
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| 46 | 2021-02-08 | flushing |
7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to th...
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7 mins after vaccine - flushing and palpitations. Then feeling of fullness in chest. Got taken to the ER and had high bp 153/101 and tachy arrhythmia, such as trigeminy and bigeminy and heart rated in the 130?s. My ear also swelled and got hot and red on the same side as the shot. I was monitored for about three hours and then released after bp went down to 130?s/ 90?s and palps decreased.
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| 46 | 2021-02-08 | numbness, muscle spasms, flushing |
0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg s...
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0930- she complained of sever neck pain and asked for Ibuprofen, 0945- nausea, blurred vision, leg spasms, she took 12.5mg of Benadryl, 1030- BP slightly elevated, dizziness, numbness in face and arms, flushing- took 25 mg Benadryl per house MD. had her lye down and within 2 hrs most of symptoms resolved. at 1530 continued to c/o facial numbness. sent home with co-worker so she didn't need to drive.
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| 46 | 2021-02-08 | tingling | See page 1. (Box 9). |
| 46 | 2021-02-09 | feeling of body temperature change |
I experienced headaches, chills, muscle aches, felt feverish, felt hot and cold but mainly severe he...
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I experienced headaches, chills, muscle aches, felt feverish, felt hot and cold but mainly severe headache. I was also having nausea. I saw PCP on 01-06-2021 and he gave me Phenergan 6.25-10mL, 5mL syrup with codeine to help with my headache. I only took the Phenergan one time in the evening before I went to bed. I also got tested for a rapid Covid-19 test which was negative.
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| 46 | 2021-02-09 | numbness |
Ten minutes after receiving the vaccine, patient reported to MD in Observation area that she was exp...
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Ten minutes after receiving the vaccine, patient reported to MD in Observation area that she was experiencing a headache, tongue and right arm numbness. After MD assessed patient (and patient relayed this was the same reaction she had with the first vaccine), MD kept her in the observation area for 30 minutes as the symptoms subsided. Patient was released when all symptoms were gone.
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| 46 | 2021-02-09 | night sweats |
Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain ove...
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Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain over left eye; Nausea; No appetite; This is a spontaneous report from a contactable consumer reported for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, brand=Pfizer, lot number=EL3247) via unspecified route of administration at age of 46 years old on 21Jan2021 05:00 PM at single dose at left arm, for COVID-19 immunization. The patient medical history included patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other concomitant medications the patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT 25mg), atorvastatin statin. It was reported patient experienced chills and night sweats started 2 days later. Pain over left eye, nausea, no appetite, can sleep at night. All the adverse events started on 23Jan2021 04:00 PM. It was reported case type non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Since the vaccination, the patient had been tested for COVID-19 on 27Jan2021: Nasal Swab (PCR): Negative. There was no treatment received for the adverse event. Outcome of events at the time of last observation was recovering.
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| 46 | 2021-02-09 | pain in extremity | headache, tired, body aches, sore arm |
| 46 | 2021-02-10 | weakness |
Describe adverse reaction: vasovagal syncope several hours after vaccine. Sent to ED via ambulance. ...
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Describe adverse reaction: vasovagal syncope several hours after vaccine. Sent to ED via ambulance. Vasovagal symptoms: dizziness; vertigo; lightheadedness; near syncope and weakness. Sent to ED via ambulance from work. ED gave IV fluids and mescaline. Studies performed: EKG; CBC; and BMP. From ED MD note DC instructions: You came to our ER with concerns of dizziness after getting your covid vaccine. We evaluated you with labs, and provided you with meclizine and fluis. The results of our evaluation were reassuring, and we believe that the causes of your symptoms are not immediately life threatening and safe to follow up with your clinic doctors. We've prescribed you meclizine, take it as needed for dizziness. Administration error: no Clinic called No; Transferred to Emergency Department from workplace several hours after vaccine was administered.
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| 46 | 2021-02-10 | weakness |
- THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymp...
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- THINK JUST STRONG IMMUNE RESPONSE: - Headache, dizzy, nauseated, weak, Pelvic pain - Enlarged lymph node on Ipsilalent side of shot - Concentration off BLOOD SUGARS SLIGHT Elevation (129-132 fasting) Decrease in Blood Pressure to 104/76 (usually 120s to 130s/80s
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| 46 | 2021-02-11 | flushing | Flushed, tingling in mouth |
| 46 | 2021-02-11 | pain in extremity, feeling hot |
within 15 minutes hot all over and 30 minutes pain in my back down my leg into my knee and ankle. Ha...
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within 15 minutes hot all over and 30 minutes pain in my back down my leg into my knee and ankle. Hard to walk. progressivly got worse to point unable to walk without pain, lay down without pain. only able to sit. Steroids, NSAIDS, ICE, Whirlpool Therapy, message, chiropractor. Neurologist consult unable to walk. 2/1/21 MRI completed Circumferential disc bulge with superimposed left lateral recess and foraminal disc protrusion at L4-5 resulting in moderate to severe left foraminal stenosis and impingement of the exiting left L4 nerve root. There is contact of the traversing bilateral L4 nerve roots with some mass effect on the traversing left L5 nerve root. Correlate for left L4 and/or L5 radiculopathy. Â 3. Circumferential disc bulge with superimposed right lateral recess and foraminal disc protrusion at L2-L3 with contact the traversing right L3 nerve root, but no nerve root compression. No compression of the exiting right L2 nerve root. Correlate for right L3 radiculopathy It is my impression that patient presents with acute onset of left L4 radiculopathy. Her MRI scan suggests a far lateral/foraminal left L4-L5 disk herniation. She also has some underlying lateral recess stenosis which is fairly mild. Â I discussed the above findings with patient and her husband. I reviewed her MRI scan with the help of a spine model. I outlined both conservative and surgical approaches. However, given her findings and the severity of her pain currently, I think one could argue that a left L4-L5 microlumbar diskectomy via far lateral approach would be her most definitive option. I did outline this procedure in detail with the help of a spine model. I outlined the risks which include but are not limited to infection, bleeding complications, nerve root and/or cauda equina injury, cerebrospinal fluid leak, recurrent disk herniation, spinal instability, the possibility that she could require additional spine surgery in the future, and the possibility that her would not be relieved to her satisfaction. We also discussed trying a left L4-L5 foraminal steroid injection but she has had injections in the past and she actually felt like it gave her more pain. At this point she would like to go ahead and schedule the left L4-L5 microlumbar diskectomy via far lateral approach with METRx. This will be scheduled on an elective basis in the near future.
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| 46 | 2021-02-11 | pain in extremity |
The first dose vaccination on Jan 8, 2021 very mild symptoms of arm soreness about 12hrs after injec...
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The first dose vaccination on Jan 8, 2021 very mild symptoms of arm soreness about 12hrs after injection. Lasted only a few hrs. Second dose vaccination on Jan 29, 2021 had more symptoms. Arm pain again about 10hrs after, lasted longer, about a day. About 18 hrs after injection was very fatigued and had a headache. This lasted about 24 hrs. Also had episodes of chills and slight fever. All symptoms were better a day later, though have noticed more headaches the following week.
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| 46 | 2021-02-14 | flushing | Patient flushed, tachycardia, elevated BP, headache, nausea, vomiting, chest pain |
| 46 | 2021-02-15 | feeling hot | Anxious, feeling hot, and claustrophobic . |
| 46 | 2021-02-15 | numbness, facial paralysis, bell's palsy |
Bell?s palsy. Numbness in front part of tongue started the afternoon of 2/12/2021. Morning of 2/13...
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Bell?s palsy. Numbness in front part of tongue started the afternoon of 2/12/2021. Morning of 2/13/2021 half of face was unresponsive and droopy. Talked to my doctor on call and she recommended I be seen at urgent care immediately for evaluation. Was seen at Urgent Care on 2/13/2021 and it was determined I had Bell?s palsy as a side effect of the COVID-19 vaccine. They still recommended to get my second vaccine as scheduled on 2/17/2021.
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| 46 | 2021-02-16 | migraine | migraine headaches daily since day 2 until present day |
| 46 | 2021-02-16 | pain in extremity |
This happened the first shot also but I thought it was just me being anxious. Immediately following...
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This happened the first shot also but I thought it was just me being anxious. Immediately following my roof of my mouth felt big. Then my tongue and lips felt the tiniest bit swollen. I could breath fine. Then my face (especially my left side) was a bit numb. The same thing happened to my friend but we couldn?t find anything online about our symptoms. I ended up telling the nurse at the front and they told me to take Benadryl and call 911 if scared. They made sure I wasn?t going to be home alone. I felt better within a 1/2 hour of taking the meds. My throat feels a little sore right now along with my arm.
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| 46 | 2021-02-16 | tingling |
Within an hour of receiving 2nd dose of Pfizer Covid Vaccine, presented to emergency department repo...
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Within an hour of receiving 2nd dose of Pfizer Covid Vaccine, presented to emergency department reporting paresthesia in lips and in feet.
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| 46 | 2021-02-17 | tingling, numbness |
tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingl...
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tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing; raised blood pressure; metallic taste; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number 0041297301), via an unspecified route of administration in left arm on 15Jan2021, at 17:00 as first single dose for covid-19 immunisation. Medical history included obesity, opiate allergy and artichokes allergy from an unknown date. Concomitant medication included unspecified probiotic, levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), linum usitatissimum seed oil (FLAXSEED OIL NATURE MADE). The patient experienced the following non-serious events: metallic taste on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; tingling sensation in jaw and it extended to nose and it felt numb with difficulty swallowing on 15Jan2021, at 17:30 with outcome of recovered in Jan2021; raised blood pressure on 15Jan2021, at 17:30 with outcome of recovered in Jan2021. Details were as follows: following vaccination the patient reported a metallic taste in her mouth, then a tingling sensation in her jaw which extended to her nose and it felt numb with difficulty swallowing, and she also had raised blood pressure. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
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| 46 | 2021-02-17 | tingling |
Paresthesias in feet and hands, strongest in the left hand; This is a spontaneous report from a cont...
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Paresthesias in feet and hands, strongest in the left hand; This is a spontaneous report from a contactable physician (patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm, on 19Dec2020 at 09:30 AM, at a single dose, for COVID-19 immunization. The patient's medical history included tinnitus, intermittent vertigo, and non-anaphylactic allergy to egg. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 26Dec2020, the patient experienced paresthesias in feet and hands, strongest in the left hand. The event was considered non-serious. No treatment was received for the adverse event. The patient was administered with the second dose of BNT162B2 (Lot Number: EJ1283) on 09Jan2021 at 09:30 AM in left arm. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.
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| 46 | 2021-02-18 | weakness |
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo...
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Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-18 | discomfort |
Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. ...
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Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. Approximately 50 min after mouth felt fuzzy/tingly, face felt tingling; had a lightening pain go across body.
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| 46 | 2021-02-18 | feeling hot |
A couple of minutes after receiving the vaccine, my cheeks and ears got really hot and red. The EMT...
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A couple of minutes after receiving the vaccine, my cheeks and ears got really hot and red. The EMTs talked to me, asked if I felt okay and if I wanted to them to take my vitals and then they said we could go. I took two benedryl that I had brought with me and that helped after about 20 minutes or so. I took another benedryl at bedtime because my cheeks were still feeling hot but not as badly as when it first happened.
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| 46 | 2021-02-18 | migraine | severe migraine headache unchanged despite Iv infusion, steroid therapy and facial nerve block |
| 46 | 2021-02-21 | migraine |
- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC...
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- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC meds. Sometimes too high for thermometer to read. - Swelling at injection site (and halfway to elbow), soreness. By Monday this was down to about a golf ball, and it resolved in a week. - Fatigue, slept all weekend and was tired but functioning the following week. - Severe joint pain and muscle aches Saturday and Sunday. I took OTC pain relievers. Went to bed. - Blindingly bad migraine Friday night, worse Saturday, and resolving some on Sunday, somewhat responsive to Naratryptin.
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| 46 | 2021-02-21 | speech disorder |
Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) ...
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Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown. Information about Lot/batch no has been requested.
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| 46 | 2021-02-21 | tenderness | 40-60 tender red bumps, mostly on torso. |
| 46 | 2021-02-22 | pain in extremity | Pain in arm, upper body aches, back, neck, shoulder, headache sore throat, congestion. |
| 46 | 2021-02-22 | pain in extremity |
Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, aff...
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Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, affected work.
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| 46 | 2021-02-22 | pain in extremity |
Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 ho...
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Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 hours, all limbs covered in hives and throat felt irritated. Took a 5mg Claritin at that point (fearing hives would worsen during night). Awoke with no reaction next day or thereafter. No hives reaction after first dose. After both doses had typical sore arm for 48 hours; fatigue after second dose only.
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| 46 | 2021-02-22 | tremor |
Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches...
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Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches, body aches, and muscle pain.
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| 46 | 2021-02-23 | bell's palsy |
on the 3rd of feb, my left lips went numb, called 911 and by 11 was diagnosed with bells palsey. Du...
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on the 3rd of feb, my left lips went numb, called 911 and by 11 was diagnosed with bells palsey. Due to the fact I have no chronic conditions, live a pretty healthy life, I was told by EMS and various ID doctors it was most likely from the vaccine. Today is day 21 and I still have no movement in face
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| 46 | 2021-02-23 | tingling, weakness |
patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness ...
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patient began feeling tingling sensation at injection site left arm. A few minutes later dizziness and (now stating shortness of breath) original evaluation, assessment and patient statements did not reveal shortness of breath. She was speaking softly, SaO2 was 98. Provided gatoraid and offered weather. Husband stated she had previous similar reaction post-anesthesia. at 1515. Patient began to feel weakness over entire body. Refused ambulance at that time. 1520- began having chest pain, tingling in legs and feet. Husband said he would take her to the ER due to BP continuing to be elevated. 1528- Unable to stand requesting an ambulance. a1530- EMS called at 1535 ambulance confirmed. 1540- Ambulance arrived. Turned over care to EMS
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| 46 | 2021-02-25 | numbness |
Numbness in face--primarily on the left side (under the eyes, on the side of my nose, on my chin and...
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Numbness in face--primarily on the left side (under the eyes, on the side of my nose, on my chin and jaw). This lasted for almost three days. Taking Benadryl and Ibuprofen helped.
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| 46 | 2021-02-25 | numbness | Numbness in tongue and hands |
| 46 | 2021-02-25 | pain in extremity |
Very Sore Arm began after shot and continued through morning of 2/26. Day after shot (2/24), fever o...
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Very Sore Arm began after shot and continued through morning of 2/26. Day after shot (2/24), fever of 100.3, chills, extreme fatigue, bone pain, headache, neckache. Everything other than sore arm resolved by morning of 2/25.
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| 46 | 2021-02-28 | cold sweat |
About 5 minutes after the shot, I developed a sudden sharp pounding headache at the top of the head ...
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About 5 minutes after the shot, I developed a sudden sharp pounding headache at the top of the head & near the temple. I also got clammy/sweaty in my neck & the back of head. My hair got damp at the scalp. At nurse took my BP & it was 142/88 which is very high for me. I usually average a low BP. This reaction slowly subsided within 30 minutes. I was able to drive home. I felt nothing more on this day other than soreness in the injection site. On 2/23/21 I woke up with stomach cramping & had looser stools than usual. I also had fatigue & lethargy all day, which got stronger towards the evening. This lasted until 2/25/2021.
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| 46 | 2021-02-28 | numbness |
About 10 min after injection, experience dizziness, lightheadedness, also described numbness to face...
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About 10 min after injection, experience dizziness, lightheadedness, also described numbness to face and drawing of hands. stated she could move her hands, developed some tachypnea and mild SOB with hyperventilation.
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| 46 | 2021-02-28 | tenderness | arm swelling, tenderness, armpit swelling |
| 46 | 2021-03-01 | feeling cold, tremor, pain in extremity |
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h...
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sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
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| 46 | 2021-03-01 | muscle twitching |
The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal s...
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The nurse that administered the vaccine at 4:00 pm and states patient went limp and had vasovagal syncope immediately upon withdrawing needle from muscle and occurred immediately after vaccine administration. The nurse lowered the patient slowly to the groundf and put the pt's feet up. The pt has had prior episodes of vasovagal syncope in the past. Her pulse was noted to be in the 70s. Small eyelid and lip twitching noted. Pt had no injury as a result of the syncopal episode. Patient transported to the Emergency Room for evaluation at 4:09 pm. Blood pressure upon arrival in the EC was 143/74, pulse 57, Resp 14, pulse ox 99%. Patient able to open eyes to command and nod yes or no. Blood Glucose was 74 and ECG was unremarkable. Discharged to home at 1822.
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| 46 | 2021-03-02 | involuntary muscle movements |
Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received fro...
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Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received from a contactable pharmacist (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included levothyroxine and gabapentin. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 24Dec2020, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 13Jan2021, the patient experienced gait issue, involuntary lips movement, dizziness and fatigue. No treatment was given for the events. The outcome of the events was not recovered. Information about lot/batch no. has been requested.
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| 46 | 2021-03-02 | facial paralysis, slurring |
On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head...
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On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head. The headache was intense. I could not open my left eye. I had facial paralysis on the right side of my face. I had slurring of speech. When I walked I was dizzy. I fell asleep all day long, and woke up each time completely disoriented.
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| 46 | 2021-03-02 | migraine, tingling, numbness |
migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fe...
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migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fever; body aches and muscle aches; body aches and muscle aches; really sick; She had the horrible headaches; Nausea; Upset stomach; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 for COVID-19 immunization and experienced flu like symptoms, body aches, headache, muscle aches and light fever. No additional vaccines administered on the same date of the Pfizer suspect. The patient had questions about the side effects of COVID vaccine. The patient experienced migraine, face numb and tingling sensation, vomiting, diarrhea, fever, body aches and muscle aches, and has been really sick the night after that second vaccine on an unspecified date in Jan2021. It is slowly getting better and now it had been a Monday a week later from the second dose and she still has the body aches, fever that comes and goes, and headaches that have just been ongoing. She wanted to know if anyone reported any of this or prolonged symptoms. She also mentioned horrible headaches, nausea, vomiting, numbness and tingling in face on an unspecified date in Jan2021. She mentioned again the nausea and upset stomach, body and muscle aches and fever she still has a little of on an unspecified date in Jan2021. The biggest thing was the headaches. The body and muscle aches and fever comes and goes. Thought she was over the fever and it started back again yesterday. She was unable to provide seriousness criteria when queried, only stated that it was very frustrating, it's not life threatening, but she is at home versus being at work. The events migraines, fever off and on, body and muscle aches, diarrhea, vomiting, numbness and tingling in face, really sick required a visit to the Physician office. The outcome of the events migraine, Tingling, Numbness in face, Vomiting, Diarrhea, Fever, Generalized aching, Muscle ache and sickness was not recovered while the outcome of the events headache, nausea and upset stomach was unknown.
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| 46 | 2021-03-02 | pain in extremity |
Major soreness in arm starting 6pm day of vaccine, and continuing through 3/2. Fatigue and nagging ...
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Major soreness in arm starting 6pm day of vaccine, and continuing through 3/2. Fatigue and nagging headache 3/2. Resolved by 3/3.
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| 46 | 2021-03-04 | slurring |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth /...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Approximately 30 minutes after administration, patient reported some difficulty breathing and extreme lightedheadness. Breathing was shallow. Also reported swollen tongue, which led to slurred speech. Benadryl was immediately given and patient was monitored for an additional hour. At the end, patient reported she felt better and speech improved, but still lightheaded like she \"just had 2 glasses of wine.\"
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| 46 | 2021-03-04 | feeling hot, cold sweat |
Clammy hands, warm wave rushed over my body, felt very hot, racing heart, tightness in my chest-last...
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Clammy hands, warm wave rushed over my body, felt very hot, racing heart, tightness in my chest-lasted approx 15-20 minutes
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| 46 | 2021-03-04 | feeling hot |
Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) s...
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Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) she began to feel " a tingly sensation in my tongue" and felt warm. She also had localized redness and swelling at the site of injection (Right deltoid). She denied any symptoms of chest pain, SOB, palpitations, difficulty swallowing, drooling, nausea/vomiting, dizziness or light-headed or near syncope. Patient was observed by provider for a course of one hour. We recommended to be taken by EMS to ER for further observation, she refused. Patient drove herself and was not able to take Benadryl. Initial vital signs taken 10:54am 177/114; HR 92; O2 98% RA; RR 18 -sitting position Second vitals 11:35am 134/96; HR 79; O2 100% RA ; RR 16- sitting position Patient was observed for an hour and decided to drive home. Recommend hydration and call 911 if needed.
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| 46 | 2021-03-06 | pain in extremity |
3 hours after started feeling tired, went to bed early. Next morning - Sore arm up into shoulder and...
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3 hours after started feeling tired, went to bed early. Next morning - Sore arm up into shoulder and neck, lasted a week Whole-body muscle ache, headache, nausea, diarrhea, exhaustion, lasted two days. The shot was given on a Thursday and had to miss work the next day.
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| 46 | 2021-03-07 | breast pain | Swollen axillary lymph nodes in left arm pit with left breast pain |
| 46 | 2021-03-07 | involuntary muscle movements |
Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM...
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Nausea, something in throat, involuntary finger movement, especially in left hand. Benadryl 50 mg IM given.
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| 46 | 2021-03-08 | feeling hot, tingling |
ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER...
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ABOUT 10 MIN AFTER VACCINATION, PT FELT WARM WITH SOME SOB AND TINGLING IN HER BODY + RINGING IN HER EARS. HUSBAND WENT TO GET HELP AND PT FELL OUT OF HER CHAIR WITH LOSS OF CONSIOUSNESS. PT RECOVERED IMMEDIATELY WITHOUT CONFUSION,. VITALS BP: 102/71 HR: 81. PMH STROKE 2008 WITH RESIDUAL L WEAKNESS. MEDS: ASPIRIN, ZYRTEC, FLONATE. NO PREVIOUS VACCINE REACTIONS OR ANAPHYLAXIS. EMS CALLED TO TRANSPORT TO ER. VASOVAGAL LIKELY.
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| 46 | 2021-03-08 | migraine, tingling, numbness |
2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light hea...
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2/26/21- At time of shot, itchy throat, mouth and face. Next day, felt like I had the flu, light headed, tingly hands and face. On 3/6/21, woke up with swelling, hot, red, itchy swelling at injection site. On 3/8/21, patches of rash that would come and go, face, mouth, and throat itchy. Hand and arms tingly and felt like I was going to pass out. Later that day, had my 1st migraine in my life. 3/9/21-Today, hands, arms, face, mouth, and throat itchy. Finger tips went numb and ring finger on left hand showed signs of bruising (I didnt hurt it that I know of). By the time I got to urgent care, finger no longer bruised color. Light headed, felt like going to pass out again.
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| 46 | 2021-03-08 | tingling |
20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized ting...
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20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized tingling in her hands and feet and felt like her tongue was a bit swollen. Stated she felt "funny". Also stated that she had a similar reaction after her first dose but states this reaction was more severe.
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| 46 | 2021-03-09 | burning sensation |
Feeling of burning up from the inside out of body. No Fever. Dizzy, light headed,especially when sta...
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Feeling of burning up from the inside out of body. No Fever. Dizzy, light headed,especially when standing. Headache. nauseated
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| 46 | 2021-03-09 | numbness |
pain/swelling under arm on side of vaccine, later felt swollen lymph area in arm pit. occasional num...
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pain/swelling under arm on side of vaccine, later felt swollen lymph area in arm pit. occasional numb sensation down left arm into wrist and fingers.
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| 46 | 2021-03-09 | pain in extremity |
Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing h...
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Within 10 minutes I got very dizzy and nausea and vomiting which lasted over 12 hours. Also racing heart rate then episodes of chills and sweating. The next day I had a hard time holding my tooth brush, pain and swelling to both hands and severe pain in left foot. When I get up from sitting position to walking it feels like my bones in my left foot will shatter. The pain is very bad even in bed when I?m not moving.
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| 46 | 2021-03-09 | pain in extremity |
got vaccine - about a week later - she sent us a message saying "I have been having right calf pain ...
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got vaccine - about a week later - she sent us a message saying "I have been having right calf pain for about a week or more. I have more increased SOB and chest pain." was able to get ddimer which was elevated - and was admitted to the hospital for this since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.
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| 46 | 2021-03-09 | tingling, numbness, hot flush |
The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything...
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The first she had numbness in arm with the injection, hives and tingling in face. Sunday, everything went back to normal. Monday around 3:00 or 3:30, face was hot and had hives. She went to the ER. Was told she had a mild rash, and gave Benadryl and ordered EpiPen for emergency. Left ER to pick up prescription but tongue began to swell, went back to ER, gave you Cortisone 50 mg and Pepcid Benadryl IV for 7 days. Yesterday, had another face reaction, had hives very mild only in the morning. Today at 8:00a.m., had redness in face. Around 3:00pm, lips and tongue were swollen and has extremely dry mouth. Today, she is on her way to the ER because her tongue has swollen again.
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| 46 | 2021-03-09 | tremor, feeling cold |
1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient ...
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1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient anxious. 1030: Red, raised rash noted to begin on forehead, cheeks, and upper chest. Shaking (slightly) noted in hands. Patient states "feeling cold." BP 162/94, P 108, O2 99% RA. Patient A&Ox3 sitting in chair. 1040: Patient complaint of "lips feeling 'tingly'". Quickly progressed to full facial tingling. Denies dyspnea or chest pain. Still states she " feels dizzy." 911 called. BP 142/88, P 95, O2 99% RA. 1045: Turned over to paramedics. Patient A&Ox3. Rash still present but no worse. Denies dyspnea or chest pain. Still shaky, slight diaphoresis. Husband & son with patient. Patients belongings given to husband. Taken by EMS offsite.
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| 46 | 2021-03-10 | face paralysis, facial paralysis |
Pt arrived to ED with CVA like symptoms. Positive F.A.S.T. per EMS with left sided weakness and left...
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Pt arrived to ED with CVA like symptoms. Positive F.A.S.T. per EMS with left sided weakness and left facial droop.
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| 46 | 2021-03-10 | tremor, flushing | flushing of face, shaking of hands. Evaluated by EMS-Cleared |
| 46 | 2021-03-11 | flushing | extreme headache, flush face, flu like symptoms and swollen lymph note under right arm |
| 46 | 2021-03-12 | flushing |
Pt. c/o dizziness and Headache, racing heart and skin flushing while in observation area of vaccina...
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Pt. c/o dizziness and Headache, racing heart and skin flushing while in observation area of vaccination site. Pt. taken to triage area and evaluated by MD. Pt. observed for an additional 30 min and then released to home. 1026- 166/117, Spo2 100%, p 72 1030- 144/105, 72 1032- pt states all symptoms have resolved. 1055- pt. released to home.
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| 46 | 2021-03-13 | involuntary muscle movements |
I felt like my vision was changing and it felt like my pupils were very tiny. I felt a strange press...
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I felt like my vision was changing and it felt like my pupils were very tiny. I felt a strange pressure in the top of my head. Not a typical headache but a weird pressure. I started feeling like I was clenching my teeth and my jaw. That night my arms were very jerky. I wasn?t thinking right. And every day since I feel like I?m tense muscles I?m dizzy I?m just not mentally like I used to be.
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| 46 | 2021-03-13 | tremor | Shaky, chills. evaluated by EMS. refusal to transport. |
| 46 | 2021-03-14 | burning sensation, tenderness |
March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (...
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March 10, 9am, received injection in left arm. Minor headache throughout the day. That afternoon (~3:00pm) noticed itchy neck and face. (Since I had a rash last year from skincare products I just thought it was same thing). March 11, rash worse. Treated with topical 2.5% hydrocortisone ointment. Back of head started feeling tender. March 12, evening, back of head feeling worse, took Ibuprofen. Rash much better on face/neck. Middle of night (March 12), head extremely painful and noticed swollen lymph nodes on back/right side of head. March 13, 8:00am, went to urgent care clinic. Received Cefdinir 300mg antibiotic for unknown infection causing swollen lymph nodes. Rash almost gone. Back of head extremely tender/painful. March 14, swollen lymph nodes multiplied on back of head and also on right side of neck. Saw neighbor anesthesiologist who thought my rash and swollen lymph nodes were caused by the vaccine. March 15, lymph nodes still swollen, but feels more burning/itching like a rash now with occasional throbbing pain. Spreading more in right side of neck, which is sore/tender. Slight rash on neck.
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| 46 | 2021-03-14 | feeling hot |
PT. STATED PRIOR TO VACCINE THAT SHE HAS SEVERE ANXIETY AND GETS VERY ANXIOUS WITH INJECTIONS. PT. P...
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PT. STATED PRIOR TO VACCINE THAT SHE HAS SEVERE ANXIETY AND GETS VERY ANXIOUS WITH INJECTIONS. PT. PLACED ON STRETCHER PRIOR TO INJECTION. FIVE MINUTES AFTER INJECTION PT. C/O BEING HOT , FEELING "WEIRD" DENIED BREATHING DIFFICULTIES. EVALUATED BY EMTS, BP 180/120, HR 96, RR32 O2 SAT 100% ON RA. BP RETAKEN WITH MANUAL CUFF BY EMT REMAINED HIGH. PT. BP FOLLOWED FREQUENTLY OVER 30 MINUTES REMAINED ELEVATED TRANSPORTED TO ER BY AMBULANCE.
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| 46 | 2021-03-14 | numbness |
Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips sw...
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Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips swelling and numbness. Epi pen given. Patient rash and hives continued. patient shaky and nervous. patient denied difficulty breathing. BP elevated. O2 sats stable. IV placed in right AC , IV Benadryl 50mg given IV push. Paramedics on site. Patient transported to ED.
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| 46 | 2021-03-15 | bell's palsy |
Bell's palsy; This is a spontaneous report from a contactable healthcare professional. A 46-year-ol...
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Bell's palsy; This is a spontaneous report from a contactable healthcare professional. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on 01Mar2021. The event was reported to have resulted in emergency room/department or urgent care visit. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the known safety profile of the COVID-19 vaccine, and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported bell's palsy and the suspect administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 46 | 2021-03-15 | breast pain |
25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave ...
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25 min after shot on my left arm Tingling in my mouth through and face swollen feelings. They gave me two Benadryl?s and 4 Pepcid Waited for a hour in a half Symptoms subsided. Around 9 pm I had horrible pain under my arm pit and top of my breast. And fast heartbeat I took two Tylenol and the pain subsided but I am also getting pain in my two lymph nodes on the left side all the time
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| 46 | 2021-03-15 | burning sensation |
Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, c...
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Face burning, severe redness to face, face swelling on the left side, twinge in left side of neck, chills.
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| 46 | 2021-03-15 | pain in extremity |
Got shot on Thursday woke up Friday 2am with achy arm, by 7am full body aches and mild temp of 99.4 ...
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Got shot on Thursday woke up Friday 2am with achy arm, by 7am full body aches and mild temp of 99.4 Friday all day arm ached,small rash developed right of injection site , brainfog, dizziness. Symptoms went away by Saturday Morning just had a achy arm until Sunday. still expierencing Brain fog . Also experienced Brain fog and dizziness with first dose
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| 46 | 2021-03-16 | numbness |
Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizzines...
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Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizziness and confusion, slow words. Uncoordinated hands and legs
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| 46 | 2021-03-16 | pain in extremity, weakness |
Fever increasing throughout the day. Currently 102.8 degrees. Taking Tylenol. No energy to move, ...
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Fever increasing throughout the day. Currently 102.8 degrees. Taking Tylenol. No energy to move, chills, muscle aches, arm pain.
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| 46 | 2021-03-17 | flushing |
Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with sh...
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Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with shellfish allergy. Face and neck area were flushed. Benadryl 50mg IM given in right arm. Pulse at 80 BPM throughout the event, alert and oriented, normal breathing. Benadryl took effect within 5 minutes with person stating she could feel her throat loosening up, and tongue feeling smaller. Requested no epinephrine unless really needed. Does carry and EpiPen with her. Observed for one hour after event pulse 78 BPM at discharged. Advised to take Benadryl every 4 hours as needed and to come to ED with any return of worsening symptoms. Escorted to car where family member will drive her home.
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| 46 | 2021-03-17 | numbness | Throat begin to close, minor reaction. And numbness on left side of body all the way down. |
| 46 | 2021-03-18 | cold sweat |
nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report ...
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nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report from a non-contactable female consumer reported for herself (Non pregnant). A 46-year-old female patient received second dose BNT162B2 (Solution for injection, lot number was EL3246) via left arm on 24Feb2021, 10:30 AM, single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose BNT162B2 (lot number:EL3247) left arm on 03Feb2021, 10:30 AM at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. After second dose vaccination patient experienced headache, nausea, malaise, cold sweats, restlessness, unable to sleep on 24Feb2021 at 08:15 PM. The patient taking treatment 600mg ADVIL taken for all events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-03-18 | numbness, tremor |
Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting to...
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Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting took a nop as the day went on the pain on my R leg got worse; vomiting fainting took a nop as the day went on the pain on my R leg got worse; Symptoms of fatigue; Pain on my R knee; Went to fever 102.2 then; Chills, into the entire night/Shivers and shakes; Headache; Into the morning could not walk on my R leg/Can not walk on either foot; Numbness to my face; Found a cyst on the back of my knee; Shivers and shakes; Damage to my ligaments; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in the left arm on 04Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history was none, and concomitant medications were not reported. The patient was not sure about allergies. The Patient not received other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via intramuscular Left arm on 14Jan2021 04:30 PM at single dose for COVID-19 immunization (at the age of 46-years). The patient stated, "on 12Feb2021 at 03:30 PM, (as reported: one week after the second dose) after the second dose of vaccination. I started having symptoms of fatigue, pain on my R knee, went to fever 102.2 then, chills, into the entire night, headache, into the morning could not walk on my R leg, numbness to my face, vomiting fainting took a nop as the day went on the pain on my R leg got worse. Went to the ER (emergency room) x ray and ultrasound was done, found a cyst on the back of my knee not sure if it was from the shivers and shakes caused damage to my ligaments, 2 hours later my right foot was in a lot of pain, two bumps onto of my L foot lots of pain went back to the ER on Sunday morning (14Feb2021), x ray was done only no broken bones foot was red turned purplish, this started Friday 12th (12Feb2021) and her Monday the 16th Tuesday missed work and still in a lot of pain cannot walk on either foot very far without my boot or crushes." No covid prior vaccination. The patient underwent lab tests and procedures which included post vaccination sars-cov-2 test Nasal Swab: negative on 23Dec2020; body temperature: 102.2 on an unknown date; ultrasound scan and X-ray: cyst on the back of my knee on 12Feb2021, x-ray: no broken bones foot on 14Feb2021. Took the following treatment measures, shot for pain, cortisone shot, naproxen 500. The adverse events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relation, the association between the event syncope and the vaccination with BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-03-18 | muscle spasms |
Severe headache, muscle cramping, aches and general body pain. Started 12 hours after receiving vac...
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Severe headache, muscle cramping, aches and general body pain. Started 12 hours after receiving vaccine and lasted for about 36 hours.
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| 46 | 2021-03-18 | pain in extremity |
On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days la...
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On March 5, I received my first dose of the Covid shot. Later that day, I was fatigued. Six days later, however, sometime early morning on March 12, (I was in and out of sleep because of it), I had pain swallowing my saliva on my left side (also the side of my vaccine in my arm). It was hard to pinpoint but the pain came from somewhere at the back of my throat and my ear. If I had to guess what time it was, it probably was around 1-2am that the pain began. March 12, I went to see my primary care doctor. He checked my ears & didn't see any concern. He saw a little redness at the back of my throat but couldn't definitively say what I had. He thought it was a virus but didn?t discount a reaction to the vaccine (although he said it was unlikely since reactions usually happen within 3 days). He ran no tests and didn't prescribe anything. March 13, I was feeling worse. I suddenly had a fever (101 was the highest it ever got), swollen lymph nodes, a white tongue. I went to the local ER at 9am who said I might have oral thrush but he didn?t sound convinced because my tongue wasn't as white o thick as thrush would present (he said for example that typically when you have thrush, you could scrap it off and it would bleed). He diagnosed me with Thrush and Lymphadenopathy. He prescribed anti-fungus medication Clotrimazole 10 mg Troche, five times a day. On Sunday, March 14, my throat pain got worse (it was constant pain v.s. pain only swallowing) so I called the on-call doc who told me to get tested for Strep. The next day, on March 15, I could swallow easier so my doctor didn't think it was necessary. My lymph nodes were still swollen, I had a bit of a fever, and it was still a bit hard to swallow but I was recovering. I had some lingering ear pain. By March 15 I was much better. Today, March 19, I still have a sensation on my left ear/throat area after swallowing but I am much better. Please note that while the ER doctor thought it was fungal and my primary care doctor thought it was viral, neither were sure/thought it was the vaccine. ** Also please note, this is the second time I am completing this because the system booted me off after 20 min the first time and it was erased. It takes times to complete. Just a thought for future reference, it might be helpful to allow for more time.**
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| 46 | 2021-03-18 | tingling |
Shortly after the injection I had tingling in my left hand which I thought was normal. Now two days ...
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Shortly after the injection I had tingling in my left hand which I thought was normal. Now two days since the injection and I still have tingling in my left hand and fingers.
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| 46 | 2021-03-20 | difficulty speaking |
1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vacc...
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1st shot , tingling lips and itchy tongue, slight swelling of tongue!Started within 5-10 min of vaccine!!Lasted 15 -25min!! 2nd shot- itchy tongue, throat swelling, flemy throat, horse voice,tongue swelling!All happened very quickly, went away within 1-2 hrs! Was very sleepy afterwards and had bad headache!!
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| 46 | 2021-03-20 | numbness |
The shot did not hurt or bleed when administered. As I was walking around the store, I could feel i...
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The shot did not hurt or bleed when administered. As I was walking around the store, I could feel it moving down my arm. It felt numb like how you feel after having dental work. The numbness traveled down my arm to the wrist, then back up the underside of my arm. The numbness and tingling went into my shoulder and then split to travel down the left side of my back. The other split went to my neck then chin. At this point I had spoken to 2 pharmacists and 1 covid question center all of whom gave me the same answer that it was nerves and it was just a pain reaction. This was not pain i was feeling, but numbness where you know you are touching your arm but can't feel it. I knew something was not right.. i know my body. I took a benadryl when the numbness hit my neck and chin. Within 20 of taking benadryl all of the numbness had subsided (at about 3:15ish).
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| 46 | 2021-03-21 | weakness |
10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine receiv...
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10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine received @9:55a in Left Deltoid. BP 100/50, HR 76 and regular. Pt reports this BP being ?a little low for her?. Pt ate breakfast and then had a snack before coming to clinic. She has a distant history of ?getting very sick with the flu vaccine?. Within a few hours of the dose 15 years ago or so, she developed a fever of 103 and had flu symptoms of aching everywhere. The next year they gave her a pediatric dose and she had a similar response and has not had another flu shot since then. She has received allergy shots for more than 10 years and takes OTC allergy meds daily. She took her Zyrtec this am. She spoke with her allergist and received the recommendation to get the Covid vaccine. Her next allergy shots are due next week. She reports feeling fine before and during the injection and then the light-headedness started 5-6 minutes after sitting in the obs area. Site director and pharmacist aware of events. 10:22a Pt drinking water and reports ?feeling strange with swallowing and jaw feels tight?. Pharmacist to pt side and decision made to give 12.5mg of liquid Benadryl. Pt states, ?I wonder how much of this is me being anxious?. 8 oz water consumed and tolerated well. Pt reports ?tongue feels thick? with drinking Benadryl 10:24 pt reports legs feel less weak. 10:29 HR 76, BP 110/70. Husband arrived. Pt reports still feeling the same level of dizzy and throat feeling ?less tight?. 10:38 No change is s/s. Consult with pharmacist-advised giving additional 12.5 mg oral Benadryl. 10:41 Benadryl given and tolerated well. ?I don?t feel great?. Finished second 8 oz bottle of water and third given. Pt reports still feeling the same level of dizzy but has some increased thickness in throat. Improves with drinking cold water. 10:46 Pt reports although throat feels better with water, that her airway still ?feels smaller?. When describing her throat and airway, ?it?s not 100% normal, but better?. 10:50 HR 64, BP 104/64. Pt reports ?dizziness unchanged throughout, legs still feel weak, jaw and tongue feel back to normal, but back of throat still feels tight, but cold water helps but when swallowing, it still feels harder to do?. Reviewed case with pharmacist and site director, recommendation to take pt to ER for further obs. Pt agrees to go. 10:59 Pt transferred safely to wheelchair and escorted to ER. ER RN given report after pt checked in with husband beside her. Recommended to pt that she notify her PCP and Allergist of today?s event and recommended they get a recommendation for receiving the second dose.
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| 46 | 2021-03-21 | feeling hot |
Notes (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: MD at 3/19/2021 9:22 AM Expand AllC...
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Notes (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: MD at 3/19/2021 9:22 AM Expand AllCollapse All 3/18/2021 Subjective female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt became hot and light headed after receiving her shot. She was brought by WC to the bay. She was given water and an ice pack was laid on the back of her neck. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Hot and sweaty: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Musculo negative Previous Reactions: None Objective Vitals Vitals: 03/18/21 1535 03/18/21 1550 BP: 131/67 130/75 Pulse: 84 65 SpO2: 100% 100% Physical Exam Vitals and nursing note reviewed. Constitutional: Appearance: She is well-developed. HENT: Head: Normocephalic and atraumatic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Bowel sounds are normal. Palpations: Abdomen is soft. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: water and ice pack Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt dismissed to go home at 3:57pm with coworker. Electronically Signed 3/18/2021 4:00 PM
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| 46 | 2021-03-21 | tingling |
Patient felt tingling/ heaviness in both arms 10 minutes after receiving the vaccine. On site EMS wa...
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Patient felt tingling/ heaviness in both arms 10 minutes after receiving the vaccine. On site EMS was called vitals BP 135/85 HR 88 100% O2 She was monitered for 20 minutes and released to go home.
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| 46 | 2021-03-21 | tenderness |
Day after injection: Swollen arm around injection site. Day two after injection: After swelling decr...
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Day after injection: Swollen arm around injection site. Day two after injection: After swelling decreased I had swelling under my arm with a knot the size of a golf ball. Very sore and tender to touch.
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| 46 | 2021-03-22 | numbness and pain in extremities, tenderness, flushing |
Bilateral arms flushed blanching red/pink color, most prominently in the proximal extremity. Bilater...
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Bilateral arms flushed blanching red/pink color, most prominently in the proximal extremity. Bilateral dependent peripheral neuropathy in hands and feet. Bilateral ear tenderness.
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| 46 | 2021-03-22 | pain in extremity | Sore arm |
| 46 | 2021-03-22 | pain in extremity |
For about 5 hours my body ached, my legs, knees, back, neck, shoulders ached and were in pain sittin...
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For about 5 hours my body ached, my legs, knees, back, neck, shoulders ached and were in pain sitting, and stiff and in pain when standing. I took 3 x 200 mg Ibuprofen at 5:30. By 10 p.m. My body aches had disappeared but I was extremely fatigued. I am feeling better now.
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| 46 | 2021-03-22 | tingling, bell's palsy | Bell's palsy symptoms. Droopy eye (right) and tingling in the ears. |
| 46 | 2021-03-22 | tingling |
After patient received COVID vaccine and was waiting the required 15 minutes, patient indicated that...
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After patient received COVID vaccine and was waiting the required 15 minutes, patient indicated that they felt a tingling sensation on their left arm that travel upwards as well. They felt their heartbeat a bit fast as well. Blood pressure was taken and it was at 148/92. No other event occurred; patient was able to leave a short time after.
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| 46 | 2021-03-22 | speech disorder |
I had extreme headache and could not focus I got dizzy and fainted and lots consciousness. I ended ...
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I had extreme headache and could not focus I got dizzy and fainted and lots consciousness. I ended up lose muscle control and urinated . Afterwards, I could not speak well. I continued to have massive headaches
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| 46 | 2021-03-23 | burning sensation |
"Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th ...
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"Covid Toes" The toes on my left foot became red, swollen, blistered and Extremely itchy on the 5th day following my first covid vaccine which lasted for approximately 6-7 days. This occurred again one week following my second vaccine (2nd shot 1/29), for approximately 5 days. It has occurred three times since then, all on the Friday anniversary of my getting the shot. The symptoms for the last 3 times lasted only 2 days, and the redness has decreased, but they are still extremely itchy and have now become scaly at the site of where the most severe itching took place. They do burn occasionally at the site of the scales.
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| 46 | 2021-03-23 | feeling hot |
Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight...
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Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight. My heart rate felt like it had jumped and my heart was pounding. I started to feel like it was very hot and I was getting somewhat nauseated and feeling like I might pass out. I checked my smart watch and my heart rate had jumped to over 120. The lady who administered the shot got the EMT on site and they took me for observation. They took my blood pressure and it was 157/114 (which is far beyond the norm for me). They took an EKG on site which they said was not alarming in any way. They checked my blood sugar and it was normal. My oxygen level stayed within a normal range. I had some mild feeling of itching/tingling in my mouth and felt like I had a lump in my throat like a marble. My BP and HR came down some after about 15 minutes but was still high. They called an ambulance and had me go to an ER for further observation since the feeling in my mouth and throat was not resolving and my BP was not coming down to a better range after about 30 minutes. By the time I got to the ER and they monitored me, my BP was still 154/70 and my HR was still in the 80s while at rest. They kept me in observation for long enough for the doctor to feel that I was not in any immediate danger so they discharged me with instructions to return to the ER if things got worse.
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| 46 | 2021-03-23 | flushing |
Symptoms: Nausea + facial flushing. Client assessed and treated by onsite Paramedics. Client cleare...
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Symptoms: Nausea + facial flushing. Client assessed and treated by onsite Paramedics. Client cleared for home at 1:34 pm. Per Paramedics all symptoms resolved, no further evaluation needed.
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| 46 | 2021-03-23 | numbness |
Face partially went numb on left side for about 20 minutes about 10-15 minutes after injection. Numb...
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Face partially went numb on left side for about 20 minutes about 10-15 minutes after injection. Numbness then went away.
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| 46 | 2021-03-23 | muscle spasms |
I was doing my normal morning jog four days after the 1st vac and a few block in I got a sudden, sta...
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I was doing my normal morning jog four days after the 1st vac and a few block in I got a sudden, staggering, lighting-bolt-like headache for about 20 seconds. Nausea. Dizzy. then the headache moved to a painful ache that spread across the back of my head. As that happened, deep in my neck where the spine meets the scull there was a hobbling pain/cramp/spasm. I went to the ER.
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| 46 | 2021-03-23 | tingling, pain in extremity, flushing, weakness |
About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throa...
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About 30 minutes after injection, I felt intense pressure on my upper chest and the base of my throat, and a headache that felt like my head was going to explode. My face felt flushed, tingly and stiff like a mask. When I stepped out of the car, I felt wobbly and weak. I started feeling nauseous, exhausted and just "out of it". I took an ibuprofen and an acetaminophen. The symptoms slowly decreased over the evening and my air was never fully cut off so I didn't go to the Emergency Room. Today (the day after vaccination), the symptoms were much less severe but I felt more lightheadedness, like I'm on a boat, however, that is something that has been an issue for me over the past several months so it might not be vaccine-related. My arm hurts quite a bit today but not debilitatingly so. I also feel alternately chilled and feverish. Although the highest my temperature measured was 98.9 F, my temperature is typically in the 97's so it was definitely elevated.
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| 46 | 2021-03-23 | unresponsive to stimuli |
This was this person's second dose. She had episode of syncope following the first dose that require...
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This was this person's second dose. She had episode of syncope following the first dose that required prolonged monitoring in the EC. Patient was laid down on stretcher prior to vaccine administration. Patient immediately went syncopal following injection and became unresponsive. Breathing remained even and nonlabored with good pulse. Patient remained lying down for about 30 minutes before she sat in a chair for approximately 15 minutes. Attempt to have patient leave but patient became syncopal again in bathroom and needed to be assisted into wheelchair and brought back to observation area where she laid down for another 15 minutes. Patient was alternating back and forth between being alert and unresponsive. Patient was finally able to leave area with mother at 1719. Refused to be transferred to the Emergency Room for evaluation.
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| 46 | 2021-03-24 | burning sensation |
Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thicknes...
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Tingling sensation in tongue within 2 minutes of injection, swelling of tongue to twice the thickness, itchy mouth, and rapid heartrate within 10 minutes, redness, burning, swelling, and itchy skin on face within 15 minutes. Epi-pen given within 14 minutes, and transport to hospital, wheezing in bases of lungs noted by ER physician and diphenhydramine, famotidine, and solumedrol given. Swelling of tongue took 1.5 hours to reduce to half. Overnight stay at hospital, due to severity and duration of symptoms.
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| 46 | 2021-03-24 | feeling hot |
Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot a...
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Follow injection of 1st dose Pfizer, she reports within 1-2 minutes both hands started feeling hot and began swelling. Within 5-10 minutes she developed a rash on hands, face, neck and chest. She notified the staff, who provided ice packs for the swelling and placed her in front of a fan. She was monitored for 45 minutes, then released with inst to call 911 if she developed airway problems. She began developing a mild headache. She drove home and took Benadryl 50 mg by mouth, and repeated the dose every 8 hours x 2 additional doses. She took Tylenol for headache. The headache and swelling resolved in 12 hours, and the rash resolved in 16-18 hours.
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| 46 | 2021-03-24 | migraine, cold extremities |
I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon a...
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I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon after, I started getting a mild headache toward the front of my head which intensified towards my temple area. My eyes felt strained ( the back of my eyes ). The feeling was similar to a migraine/sinus pressure. I started getting cold and then my extremities were freezing. I got chills and was shivering ( it was cold in the building, but I wasn?t that cold upon entering ). This was all in the first 15 minutes. I was told to stay for 30 minutes in the waiting area because of my allergy to erythromycin, just as a precaution. Around 20 minutes my mouth became very dry. I also had a metallic taste in my mouth. It became hard for me to swallow and I had to think to swallow because it wasn?t happening naturally. At that time I alerted someone and asked if these reactions were normal. I was given a 25mg Benadryl and had people continuously check on me. It took some time before I was able to not feel the choking closed feeling from swallowing. Once I was able to swallow it felt as if I had something lodged in the back of my throat. Similar to the feeling of phlegm. I kept having to clear my throat because that phlegm feeling wouldn?t ?wash down?. I felt light headed, but not dizzy. More of a foggy feeling. Once they felt it was safe for me to leave I came home and rested. The headache lessened, I was still cold, but not chilled. Into the evening I was very tired and foggy in thinking.
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| 46 | 2021-03-24 | pain in extremity |
It feels like I have covid again. My main symptom is inflammation or pleurisy around the lungs, but ...
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It feels like I have covid again. My main symptom is inflammation or pleurisy around the lungs, but the tightness has gone up into my airway as of today. Arm is still very sore from shot 8 days later. Doctor put me on pain meds (hydrocodone and gave me a shot to help with inflammation)
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| 46 | 2021-03-24 | tingling, numbness |
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu...
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congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
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| 46 | 2021-03-24 | tingling, pain in extremity |
Hands getting brown spots, like potentially blood; Hands felt achy; Hands tingly; This is a spontane...
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Hands getting brown spots, like potentially blood; Hands felt achy; Hands tingly; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration on 19Feb2021 at 13:00 (at the age of 46-years-old), at single dose for COVID-19 immunisation. Medical history included congestive heart failure (CHF), dilated cardiomyopathy, psoriatic arthritis and airborne allergies. Concomitant medications included carvedilol, sacubitril valsartan sodium hydrate (ENTRESTO), eplerenone and allopurinol. It was reported that on 25Feb2021 patient hands were getting brown spots, looked like potentially blood. Hands felt achy and tingly. Spots went away in a day then came back. They first appeared on day 6 post vaccine and occurred on day 6, 7 then not again until day 16 but it's the worst at time of reporting. Started on 1 finger, at the time of reporting on several and palm. Mostly occurring on left hand, same arm as shot. The patient did not receive treatment for events. The events were not recovered.
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| 46 | 2021-03-24 | tingling |
Foot Tingling like vibrating. Felt like a vibrating cell phone under right foot. Lasted for almost 4...
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Foot Tingling like vibrating. Felt like a vibrating cell phone under right foot. Lasted for almost 48 hours after shot. Slight throat scratchiness and tight chest and asthma flair up.
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| 46 | 2021-03-25 | tingling |
Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusi...
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Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusion, tingling, swelling lymph nodes, body ache, headache.
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| 46 | 2021-03-26 | migraine | High fever, extreme bodyaches, migraine headache and nausea |
| 46 | 2021-03-26 | night sweats |
Muscle aches, red face, chills, night sweat, headache, fever from 7:00 3/23 to 12:00 pm 3/25. Symp...
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Muscle aches, red face, chills, night sweat, headache, fever from 7:00 3/23 to 12:00 pm 3/25. Symptoms stopped as suddenly as they appeared.
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| 46 | 2021-03-26 | tingling | Tingling of left hand. Resolved in 20 minutes. |
| 46 | 2021-03-27 | hot flush | heart racing, palpitations, shortness of breath, hot flashes |
| 46 | 2021-03-27 | pain in extremity, feeling cold |
5.5 hours after the sore arm. Next morning I was cold but about noon chills started till 7pm with ex...
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5.5 hours after the sore arm. Next morning I was cold but about noon chills started till 7pm with extreme exhaustion.
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| 46 | 2021-03-27 | tingling |
Immediate tingling sensation on left side of face, mainly around the mouth area. As days continue, ...
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Immediate tingling sensation on left side of face, mainly around the mouth area. As days continue, still tingling sensation around the mouth, and fatigue. The fatigue never went away.
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| 46 | 2021-03-28 | bell's palsy |
facial drooping/Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 4...
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facial drooping/Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received dose number 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206) via an unspecified route of administration, administered in the left arm, on 11Mar2021 08:15 AM at a single dose for COVID-19 immunisation. Medical history included diabetes, thyroid, and hernia. The patient had no known allergies. Concomitant medication(s) included metformin hydrochloride (METFORMIN ER); levothyroxine; and omeprazole. The patient had no other vaccine in four weeks. On 12Mar2021 at 2AM, the patient woke up and had facial drooping; went to the ER and was admitted for possible stroke. It was further clarified that it was not a stroke but she has Bell's palsy. The adverse event (AE) resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization (duration for 1 day, from 12Mar2021 to 13Mar2021). AE treatment included medicine, methylprednisolone, valacyclovir, eyedrop. The patient had no COVID prior to vaccination. The patient underwent lab tests which included COVID test type post vaccination (nasal swab, rapid test): negative on 12Mar2021 (COVID tested post vaccination). The outcome of the event was not recovered.
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| 46 | 2021-03-28 | feeling cold |
The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost pass...
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The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost passed out; tired; nausea; headache; almost passed out; Hypertension/BP 155/103; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, expiry date not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at a single dose for COVID-19 immunisation. Medical history included interstitial cystitis and endometriosis, known allergies to milk and sulfa, have had a complete hysterectomy, and patient was getting hormone injections. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior to vaccination. Concomitant medications were unspecified; it was reported that patient had other medications in two weeks. The patient previously took ibuprofen and experienced known allergies; and had first dose of bnt162b2 for covid-19 immunisation on an unknown date. The patient had no other vaccine in four weeks. The second day after injection (06Mar2021), temperature dropped to 93.7, BP 155/103, and patient was very cold. Patient was dizzy, almost passed out (Mar2021). Patient temp ran from 97 to 98 and was able to get temp up to 95 (2021) but it's been there and dropping to 94.9 since 06Mar2021. Patient did have hypertension BP but take meds for it (Mar2021). Patient was also very tired, nausea and headache on and off (Mar2021). But all those have been reported. It's not normal for the patient to be cold because patient have had a complete hysterectomy and was getting hormone injections. Therapeutic measures were taken as a result of the event hypertension. No treatment received for the other events reported. The patient was not tested for covid post vaccination. The outcome of the events was not recovered.
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| 46 | 2021-03-28 | numbness, tingling, burning sensation |
Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resul...
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Burning, tingling, numbness on left arm, shoulder, face. Most symptoms resolved in 36 hours. Resulted in sinus disease left maxillary sinus and swollen lymph glands in neck
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| 46 | 2021-03-30 | cold sweat, weakness |
felt very faint and weak; chills/shivers; cold sweating; felt very faint and weak; extreme lethargy;...
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felt very faint and weak; chills/shivers; cold sweating; felt very faint and weak; extreme lethargy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 17Mar2021 10:45 (Lot Number: EL3247) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medication was reported as none. The patient previously had BNT162B2 first dose lot number: EL3247 on 24Feb2021 10:00 AM, in left arm for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Mar2021 20:30, the patient experienced chills, shivers, cold sweating, felt very faint and weak and extreme lethargy. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date.
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| 46 | 2021-03-30 | feeling hot, tingling, numbness, facial paralysis |
3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bla...
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3/22 When administered shot body felt a little warm 3/24 Burning pain like a yeast infection or bladder infection. Treated at urgent care for a yeast infection 3/25 Woke up with a fever and a rash on my back and chest 3/27 Right side of face was droopy 3/28 Right side of face felt numb, more swollen, droopy, and tingly went to the doctor immediately as worried about Bell's Palsy or worse case a stroke
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| 46 | 2021-04-03 | flushing, tingling, discomfort, slurring |
She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. S...
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She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. She ended up getting a cardiac catheterization while she was there which was normal. The day prior to this she had actually received her second Covid vaccination in her left arm. She noticed achiness and soreness across her shoulders bilaterally into her chest and into her neck. She had some subjective fevers and chills and felt generally fatigued. She also had a lot of swelling in her left axilla and she ended up getting a CT scan during her workup which revealed some left axillary adenopathy. She returned to the ER on 3/16: while brushing her teeth, she developed right facial paresthesias that marched over approximately 20 minutes to involve the right arm and the right leg. She went to the hospital. She was seen in the ER. They felt this represented possible ischemia. They gave her tPA. She had a hemorrhagic nosebleed. Did not develop any other signs of bleeding. Her symptoms had not resolved. She was discharged from home. She had a headache at the time of her visit to the ER. Her headache had resolved by the time she was discharged home, but she continues to note paresthesias in the right side of her body, right face, and notes over the last day or 2, she has had increased dysarthria, dizziness and slurred speech, brain fog, a sensation of heaviness and inability to think. She states she currently does not have head pain per se, but she does note that she just feels generally poorly. She feels like her brain is working faster than her mouth muscles are. She is in today for neurologic followup, concerned about these ongoing issues. she continues to struggle with her speech feeling quite slow and deliberate, she feels like it is difficult for her to concentrate, she is forgetful, she still has intermittent episodes of paresthesias in her face, arm, and hand, she feels like she becomes heart and flushed and she has some heart rate variability with her heart going slow and fast, and she has significant disequilibrium. She is extremely fatigued where she is only able to get up for 1-2 hours before she is extremely fatigued and has to go back to bed.
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| 46 | 2021-04-06 | pain in extremity, bell's palsy, numbness |
Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side o...
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Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side of face; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 18Mar2021 13:00 (at the age of 46-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health clinic facility. No other vaccine in four weeks. The patient received the first dose of bnt162b2 (lot not reported) in left arm on 24Feb2021 at 14:00 (at the age of 46-years-old) for COVID-19 immunization. Medical history included known allergies: Sulfa. The patient's concomitant medications were not reported. The patient did not have covid prior vaccination and was covid tested post vaccination by nasal swab on 03Mar2021 with result of negative. The adverse events were swelling in head, headache, dizzy, sore arm, numbness left side of face and Bells palsy, all on 19Mar2021 at 01:00. On day 4, went to hospital no stroke or heart attack was told swelling from vaccine. The events were reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. Treatment for the events included pain meds, nausea meds. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-04-07 | unresponsive to stimuli, difficulty speaking, seizure |
post vaccine observation session, patient complained of throat tightness/trouble swallowing and voic...
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post vaccine observation session, patient complained of throat tightness/trouble swallowing and voice became raspy. patient has multiple reported allergies and carries epipen. Received 2 doses of epi IM and one dose Benadryl prior to arrival in EC, for throat and tongue swelling again. At triage, sleepy, on transfer to floor became unresponsive and noted to be seizing (received 3 doses ativan) with no resolution, subsequently intubated for airway protection and transferred to ICU.
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| 46 | 2021-04-10 | burning sensation, tingling, pain in extremity |
7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the nig...
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7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the night, it wouldn?t go away,, with pins and needles itching all day. Then again the following night (last night) my feet burned all night. In hindsight, I had had a very bad reaction after the second shot on 4/2 that started the night of the shot, when I woke up at 3 am feeling like my feet, legs and entire body was burning, then Saturday I had a high fever all day, 103.8, chills, burning sensation on and off, chest pain, heart pain, which I treated first with Tylenol then Motrin. It was a horrible two nights, but by Sunday 4/4 I was fine. I have been fatigued all week but didn?t think much about it. Then Friday night into Saturday of exactly a week after the second shot, this has happened. The burning sensation on my feet is intolerable and I haven?t slept for two nights.
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| 46 | 2021-04-12 | burning sensation, numbness, tingling |
Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left...
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Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; This is a spontaneous report from a contactable health care professional and consumer. A 46-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP7533 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 25Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes type 2, hypertension. The concomitant medications included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. The patient did not have any allergies to medications, food or other products. The patient previously received first dose of BNT162B2 (lot number EN6204; 46-year-old) on 04Mar2021 09:00, at Left arm. The patient received within 2 weeks of vaccination included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. On 25Mar2021 at 09:15 on same day (as reported), the patient experienced burning, tingling, and numbness on left arm, shoulder and face. Patient went to emergency room/department or urgent care due to event. The patient was treated with oral steroid. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 25Mar2021, Test Name: COVID-19 PCR, Test type: Nasal Swab, result was Negative. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
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| 46 | 2021-04-12 | difficulty speaking, numbness and pain in extremities |
skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla...
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skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-04-12 | feeling hot |
overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This i...
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overwhelming since of hotness; Dizziness; broke out in a rash everywhere; heart rate went up; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself that a 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot no: EP7534, Expire Date: 31Jul2021), 0.3ml intramuscular injection in left deltoid as a single dose for covid 19 immunisation on 26Mar2021 at 1:00PM. The patient medical history included blood pressure, migraine. The patient concomitant medication included Amitriptyline 100mg once a day for Blood pressure, Amlodipine Besilate at 5mg every day for Migraine, Sumatriptan (Sumatriptan)100mg as needed for Migraine. The patient received the first dose of Pfizer COVID19 vaccine on 26Mar2021 and had an immediate reaction. She needed 50mg of Benadryl, within 15 seconds of the vaccine. she had an overwhelming since of hotness and did not last very long, maybe 3 seconds and It washed over her. The feeling like she was going to pass out came after the overwhelming since of hotness. They put her feet up and put on nasal cannula with 2L of oxygen. The feeling like she was going to pass out came and went with the dizziness. She was dizzy on and off for 30 minutes. The rash started immediately, and It went away about 5 o'clock that evening and the Heart rate went up: it was 122 beats per minutes on 26Mar2021. It came down back to normal within an hour. All the events were assessed as medically significant. The outcome of felt like she was going to pass out, overwhelming since of hotness, Dizziness, broke out in a rash and heart rate went up was recovered on 26Mar2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-04-12 | numbness, tingling |
she had numbness and tingling on the left side of the face, then her left arm; she was tired and sle...
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she had numbness and tingling on the left side of the face, then her left arm; she was tired and sleepy; she was tired and sleepy; she felt a bit tingling in her right ankle; tingling on the left side of the face; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 subcutaneous, administered in left arm on 27Mar2021 09:15 (Lot Number: EP6955) as single dose for covid-19 immunisation at age 46 years old. Medical history was not reported. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified medications received within 2 weeks of vaccination. No other vaccines received within 4 weeks prior to COVID vaccine. The patient got the vaccine Saturday 27Mar2021, she felt a bit tingling in her right ankle in the evening. On Sunday, 28Mar2021, she was tired and sleepy. On Monday, 29Mar2021, around 10:00 she had numbness and tingling on the left side of the face, then her left arm. She called her primary care doctor and she was directed to go to urgent care. She went to urgent care and the doctor sent her to the emergency room then she was admitted to the hospital. Multiple tests were done, CT-Scan, MRI, echo results came back negative and everything looked fine. She was discharged from the hospital Tuesday 30Mar2021. The patient was tested for COVID (nasal swab) post vaccination on 29Mar2021 with negative result. The patient recovered from the events. Information on the batch number has been requested.
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| 46 | 2021-04-12 | night sweats |
DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at...
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DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at ER
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| 46 | 2021-04-14 | numbness, tingling |
Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face...
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Slight itching began within minutes, but it was minor. Itching was mid way down left arm and in face? chin area. Within 39 minutes, left side of face was numb with tingling sensation and lips were fully numb and tingly. Tongue felt swollen and itchy, as well. Symptoms lasted several hours. It is now more than a week later and there is still slight numbness in lips and on left side of face. No visible changes have been noticed, just the sensation of numbness as of given Novocain at the dentist.
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| 46 | 2021-04-15 | cold sweat, slurring, cold extremities |
Pt c/o of light headedness while in observation. Pt had slurred speech, skin was cold and clammy, an...
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Pt c/o of light headedness while in observation. Pt had slurred speech, skin was cold and clammy, and pt had intermittent loss of consciousness. Maintained pt in a comfortable position until EMS arrived. BP 193/130, HR 124, O2 99%, RR 14.
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| 46 | 2021-04-20 | tremor, weakness |
passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy o...
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passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy out; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 46-years-old, administered in Arm Left on 01Apr2021 13:30 (Lot Number: ER8734) as single dose for COVID-19 immunization. Medical history included ongoing High Blood Pressure, hyperthyroidism from 28Mar2021 and ongoing, allergy to Cheese and penicillin. Everyone in her family has done fine with the vaccine except her. Concomitant medications included thiamazole (METHIMAZOLE) taken for hyperthyroidism from 28Mar2021 and ongoing; atenolol, chlortalidone (ATENOLOL AND CHLORTHALIDONE) taken for hypertension from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing. On Thursday 01Apr2021, the patient had her first shot and she stayed for 30 minutes. After she was allowed to leave, she passed out and went completely unconscious and she was rushed to the ER. She sat for the 30 minutes, then got to her car and it took 10 minutes to get to department store and with in 7 minutes of being at department store she started feeling nauseous then came the fatigue and she felt nauseous and felt like she was going to pass out so she sat down, she didn't know what was going on. It started with her feeling nauseous and then she started to feel weak like someone sucked all her energy out. She states in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills. The EMS took her to the ER. The adverse events occurred on 01Apr2021 14:30 (as reported). The ER let her go home Thursday night. They gave her an IV and did lab work and the lab work came back fine. It was a combination of her meds and the vaccine or it was just the vaccine. Her primary doctor said it was the vaccine. She is scheduled 22Apr2021 for her second one and she is calling to see if there is any advice or anything she needed to do for the second shot. Her doctor told her that when she takes it, she needs to be close to the ER so a doctor can monitor her. Treatment for events included IV fluids to help from being dehydrated and throwing up, Emergency Room, possibly Benadryl. The events required a visit to Emergency Room on 01Apr2021 and to the Physician Office on 05Apr2021. The outcome of the events passed out and went completely unconscious and felt weak like someone sucked all her energy out was recovered on 02Apr2021 while for the rest of the events was recovered on 01Apr2021. The events were considered as serious (medically significant). No Prior Vaccinations (within 4 weeks), no adverse events following prior vaccinations. Information on Lot/Batch number was available. Additional information has been requested.
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| 46 | 2021-04-21 | numbness, tingling |
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue l...
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: numbness under tongue left side, jaw left side, forhead left side novacaine like feeeling-Medium, Additional Details: left side under tongue numb, left jaw numb, forhead numb decreased with administration of benadryl butr did not go away 1.5 hors post shot. pt states feels like when she gets novacaine at dentist..tingly as well\r\n
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| 46 | 2021-04-24 | weakness |
fainted/fainting; felt weak and dizzy/weakness; felt weak and dizzy/dizziness; blood pressure was ve...
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fainted/fainting; felt weak and dizzy/weakness; felt weak and dizzy/dizziness; blood pressure was very high; fast heartbeat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via an unspecified route of administration, administered in arm left on 27Mar2021 18:15 (at the age of 46-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. No other medication in two weeks. No other vaccine in four weeks. On 27Mar2021 18:45, the patient felt weak and dizzy a few minutes after getting the vaccine and then she fainted. The paramedics took her to the ambulance to check her vitals. EKG, blood sugar and blood oxygen was good, but her blood pressure was very high. Clinical course details was reported as she received the first dose of the Pfizer COVID vaccine on 27Mar2021 and she experienced fainting, dizziness, weakness and a fast heartbeat. The patient would like to know if fainting was considered an allergic reaction. The patient would like to know if she should receive the second dose of the vaccine. She received the 1st dose last 27Mar2021 and 2nd dose will be on 17Apr2021. The reported events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the events. The outcome of the events was recovering. The patient did not covid tested post vaccination.
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| 46 | 2021-04-24 | pain in extremity |
mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm...
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mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm soreness and swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 17:10 (Lot Number: EN6199) as single dose on left arm for covid-19 immunization. The patient medical history included COVID-19. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause from 2019 and ongoing. The patient left arm became swollen and sore after first dose on 10Mar2021, mass on left side of thyroid on 11Mar2021, sore throat on 11Mar2021. There was no treatment received for the adverse event. The patient did not received any other medications within 2 weeks of vaccination. There was no vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT/CAT Scan on 03Apr2021: a mass on her left thyroid, 40x36x31mm and it is definitely deviating her trachea. Caller stated that she is going to the doctor tomorrow to try to get a biopsy of this mass. The outcome of event mass on left side of thyroid was not recovered, the event left arm became swollen and sore outcome was recovered on 13 Mar 2021, sore throat was unknown. No follow-up attempts are needed. No further information is expected.
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| 46 | 2021-04-24 | pain in extremity |
severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones ...
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severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones in my leg/comes on instantly with various movements; severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones in my leg/comes on instantly with various movements; severe pain in my right leg from mid thigh to lower ankle- feels like someone is crushing the bones in my leg/comes on instantly with various movements; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 04Apr2021 15:00 (Lot Number: ER8730) as a single dose for covid-19 immunisation. Medical history included major depressive disorder and (CVID) common variable immunodeficiency. The patient has no known allergies. The patient was not diagnosed with Covid-19 prior to vaccinationThe patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) on 14Mar2021 at 15:00 (lot number: EN6202) in the left arm at vaccination age 46-year-old for covid-19 immunization. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), valacyclovir [valaciclovir] (VALACYCLOVIR), cyanocobalamin (B-12), and gam; all indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient received the vaccine in a pharmacy or drug store. It was reported that 6 days later (05Apr2021 10:30 AM), she had severe pain in her right leg from mid-thigh to lower ankle. She feels like someone is crushing the bones in her leg (comes on instantly with various movements), has 9-10 on a pain scale of 0-10 and 98% of time can no longer bend her leg when sitting on ground or pain is unbearable. The adverse event resulted in emergency room/department or urgent care for the disability or permanent damage. The events received treatment which included wrapped knee and was referred to an orthopedic doctor. The patient has not been tested post vaccination. The outcome of the events was not recovered.
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| 46 | 2021-04-25 | muscle spasms |
2 days after 2nd dose, experienced sever, intense cramps, and profuse menstrual bleeding. only one w...
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2 days after 2nd dose, experienced sever, intense cramps, and profuse menstrual bleeding. only one week after my normal cycle had stopped. day 1 was unusually heavy, day 2 was extremely heavy the whole day and night. days 3 and 4 and 5 were heavy, but not as painful. the bleeding seems to have finally subsided now, day 9. my normal cycle usually only lasts a few days and is very light, rarely painful or with cramping.
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| 46 | 2021-04-26 | pain in extremity |
Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the ho...
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Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later, the patient went to the hospital and was diagnosed with a blood clot/DVT. AE resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events: Vitals taken, blood work, prescribed blood thinner. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date ae treatment= Vitals taken, blood work , investigation: blood clot/dvt on 08Apr2021 3 days later I went to the hospital and was diagnosed with a blood clot/DVT, investigation: unknown result on an unspecified date ae treatment= Vitals taken, blood work. The outcome of the event was recovering. The patient does not have COVID prior vaccination, and was not COVID tested post vaccination. The patient has no known allergies.
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| 46 | 2021-04-26 | pain in extremity |
Fever 102; very fatigued; Headache; left arm pain; increased nasal congestion; This is a spontaneous...
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Fever 102; very fatigued; Headache; left arm pain; increased nasal congestion; This is a spontaneous report from a contactable consumer (Patient herself). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Formulation: Solution for injection via an unspecified route of administration in the left arm on 17Feb2021 09:00 (Batch/Lot Number: EN 5318) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM; famotidine (PEPCID [FAMOTIDINE]); beclometasone dipropionate (QNASL); magnesium (MG [MAGNESIUM]); amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (JUICE PLUS); ergocalciferol (VIT D). The patient previously took BNT162b2 for covid-19 immunisation, anaprox and experienced drug hypersensitivity. On 17Feb2021 17:00 patient experienced fever 102, very fatigued, headache, left arm pain, increased nasal congestion. Patient perform lab tests which included body temperature: 102. The patient not tested for COVID-19 prior to vaccination and post vaccination. The patient did not receive treatment. The outcome of the events was not recovered.
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| 46 | 2021-04-27 | depressed level of consciousness |
Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; ...
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Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; This is a spontaneous report from a contactable consumer via Program. The 46-years-old female consumer (patient) received BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown,) on 19Mar2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. The other medication included XELJANZ XR TAB 11MG since 28Jul2020. Patient reported that she had an anaphylactic reaction to her first Pfizer COVID-19 vaccine on 19Mar2021. Since this reaction she has had a lot of brain fog and diarrhea, that was not happening before the reaction. Patient also said that her hip pain has gotten progressively worse and affecting her ability to dress herself. Further patient explained she will miss 2 doses of Xeljanz before she receives the medication on 15Apr2021. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 46 | 2021-04-27 | pain in extremity | Left arm pain to the point of unable to use it |
| 46 | 2021-04-28 | speech disorder, inability to speak, migraine |
Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensi...
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Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 46 | 2021-04-30 | muscle spasms, numbness and pain in extremities |
Experiencing neuropathy in both feet/legs/hands; intense cramping in both calves; nausea; This is a ...
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Experiencing neuropathy in both feet/legs/hands; intense cramping in both calves; nausea; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 19Mar2021 17:30 (Batch/Lot Number: ep75534) as single dose for covid-19 immunization. Medical history included cancer survivor from an unknown date and unknown if ongoing , chemotherapy from 2017 to an unknown date, known allergies: penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced experiencing neuropathy in both feet/legs/hands, intense cramping in both calves and nausea for past 4 weeks on 20Mar2021. No treatment was received for the events. The patient did not recover from the events.
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| 46 | 2021-05-04 | muscle spasms, pain in extremity, tremor, muscle twitching, tingling |
12 hrs after vaccine I was awaken by stabbing pain in my right thigh and chest pain. Pain lasted ab...
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12 hrs after vaccine I was awaken by stabbing pain in my right thigh and chest pain. Pain lasted about 5 min, after which my muscles started rapidly twitching all over body. Muscles are twitching every few seconds, I am having multiple muscle cramps at random times, sharp intermittent pain all over body. I started having frequent tremors in my hands, muscles feel strained and it is difficult to walk or perform on the piano (my job). 2 days ago I started experiencing constant pins and needles all over my body. My pulse is in the 80s (normally in the 60s), I feel frequent heart palpitations.
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| 46 | 2021-05-04 | tremor |
Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency...
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Throwing up; nausea; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move; tremor increased; post COVID syndrome & orthostatic hypertension.; post COVID syndrome & orthostatic hypertension.; Lymph node pain; Tilt Table Testing confirmed Covid-induced POTS; mild injection site pain; COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain); COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain).; chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID; dizzy; Fatigue; vasovagal response; Passed out; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:30 (Lot Number: EL9261) (at the age of 46-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included infectious mononucleosis (Recent mono) in 2020 (Spring), urinary tract infection (UTI) in 2020 (Summer), venous Insufficiency on Dec2020, shingles in past on an unspecified date, lactose & gluten intolerance from an unknown date and unknown if ongoing, COVID-19 from Jun2020 to an unknown date (I had recovered from mild COVID in Jun and Oct2020 that required no hospitalization and was managed with DAYQUIL, XYZAL, Prednisone, Vit D and melatonin). Concomitant medications included ibuprofen at 2400 mg and 800 mg; pregabalin (LYRICA); progesterone; bifidobacterium bifidum/bifidobacterium lactis/bifidobacterium longum/lactobacillus acidophilus/lactobacillus rhamnosus (PROBIOTIC), all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient experienced mild injection site pain, COVID symptoms in same order as the Oct2020 COVID (upper respiratory, less intense headache, shortness of breath, chest pain), dizzy, fatigue, vasovagal response, passed out, nausea, throwing up, tremor increased, chest pain & tightness to the point I could not move my arm to use my emergency inhaler prescribed after COVID/ I couldn't move, post COVID syndrome and orthostatic hypertension, tilt table testing confirmed COVID-induced POTS (postural orthostatic tachycardia syndrome) and lymph node pain, all on 05Feb2021 at 11:00. All events were serious disabling and required hospitalization. The patient underwent lab tests and procedures which included computerized tomogram (CT): unknown results on an unspecified date, D-dimer: 1300 is very elevated, it shows that I have a lot of inflammation in my body or I could have the clot, 1300, almost 3 times the normal value; magnetic resonance imaging head (MRI): unknown results on an unspecified date, SARS-COV-2 test (nasal swab): negative on 19Feb2021, tilt table test: COVID-induced pots on 05Feb2021 . Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the event passed out was unknown and not recovered for all the other events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-05-10 | hot flush |
had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills;...
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had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
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| 47 | 2020-12-31 | facial paralysis, numbness |
Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then ...
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Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then yesterday 12/31 at 330pm while painting my left face became paralyzed and numb. Went to ER Had CT/CTA of head EKG, chest Xray and multiple labs including Lyme test which will not be resulted for 5-7 days. ER started me on taper prednisone and doxycycline. Diagnose with significant Bell's Palsy
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| 47 | 2020-12-31 | tenderness |
Left side area of spleen, splenomagaly to palpation. Dull ache, increased pain on inspiration, sharp...
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Left side area of spleen, splenomagaly to palpation. Dull ache, increased pain on inspiration, sharp pain to palpation.
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| 47 | 2021-01-02 | weakness | dizziness weakness headache neck pain |
| 47 | 2021-01-03 | inability to speak |
Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breat...
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Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breathing got worse, called 911, 1 Epipen given, she started to cough and talk to us, then couldn't breathe again, couldn't talk, paramedics arrived.
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| 47 | 2021-01-03 | depressed level of consciousness |
12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out m...
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12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return
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| 47 | 2021-01-03 | flushing | EE presented to EH with c/o hives to face and racing heart rate at 1445 |
| 47 | 2021-01-03 | pain in extremity, migraine |
Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise ar...
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Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise arm without significant pain), left wrist pain
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| 47 | 2021-01-03 | pain in extremity, tingling |
Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilate...
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Initial 36 hours sore at injection site Day #4 pain in hip joints and moderate aching in legs bilaterally Day #5 prickling needles feeling soles of feet bilaterally and palms of hands for short time. Palms have resolved. Soles of feet remain on Day #6.
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| 47 | 2021-01-04 | weakness |
Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip p...
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Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.
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| 47 | 2021-01-04 | feeling cold | Felt tired and cold Fever |
| 47 | 2021-01-04 | flushing | high heart rate, blotchy/flushed skin, urticaria |
| 47 | 2021-01-04 | flushing |
Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light hea...
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Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light headed. She was alert and oriented x 3. V/S: 120/72; pulse 140; resp 22; O2 sat 99% on RA; pupils equal and reactive; skin pink. Dr was notified and assessed the employee. Dr. ordered Benadryl 25mg PO which was administered at 1050. 1120 - o2 sat was 98% on RA; pulse 85; employee reported that chest tightness resolved and light headedness impoved, but not resolved; she continued to be flushed. Symptoms continud to improve. Employee remained in the observation area and was instructed to seek emergency treatment if symptoms returned, worsen or new symptoms occured. She verbalized understanding.
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| 47 | 2021-01-04 | numbness |
Right facial numbness; This is a spontaneous report from a contactable other healthcare professional...
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Right facial numbness; This is a spontaneous report from a contactable other healthcare professional. A 48-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration on 16Dec2020, 18:00 at single dose (dose 1, reported as right arm, and also reported as left arm) for COVID-19 immunization. Medical history included DM, hypothyroid, and HTN from an unspecified date. The patient's concomitant medications were not reported. No other vaccines were given in four weeks. Patient has no COVID prior vaccination and did not undergo COVID testing post vaccination. The patient has no known allergies. The patient experienced right facial numbness on 16Dec2020 19:00, also reported as 50 minutes after receiving the vaccine. She was instructed to take one dose of BENADRYL as treatment. It was reported that numbness last for about 2.5 hours. Outcome of the event was recovered on 16Dec2020. The event was reported as non-serious.
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| 47 | 2021-01-04 | pain in extremity |
12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled musc...
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12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled muscle from my neck all the way down arm. This went on for 4 days. The pain woke me up at night for 2 nights. Just took Ibuprofen. This pain has resolved. 12/29 - body aches, chills, joint pain, fatigue, SOB on exertion, runny nose, and sneezing. These symptoms went on for 5 days. Mostly resolved - still some fatigue and SOB on exertion, runny nose, and sneezing. Again, treated with ibuprofen and rest. 1/31 - Extreme nausea, aggitatation, and fatigue. Took Zofran and went to bed at 7pm and slept until 9am. Felt much better. 1/2 - Completed a virtual visit. Advised to come in to clinic for covid test only. Not seen by physician. Negative results, and no F/U from a provider. 1/5 - All symptoms resolved except some fatigue and SOB on exertion, runny nose, and sneezing.
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| 47 | 2021-01-04 | pain in extremity |
All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My ...
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All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My left arm started swelling, it started in fore arm and it started getting marks on it; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in her right arm on 21Dec2020 at single dose for covid-19 immunization. Medical history included Blood pressure high, Attention deficit hyperactivity disorder (ADD), depression and cancer four years ago and she didn't have any left node in left arm. Concomitant medications included losartan (LOSARTAN) for Blood pressure high, venlafaxine hydrochloride (EFFEXOR) as antidepressant, tamoxifen (TAMOXIFEN) for her cancer and it was hormone blocker, lisdexamfetamine mesilate (VYVANSE) for ADD. The patient received the vaccine last this last Monday on 21Dec2020, in her right arm, she was fine, on Thursday on 24Dec2020 like all of sudden she started feeling bad, she mean it just hit her. She had fever, she was very nauseous and her arm, her left arm started swelling, it started in forearm and it started getting marks on it. Anyway she went go and got tested for Covid yesterday 26Dec2020 because in middle of night, that night I felt so bad. She have got just headache on 24Dec2020, its most of that before then. Anyways she had just got her results back that was negative but so she didn't know that her arm, it was the opposite arm. The patient still experiencing pain in arm, she haven't had fever in last night and she haven't checked it today. She took Tylenol and she called her doctor yesterday and they made of me some antibiotics for her arms, probably the 7mg and the patient guess it is every 8 hours. The outcome of the event pain in arm was not recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-04 | tingling, feeling hot, flushing |
At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, f...
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At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, face flushed and warm. Resolved without intervention. No other side effects except muscle soreness to this arm. ( Wouldn't report but a coworker had a similar but more severe reaction and is still having effects 3 wks out)
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| 47 | 2021-01-04 | tingling |
Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. P...
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Pt reported itchiness and tingling on her neck and back around 20 minutes after receiving vaccine. Pt given 25 mg of diphenhydramine tab, and she refused 2nd diphenhydramine tab. Pt reported cessation of itchiness and tingling 20 minutes after receiving diphenhydramine.
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| 47 | 2021-01-05 | weakness, tingling |
Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous ...
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Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC1284), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue, tingling in arm that was vaccine was given, fever, and weakness on 30Dec2020. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 47 | 2021-01-05 | weakness | Chills, fever, general weakness & fatigue, sweating |
| 47 | 2021-01-05 | feeling hot, tingling, flushing |
Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain...
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Chest tightness, flushing, arm tingling, lip swelling, warmth No shortness or breath, no chest pain, no palpitations, no tongue swelling, no rash, no redness, no nausea, vomiting or lightheadedness, no diaphoresis, no Hives improved in 1 hour and with Benadryl
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| 47 | 2021-01-05 | tingling |
Patient states that about 5 minutes after vaccine they felt "pins and needles" sensation in their le...
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Patient states that about 5 minutes after vaccine they felt "pins and needles" sensation in their left arm and hand. Covid vaccine was given in left deltoid. Patient waited 30 minutes after vaccination with no new symptoms. Patient denies the need for any further medical attention. Patient left with a companion.
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| 47 | 2021-01-06 | flushing, feeling hot | Dizziness, UrticariaPruritus, HYPERtension, facial flushing, face felt warm |
| 47 | 2021-01-06 | flushing |
Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 ...
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Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.
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| 47 | 2021-01-06 | tingling |
Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins a...
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Roughly 9 days after first vaccine, noticed your right hand middle finger became purple, with pins and needs sensation. This was followed by some swelling. Improved over 24 hours. Still feeling "tight" in knuckles.
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| 47 | 2021-01-06 | tremor | Shaking chills, myalgia and bone pain |
| 47 | 2021-01-07 | burning sensation |
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h...
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dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | difficulty speaking |
After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER...
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After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER gave me Steroids and Pepcid. Since then I have taken Benadryl. On 12/30 at 10am I was exp reaction again went back to the ER. They provided me with breathing treatment and was sent home on Prednisone. I contacted my PCP to inform her that I have to continue taking Benadryl to help with sob and my voice changes. It seems like my lungs are affected due to taking the vaccine. I'm currently off and not able to receive comp due to the vaccine being voluntary.
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| 47 | 2021-01-07 | feeling hot |
Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I r...
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Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I received a rash over the arm in which I had the injection. Since the shot Monday, I have continued to have redness on neck and face and along with felling hot. I have been taking Benadryl since Monday and finally went to UC on Thursday 01/07/2021. At the appointment, I received a Decadron injection, which helped, but today I am back to red face/neck and warmth.
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| 47 | 2021-01-07 | flushing, flushing |
12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling li...
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12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling like throat was swelling. Patient was taken to ED via wheelchair. Monitoring and BP @7:40 135/83 HR 72 Resp. 18. Under oBS at hospital, not admitted. *Initial dose reported symptoms of feeling sick with dose 1 but not to extent of second dose
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| 47 | 2021-01-07 | flushing |
Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontan...
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Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | numbness |
Numbness on the left side of the face; This is a spontaneous report from a contactable physician (pa...
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Numbness on the left side of the face; This is a spontaneous report from a contactable physician (patient). A 47-year-old non-pregnant female patient received the first dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1284), via an unspecified route of administration on 22Dec2020 at 14:00 at single dose in left arm for covid-19 immunization. Medical history included trigeminal neuralgia. Concomitant medication included colecalciferol (VITAMIN D) and multivitamin. The patient experienced numbness on the left side of the face on 22Dec2020 at 16:00, started within 2 hours of the shot and had continued for 2 weeks. The event was reported as non-serious by reporter. The patient didn't receive treatment for the event. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination, and was not tested for COVID 19 since vaccination. The outcome of the event was not resolved.
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| 47 | 2021-01-07 | pain in extremity |
Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; He...
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Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; Headache; Feeling sluggish and unwell; Feeling sluggish and unwell; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at right arm on 28Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. Concomitant medication included Alive multivitamin which received within 2 weeks of vaccination. The patient experienced soreness at injection site and entire upper arm, headache, feeling sluggish and unwell, all on 28Dec2020 16:00. No treatment received. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. This is a non-serious report. The outcome of the events was recovered on an unspecified date.
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| 47 | 2021-01-07 | tingling, flushing, feeling hot |
flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contact...
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flushed; small amount of tingling to left hand; face warm; This is a spontaneous report from contactable consumer (patient). A 47-year-old female patient first dose received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EKS730, intramuscular Left arm from 18Dec2020 16:00 to 18Dec2020 16:00 as single dose for COVID-19 immunisation. Medical history included osteoarthritis. Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL). On 18Dec2020 16:30, immediately after injection, the patient experienced small amount of tingling to left hand, face warm, and flushed, which resolved within 30 minutes without intervention. The outcome of the events was recovered. No treatment was received for the events.
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| 47 | 2021-01-07 | tingling, pain in extremity |
Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; modera...
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Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; moderate leg aches bilaterally; Sore arm at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm, on 30Dec2020 at a single dose for COVID-19 immunization. The patient was 47 years old when she received the vaccine. Medical history included RSD (Reflex sympathetic dystrophy), had allergies to medications, food, or other product particularly NSAID and to contrast dye. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. She had not been tested for Covid-19 since vaccination. The patient had sore arm at injection site for 36 hours after administration (02Jan2021) with outcome of recovered in Jan2021. In day #4 (03Jan2021), she had pain in hip joints and moderate leg aches bilaterally with outcome of unknown. In day #5 (04Jan2021), she had prickling needles feeling soles feet bilaterally and some in the palms of her hands with outcome of unknown. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-01-07 | tingling | Throat flem, body tingles, EMS screened, increased observation time, resloved in 15 min |
| 47 | 2021-01-07 | tingling | Pt report bilateral cheek tingling. Treatment include Benadryl, |
| 47 | 2021-01-08 | breast pain, hot flush |
1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left...
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1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left chest/breast pain, fatigue, stuffy nose.
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| 47 | 2021-01-08 | numbness |
She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes...
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She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes after the vaccine and lasted about 2 hours. She had no facial muscle issues. She then developed intense vertigo and nausea. I question possible vestibular neuritis. This lasted about 5 days and was more severe the first 3-4 days. At day 7 she was almost back to normal. She also had a frontal tension style headache
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| 47 | 2021-01-08 | tingling, flushing |
Arms started tingling immediately after injection but did not think it was a significant response. A...
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Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.
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| 47 | 2021-01-08 | speech disorder |
About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did...
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About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very "fuzzy". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very"plastic" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.
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| 47 | 2021-01-10 | feeling cold |
? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to...
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? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
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| 47 | 2021-01-10 | one side paralysis, weakness |
vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can o...
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vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can only say it is what I would imagine restless leg syndrome might feel like, weak and achy that disrupted sleep all night. 12/28/20 noticed enlarged lymph node on left side near clavicle tender to touch
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| 47 | 2021-01-10 | numbness, tingling |
c/o tingling and numbness down length of left arm (site of covid vaccine) extending to finger tips -...
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c/o tingling and numbness down length of left arm (site of covid vaccine) extending to finger tips - per physicians consideration: patient should continue to watch or any signs of swelling, redness, and/or soreness. Tingling/numbness possibly due to hitting a nerve.
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| 47 | 2021-01-10 | nerve pain, facial paralysis |
ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consume...
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ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
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| 47 | 2021-01-10 | pain in extremity, weakness |
I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccina...
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I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccination (01/04/2021). It is especially troublesome on my left hand/fingers. It is worse in the morning when I wake up, but it gets better with movement of my arm/hand to complete my normal day activities.
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| 47 | 2021-01-10 | pain in extremity |
01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and thro...
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01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and throbbing excruriating pain in the left arm (10/10). I was barely able to move the left arm, and I could not bend it due to severe pain in the elbow joint. At approximately 0800, I started having diarrhea that lasted for no more than an hour. By noon the soreness and aching had reduced to a moderate pain (5/10). I was able to bend my left arm, but the arm remained sore at the elbow joint until 01/10/2021. By the morning of 01/10/2021, all the symptoms were gone.
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| 47 | 2021-01-10 | seizure |
Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her head...
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Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her headache and was observed for a few minutes. She was offered Benadryl but patient was allergic to Benadryl. She exhibited grand mal seizure twice. The ambulance was called after the second grand mal seizure.
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| 47 | 2021-01-10 | tremor, tingling, feeling hot, pain in extremity, weakness |
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of...
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Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
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| 47 | 2021-01-11 | weakness | Arm pain and weakness for 10 (ten) days. 600 and 800 mg doses of ibuprofen |
| 47 | 2021-01-11 | weakness |
Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later...
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Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.
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| 47 | 2021-01-11 | discomfort |
Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increase...
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Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; pain and inflammation has significantly increased; feels very sharp especially in my hands in my back near my scapula, and my knee joints; My muscles also feel tight in these areas; The pain and discomfort are significantly greater than normal; This is a spontaneous report from a contactable other hcp. This 47-year-old female other HCP (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 30Dec2020 09:00 at single dose on right arm for COVID-19 immunisation. The patient was mostly healthy, no chronic health conditions. No known allergies. Her family had a lot of auto immune disease history. Concomitant medication included paracetamol (TYLENOL), ibuprofen. The patient had mild arthritis joint pain in her hands, and feet that were usually resolved with OTC pain medications. The pain and inflammation has significantly increased since the COVID-19 vaccine injection and felt very sharp especially in her hands, in her back near mhery scapula, and her knee joints. Her muscles also feel tight in these areas. The pain and discomfort are significantly greater than normal. Symptoms were the worst 2-5 days Post injection and have not resolved. All of the events were on 31Dec2020 09:00 and no treatment was received, all considered as non-serious. No COVID tested post vaccination. The outcome of the events was not recovered. Information on the Lot/Batch number has been requested.
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| 47 | 2021-01-11 | flushing, weakness |
patient developed occipital headache, backache, flushed sensation, and weakness; has known history o...
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patient developed occipital headache, backache, flushed sensation, and weakness; has known history of "MS". pt. given a water, vitals signs taken, and 1st response team called to transport to ED.
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| 47 | 2021-01-11 | flushing |
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes...
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Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-01-11 | numbness, feeling cold |
Pt states cool sensation to right side of face and numbness to right hand- EMS evaluated and some re...
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Pt states cool sensation to right side of face and numbness to right hand- EMS evaluated and some resolution of cool sensation to face, hand remains numb
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| 47 | 2021-01-11 | numbness |
tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole f...
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tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-11 | pain in extremity, feeling jittery |
Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (l...
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Received first dose COVID vaccine at 6:30am on 1/5/21. Developed redness to face, arms, and chest (like a sunburn) at 2pm. Also felt jittery. Spoke to ER physician and advised to take po Benadryl. Took 2 doses before redness cleared. Jitteriness cleared the next day without Benadryl.
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| 47 | 2021-01-11 | pain in extremity |
Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 ...
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Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 @ ~ 1am I awoke from sleep with worsening LEFT Arm soreness, headache (bad) and body aches 1/9/21 @ ~ 11am Feeling more fatigued, chills, low grade fever 99.9 1/9/21 @ ~ 2 pm, continue to have body aches, fatigue, itchy nose/post nasal drip, chills fever 100.7 1/9/21 @ 8pm continued w/ prior symptoms, developed mild cough ( at this point I felt symptoms may be outside vaccine side effects, honestly wasn't sure if it was seasonal allergies w/ vaccine side effects) 1/10/21 ~ 10 am Awoke feeling better, remained fatigued and with mild intermittent cough but body aches/headaches resolved, opted to go for testing 1/12/21 informed of Covid + test (PCR), was advised by my hospital employee health to complete this form It should be noted I underwent mandated employee testing on 1/5/21 which was negative.
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| 47 | 2021-01-11 | pain in extremity |
tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her a...
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tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
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| 47 | 2021-01-11 | pain in extremity |
Pain in arm to the point patient states they are unable to lift the arm. Patient instructed to foll...
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Pain in arm to the point patient states they are unable to lift the arm. Patient instructed to follow up with PCP to have arm visualized and treated if necessary.
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| 47 | 2021-01-11 | pain in extremity | Headache, Sore Arm |
| 47 | 2021-01-11 | pain in extremity |
Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued t...
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Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued to get better of the course of 3 days. No fever but felt ache all over and chills starting 1/8/21 about 8PM, pain in L arm 1/8/21 starting about 2 hours after injection. resolved 1/10/21
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| 47 | 2021-01-11 | tenderness |
Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of...
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Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of voice. Day after vaccination, Severe body pain - back, shoulders, hips, abdomen with Muscle aches, Headache, Mild Discomfort in chest and ribs when breathing, and General feeling of being unwell
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| 47 | 2021-01-12 | weakness, feeling hot |
feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my ...
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feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown. Information about Lot/batch number has been requested.
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| 47 | 2021-01-12 | feeling hot, flushing |
Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving...
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Pfizer-BioNTech COVID-19 Vaccine On 1/13/2021, patient got her 2nd dose of vaccine. After receiving the dose, she felt warm, flushing and redness in chest area. Patient was brought to ED for evaluation at 9:52am. Treated as allergic reaction, got diphenhydramine 50 mg and famotidine 20 mg. At 11:20am redness was resolving and patient felt better. Her BP was high and got clonidine 0.3mg at 12:18pm. Patient was discharged at 12:31pm
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| 47 | 2021-01-12 | feeling hot, flushing |
Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart ra...
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Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart rate 100. 8:32 b\p 130/80 Heart rate 100 discomfort in neck back and headache. Reported she had a headache with the first dose. 8:50 states she is better and ready to go home. b\p 128/88 heart rate 90 Advised to seek medical help if symptoms worsen.
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| 47 | 2021-01-12 | feeling hot |
1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79...
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1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79, 125/78, O2 Sat 100%, placed supine position 1343: Felt shakey like low BG - got cookies, water, 80 HR, 128/88, 100% O2 1348: Felt like she wanted to sit up. 66 HR, 107/72, 100%, wave of dizziness and nausea 1349: HR 82, 123/86, 100% applied O2 8L Mask 1353: 92 HR 128/84, 100%, nauseated - coolw ash clothes applied - needed to transfer to a better chair that would lay back 1400: HR 72, 120/80, 100%, 36.7 - Felt warm but cool, wanted warm blankets - said she feels like she is sinking into the chair. HR 73, 118/78, 100% feeling better. 1409: 70 HR, 115/76, 100%, orthostatics taken. 1411: 69 HR 118/77, 100%, sat up 1414: 79 HR 123/87 99% took O2 off - felt ok. 1419 67 HR 121/83 100% standing felt okay, not dizzy.
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| 47 | 2021-01-12 | flushing | Systemic: Nausea-Medium, Systemic: flushing; symptoms lasted 1 day |
| 47 | 2021-01-12 | flushing |
Pfizer-BioNTech COVID-19 Vaccine 1/13/2021, patient got 2nd dose of vaccine and minutes later exper...
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Pfizer-BioNTech COVID-19 Vaccine 1/13/2021, patient got 2nd dose of vaccine and minutes later experienced flushing and redness in chest area and sent to ED for evaluation. Arrived to ED at 9:52 am and was given diphenhydramine 50 mg and famotidine 20 mg. Clonidine 0.3 mg given at 12:18 pm for high BP. At 11:20 am rash almost resolved, feeling better; discharged at 12:30pm
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| 47 | 2021-01-12 | pain in extremity | Chills, headache, arm pain, nausea, body aches and pain |
| 47 | 2021-01-12 | pain in extremity |
Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and tod...
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Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and today. Major headache today, not all day just part of day.
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| 47 | 2021-01-12 | tingling |
approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down...
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approx. 19 mins after the injection my right arm began to feel a tingle sensation that radiated down to my hands and right side of my chest. Lips felt swollen but not visible to the eye. My right lower extremity had the same feeling as describe what happened to my right arm. I went to the ED of the hospital where I worked. This my second dose and I had the same experience with the first dose but on my left side.
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| 47 | 2021-01-12 | tingling | Light fluttery, tingles throughout bilateral arms down through hands- |
| 47 | 2021-01-12 | tenderness |
Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my ...
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Patient's report: "Started to notice swelling in my right arm pit on 1/12/2021 and tenderness in my neck also on 1/12/2021 I had the second shot on 1/11/2021 at 12pm"
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| 47 | 2021-01-13 | discomfort |
12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and...
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12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and the chills. I was up the remainder of the night. By morning I had a bad headache and terrible body/muscle aches. I was unable to report to work that day. By midafternoon, the nausea and stomach pains subsided, all other symptoms remained along with then getting a 100.5 fever. I was taking Tylenol every 4 hours since 1am and keeping hydrated. By midnight I was exhausted and was finally able to sleep. I woke the following morning with a dull headache and just felt achy. I felt much better by that evening (now Monday). Tuesday morning I woke with discomfort to my left armpit and clavicle area. I then noticed swelling, the areas felt ?lumpy? and were very tender to touch. That lasted about 2 days.
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| 47 | 2021-01-13 | feeling hot |
Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms las...
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Systemic: heart rate went up to 170bpm, felt hot, bp 160/80, came down to 109 bpm-Mild; symptoms lasted 1 day
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| 47 | 2021-01-13 | numbness |
Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after takin...
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Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after taking benadryl and is back to normal-Severe; symptoms lasted 0 days
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| 47 | 2021-01-13 | migraine |
Fever, chills, dizziness, headache. Fever on and off from 1/9/21 through 1/14/21. Fever, chills, mus...
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Fever, chills, dizziness, headache. Fever on and off from 1/9/21 through 1/14/21. Fever, chills, muscle ache 1/9/21 through 1/14/21. Severe headache/migraine from 1/11/21 to present (still have).
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| 47 | 2021-01-13 | pain in extremity |
a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued a...
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a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM. On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy. For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered, outcome of other event was unknown. Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
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| 47 | 2021-01-13 | pain in extremity |
intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of...
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intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of Benadryl. via IV in right arm. I went home and slept for 3 hours. Woke up Right hand swollen and painful, muscle aches, headache, itching
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| 47 | 2021-01-14 | facial pain |
I developed left forehead and scalp pain associated with a rash-shingles. I did seek care with my ...
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I developed left forehead and scalp pain associated with a rash-shingles. I did seek care with my PCP and was treated.
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| 47 | 2021-01-14 | feeling hot | felt body rush, got hot rise from legs on up |
| 47 | 2021-01-14 | flushing |
Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old fema...
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Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 (Batch/lot number: EJ1685) at a single dose on left arm, and received the second dose, intramuscular on 08Jan2021 (Batch/lot number: EK9231) at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded and flushed on an unspecified date. Treatment not received for the adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 47 | 2021-01-14 | numbness |
24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No S...
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24 hours post injections, tongue numb, r.side of face, lips tingling, up to r.ear and r.cheek. No SOB, no swelling. 4 days later lips tingling. 7-9 days later random numbness and tingling of tongue, r. cheek, lips....comes and goes. No rescue medication used. No follow up pursued by patient.
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| 47 | 2021-01-14 | throat numbness, slurring, inability to speak |
approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to t...
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approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to take deep breath. Severe difficulty swallowing. Difficulty getting words out, then slurring of words/poor pronouncing of words. Foggy head. Poor balance.
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| 47 | 2021-01-14 | tenderness, pain in extremity |
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I f...
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The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
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| 47 | 2021-01-15 | numbness, tingling |
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s...
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Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
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| 47 | 2021-01-15 | tingling |
Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anor...
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Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anorexia, intermittent paresthesias, SOB, Chest Discomfort for 14 days straight, slightly better today.
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| 47 | 2021-01-15 | tingling |
Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness contin...
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Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness continuted through out the day Increased Heart Rate had continued off and on, went to ER and have seen Cardiologist
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| 47 | 2021-01-16 | feeling hot |
I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on m...
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I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on my back, swelling of my eyelids, and lips.
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| 47 | 2021-01-16 | pain in extremity |
Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscle...
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Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscles aches through mid back and chills Day 3 - Exhausted and achy, nauseous, chills, sweats Day 4- Adverse reactions gone.
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| 47 | 2021-01-16 | pain in extremity |
severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine d...
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severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine dose, extreme pain in right arm, leg, neck, and right side of the stomach started on day 2 - phone appointment with doctor , rash started on day 3 - urgent care visit, diagnosed with shingles after dermatology consult
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| 47 | 2021-01-17 | weakness, tremor, feeling cold |
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my...
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I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
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| 47 | 2021-01-17 | tingling |
Received covid vaccine number one on December 23. By December 25 she developed tingling in the tips ...
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Received covid vaccine number one on December 23. By December 25 she developed tingling in the tips of her toes and in her fingers. She found this concerning. She spoke to her rheumatologist as well. The rheumatologist recommended she go to the ED. She was recommended to see a neurologist. Neurologist is planning to test her for GBS.
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| 47 | 2021-01-18 | weakness |
fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, we...
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fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, weakness, bone pain, abdominal cramps, loose stool--that had mucous and blood in it. Also had a small amount of vaginal bleeding/spotting not associated with her period. Multiple days of these symptoms.
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| 47 | 2021-01-18 | weakness | Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever |
| 47 | 2021-01-18 | involuntary muscle movements |
I was having involuntary muscle movement in my arms, neck and legs while trying to sleep last night....
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I was having involuntary muscle movement in my arms, neck and legs while trying to sleep last night. I've been up for approximately 4 hours and have not had any symptoms once I was awake and moving around.
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| 47 | 2021-01-18 | flushing, pain in extremity |
Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mi...
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Face flushed like a sunburn and sweating a lot since about 17 min after. Pain in left eye down to mid cheek and full face mild puffiness. Difficulty swallowing only for 5 min then sore throat since then. Nausea starting about 2 hours after. Left arm swelling and a lot of pain for a couple hours in the middle of the night and still very sore but better. Woke up with both eyes bloodshot. Feeling like my scalp was hot and tight for about a half hour but that went away.
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| 47 | 2021-01-18 | pain in extremity, pain in extremity | Arm soreness, chills, sore throat, nausea, body aches, headache |
| 47 | 2021-01-18 | pain in extremity |
Body aches, sore throat, runny nose, and sore arm beginning 1/14/2021. Took OTC medication on 1/14/...
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Body aches, sore throat, runny nose, and sore arm beginning 1/14/2021. Took OTC medication on 1/14/2021 with improvement. Symptoms have since resolved.
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| 47 | 2021-01-18 | pain in extremity |
Recieved 1st dose of Covid Vaccine Lot #EH9899 on 12/22/20. Employee had tested positive for Covid ...
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Recieved 1st dose of Covid Vaccine Lot #EH9899 on 12/22/20. Employee had tested positive for Covid 7/5/20 and had recovered from severe cough. After recieving 1st dose of vaccine later that day, patient started having return of the cough. , then also had HA and leg pain. Received 2nd dose of Covid on 1/12/21 and immediately had severe stomach pain, then had diarrhea. Cough worsened the next day, developed sore throat, HA, runny nose, congestion, shortness of breath and would feel faint at times.
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| 47 | 2021-01-19 | weakness, night sweats |
Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cra...
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Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cramping; Fatigue; Some sweating in the middle of the night; some pain behind her eyes; Shoulder area is sore; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 09Jan2021 11:00 in left arm at single dose for COVID-19 immunization. Patient take medications for mood and sleep with were very low doses. But she didn't have any medical problem. She took 10 mg of fluoxetine hydrochloride (PROZAC), 150 mg of bupropion hydrochloride (WELLBUTRIN) and 10 mg of doxepin for sleep. Yesterday after the vaccination towards the end of the day (09Jan2021 approximately 11 o' clock am), she developed a stomach ache about 5 pm and it went on throughout the night and she normally didn't have issues with her stomach. Maybe it was because she was hungry because she went ice skating with her son where they wore mask in the afternoon yesterday and she was feeling perfectly fine. But when she came home, she noticed her stomach started hurting at 5 pm and she wondered maybe it is because she was hungry. And after she ate it was still bothering her and then it got progressively worst in the middle of the night where it would wake her up periodically. But she was so fatigue that she was able to sleep still. But she noticed in the middle of the night that her stomach would wake her up because it was aching and cramping in the middle of the night. And then she also had some sweating in the middle of the night as well as some pain behind her eyes. And today (10Jan2021) she had some fatigue which she noticed was not usual, she had mild headache which she saw was a common side effect. And then in the morning (10Jan2021) some fatigue and weakness like when she walked to the bathroom it was hard for her to walk. And when she went to use the bathroom she had some loose stools which was not common for her unless at all she was sick or have eaten something that makes her stomach really sick which was very unusual for her. Her stomach was still hurting her, if she walked it will start getting cramped so she was sitting down. The only thing she toon this morning was 2 acetaminophen medicine tablets because she was having pain behind her eyes when she woke up. She was just going to say she had influenza type A and type B on several occasions. And these symptoms are similar to when she had type B influenza, which was not as difficult as type A. So this is, they seemed to be like a mild version of type B influenza which she had terrible stomach issues, diarrhea and fatigue and pain behind the eyes from type B influenza. She had not any sickness because she work from home and she had limited field contact. So, she hadn't had illness from past year now. Because she worked from home. She provided mental health counselling remotely. So, she didn't think it could be attributed from anything else. The left on arm which was up toward like shoulder area and it was sore but it was tolerable in Jan2021. Outcome of stomach ache/stomach cramping was not recovered, and outcome of other events were unknown.
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| 47 | 2021-01-19 | weakness | Fever of 103, severe chills, body aches, joint pain, weakness, cough, headache, sore throat |
| 47 | 2021-01-19 | weakness |
Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with...
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Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with fever and chills until 7pm. Had a throbbing headache from 2pm until midnight. Severe muscle weakness and bone pain. No appetite at all. Next day still weak and sore but fever gone and about 75% better.
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| 47 | 2021-01-19 | pain in extremity |
Sore arm- could not raise arm above shoulder, 106 fever, muscle/joint/body aches for 3 days, seen in...
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Sore arm- could not raise arm above shoulder, 106 fever, muscle/joint/body aches for 3 days, seen in ER after 24 hours of symptoms. Fatigue for 1 week post vaccination.
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| 47 | 2021-01-19 | tenderness |
Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my va...
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Pfizer-BioNTech COVID-19 Vaccine EUA On the evening of 1/19/21 I noticed my arm in the area of my vaccine was sore to the touch. As the evening progressed, my shoulder joint became sore and got worse throughout the evening and became very sore to lift my arm. This morning it is still very sore, and now my neck feels ?stiff? and also it?s tender to move.
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| 47 | 2021-01-19 | tremor |
Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt h...
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Patient had her vaccination and went back to work for about 15 min. When she was at work, she felt her legs shaking and tingling on her top lip. She came back to the vaccine clinic and asked to be monitored. Vital signs taken 138/90, HR 109 POX 100 RA. Continued to have tingling upper lip and brought to ED for further observation. Warm hand off to ED RN
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| 47 | 2021-01-20 | weakness, tingling, pain in extremity |
weakness, dizziness, tingling to body, palpitations, skipping heart beat, pain to left leg, describe...
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weakness, dizziness, tingling to body, palpitations, skipping heart beat, pain to left leg, described her left leg veins appeared transiently engorged soon after 1st dose of pfizer covid vaccine
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| 47 | 2021-01-20 | discomfort |
First dose without incident. 18Jan2021 6:40am 2nd dose - 12hr later felt blah, 24hrs later extremely...
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First dose without incident. 18Jan2021 6:40am 2nd dose - 12hr later felt blah, 24hrs later extremely dizzy with moderate headache and body aches. then at 4am 20Jan2021 (right around 48hrs), I had erythema with a blister on left lateral side around rib region 8-10 with itching and burning. This improved to no erythema and this morning (21Jan2021) only 3 blisters with mild discomfort.
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| 47 | 2021-01-20 | feeling hot, flushing |
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and f...
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10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous, and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
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| 47 | 2021-01-20 | numbness, pain in extremity |
Pain and numbness in arm of injection; Pain and numbness in arm of injection; This is a spontaneous ...
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Pain and numbness in arm of injection; Pain and numbness in arm of injection; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1282 and expiration date not provided), via an unspecified route of administration in the left arm on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included diabetes mellitus. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications included metformin, lisinopril, and aspirin (ACETYLSALICYLIC ACID). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 11Jan2021 14:00, the patient experienced pain and numbness in arm of injection. Treatment was not provided in response to the events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
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| 47 | 2021-01-20 | numbness, tingling, pain in extremity |
I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm s...
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I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm soreness and body aches. On 12/20/20, I had a sore throat, headache, body aches, and nasal congestion that continued through 12/24/20. On 12/25/20, I had extreme body aches, fatigue, left arm and leg numbness and tingling, SHOB, temp of 100.6, and back pain. On 12/27/20, I went to the ER for my symptoms and to be tested for COVID-19, to which I tested positive. They also tested me for strep and flu, both were negative. I also developed intermittent and random tachycardia (HR 120-150's), palpitations, chest tightness and chest pain. I am a RN and monitored my O2 Sats and HR frequently. My symptoms finally resolved enough for me to return to work on 1/11/21.
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| 47 | 2021-01-20 | numbness, tingling |
Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 1...
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Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 102 fever, severe body aches, chills, stomach ache, and diarrhea. Took acetaminophen 1000 mg at 2 am. Stomach issues subsided 7 am, 20 hours after vaccine. Fever over 101, chills, body ache, and headache remained for 3 days. All symptoms have subsided except right side of face still tingling and numb.
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| 47 | 2021-01-20 | migraine, pain in extremity |
she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints...
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she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints all over yesterday; had achy joints all over yesterday, saying her neck hurt; felt sick with a runny nose; felt sick with a runny nose; the gland in her armpit (clarified as left armpit) area is swollen and very painful; the gland in her armpit (clarified as left armpit) area is swollen and very painful; hard time sleeping.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 11:50 at single dose (left arm) for COVID-19 immunization. Medical history included penicillin rash. There were no concomitant medications. The patient previously took diflucan 15 years ago and experienced extreme allergic reaction to diflucan; and amoxicillin and experienced rash. She stated she had a rash in the past to Amoxicillin and Penicillin. She received the COVID-19 vaccine on Saturday (09Jan2021), and the gland in her armpit (clarified as left armpit) area was swollen and very painful. She said she took Tylenol, and the Tylenol cut the pain. She stated she still has a little pain today. Her left armpit started feeling uncomfortable on Saturday night, and she had a hard time sleeping. She said when she woke up on Sunday morning, 10Jan2021, her left armpit area was extremely painful, clarifying she had left arm pain as well. She said the pain in her left arm has lessened today, but her left armpit area was still painful. Clarified she took a repeated 3 Tylenol 200 mg (600mg) dose over the past couple days for her left armpit pain. She took her first dose of 3 Tylenol 200mg tablets (600mg dose) at noon on Saturday, 09Jan2021, and another 3 Tylenol 200mg (600mg dose) at 5:00PM on Saturday evening and went to sleep. She said she woke up after her nap on Saturday evening, and was sweaty and had left armpit pain. She said she took another 3 Tylenol 200mg tablets (600mg dose) on Sunday, 10Jan2021, at 5:00PM. She said she took her last dose of 3 Tylenol 200mg tablets (600mg dose) this morning, 11Jan2021, at 7:00AM. On Saturday night, 09Jan2021, it was only her left armpit that was sore, but by Sunday, 10Jan2021 morning, her whole left arm was in pain and the gland in her left armpit was swollen. On 10Jan2021, the patient was very sweaty, and had a migraine. Clarified she felt sweaty now, like she just woke up from a fever. She said she was not overdressed, but maybe she was in a hot environment. She said she had no fever when she checked her temperature. She also had achy joints all over and her neck hurt on 10Jan2021. Patient reported that she had a PPD skin test administered 2 months ago and had no reaction to the PPD skin test. She felt sick with a runny nose on 10Jan2021, but she felt fine today, 11Jan2021. She said that after she received the COVID-19 vaccine, it was less than 24 hours when everything started happening. The patient had no history of all previous immunization with the Pfizer vaccine and no vaccines administered on the same date of the vaccine. The patient had no prior vaccinations within 4 weeks. Outcome of event hard time sleeping was unknown; she had left arm pain as well, had achy joints all over yesterday, saying her neck hurt, felt sick with a runny nose, was recovering; had a migraine yesterday was recovered on an unspecified date; and outcome of the rest of events was not recovered.
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| 47 | 2021-01-20 | pain in extremity |
For my first dose I had no significant side effects, LOT: EJ1686. ) After receiving my second dose...
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For my first dose I had no significant side effects, LOT: EJ1686. ) After receiving my second dose injection, I felt lethargic, had cold, chills with soreness to left arm. I had significant abdominal pain, my abdomen was distended and swollen. Two weeks prior to the 1st dose injection I had had abdominal surgery. I experienced peristalsis with pain with possible obstruction. I have an ileostomy., and with the vaccine I experienced (high pitched noise coming out of my stomach which caused me to vomit and fee weakness to my abdomen. i took Octeotide injection for my abdominal pain. I also took Ibuprofen for pain. My doctors said that my abdominal pain was most likely related to the injection. I went into surgery 12-14-2020 for removal of an abdominal mesh due to the ileostomy and infection. I currently can not lift no more than 10 pounds. At this time, I feel better and will be returning to work.
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| 47 | 2021-01-20 | tingling |
Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. Has tingling in hand, head ache, spin...
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Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. Has tingling in hand, head ache, spinning, body aches. Has been a week since covid vaccination.
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| 47 | 2021-01-21 | migraine |
Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull o...
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Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull on the same side where I got the shot in my left shoulder
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| 47 | 2021-01-21 | migraine |
Migraine- worse I ever had, with shooting pain on the left side of my neck up to base of skull on th...
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Migraine- worse I ever had, with shooting pain on the left side of my neck up to base of skull on the same sideI received the shot in my shoulder
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| 47 | 2021-01-21 | pain in extremity | Extreme Fatigue, lethargy, arm soreness, headache, fogginess. |
| 47 | 2021-01-24 | pain in extremity | Fever Body Aches left underarm pain, and swollen |
| 47 | 2021-01-24 | pain in extremity |
Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontane...
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Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontaneous report from a contactable Other-HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at SINGLE DOSE for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced side effects after she got her 1st dose last 24Dec2020. On 26Dec2020, she had pain underneath arm and then whole lymph nodes were swollen up until her armpit 2 days after receiving the vaccine. Her 2nd dose is scheduled this Thursday and wants to know if she should get it. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 47 | 2021-01-25 | cold sweat, tremor | Tachycardia, sweating, uncontrollable shaking, clamy hands and vomitimg |
| 47 | 2021-01-25 | flushing, flushing |
47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd ...
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47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd dose of COVID 19 vaccine. Patient denied experiencing any SOB, difficulties breathing and difficulties swallowing. She described abdominal pain as sharp with sudden onset following vaccine. Patient does have a history of abdominal pain and is currently followed by GI. At that time, RN contacted provider for consult. Patient was evaluated by provider and 25 Mg PO Diphenhydramine ordered and given at 1533 Log: 502213 EXP: 3/31/21. Patient V/S at that time were: BP 144/90, HR 98, 02 99, Temp 98.1. Patient was observed by RN for an additional 15 minutes. V/S at 1545 - BP 129/79, HR 83, O2 99, temp 98.1. Pt facial flushing had visibly improved and her husband was contacted to pick up. Per provider, patient was released to self care with ER precautions provided.
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| 47 | 2021-01-25 | flushing |
47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd ...
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47 y/o female c/o abdominal discomfort as well as facial flushing approximately 10 minutes post 2nd dose of COVID 19 vaccine. Patient denied experiencing any SOB, difficulties breathing and difficulties swallowing. She described abdominal pain as sharp with sudden onset following vaccine. Pt does have a history of abdominal pain and is currently followed by GI. At that time, RN contacted provider for consult. Patient was evaluated by provider and 25 Mg PO Diphenhydramine ordered and given at 1533 Log: 502213 EXP: 3/31/21. Pt V/S at that time were: BP 144/90, HR 98, 02 99, Temp 98.1. Patient was observed by RN for an additional 15 minutes. V/S at 1545 - BP 129/79, HR 83, O2 99, temp 98.1. Patient facial flushing had visibly improved and her husband was contacted to pick up. Per provider, patient was released to self care with ER instructions if symptoms return/worsen provided.
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| 47 | 2021-01-25 | migraine |
Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pa...
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Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pain with swelling. 72 hours into time left side of body was swollen to point that clothing and jewelry do not fit. Left under arm and Breast are extra swollen *approximately triple size of right side. Migraine at 30 hours. Stomach pain in right side at 28 hours, also nausea and diarrhea.
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| 47 | 2021-01-25 | pain in extremity |
This is a spontaneous report from a contactable nurse (Patient). A 47-year-old female patient receiv...
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This is a spontaneous report from a contactable nurse (Patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on30Dec2020 to 30Dec2020 at single dose for COVID-19 immunization. She had a history of pancreatitis and was hospitalized with elevated lipase levels one and a half weeks prior to getting her first dose in Dec2020. When she received the first dose she had recovered and her lipase levels were normal in Dec2020. Her gastroenterologist has scheduled her for a colonoscopy and upper endoscopy but would like for her second dose to be spaced out a week from her first dose. She is asking if there is any data to support efficacy of the second dose of the vaccine between days 28-32. The doctor stated she is okay as long as she gets the second dose of the vaccine within 5 months from the first dose. She had pancreatitis and needs to have a procedure for it. She was scheduled for second dose on 18Jan2021. She has an endoscopy and colonoscopy scheduled for 21Jan2021 and her GI doctor advised to postpone her second dose which she was told she should get 17- 21 days after her first dose since it would coincide with her procedure. She does not have a problem with the vaccine. She had a sore arm on an unknown date and was totally fine. The outcome of the event sore arm was recovered on an unknown date. Information on the lot/batch number has been requested.
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| 47 | 2021-01-25 | pain in extremity |
Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was ab...
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Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was about 14 hours after injection
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| 47 | 2021-01-26 | flushing | Flushing, heart racing, itching in fingers |
| 47 | 2021-01-26 | migraine, weakness |
Migraine headache unresponsive to migraine medication, lasting 24 hours, mild fever, dehydration. We...
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Migraine headache unresponsive to migraine medication, lasting 24 hours, mild fever, dehydration. Weak/tired for the following 24 hours.
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| 47 | 2021-01-27 | burning sensation, tingling |
Tingling/ burning sensation first started in toes on bilateral feet. On day 17, severe tingling/burn...
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Tingling/ burning sensation first started in toes on bilateral feet. On day 17, severe tingling/burning started on left hand.
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| 47 | 2021-01-27 | flushing | facial flushing, mild generalized puritis |
| 47 | 2021-01-27 | migraine |
Migraine, muscle aches, fever and chills. Treated with Tylenol. All symptoms resolved within 36-40 h...
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Migraine, muscle aches, fever and chills. Treated with Tylenol. All symptoms resolved within 36-40 hours.
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| 47 | 2021-01-27 | pain in extremity, cold extremities |
deltoid was still sore, but felt cold/entire arm and hand feels cold, worse when the area is rubbed;...
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deltoid was still sore, but felt cold/entire arm and hand feels cold, worse when the area is rubbed; Deltoid still sore/soreness in the forearm; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ES1686), via an unspecified route of administration in the left arm on 04Jan2021 14:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D), probiotics, and elderberry [sambucus nigra]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's deltoid was still sore, but felt cold on day 3 (07Jan2021). By day 7 (11Jan2021), the entire arm and hand feels cold, worse when the area is rubbed. By day 8 (12Jan2021), the patient had soreness in the forearm and still unchanged at day 11. No weakness was noted. The patient had good pulses on Jan2021 and no visible change to the skin. No treatment was received for the adverse events. Outcome of the events was not recovered.
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| 47 | 2021-01-27 | tenderness |
left underarm was hurting; There was a pear size lump that is very tender there. It feels fluid fill...
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left underarm was hurting; There was a pear size lump that is very tender there. It feels fluid filled to her; There was a pear size lump that is very tender there. It feels fluid filled to her; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3302,via an unspecified route of administration in the left arm, on 12Jan2021 10:00 at SINGLE DOSE for COVID-19 immunization. Medical history sleep apnea, GERD, TMJ and depression. Historical vaccine included first dose of BNT162B2 on 22Dec2020 for COVID-19 immunization. Concomitant medication included cefixime (FLEXERIL), fluoxetine hydrochloride (PROZAC), omeprazole (PRILOSEC) and trazodone. on 13Jan2021 12:00, 24 hrs post vaccination, patient noticed that her left underarm was hurting, and she touched it. There was a pear size lump that is very tender there. It feels fluid filled to her. Therapeutic measures were taken as a result of events included an unspecified treatment and will be receiving an ultrasound. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 47 | 2021-01-27 | tremor |
Severe chills lasting 24 hours, Severe shaking x 2 hours, Headache x 5 days, Fatigue x 3 ays. Trea...
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Severe chills lasting 24 hours, Severe shaking x 2 hours, Headache x 5 days, Fatigue x 3 ays. Treated with Tylenol (for up to 5 days post injetion), Ibuprofen.
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| 47 | 2021-01-28 | weakness |
she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so ...
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she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; tested positive for COVID; tested positive for COVID; not feeling very well; feeling dizzy and weak; feeling dizzy and weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included Diabetes which was diagnosed in Apr2020. There were no concomitant medications. The patient received the first dose of the vaccine on 22Dec2020. She tested positive for COVID19 on 08Jan2021. The second dose of vaccine on 12Jan2021 was deferred as the patient was not feeling well on an unspecified date in Jan2021. She asked for guidance/information about receiving the second dose after testing positive. She stated that she was still feeling dizzy and weak on an unspecified date in Jan2021. She said that she heard the people were not feeling too well after the second dose and she will get it as long as it will not kill her. She asked what will happen if she does not take the second dose and will she need to get the series again. She wanted to know if she can take the second dose of vaccine. She clarified that she was supposed to get her second dose on 12Jan2021 but she was not feeling very well so now they were telling her to go on the weekend. She does not feel fine. She asked if it was safe for her to take the second dose or should she wait. She wanted to know if the effect of the first dose is null since she has now delayed it so long. She is the supervisor of ultrasound department. She started having COVID symptoms of 04Jan2021, she was tested on 05Jan2021 and got a positive result on 08Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID19 based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 47 | 2021-01-28 | bell's palsy | Bell Palsy |
| 47 | 2021-01-28 | feeling cold, feeling hot |
ears have been burning; she checked her temperature and it is lower than normal, her temperature is ...
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ears have been burning; she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit; feels like her ears are hot; low iron; it feels like someone is pouring ice on her back/ she finds herself so cold; chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) intramuscular on 30Dec2020 at, single for COVID. The patient had no medical history. There were no concomitant medications. The patient said that calling she was having a side effect that is not on the list of side effect. She does not know if it was from the chills but her ears have been burning ever since had the shot. She feels like her ears were hot. Can the vaccine cause this to happen? She clarified she was not having chills, it doesn't feel like chills, she said on the second day after the vaccine she had chills but right now it felt like someone was pouring ice on her back and she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit. Her ears have been burning. Her first dose was given 30Dec2020. That was another reason she was calling should she get the second dose if she was feeling this way. She said her ears began burning sometime last week and it has not stopped. Sometimes it will go away and come back but she find herself so cold she has to get under the covers and it takes forever to warm up. Today she put a hat and a scarf around her ears to warm up in doors. She has low iron. She doesn't know with her having low iron all her life and she has never experienced this before. Outcome of the event ears have been burning was not recovered while unknown for the other events.
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| 47 | 2021-01-28 | feeling hot |
Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision;...
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Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; has pain in her rib cage close to the arm pit occurring mostly at night; hot at night; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). This 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left upper arm on 11Jan2021 at 11:00 at single dose for COVID-19 immunisation. Relevant medical history included knee pain. There were no concomitant medications. On 11Jan2021, the patient experienced "blurry vision; darkening in the eyes; I felt like something in my eye like heaviness" and in Jan2021 she experienced pain in her rib cage close to the arm pit occurring mostly at night and hot at night. The patient stated "I wanted to tell you that after the shot I was for 15 minutes sitting on a chair and I didn't feel anything and then I left and went for a walk and when I was walking by the gift shop at hospital, I noticed I just got blurry vision like when I looked at the stock, it kind of looked darkening in the eyes and blurry". She stated also "You know exact time I wouldn't tell but for the day like it happened first time near the store and later in the day when I was working, I felt like something in my eye you know like heaviness I don't know if that's blurriness but then runs away so like later yesterday I am fine and today I am okay". The patient also specified that blurry vision started 20 minutes after the vaccine and lasted 10-20 seconds and later during the day when she was reading. The patient also reported she was hot at night and has pain in her rib cage close to the arm pit occurring mostly at night. The patient did not receive corrective treatments; she just blinked and then she went and sit down, it never came back again. At the time of the report, the outcome of the events was unknown. The information on the lot/batch number has been requested.
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| 47 | 2021-01-28 | nerve pain |
First dose given 12/24/2020 injection site pain developed 12 hours after vaccine given and resolved ...
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First dose given 12/24/2020 injection site pain developed 12 hours after vaccine given and resolved by 24 hours post vaccination. Trunk rash developed 48 hours after vaccine and resolved within hours. Twelve hours after second dose on 1/14/2021, developed chills, aches, burning neuropathic pain all over, temperature of 101 degrees F. After 5 hours took 600 mg ibuprofen with relief and required another dose at noon the day after vaccination. Symptoms resolved within 24 hours. Developed pruritic trunk rash that lessened within hours but took > 2 weeks to resolve.
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| 47 | 2021-01-28 | pain in extremity |
Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decr...
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Left arm pain and stiff; left clavicular lymph node swollen and painful; temp max 101; malaise, decrease appetite; loose bowel movement.
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| 47 | 2021-01-28 | tingling |
Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccinat...
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Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccination in her left arm. Within the 15-minute observation. She started developing a dry cough. She subsequently felt shaky, short of breath and felt a tingling in her throat. She states it feels funny when she swallows. She has noted tingling in her fingertips with associated discoloration. She has not noted any redness or swelling at the injection site. She has not developed a rash on her skin. She does have a history of COPD and uses inhalers and nebulizers. She has not tried an inhaler for the cough. She has had multiple medication allergies in the past including reactions to the Pneumovax and MMR. She denies chest pain. She has no abdominal pain. No nausea or vomiting. No leg pain. The patient presents to the emergency department after developing a cough, throat discomfort, shortness of breath and paresthesias following COVID-19 vaccination at 4 PM. She has no evidence of swelling of the lips, tongue or oropharynx on exam. She has no stridor or wheezing on exam. Her pulse oximetry readings are in the high 90s on room air. She received Benadryl, prednisone and a nebulizers treatment. She was observed in the emergency department for 2 hours and had improvement in symptoms. She was discharged in stable condition.
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| 47 | 2021-01-28 | tremor |
Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with h...
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Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with hospital grade temporal thermometer. Pulse rate of 140 and POX of 96. At 07:23 took 650mg Tylenol and 50mg oral diphenhydramine with 16 oz water. Chest tightness subsided around 10 minute mark and shaking stopped after one hour. Sleep from 10:00-16:00. Woke up with a headache and mental confusion.
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| 47 | 2021-01-29 | numbness, muscle spasms |
Woke with severe pain in right cervical spine muscles, right upper shoulder. Sharp burning radiatin...
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Woke with severe pain in right cervical spine muscles, right upper shoulder. Sharp burning radiating pain progression to right deltoid. Treatment, tried Aleve, Tylenol, massage without relief. Emergency room visit 1/27 8am due to worsening Symptoms. Dx of muscle spasms, prescribed Valium a 8 hours, lidocaine patch and Tylenol, heat. No relief to of pain. TeleHeath with pcp on 1/28, who again dx muscle spasm. Changes script to flexeril. No relief in pain and now new onset of numbness right . uncertain if this is related to covid but occurred less than 24 hours after vaccine and have never experienced this issue before and no other mitigating cause known
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| 47 | 2021-01-31 | burning sensation, tingling |
my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across ...
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my right arm started to feel like it was on fire; This feeling quickly spread up my neck and across my chest; red splotchy rash; right side of my head was tingling; I was mildly tachycardic; This is a spontaneous report from a contactable other Health Professional (patient). A 47-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1284), via an unspecified route of administration on 06Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included allergies to adhesive and nickel. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. There were no concomitant medications. It was reported that the day after vaccination, patient's right arm started to feel like it was on fire. This feeling quickly spread up neck and across chest and this area had a red splotchy rash. The right side of head was tingling. Patient took 50 mg diphenhydramine hydrochloride (BENADRYL) and headed to ER (Emergency Room) where patient received Dexamethasone. Patient was mildly tachycardic. Above events started on 07Jan2021 at 12:30. Outcome of the events was resolved.; Sender's Comments: The events are considered related to the suspect product based on the strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-01-31 | facial paralysis |
Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. ...
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Individual developed a severe headache followed by a bloody nose post-vaccination with second dose. Individual reports continuing intermittent headaches followed by a bloody nose. She is to follow up with an ENT specialist. Patient also experiencing eye droop of right-side along with facial swelling of that side.
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| 47 | 2021-01-31 | flushing, night sweats |
Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, ...
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Onset of headache during wait time. 2130 chills, feverish, headache, rash. 0230 rash, itchy throat, flush, feverish, chills 1/23/21 headache, irritated throat, chills, feverish, rash, night sweats, swelling hands and feet, fatigue 1/24/21 itchy throat, rash, headache, chills, feverish, flush, swelling hands and feet 1/25/21 rash, irritated throat, headache, chills, feverish 1/26/21 mild rash, headache, chills, feverish 1/27/21 chills, feverish, mild rash 1/28/21 itchy throat, flushed, itchy, rash on entire body, feverish 1/29/21 mild rash, chills. 1/30/21 flushed and itchy, itchy throat, chills, feverish
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| 47 | 2021-01-31 | pain in extremity | Chest pain. Upper back pain, jaw pain, pain in opposite arm |
| 47 | 2021-01-31 | tremor | Days 1-3: Fatigue Day 4 (2/1/21): Fever of 100.5, shakes, and rash on left forearm |
| 47 | 2021-02-01 | weakness, tremor |
discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my l...
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discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my legs; Within 10mins I was feeling dizzy; increase palpitation; I told the nurse she checked my blood pressure. It was 157/87; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on the right arm on 15Jan2021 15:45 at a single dose for an COVID-19 immunization at a hospital. Medical history included GERD. There were no concomitant medications. On 15Jan2021 at 15:45 (reported as within 10 mins), the patient felt dizzy and increase palpitation. The patient told the nurse and she checked her blood pressure, it was 157/87. After 15 mins of vaccine infusion (16:00), she came back home and increased weakness with shakiness in legs noted. After 2 hrs. (18:00) all symptoms were gone. The next morning (16Jan2021), the patient had discomfort in her sternum. By late afternoon, she had trouble breathing with chest congestion. The patient took 3 puffs of inhaler so she can breathe. The patient mentioned that her inhaler is expired, it was given to her 3 years ago. She didn't want to use it but used it anyway so she can sleep. The events dizzy, palpitation, blood pressure high, weakness, shakiness, and discomfort in sternum were not treated. The outcome of the events weakness and shakiness was recovered on 15Jan2021 at 18:00 while the other events were unknown. Information about lot/batch number has been requested.
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| 47 | 2021-02-01 | feeling hot, flushing |
Employee reported that she had "flushing and felt very warm" for about 1 hour post Covid vaccination...
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Employee reported that she had "flushing and felt very warm" for about 1 hour post Covid vaccination at 2pm on 12/17/20. This dissipated after 1 hour. Employee then reports she "felt constipated and took some Dulcolax," and ate some food on the way home. At 1 am on 12/18, employee awoke with sore throat and began to experience intractable nausea, vomiting and diarrhea. At 5 am on 12/18, employee came to emergency department for treatment. She was given Zofran, dicyclomine and Tylenol # 3 and then discharged to home. Employee reports that nausea, vomiting, and diarrhea (with blood present), continued for several days and she was unable to work. On 12/22/20, employee still feeling ill, unable to eat with severe n/v/d. was given new prescription for Zofran as she reports she had used all of prior prescription from ER (was taking every 6-8 hrs). Employee began feeling better on 12/23/20 and returned to work. She reports she is not sure if reaction was from vaccine or not.
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| 47 | 2021-02-01 | feeling hot |
Felt warm and pain in upper back, 5 minutes after receiving vaccine. No numbness or tingling. BP - 1...
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Felt warm and pain in upper back, 5 minutes after receiving vaccine. No numbness or tingling. BP - 140/90, pulse 62, O2 sat 100%. Patient rested and felt better. Resolved, went home.
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| 47 | 2021-02-01 | numbness, tingling |
Patient reports intermittent numbness and tingling to bilateral thumbs, index and middle fingers and...
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Patient reports intermittent numbness and tingling to bilateral thumbs, index and middle fingers and palms. Patient states symptoms started the same day as receiving her second dose, later in the day. Patient unsure if she will seek further evaluation.
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| 47 | 2021-02-01 | numbness |
Received shot at approximately 2pm and was in observation chairs. Around 205pm I took a dose of tyl...
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Received shot at approximately 2pm and was in observation chairs. Around 205pm I took a dose of tylenol to attempt to prevent fever. I immediately noticed that the medication felt stuck in my esophagus and it was hard to swallow them down. Being a nurse I began to monitor more closely my breathing. I was able to take air into my lungs easily. Next I noticed that my nose became very stuffy and was difficulty to breath through but my airway continued to seem ok and I was breathing without difficulty through my nose. By about 210pm I had noticed that my face felt strange. As another few minutes progress my entire face felt numb like when your dental lidocaine is wearing off. It was a very disturbing feeling. I never had difficulty breathing but the throat and nasal swelling lasted about 1 1/2 hours. The facial numbness lasted at least 4 hours and my nose and tongue still feel a little strange even at this moment. I stayed in the observation area for about 35 minutes just to make sure I was not going to lose my airway before leaving. I am a nurse and I didn't want to get sent to the ER for hours just to be given benadryl since my airway was ok so I didn't report it at the time of incident. I had preloaded with zyrtec, pepcid and ibuprofen the morning prior to injection to try and avoid reaction or side effects that others were reporting. I think if I had not had antihistamine in my system I would have had anaphylaxis for sure. I went straight home and took more antihistamine. Contacted my doctor so she knew of the symptoms. She told me to continue the antihistamines for a few days and to go to the ER if severe issue happened. This was a VERY VERY scary incident. For a little history: after my first vaccine I noticed itching on my chest but couldn't see any rash. About day 3-4 a rash appeared. I was unsure if this was vaccine related since it took 3 days to appear. It was cleared after a few days of steroid cream.
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| 47 | 2021-02-01 | pain in extremity |
FEVER 100.4, BODY ACHES, HEADACHE, LEFT ARM PAIN - INITIALLY AT INJECTION SITE LATER ON FIRST DAY, A...
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FEVER 100.4, BODY ACHES, HEADACHE, LEFT ARM PAIN - INITIALLY AT INJECTION SITE LATER ON FIRST DAY, AND THEN ON 1/3/2021 NOTICED RED SPOT JUST BELOW INJECTION SITE THAT WAS TENDER AND WARM TO TOUCH, ROUGHLY 3X3 IN SIZE. ALSO FELT PAIN IN ARMPIT, TENDER TO TOUCH, BUT NO REDNESS. SINCE 1/30/2021 TOOK TYLENOL 5OOMG 1 - 2 TABS EVERY 6-8 HOURS AS NEEDED. RELIEVED MOST OF PAIN FEVER AND BODY ACHES SUBSIDED BY DAY 2 WHICH WAS 2/1/2021. HEADACHE AND ARM AND ARMPIT PAIN PERSIST
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| 47 | 2021-02-01 | tingling |
throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from...
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throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "throat closing" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-03 | weakness, numbness, face paralysis, throat numbness |
Immediately upon having the injection administered, my heart rate sped up. I sat down within the wai...
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Immediately upon having the injection administered, my heart rate sped up. I sat down within the waiting area for monitoring thinking that if I sat down for a bit, that it would maybe pass . Within about 7 minutes of that, I began to feel the back, left side of my throat go numb. I began to get very dizzy after that and I alerted one the pharmacy Nurses, that was on duty. She asked for me to open My mouth so that she could see if my throat was swelling & said that she didn?t see anything and I was told by her that it may just be anxiety that I was experiencing and she asked me to take a few sips of water and to try and relax a bit. She resumed helping others, while I continued to sit there. It was then when I experienced a heavy onset of chest tightness and the inability to breathe. The left side of my face and jaw went numb & that?s when I really knew something was wrong. I was taken outside for some fresh air and realize that I was so nauseous, more dizzy, very weak upon standing and I told the same nurse and another young lady that was assisting me that I felt like I was going to pass out and to please call EMS for me . At that time, I lost temporary feeling in all 4 limbs and I began to experience heart palpitations . I was having some trouble swallowing and I was laid down and. My blood pressure was taken. Blood Pressure was 235/130 and it was taken several times until emts arrived. It was then 200/120 and 180/112 by the time help arrived. Overall I experienced burning sensation in chest and abdomen, facial weakness and numbness left side fever loose stools weakness, shortness of brEath and chest tightness blurred vision felt like I?m out of touch with reality Malaise restless and the loss in feeling in my Limbs are slowly returning body And muscle and joint aches and pains and wheezing bouts
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| 47 | 2021-02-03 | bell's palsy | Acute development of Symptomatic Facial Bell's Palsy |
| 47 | 2021-02-03 | feeling of body temperature change | NauseaVomiting "Hot and cold, afebrile" Narrative: |
| 47 | 2021-02-03 | numbness, weakness | severe body pain, right leg numbness ,weakness and tired, diarrhea. |
| 47 | 2021-02-03 | numbness, tingling, weakness |
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ...
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Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-03 | numbness, tingling, feeling cold |
Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and ...
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Employee began complaining about a "cold feeling" in her rt arm followed by numbness and "pins and needles" like sensation. She also complained that her rt arm was feeling swollen and red. Mild redness noted upon assessment but no obvious swelling visually. Observed employee for 30 minutes after vaccine and symptoms persisted. Employee has a history of severe reactions to food and medications. Vital signs obtained and BP noted to be in 150s/90s, Hr in 90's, temperature and oxygen saturation were both within normal limits. Employee denied any feeling of swelling of face or throat, but was taken to emergency department onsite for further evaluation as her numbness continued to persist past 30 minutes observation. Employee reported that she was triaged only and was in lobby for about 2.5 hours after which time she left since she felt her symptoms were improved. She called her PCP when she arrived home and was instructed to take 25 mg of Benadryl orally. Employee reported that her symptoms completely resolved after that and that she had no subsequent symptoms.
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| 47 | 2021-02-03 | pain in extremity | Nausea, body aches, chills, swollen glands, sore arm. |
| 47 | 2021-02-03 | tingling |
Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressu...
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Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
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| 47 | 2021-02-04 | feeling cold |
Fever recorded was 101.6/fever recorded was 101.9; body aches; feel chill/fet chill; This is a spont...
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Fever recorded was 101.6/fever recorded was 101.9; body aches; feel chill/fet chill; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247; expiration date not provided), via an unspecified route of administration (anatomical location: left arm) on 20Jan2021 at 09:20 am at SINGLE DOSE for covid-19 immunisation. Patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient has no allergies to medications, food, or other products. Patient reported that she got the vaccine at 9:20 am on Tuesday (20Jan2021). Patient started to feel chill at 08:30 pm. Fever recorded was 101.6 at 11 pm. Patient took paracetamol (TYLENOL extra strength). Felt chill again and fever recorded was 101.9. Took again 1 extra strength paracetamol. Felt chill and fever at 11 am. It was reported that patient also experienced body aches on 20Jan2021 at 08:30 pm. The patient underwent lab tests and procedures which included body temperature with result of 101.9 and body temperature with result of 101.6 on 20Jan2021. The events were assessed as non-serious. Outcome of the events was unknown.
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| 47 | 2021-02-04 | feeling cold | Sever chills, fever, feeling of being cold, headache, exhaustion and terrible body aches |
| 47 | 2021-02-04 | feeling jittery |
getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from ...
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getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from a contactable pharmacist, reporting for herself. A 47-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via an unspecified route of administration on 14Jan2021 at 16:30 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Stage IV endometriosis, AVNRT/SVT cardiac arrhythmia, survivor of clear cell renal cell carcinoma (treated 2010), allergies: Lupron (rash), environmental allergies (grasses, trees, weeds, molds, animal dander), all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Drospirenone, ethinyl estradiol, betadex clathrate (YAZ), levonorgestrel (MIRENA), cetirizine hydrochloride (ZYRTEC), metoprolol succinate (TOPROL XL), and unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 21:30, the patient starting getting jittery, tense, antsy, "keyed up". She took her blood pressure and it was 154/85. One hour later it was 148/89. Two hours later it was 158/88. The next day, on 20Jan2021 (day 6 post-vaccine), the blood pressure reading in the morning upon arising was 154/86. At 5 pm, it was 166/91. She doubled up on metoprolol succinate (TOPROL XL) dose, which didn't seem to alter the blood pressure at all, based on the home monitor readings. On day 7 post-vaccine (21Jan2021) it is as if the preceding day with the elevated blood pressure never happened; she felt perfectly fine and normal. Day 7 post vaccine, blood pressure resumed normal levels (115-120/70-80). The patient did not receive treatment for the events. The clinical outcome of getting jittery, tense, antsy, "keyed up", and blood pressure: 154/85 was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 47 | 2021-02-04 | numbness, weakness | Body pain Diarrhoea Numbness of right arm Weak and tired |
| 47 | 2021-02-04 | pain in extremity | Severe arm pain and arm sensitivity changes |
| 47 | 2021-02-04 | tingling, numbness, discomfort |
2nd dose: Pt c/o "numbness down my arm and it feels cold down to my hand" left arm, "intermittent ...
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2nd dose: Pt c/o "numbness down my arm and it feels cold down to my hand" left arm, "intermittent numbness". Tingling felt like crawling ants on arm. "more numb in my last two fingers", "discomfort in nape of neck, lightheadedness, and tunnel vision". Patient given 8oz of fluids, PO. BP: 180/105. No medications administered. Transported to ED. Recovered night of 1/16/21.
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| 47 | 2021-02-05 | muscle spasms |
12 hours after second injection, localized swelling and edema of right arm and shoulder extending to...
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12 hours after second injection, localized swelling and edema of right arm and shoulder extending to right ribcage. Fourteen hours post-injection (2nd dose only)Fever of 103.5, myalgia, chills, stiff neck, sheadache, and significant sharp pain in joints, muscle cramping in legs and arms. After treating with 600 mg ibuprofren, fever was reduced to 101.0. Fever recurred four hours later with profuse sweating. 600 mg of ibuprofren taken which again reduced fever to 99.8. At 24 hours post injection, swelling of ribcage and shoulder is subsiding, fever of 99.9. Having survived septic shock in 2011, I can say this felt the same. It was extremely painful.
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| 47 | 2021-02-06 | weakness, numbness, cold sweat, pain in extremity |
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w...
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2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
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| 47 | 2021-02-06 | cold extremities, feeling cold |
By 2nd night my hands and feet were freezing.. I felt extremely cold but had no fever and didn't fe...
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By 2nd night my hands and feet were freezing.. I felt extremely cold but had no fever and didn't feel sick.. By third night my lower back down thru my hamstrings and half muscles were weak and extremely sore. It felt like I overworked my muscles but I didn't workout or strain myself during this vaccination and thereafter. Hopeful few days soreness will be gone. Just wanted to report what I'm experiencing so far. Used heating pad and advil.
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| 47 | 2021-02-07 | difficulty speaking |
#1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surf...
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#1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surface of the skin, then it was black and blue. From start to finish from the redness to the bruising was about 3 days. #2 Sore throat, followed by hoarseness and then ultimately loosing my voice, body aches, headache, fever and chills with the fever lasting 4 days and ranging from 99.5 to 106.1. Also have had a runny nose, followed by congestion with a course and constant productive cough. I still have all the symptoms listed above today 02/08/2021 except the fever, chills and body aches.
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| 47 | 2021-02-07 | flushing |
Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushe...
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Patient received injection and then started feeling heart racing like palpitation, dry mouth, flushed feelings. Patient stated she did not eat breakfast and has not been drinking water. Patient also states she has a history of panic attacks, anxiety, IBS, Cevo. Patient did have c/o a slight headache however, felt it was due to lack of water intact today. Patient sat for remaining 30 minute observation with nurse and provider on duty and was given water. At the end of the 30 minutes patient had decreased symptoms and stated her husband drove her. Provider gave ok for patient to take a prescribed Lorazepam when arriving home today. Patient discharged home after 30 minute observation period was complete with husband.
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| 47 | 2021-02-07 | numbness, tingling |
Numbness in left leg severe enough that could not walk properly. Heart was racing per patient, Pul...
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Numbness in left leg severe enough that could not walk properly. Heart was racing per patient, Pulse felt normal approx. 80bpm. Left foot was tingly. Wheelchaired to Emergency Room.
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| 47 | 2021-02-07 | pain in extremity | Very sore arm leading up to the shoulder, body aches especially neck area, chills, tiredness. |
| 47 | 2021-02-07 | pain in extremity |
she felt pain in the arm and body; she felt pain in the arm and body; inflammation in the injections...
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she felt pain in the arm and body; she felt pain in the arm and body; inflammation in the injections site; fever; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 21Jan2021, she felt pain in the arm and body, inflammation in the injections site and fever and had taken 6 Tylenol tablets as treatment, but the fever has not been fully controlled. The outcome of event fever was not recovered; for other events was unknown. Information about lot/batch number has been requested.
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| 47 | 2021-02-07 | tremor |
Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (cli...
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Patient complained of visual changes, shakiness, N/V and fatigue. Remained in Observation Area (clinic) extended by per RN. VS assessed frequently. EMS called due to patients condition not improved but worsening and transported to ER. Patient noted similar reaction with first vaccine. Patient had COVID in September.
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| 47 | 2021-02-08 | weakness |
Light headed. Heart palpitations. Faint. Headaches. Weakness. Dizzy. Since vaccine. Been seen by u...
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Light headed. Heart palpitations. Faint. Headaches. Weakness. Dizzy. Since vaccine. Been seen by urgent care and doctors. Wearing heart halter monitor. Symptoms have not gone away. Insomnia worse. Started 12 hours after vaccine. All labs normal 5 days before and all labs normal now., but still having symptoms. Missing work.
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| 47 | 2021-02-08 | hot flush, cold sweat |
Having redness, swelling and site of injection is warm to the touch still today 2/9 .. 2 days after ...
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Having redness, swelling and site of injection is warm to the touch still today 2/9 .. 2 days after injection. Yesterday 2/8 I had flu like symptoms all day including hot flashes followed by cold sweats, body aches all over body and extreme fatigue.
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| 47 | 2021-02-08 | numbness | high blood pressure, dizziness, numbness of leg |
| 47 | 2021-02-09 | weakness |
Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart ...
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Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart rate racing; injection site pain; This is a spontaneous report from a non-contactable consumer (patient herself). A 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration (left arm), on 21Jan2021 16:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever up to 102.5, nausea, dizziness, muscle aches, joint aches, headache, fatigue, weakness, heart rate racing, and injection site pain - all on 22Jan2021 02:00. No treatment was received for the events. The patient had not recovered from the events at the time of the report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-02-09 | involuntary muscle movements |
Mild headache, mild vertigo, aches and pains, in particular upper body joint pain through the should...
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Mild headache, mild vertigo, aches and pains, in particular upper body joint pain through the shoulders (that felt different from fibro fog), and congestion. Waking up the next day I had some pretty severe congestion and was experiencing gross motor control problems, I felt like everything was in slow motion. The next day I woke up and the body pain was much better. I was fatigued. Cognitively, I was not thinking straight. Waking up Tuesday, I was still tired but acting more like myself with a mild headache.
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| 47 | 2021-02-09 | migraine |
Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swol...
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Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swollen on left arm pit area; This is a spontaneous report from a contactable other healthcare professional(patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302), intramuscularly into the left arm on 23Jan2021 11:45 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included escitalopram oxalate (LEXAPRO), riboflavin (RIBOFLAVIN), multivitamins and antihistamine (unspecified). The patient was previously administered with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El0140), intramuscularly into the left arm on 02Jan2021 12:30 at a single dose for covid-19 immunization. On 23Jan2021 20:30, patient experienced chill, fever, body aches, migraine and dizziness. On 23Jan2021, patient experienced soreness at injection site, headache and lymph node swollen on the left armpit area. The patient did not receive treatment for the events reported. Outcome of events were recovering.
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| 47 | 2021-02-09 | pain in extremity |
Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the tas...
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Arm and head hurt badly; Sick to her stomach; Lost most of the taste and smell; Lost most of the taste and smell; Weird taste in her mouth; Headache; Swelling in her throat; Injection site pain; Muscle pain; Injection site swelling and redness; Injection site swelling and redness; Swollen lymph node; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 24Jan2021 at a single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medications were not reported. It was reported that the patient got the COVID-19 vaccine shot on 24Jan2021. When she sat there for 15 minutes, she got a weird taste in her mouth and got a headache. At 2 PM she still had a headache and she lost most of the taste and smell; at 4 pm she was sick to her stomach; by 5:15, her arm and head hurt badly, the taste in her mouth was like super weird but it was not exactly metallic taste it was weird bizarre taste she never had before. Her smell came back. She was extremely nauseated and had a bad headache. She stated that all of her symptoms were gone away except the swelling in her throat. She further stated she called the hospital and stated she got injection site pain, headache, and muscle pain. She also got injection site swelling and redness, nausea, swollen lymph node and a headache and the weirdest part that really bothered her was the strange taste in her mouth. She got some of the smell and taste back and now it's gone; it's really bizarre like the injection site pain, the headache everything was gone literally gone. The only things that was still hanging on was her lymph nodes and throat. The second due dose of vaccine was on 14Feb2021. The patient has not recovered from swelling in her throat and swollen lymph node, and has recovered from other events. Information on the lot/batch number has been requested.
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| 47 | 2021-02-09 | pain in extremity |
8-10 hrs post injection bad arm pain; with in 16-24 hours cold symptoms that are getting worse; we a...
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8-10 hrs post injection bad arm pain; with in 16-24 hours cold symptoms that are getting worse; we are now over a week a later and still runny nose; sore throat; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 47-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), at age 47 years, via an unspecified route of administration on the left arm, on 16Jan2021 13:15, at single dose, for COVID-19 vaccination. Medical history included low level diabetic, knee issues and milk allergy from an unspecified date. Patient had not had COVID prior to vaccination. Patient had not had other vaccine in four weeks. Concomitant medication included calcium (CALCIUM), fish oil (FISH OIL), glucosamine sulfate (GLUCOSAM), methylsulfonylmethane (MSM [METHYLSULFONYLMETHANE]), magnesium (MAGNESIUM) , cetirizine hydrochloride (ZYTREC) from unspecified dates. The patient previously took ASPRIN and was sensitive to it on an unspecified date. It was reported that on 16Jan2021 21:30, 8-10 hrs post injection bad arm pain, like yellow fever shot, then with in 16- 24 hours cold symptoms that are getting worse, at the time of report, over a week a later and still runny nose, and sore throat, no symptoms prior to shot. There was no treatment for the events. Patient was not tested for COVID post vaccination. Facility type vaccine: Doctor's office/urgent care. The outcome of the events was recovering.
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| 47 | 2021-02-09 | tingling, weakness |
Fatigue; headache; weakness; nausea; tingling on right side of body; This is a spontaneous report fr...
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Fatigue; headache; weakness; nausea; tingling on right side of body; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (right arm) on 22Jan2021 17:30 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included lisinopril from an unspecified date for an unspecified indication. The patient previously took Codeine and Compazine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 (13:00), the patient experienced fatigue, headache, weakness, nausea, and tingling on right side of body. There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-02-09 | tremor |
Two days later I developed fever and shaking and headache; Two days later I developed fever and shak...
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Two days later I developed fever and shaking and headache; Two days later I developed fever and shaking and headache; Two days later I developed fever and shaking and headache; This is a spontaneous report from a contactable healthcare professional. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on her left arm on 22Jan2021 09:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included terconazole, duloxetine hydrochloride (CYMBALTA), fluconazole. The patient reported that two days later, she developed fever and shaking and headache; all on 24Jan2021 11:00AM. No treatment was received for the events. The outcome of the events was not recovered. Information on the Batch/Lot number has been requested.
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| 47 | 2021-02-09 | tremor |
Muscle pain from the injection occurred and lasted approximately 4 days. In addition, about 24 hour...
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Muscle pain from the injection occurred and lasted approximately 4 days. In addition, about 24 hours after receiving the vaccine, I began having uncontrolled tremors that lasted about 12 hours. I also had a fever and fatigue which lasted about 3 days.
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| 47 | 2021-02-10 | pain in extremity |
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f...
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her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-14 | cold sweat |
0944 pt c/o lightheadness, sweaty, clammy. physician at vaccine clinic saw pt at that time. b/p 129/...
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0944 pt c/o lightheadness, sweaty, clammy. physician at vaccine clinic saw pt at that time. b/p 129/70 HR 94 O2 100% on room air. pt was laid down flat on a stretcher. 0946 pt states felt better. b/p 123/71 hr 86 O2 99% 0948 pt states better 123/82 hr 90 O2 99% 0952 b/p 128/78, hr 97, O2 99% 0955 b/p 122/75, hr 95, O2 100%. given water. physcian saw pt again and discharged pt.
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| 47 | 2021-02-14 | feeling cold | cold shivers, headaches, dizziness, nausea, temperature |
| 47 | 2021-02-14 | feeling cold |
The same day coming from Laredo, TX to Midland, TX exp body aches in my back. I started feeling cold...
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The same day coming from Laredo, TX to Midland, TX exp body aches in my back. I started feeling cold chills took 2 Tylenol on that Monday. On Tuesday around 3:00 am started chills (bilateral hands), body felt cold and very hard for me to walk. Due to the chills I was taking warm showers (10 mins) for my body to get to regular temp. I went to Urgent Care get tested. The following Friday I felt really,really bad I thought something else was going on with me. I called the Urgent Care again I began to have fever was told might be side effects from vaccine. I followed up with PCP on 1/14 advised to take the second dose and continue taking vitamins.
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| 47 | 2021-02-15 | weakness, facial pain |
With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose ...
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With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose I had severe fatigue, joint pain, my wrist and my armpit was budging, I noticed swelling my clavicle on my left side, chills, and dizzy. I had to miss work for 2 days. I had to lay bed in for 2 days. By 3rd it was much improved but I still feel weak. About 4 days after receiving the vaccine I was back to feeling my self. On 2/14-15/2021, my face was itching, I scratched it, and there is a small abrasion. My face started to swell, around 2AM this morning I had to go to the ER because my eyes were getting small, the swelling was getting worse. I also had bumps that looked like hives on my face, there was some fluid coming out of my face. I went to early this morning, The ER doctor said she thinks it is not infected she thinks it is inflamed. I did not mention that I had recently received the COVID vaccine and did not realize that it may be linked to the vaccine until later in the day. She prescribed Hydrocortisone 0.5 % cream and Mupirocin 2% cream. Since I have been home the ER the swelling has worsened. My face is painful, it feels like an orange peel when you touch.
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| 47 | 2021-02-15 | hot flush |
I started 2/11/21 at 11:45 am to have stomach cramps. The stomach cramps started mildly. Around 1:30...
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I started 2/11/21 at 11:45 am to have stomach cramps. The stomach cramps started mildly. Around 1:30 pm, the stomach cramps became very intense followed by hot flashes and nausea. I vomited twice and caused my head to ache. I decided to be observed. Once I arrived at clinic, I started to have chills and muscle pain.
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| 47 | 2021-02-15 | pain in extremity |
Arm was very achy the first 12-14 hours. Kept me awake that night. Injection site was very sore to...
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Arm was very achy the first 12-14 hours. Kept me awake that night. Injection site was very sore to touch. After 5 days, still have severe joint pain in left shoulder (side which injection was given) which is constant.
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| 47 | 2021-02-15 | tingling | Tingling in arms/hands and legs/feet |
| 47 | 2021-02-17 | numbness, nerve pain |
My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, g...
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My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, gums, and inside lips); sores in nostril; sores on nose and lips; sores on nose and lips; Face swelled significantly on my left side; pink eye; severe headache; sinus pain; jaw main and numbness in my molars; severe shooting nerve pain in my front teeth; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 18:45 at a single dose for covid-19 immunization. Medical history included breast cancer survivor as of 11Sep2019. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), clonazepam, anastrozole (ARIMIDEX), vitamin D3, calcium, vitamins NOS (MULTIVITAMIN), "It Works" and "Fat Fighter". The patient previously took fentanyl but had allergies. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph node in her neck swelled to the point it stuck out like a robin egg. It was mentioned that it was more swelled there as well and super sensitive to touch. These reactions occurred only on left side of her face, sores in mouth (roof, gums, and inside lips) and sores in nostril. She had sores on nose and lips. The patient mentioned that her face swelled significantly on her left side. She had pink eye, severe headache, sinus pain, jaw main and numbness in her molars, severe shooting nerve pain in her front teeth. The events were considered as non-serious and adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. The events required treatment for the adverse events that included Keflex, Bactroban, prednisone, Valtrex, and lidocaine viscous-aluminum &magnesium hydrAM. The outcome of the events was recovering.
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| 47 | 2021-02-18 | burning sensation |
After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 4...
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After the first injection, I got a upper chest rash but did not relate this to the vaccine. After 48 hours of the second injection on 1/8/2021, I had angioedema facial swelling on the lids of my eyes bilaterally, facial burning- lips, nose, and right side of face, as well as the upper chest rash. Tried cool compresses, ibuprofen and rest however did not go away. Went to employee health, threw away all my make up incase, prednisone taper and antihistamine QD, eat clean, lots of water. The swelling went away after a few days of cool compresses and when on 10 mg of the prednisone taper, it came back. Went to PCP this time and gave me dexamethasone injection, prednisone taper, antihistamine BID and continue all other o
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| 47 | 2021-02-21 | numbness, flushing |
About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, stron...
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About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated. Received 50mg of Benadryl.
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| 47 | 2021-02-21 | pain in extremity |
sore arm x2 days; This is a spontaneous report from a contactable consumer (patient). A 47-year-fema...
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sore arm x2 days; This is a spontaneous report from a contactable consumer (patient). A 47-year-female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Jan2021 16:15 (lot number: el3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history was not reported. The patient's concomitant medication included hydrochlorothiazide, quinapril hydrochloride (ACCURETIC). The patient did not receive other vaccines within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm x2 days on 21Jan2021 at 07:00 AM. The patient did not received treatment. The consumer assessed the event as non-serious. The outcome of the event was recovered in 23Jan2021. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-02-23 | pain in extremity, weakness |
One day after vaccine-lethargy, no energy Two days after vaccine- lethargy, no energy, joint pain in...
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One day after vaccine-lethargy, no energy Two days after vaccine- lethargy, no energy, joint pain in arms and hands, swollen face Three days after-same symptoms Four days after-same symptoms but lethargy worse and some dizziness
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| 47 | 2021-02-23 | pain in extremity |
Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelli...
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Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
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| 47 | 2021-02-24 | weakness |
I had Covid-19 after my 1st vaccine. I experienced shortness of breath, fever, body aches, headaches...
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I had Covid-19 after my 1st vaccine. I experienced shortness of breath, fever, body aches, headaches, nausea, diarrhea, cough and also had loss of energy.
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| 47 | 2021-02-24 | tingling |
Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past menin...
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Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past meningitis event. Insomnia, vision changes, agitation. Prednisone is helpful in making pain bearable. Gabapentin started today. Labs pending.
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| 47 | 2021-02-25 | migraine |
sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit,...
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sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was more diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: May2021), via intramuscular route of administration on 26Jan2021 at 11:30 at 0.3 mL, single on the left arm for COVID-19 immunization. Medical history included ongoing migraine and vomiting. Concomitant medications included ongoing sumatriptan succinate (IMITREX) for migraine, ongoing nadolol for migraine, ongoing sertraline for migraine, and ongoing ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). On 26Jan2021 at 13:00, the patient experienced really bad migraine. The patient always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea. The husband does not know if it was because of the shot or if it was because of the warm front that they are receiving because sometimes that can trigger her migraines. The husband reported that it was pretty typical for her and she will sleep with a fan on, but today she is actually covered up (for clarification) and does not want the fan on. Patient also started sweating and got nauseated on an unspecified date. The husband wanted to know if he needs to take her to the doctor. The outcome of the events really bad migraine and diarrhea was not recovered while the other events was unknown.
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| 47 | 2021-02-25 | tingling |
Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Betw...
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Around 4:00pm-4:15pm, began pin and needles discomfort in joints between fingers on right hand. Between 4:15pm-4:30pm, the palms of both hands, and my left wrist began to itch uncontrollably. Reported to EMT on duty to exam. Experienced elevated blood pressure of 163/93. No itching of throat nor any other body parts. Was advised to take Benadryl.
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| 47 | 2021-02-28 | discomfort, muscle spasms |
At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping...
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At roughly 2:30pm, started with nausea and chills, went home went to bed. Severe muscles cramping and soreness. Went to ER for this was perscribed naproxen for inflammation. Still nothing helped. Went back to ER with elevated heart rate and BP due to the discomfort was accused of being a pill seeker. I just want the pain and muscle cramps to stop. I hurt from head to toe.
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| 47 | 2021-02-28 | feeling cold |
Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, foll...
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Perfectly fine until about 25 minutes after the injection. Then, nausea and dizziness started, followed by burning and itching on both sides of tongue. Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth. Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy. It was not anaphylaxis because my breathing was okay. We drove home, and I took two Benedryl (50 mg) upon arriving home. Within 2 hours all symptoms subsided with the exception of a nasty headache. Today, I am fine, but just have a sore arm at the site.
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| 47 | 2021-02-28 | numbness, tingling |
Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling trav...
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Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling traveled down to legs bilat. Approx 15min after that, tingling traveled into face around cheeks and lips bilaterally. Patient noted numbness around face and lips. Pulse 70, Resp 14, no BP taken due to equipment failure. Recommended patient seek further medical observation by ER or Urgent Care, patient verbalized understanding.
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| 47 | 2021-03-02 | weakness | Chills, rapid Heart beat, weakness, fever |
| 47 | 2021-03-02 | pain in extremity |
I had my 2nd dose of Phizer Covid Vaccine on February 19, 2021 and had it in my left arm. My first ...
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I had my 2nd dose of Phizer Covid Vaccine on February 19, 2021 and had it in my left arm. My first dose 3 weeks prior was in my right arm. I did not experience any side effects from the shot for 4 days. I woke up on Tuesday, February 23rd and had pain in my right arm - the arm I had the 1st shot in, not the 2nd! I continued to have pain in my right arm for several days and then 6 days after my 2nd dose I started having extreme pain in my legs - from my knees up the back of my thighs for two days. Then 8 days after my 2nd dose my other arm became very sore, the arm I had the 2nd dose in. So both arms are sore and the lymph nodes under the arms are tender. Today I am 11 days out since my 2nd dose and I woke up and could barely lift my left arm. I have pain in both arms and lymph nodes. I went to my family doctor and he does not have any answers for me. I need to know if this is something I should be concerned about and if there is anything I can do to help these side effects go away. How long can this last???
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| 47 | 2021-03-02 | tingling, numbness |
numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to ...
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numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); felt acutely short of breath and anxious; felt acutely short of breath and anxious; numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 16:00 (at the age of 47 years old) at a single dose for covid-19 immunization. Medical history included known allergies: shellfish, seasonal allergies and psoriasis. Concomitant medications included several medications in two weeks. The patient is not pregnant. The patient had no other vaccine in four weeks. On 29Jan2021 23:45, after being asleep for approximately one hour, felt acutely short of breath and anxious, which lasted less than a minute and was then followed by numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE). These events resulted in emergency room visit. The patient underwent lab tests and procedures which included PCR/nasal swab on 29Jan2021 (post vaccination) which showed negative. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL), IVF. Outcome of all the events was recovering. Information on the lot/batch number has been requested.
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| 47 | 2021-03-03 | numbness |
Tachycardia. Laying in bed watching TV, suddenly my heart was racing. I just stayed in bed and it we...
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Tachycardia. Laying in bed watching TV, suddenly my heart was racing. I just stayed in bed and it went away after a few minutes. Numbness in the arm: started that night and I would get numbness about every other day. Numbness lasts for about 10 hours and comes and goes throughout the day. About 6 weeks after the vaccine, i got numbness in the left leg. Now the numbness in the arm is pretty much gone but the leg numbness is there.
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| 47 | 2021-03-04 | weakness |
Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; s...
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Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
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| 47 | 2021-03-04 | facial paralysis, night sweats, feeling hot, numbness |
The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I ...
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The entire left side of my body immediately felt mildly heavy and affected, but it was so minimal I thought it could be in my head. Throughout the evening after my shot I felt a bit of contracting of leg muscles and neck/shoulder muscles on the left side of my body. The left side of my face felt noticeably warmer than the right. This was all very mild, but just noticeable. In the middle of the night, I woke up with extreme night sweats but only on the left side of my body. The next morning (today) the left side of my face is still warmer but it feels droopy and bloated and slightly "Numbish". My left eyelid feels heavy. My left cheeks feel swollen and puffy and my left gums and lips feel slightly numb. I also have a very mild headache only on the left side. This is disturbing, while it is not debilitating or painful, it is strange and makes me think I should not get the next shot. Even as I type this, my left hand feels very fatigued. I don't know who to call or talk to about this. I do not have a health care provider.
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| 47 | 2021-03-04 | feeling hot |
1430 vaccine given. 1443 started feeling dizzy, light-headed, hot. b/p 140/90,hr-78,r-20, 02 sat 98%...
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1430 vaccine given. 1443 started feeling dizzy, light-headed, hot. b/p 140/90,hr-78,r-20, 02 sat 98%ra. 1450 cont hot and dizzy. HR-77,02 sat 98%ra. 1500 report cont hot and dizziness gone and starting to feel better. 1510 report dizziness gone and starting to feel tired. 1515 dizziness resolved, pt stood up no dizziness. b/p 142/82. hr-66, r-18, 02 sat 98%ra, 1520 pt went home with husband who is here with her. Instructed to f/u with MD prn
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| 47 | 2021-03-06 | numbness, tingling, throat numbness, tremor |
Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst ...
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Scratchy throat and tingly lips almost immediately, itchy inner wrists and ankles Growing to worst point about 36 hours after injection: Swelling in throat, tongue, face, lymph nodes, generalized swelling (all the way to fingers and toes). Tingling in lips, tongue, face, scalp, left leg and left arm Shaking hands and racing heart, intermittently 48 hours later Entire left hemisphere of body want numb for about three hours. I freaked out and cried. *I had the vaccine in my left bicep, and I have a pinched nerve in that shoulder, which is teemed to activate. The nerve has never caused numbness beyond my left arm before, however, Last round of trembling about 48 hours after injection 72 hours later: Left tonsil and throat and armpit lymph nodes still swollen, but markedly less. Moderate numbness in left cheek and left side of throat, but less.
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| 47 | 2021-03-07 | pain in extremity |
Nausea, uncontrollable chills, bone pain through out entire body, tired, sore arm, stomach cramps, h...
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Nausea, uncontrollable chills, bone pain through out entire body, tired, sore arm, stomach cramps, headache
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| 47 | 2021-03-07 | tingling, numbness |
Facial numbness, tingling in the nose, right ear hearing affected. Consulted with doctor's office ov...
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Facial numbness, tingling in the nose, right ear hearing affected. Consulted with doctor's office over the phone daily on 03/03, 03/04, 03/05.
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| 47 | 2021-03-08 | numbness |
I received my first COVID vaccination and woke up the next morning and I could not move my neck, my ...
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I received my first COVID vaccination and woke up the next morning and I could not move my neck, my shoulder hurt and my arm was numb all the way down it. The symptoms have persisted since 1/27/21
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| 47 | 2021-03-08 | nerve pain |
On 3/8/21 patient reports itchiness noted to injection site. On the following day 3/9/21, swelling ...
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On 3/8/21 patient reports itchiness noted to injection site. On the following day 3/9/21, swelling and redness noted to the area and feelings of slight nerve pain noted to left wrist area.
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| 47 | 2021-03-08 | pain in extremity |
Headache, tired, could not stay awake, chills, fever of 102, dizzy, sore muscles, sick at stomach, v...
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Headache, tired, could not stay awake, chills, fever of 102, dizzy, sore muscles, sick at stomach, vomited... started 3/5/2021 early morning, felt some better by 3/6/2021 in the morning, but still headache, sore muscles, and tired, felt significantly better morning of 3/7/2021. On 3/7/2021 injection site on left arm became red, swollen, warm, and itchy about the size of a hand, also had a similar spot on thigh about size of golf ball. Arm very sore. Redness, swelling, and warmth on arm and thigh getting better within 24-36 hours after appearing. By 3/8/2021 all symptoms seem to be gone or extremely minor.
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| 47 | 2021-03-09 | flushing |
I experienced red face/flushed face. I was already experiencing asthmatic symptoms the day before. ...
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I experienced red face/flushed face. I was already experiencing asthmatic symptoms the day before. I received benadryl at the vaccination site as they were concerned it was allergic. However, after follow up with my allergist/immunologist this was not determined to be an allergy. I have never had an allergic reaction to vaccinations in the past. She has cleared me to receive the second dose.
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| 47 | 2021-03-09 | pain in extremity |
I have sore joints in both hands/fingers, elbows, shoulders, ankles, and toes. The right side is wo...
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I have sore joints in both hands/fingers, elbows, shoulders, ankles, and toes. The right side is worse than the left. I take Advil for pain. I am uncomfortably sore. I am walking each day and we are painting our basement so those areas are getting a lot of movement.
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| 47 | 2021-03-09 | throat numbness |
Within 5 minutes of receiving my vaccine, I suddenly felt the back of my mouth, throat, and back of ...
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Within 5 minutes of receiving my vaccine, I suddenly felt the back of my mouth, throat, and back of my tongue feel numb. I also felt a slight nausea. The sensation lasted for about a minute. I told the staff at the hospital that was observing me. It started to subside gradually, but twice while I was still being observed the sensation came back, but not as strong and not for as long as it did the first time. I had no other symptoms. I want to add that I was not anxious about receiving the vaccine and nothing like this has ever happened to me before, but it was quite alarming at the time. I was observed for an hour in total after the shot. I was offered to go to the ER if I wanted to but I declined. It is now about 3 hours since the shot and I feel ok now just slightly tired.
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| 47 | 2021-03-11 | feeling cold, pain in extremity |
Injection site soreness started a few hours after the initial dose. That seem to ease up after three...
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Injection site soreness started a few hours after the initial dose. That seem to ease up after three days, but did not resolve. Between day five and seven, the soreness continued and progress into my arm and hand. By day eight, a deep cold sensation would randomly occur at the injection site that would radiate into the hand. Rubbing in the area intensified the cold. This has continued on and off over the past 10 weeks. Constant, Chronic soreness at the injection site that radiates into the arm with episodes of cold sensation
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| 47 | 2021-03-11 | numbness, throat numbness |
Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, ...
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Lips started swelling, heart rate doubled, bright red hives from head to toe, profuse perspiration, tightness in chest and throat, numb mouth and throat and chest, blood pressure very high, difficulty breathing, fever, PVCs (detected by EKG from EMS); benadryl 62.5mg then EMS arrived and gave IV steroid 125mg; EMS transported to ED where another 25mg Benadryl was administered and Pepcid 20mg; symptoms improved enough to discharge patient
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| 47 | 2021-03-11 | tremor |
near syncope, hypotension, shaking. Lasted 20 minutes in clinic with stable BP, HR, and SpO2 mostly...
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near syncope, hypotension, shaking. Lasted 20 minutes in clinic with stable BP, HR, and SpO2 mostly >96%. Dipped to 88% a few times. no respiratory symptoms, rash, or throat swelling. transferred from clinic to ED via ambulance
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| 47 | 2021-03-12 | depressed level of consciousness |
The patient reported to the pharmacy counter after her 1st dose of the COVID19 (Pfizer-Biotech) vacc...
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The patient reported to the pharmacy counter after her 1st dose of the COVID19 (Pfizer-Biotech) vaccination within 5 minutes stating "Guys, I don't feel good." One of the pharmacists grabbed her chair and moved it to our check out window and sat down with her to ask her what she was experiencing. I grabbed the blood pressure cuff and returned to the patient. The other pharmacist reported to me that she felt light-headed, dizzy, and that her throat was itchy. We administered 25mg of diphenhydramine (oral tablet) and gave the patient some water. We then checked her BP and it was 68/40, which prompted us to call 911 for assistance. The other pharmacist stayed with her until the paramedics arrived (~15 minutes). About 5 minutes later we rechecked her BP and it jumped to 144/90. I tried to assess the patient's coherence, which began to diminish as she was very confused and could not understand the questions we were asking her. About 1 minute before they arrived, the patient said her throat was feeling worse and swelling, so we went to grab an epinephrine pen. EMT's arrived right as the dose was about to be administered, so we stopped to let them take over.
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| 47 | 2021-03-13 | numbness, migraine |
3/3/21: 8:00PM development of fever (100.4F), chills, headache and slight abdominal pain 10 PM. In a...
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3/3/21: 8:00PM development of fever (100.4F), chills, headache and slight abdominal pain 10 PM. In addition to listed symptoms numbness in feet develops and abdominal pain worsens; treatment with acetaminophen 11:30 PM. Fever of 100.8F; severe URQ/ULQ abdominal pain; moderate chest pain; treatment with oxycodone. Also joint pain in shoulders and wrists (clears after a few hours) 3/4/21: 1 AM. Chest pain and abdominal pain and numbness in feet persist, while dizziness and migraine develop; treatment with 2.5 mg Zolmitriptan 6 AM. Moderate abdominal pain. Treatment with oxycodone 7:30 AM extreme dizziness develops rendering me unable to walk or stand 8:30 AM: temperature 99.8F rest of day: abdominal pain persists
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| 47 | 2021-03-14 | weakness, unresponsive to stimuli |
PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first sh...
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PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first shot, she complained of body soreness, weakness and headaches that did not go away until she had the stroke on 03/12/2021". Patient is now hospitalized and unresponsive.
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| 47 | 2021-03-15 | migraine |
Severe injection site pain; fever of 101.5 for 24 hours; severe chills; body aches; migraine; This i...
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Severe injection site pain; fever of 101.5 for 24 hours; severe chills; body aches; migraine; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 11Feb2021 at 14:00 (at the age of 47 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date for COVID-19 IMMUNIZATION. Relevant medical history included Epstein Barr. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included "Fiornel" and ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine. The patient received treatment for these events which included ibuprofen (ADVIL), acetaminophen, (TYLENOL) and "fiornel". The outcome of the events severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine was unknown. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 47 | 2021-03-15 | tingling |
Noticeable swelling of face and neck about 20-25 min or so after vaccine . No breathing issues but f...
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Noticeable swelling of face and neck about 20-25 min or so after vaccine . No breathing issues but felt face tingling similar to hyperventilating. ER visit identified normal o2 and provided allergic reaction treatment of benadryl pills and prednisone injection right arm.
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| 47 | 2021-03-15 | tenderness |
Today is the 8th day after 1st vaccination and I have swelling about the size of a quarter, heat and...
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Today is the 8th day after 1st vaccination and I have swelling about the size of a quarter, heat and itching at the vaccine site on my left arm. I also noticed earlier this morning around 6:45am that I had tenderness in the underneath [armpit] area of that same arm.
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| 47 | 2021-03-16 | burning sensation | Swelling red blotches burning feeling wierd shape tierd |
| 47 | 2021-03-16 | numbness, night sweats |
I got shot in left arm and entire left side of my body reacted. One the day of the shot, I got muscl...
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I got shot in left arm and entire left side of my body reacted. One the day of the shot, I got muscle aches in my left leg and my left arm and leg felt heavy. During the night, I got extreme night sweats but ONLY on the left side of my body. Right side was dry. The next day I got a headache on the left side of my head only, the left side of my face was hot and right side was cool, aches in my left leg arm, neck, and shoulder. Then my left side of my face became numb and swollen. The numbness on the left side of my face got a little better every day but lasted for a week and even 2 weeks later it feels a bit tighter than the right side. I am supposed to get the 2nd shot in a week, and I do not believe I should but really need to talk to someone about this. No one is returning my messages and I have emailed VAERS.. please help.
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| 47 | 2021-03-16 | tingling, numbness, pain in extremity, burning sensation |
This is a follow up report starting from day after that first report was made -Report # 244159 - Sta...
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This is a follow up report starting from day after that first report was made -Report # 244159 - Starting with the 17th of January - I was still having facial numbness/tingling/pressure in my head/feeling like head was going to swell; arms were so heavy - couldn't lift my arms - like a heavy pressure on my chest; breathing was a problem; Swelling in my head caused eye issues. 18th - tingling started on back of neck; affecting my hearing and eyes (swelling in head); a lot of cognitive challenges. 1-20-2021 - heart racing; itchy all over; blood pressure spikes. Heart can feel like it's too fast and then going too slow. 1-21-2021 - legs burning from waist to hip; chest pain; heart racing; struggling to breath. 1/22 - chest pain and discomfort - pain shooting through arms; didn't sleep well. Arms wanted to pull into my chest. Stomach cramping on 1/23 - stabbing pain in wrists and hands; left side on heart pain. Pain was like having a beating. Left knee pain - January 24 - up all night with shooting pain in arm; fine motor pain skills shot - can't do what I need to do. January 25 - Elevated heart rate; elevated blood pressure. 1/26 - vision challenges; fuzzy. Heart racing; feet swollen; face feels puffy doesn't look puffy - pressure/tingly feeling in left cheek. Ongoing and Changing symptoms every day/week - with no let up. 3/11/ - buckling of legs started. Big thing now is my legs are buckling (happening from the hips) - when I try to get up or walk. I haven't fallen yet but I know it's coming. 3/12/2021 - heavy weight back in the arms. I still don't have the fine motor skills. I still can't drive and don't have control over my body and reflexes enough. Still having Pressure in chest and the face and head swelling - is unbearable and affecting my vision. I will see a neurologist next month. Dr is not sure what to do. Jan 12 - first ER visit. I have specific notes/log on all of my symptoms each day. If anyone wants to call - please call on Mondays or Wednesdays only( or Saturday or Sunday.) Also, Menstrual cycle is wonky. I had a normal period before the vaccine - 12/28-12/31/2020 - but didn't have one in January and I had one in February 10th - but just one day; 3/11/2021 - I had my next one and it was four days long and fourth day was very heavy then all the rest of the days.
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| 47 | 2021-03-16 | tingling, seizure |
Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower...
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Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower lip, tingling in hands and feet, consistent headache, fatigue, memory problems, and filling out of my body are all still occurring five days later.
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| 47 | 2021-03-17 | feeling hot |
Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal...
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Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal but then became external. I felt light headed as if my BP was low. The next day I have a rash on my neck with bumps on the side I received the vaccine. I also have had a headache all day as well.
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| 47 | 2021-03-17 | numbness |
At 11:30 pm I woke up not being able to move any extremities except for my finger tips. I was fully ...
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At 11:30 pm I woke up not being able to move any extremities except for my finger tips. I was fully awake but my body would not follow any brain commands regarding any thoughts about moving any part of my body. I dozed back off to sleep and at 4 am I woke again only this time feeling pain all over my body. This time after heavy concentration my body began to follow thoughts of moving starting from my toes up to my neck. I had bad body aches and headache the next day and took Tylenol for it.
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| 47 | 2021-03-17 | pain in extremity |
Shoulder pain where shot was administered, arm still, hard to move. Took some Aleve and symptoms ha...
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Shoulder pain where shot was administered, arm still, hard to move. Took some Aleve and symptoms have lessened.
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| 47 | 2021-03-17 | pain in extremity | Injection site reaction - severe .. painful touse my arm.. lasted almost 24 hours |
| 47 | 2021-03-17 | tingling | Tingling on left side of face |
| 47 | 2021-03-18 | pain in extremity |
I had my vaccine shot at 6:50 in the afternoon, went home, felt sore and pain in my right shoulder w...
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I had my vaccine shot at 6:50 in the afternoon, went home, felt sore and pain in my right shoulder where I had the shot, sleep, took some advil pm so I can sleep, wake up today to get ready for work,(March 19), I cant move my right hand especially when im trying to lift it, causing too much pain, texted and called my company that i cant come to work because moving my right hand causing too much pain, called my doctor also
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| 47 | 2021-03-18 | pain in extremity |
Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain ...
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Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain and throbbing in leg couldn?t sleep with pain so on the evening of March 3rd I went to urgent care . Doctor didn?t think it was blood clot because I had no swelling or redness in my leg but gave me a script for ultrasound. I couldn?t get an appointment until the morning of March 5th . Was diagnosed with a very large blood clot in lower leg going up past my knee. I am now in Eliquis blood thinner for 3 months while they run tests
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| 47 | 2021-03-18 | pain in extremity |
Severe pain and heat radiating down right leg from the lower back down the buttock and front of righ...
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Severe pain and heat radiating down right leg from the lower back down the buttock and front of right thigh
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| 47 | 2021-03-18 | pain in extremity |
upper arm soreness for about 28 hrs; This is a spontaneous report from a contactable consumer (patie...
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upper arm soreness for about 28 hrs; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Left Arm on 05Feb2021 (Batch/Lot Number: EL3247) at a single dose for COVID-19 immunization. Patient had no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Feb2021 13:00, the patient experienced upper arm soreness for about 28 hrs. The outcome of event was recovered on 06Feb2021 17:00. Patient did not received any treatment for the event. Follow-up attempts are completed. The information on the batch/lot number has been obtained.
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| 47 | 2021-03-19 | flushing, difficulty speaking | Chest pain, funny feeling in throat, hoarse voice, headache, flushed |
| 47 | 2021-03-19 | muscle spasms |
Severe leg cramps in left calf muscle overnight, strong enough to wake me from sleep between 3:00-4:...
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Severe leg cramps in left calf muscle overnight, strong enough to wake me from sleep between 3:00-4:00 AM, with lingering pain in that muscle and in hip joints still present at time of reporting approximately 24 hours later. Ongoing treatment with naproxen sodium and regular stretching.
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| 47 | 2021-03-19 | pain in extremity |
I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at ...
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I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at the site of injection the next day for about 24 hr. I started to notice pulsation on my ears. Then as the days went by, this turned into hyperacusis and I consulted about it on Feb 26th. the day of the second shot.. My physician referred me to an ENT. I saw the ENT on Feb 29 and had a hearing test the same day, they found no signs of hearing loss or abnormal conditions. I was diagnosed with pulsation tinnitus and hyperacusis. After the second dose, I had a skin reaction. I had redness at the site of the injection and developed a blister the same day. Then, two days later I noticed a swollen lymph node on the left side of the neck. My arm was very sore from the injection again. I noticed that the joints on my right arm are in acute pain.
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| 47 | 2021-03-19 | tingling |
She had tingling fingers and palm without swelling. The tingling did not travel up or down her arm. ...
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She had tingling fingers and palm without swelling. The tingling did not travel up or down her arm. She had not eaten that day and she said she had just finished cleaning her sister's salon where she was hand scrubbing the floor. She had no other complaints. She said that this started about 5 minutes after the injection and upon follow up in the afternoon she said the tingling had resolved.
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| 47 | 2021-03-19 | tremor |
Symptoms began with headache immediately after received shot. A few hours after, experienced fatigue...
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Symptoms began with headache immediately after received shot. A few hours after, experienced fatigue and fogginess. The next day headache, fatigue, fogginess was worse. That night noticed slight muscle tremors, especially in legs. Also, woke up with night sweats. Although headache, fatigue and fogginess seemed to lessen significantly by day 4, muscle tremors increasing, especially at night. Also, night sweats remained. On day 6, muscle tremors worse.
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| 47 | 2021-03-21 | weakness |
By that evening, I started experiencing severe chills, headaches and I was very weak. I took Tylenol...
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By that evening, I started experiencing severe chills, headaches and I was very weak. I took Tylenol. I tried to go to work the next day, but I could barely move my feet. Then, the diarrhea started to where I was having very watery stool about 10-15 times a day. I couldn't eat anything. I had never been that sick in my life. I was in the bathroom every few minutes. On Saturday, I went to urgent care to get rehydrated since I had lost so much fluids. I was given meds to stop my stomach cramping along with another prescription, but I still couldn't eat at that point. For the next week, I was still extremely sick. I ended up losing 10lbs. I have to see my doctor tomorrow to be evaluated for surgery since this has caused issues with my hemorrhoids. I still experience diarrhea occasionally, so I have to be really careful what I eat. I don't have much of an appetite, so I eat very light.
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| 47 | 2021-03-21 | weakness |
The next day, I had a fever, chills, nausea, fatigue, dizziness, off balance and just not myself. It...
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The next day, I had a fever, chills, nausea, fatigue, dizziness, off balance and just not myself. It got worse during the day, so I had to leave work. I was out work for two days. It continued to get worse and I was starting to get weaker. I just got a lot of rest and took Advil. Consulted doctor by phone.
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| 47 | 2021-03-21 | pain in extremity |
Patient states she is having soreness to her injection site and soreness up her arm, neck and into h...
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Patient states she is having soreness to her injection site and soreness up her arm, neck and into her left jaw.
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| 47 | 2021-03-22 | weakness, pain in extremity | Weakness, body aches, joint pain, left arm in pain, intermittent pain in right thigh |
| 47 | 2021-03-22 | feeling hot, difficulty speaking |
Upon leaving vaccination site I realized my face, neck, chest & lips were red, hot, & itchy. I imme...
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Upon leaving vaccination site I realized my face, neck, chest & lips were red, hot, & itchy. I immediately went to the emergency room. The staff took my blood pressure 177/111, they administered Benadryl, Pepcid, & Prednisone. I got to the ER around 6:45 pm and left after observation around 11pm. I was sent home with prescriptions for Prednisone, Epi pen, Pepcid and was told to buy OTC Benadryl to take for the next few days. The next day the redness & hives were not as bad, later that night I felt that I had hives around my lips again. I also had a hoarse/scratchy throat. Spoke to Primary Physician the next day (Saturday) she said to follow the course of action from the hospital & that I could receive the 2nd dose of the vaccine however the ER Dr's said I should not.
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| 47 | 2021-03-22 | pain in extremity, tingling, migraine |
10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as...
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10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as the day/night went on. Eventually, painful to lift. 12:30pm: Nauseous and not feeling well. Headache increasing. 7pm Migraine, chills, feeling awful, tired, muscle & joint pains, body aches, fever, left arm super painful. Slept restlessly Friday: Slept all day restlessly, chills, fever high of 102, tired, migraine, muscle & joint pain, no appetite. Sat: Migraine, some chills, muscle, joint, arm pain. Sun: Feeling much better, joint pains, arm sore, headache. Sun PM: Red, swelling, tingling on face around chin and mouth. - right side of face Mon: Rash on neck - right side of face Tues: Rash on torso
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| 47 | 2021-03-22 | pain in extremity |
PER PT, they have a bruised muscle due to the covid19 vaccine. they've visited the dr numerous times...
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PER PT, they have a bruised muscle due to the covid19 vaccine. they've visited the dr numerous times and the md has confirmed that it is bruised. ever since the shot, pt cannot lift or move arm like before and is in pain.
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| 47 | 2021-03-22 | pain in extremity |
sore arm the evening after the shot but gone in 24 hours. About 4 days later malaise, headache, swo...
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sore arm the evening after the shot but gone in 24 hours. About 4 days later malaise, headache, swollen lymph note on right side (shot on the left) so tired, no appetite
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| 47 | 2021-03-23 | weakness | Weakness, chill, head ache, sore throat, |
| 47 | 2021-03-23 | feeling cold |
I had a super soar arm and was tired, I also had a headache. I had a lot of muscular pain in my uppe...
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I had a super soar arm and was tired, I also had a headache. I had a lot of muscular pain in my upper back . I was feeling off and this lasted for about three weeks, until I got my second dose. I ran a fever with the second dose and couldn't warm, lasted 24 hours. I have been doing better and feeling back to myself.
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| 47 | 2021-03-23 | feeling hot |
After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe ...
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After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe 30seconds and immediately after that I had feeling of sinking as if l am going to die for 30 seconds and I was alright after.
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| 47 | 2021-03-23 | speech disorder | became foggy, forgetful, lose thought, couldn't articulate thoughts |
| 47 | 2021-03-24 | weakness |
Dizziness, anxiousness, nervousness, generalized weakness. Patient given a bottle of water, seated, ...
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Dizziness, anxiousness, nervousness, generalized weakness. Patient given a bottle of water, seated, encouraged to relax, calm down.
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| 47 | 2021-03-24 | burning sensation | Tongue swelling with sores, burning sensation |
| 47 | 2021-03-24 | pain in extremity |
Since the time of receiving the vaccine I have had the following: Almost three days of extreme pain ...
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Since the time of receiving the vaccine I have had the following: Almost three days of extreme pain in my arm. I was not able to sleep the first two nights, because I was in so much pain. Shortly after, I had symptoms resembling that of the flu to include body aches, chills, headache, nausea and vomiting. I have had a headache everyday since receiving the shot. I have been nauseous since receiving the shot.
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| 47 | 2021-03-24 | tingling, flushing |
Full body flushing, mild tingling on face, mild hives on neck Duration ~12 hours 50mg Benadryl at on...
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Full body flushing, mild tingling on face, mild hives on neck Duration ~12 hours 50mg Benadryl at onset 25mg Benadryl at 4 and 8 hours after onset 650mg Tylenol at 4 and 8 hours after onset
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| 47 | 2021-03-24 | tingling |
first developed tingling in both hands, then developed numbness and tingling in lips, then palate, t...
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first developed tingling in both hands, then developed numbness and tingling in lips, then palate, then throat. She was given water, and while she could swallow, the water felt thick and her swallow felt off/weird. she was given IV benadryl and taken to the ER. There she was given steroids and H2 blockers. She felt her symptoms resolve about 20 minutes later.
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| 47 | 2021-03-25 | tingling, feeling hot |
15 min after shot (235pm 3/24) strong tingling in left calf and foot. Continues through today with l...
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15 min after shot (235pm 3/24) strong tingling in left calf and foot. Continues through today with lighter tingling however now left foot and toes are extremely cold.
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| 47 | 2021-03-26 | inability to speak |
12:35pm - patient self administered Epi pen into her thigh - alerted EMS and MD on site, she was mov...
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12:35pm - patient self administered Epi pen into her thigh - alerted EMS and MD on site, she was moved to a private location and EMS began assessment. aprox 12:40pm EMS called for transport to a medical facility - the patient experienced vomiting, neck swelling, facial swelling and inability to speak - IV access was obtained by EMS and Benadryl was given IV - she was then given another IM injection of Epi by the EMS team she agreed to transport and was then transported to the hospital around 1:30pm
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| 47 | 2021-03-26 | burning sensation | Left pain burning in breast. |
| 47 | 2021-03-26 | tingling |
After adminstaration of medication, patient had palpitations, shortness of breath, and tingling in t...
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After adminstaration of medication, patient had palpitations, shortness of breath, and tingling in the fingers. Paramedic came and took vitals signs and ekg. Patient symptoms subsided and she spoke to a behavioral health. As her smptoms dessipate she was release by the nurse.
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| 47 | 2021-03-27 | tingling |
3/28/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ...
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3/28/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness, and tingling down left arm. Assessment : Time of assessment . Alert and oriented.complains of dizziness, and tingling down left arm. Actions taken: Water given and drinking, VS at 0840 BP- 149/82, P- 82, O2- 100% Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 0841. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/28/2021 8:25 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8733
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| 47 | 2021-03-28 | weakness |
Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular ner...
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Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; This is a spontaneous report received from a contactable physician (who is also the patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 12Jan2021 13:30, as single dose, for COVID-19 immunisation. There was no medical history. The patient did not have COVID-19 prior to vaccination and has not tested for COVID-19 post vaccination. The patient had no known allergies and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 12Feb2021, the patient experienced brachial neuritis w/ suprascapular nerve injury and weakness. The events required physician's office visit and resulted to disability or permanent damage. Treatment for the events included physical therapy. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-03-28 | tremor | Vomiting, Shaking violently, muscle contractions throughout body, joint pain, headache |
| 47 | 2021-03-30 | numbness |
it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria...
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it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); This was characterized by severe abdominal pain; headache; extreme dizziness; chest pain; brain fog; numbness in feet; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration, in left arm on 03Mar2021 09:00 (second dose, Batch/Lot Number: EN6203), via an unspecified route of administration in left arm on 09Feb2021 12:45 (first dose, Lot number: EC(L?)8982) both as single dose for covid-19 immunization. Medical history included acute intermittent porphyria, migraine, hypertension (HTN), dermatitis contact (Known allergies: adhesives (contact dermatitis)), COVID-19 (If COVID prior vaccination: Yes) all from unknown date and unknown if ongoing. Concomitant medications included givosiran sodium (GIVLAARI); lisinopril; hemin (PANHEMATIN DRY); zolmitriptan taken for an unspecified indication, start and stop date were not reported. The patient experienced after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain), it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria), this was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet all on 03Mar2021 20:00. After each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain) and it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria). This was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet. She received treatment for the attack and symptoms resolved after several days. The treatment included: Intravenous treatment with hemin (PANHEMATIN). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was resolved. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID tested post vaccination.
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| 47 | 2021-03-30 | pain in extremity |
swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spon...
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swelling and pain to the left arm; swelling and pain to the left arm; throat closing; This is a spontaneous report from a contactable Physician. This 47-year-old female Physician reported for herself that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 27Jan2021 to 27Jan2021 at single dose, dose number; 2 on left arm for covid-19 immunization. Patient was 47 years old and not pregnant at the time of vaccination. Patient's medical history included covid-19 from an unknown date in Apr2020 to an unknown date (if covid prior vaccination: Yes), known allergies to aspirin and lactose intolerant (dates unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number; unknown; reason; not available/provided to reporter at the time of report completion. via an intramuscular route from 06Jan2021 at 12:00 pm to 06Jan2021 at 12:00 pm at single dose, dose number; 1 on left arm for Covid-19 immunization. Facility type vaccine was reported as hospital. Patient was tested for covid post vaccination. Relevant test included nasal swab (covid test type post vaccination); rapid test (covid test name post vaccination) on 08Jan2021 which resulted as negative. Concomitant medication (if other vaccine in four weeks, other medications in two weeks) was reported as none. On 10Jan2021 at 10:00 pm patient experienced left axilla swelling and tenderness 4 days after the first injection with pain at the injection site with the outcome of recovering. She stated that ‘'scared I might have had breast cancer at the time, as there is family hx of cancer''. On an unknown date in Jan2021 she experienced repeat swelling and pain to the left arm which occurred less than 1 day after the second injection. She was concerned of the hot flashes and disturbed sleep consistent to the time when she was infected with covid back in Apr2020. She also experienced slight feeling of throat closing both times with the injections, with the first injection occurred 3-4 days afterwards with no SOB (shortness of breath) and with the second injection it occurred the within 24 hrs. No treatment for adverse event was given. The outcome of events was unknown.
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| 47 | 2021-03-30 | pain in extremity |
Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested posit...
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Arm hurt; Little tired today/Exhaustion; Chills; Legs look swollen; Itching everywhere; Tested positive for Covid/can't stop coughing/ like the whole kind of flu symptoms, body aches, arm hurt; Tested positive for Covid; Hives all over body and tested for Covid 2 days later; This is a spontaneous report from a contactable consumer. The consumer (patient) reported that the 47-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 05Mar2021 15:15 at single dose for covid-19 immunisation. Medical history was none. Allergies to medications, food, or other products was nope. Concomitant medications were not reported. The patient previously took dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer), via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:15 at single dose for covid-19 immunization. The patient experienced tested positive for covid on 07Mar2021 with outcome of unknown, hives all over body and tested for covid 2 days later on 06Mar2021 06:00 AM with outcome of recovering, can't stop coughing on an unspecified date with outcome of unknown, like the whole kind of flu symptoms on an unspecified date with outcome of unknown, body aches on an unspecified date with outcome of unknown, arm hurt on an unspecified date with outcome of unknown, little tired today/exhaustion on an unspecified date with outcome of recovering, chills on an unspecified date with outcome of unknown, legs look swollen on an unspecified date with outcome of unknown, itching everywhere on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Mar2021. She is not pregnant. She is not pregnant at the time of vaccination. No covid prior vaccination. Covid tested post vaccination included Nasal Swab, Pcr, on 07Mar2021with result of Positive. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was none. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and test name was Pcr. The clinical course was reported as follows: Consumer stated, The other day, on Friday, I got my second dose of the Pfizer COVID-19 vaccine. And of course that's why I have like horrible symptoms, but since then I am covered in hives and it's really itchy. When paraphrased the concern, consumer stated, And then I just have a question, what happened was, we found out the same day, my son tested positive for COVID when I got the shot. And then like within 4 hours later of the shot, I can't stop coughing either. Means yesterday, I had like the whole kind of flu symptoms, body aches, arm hurt, you know, which are definitely going away. Little tired today but I still have the cough more in the throat and I am covered in hives. Consumer further stated, My husband and my other son were tested, they are negative. I am supposed to go today. Like I do not know what to do and I do not know what's going on but I am itching everywhere. Yesterday, I had like kind of the symptoms they said like body aches, like flu like symptoms, chills. I did not have a fever, just exhaustion and I did have hives yesterday but today I feel like my legs look swollen. I am itching everywhere and they are not away and I still have a 'cough like in ear through my throat' (not clarified). So, do you think should I still get tested today? Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Consumer stated, What should I do as I got the rash and everything. I would rather, I just need to get tested for the rash and the 'cough' (not clarified). Consumer stated, And they are going to give me information on these hives and everything? Inofrmation regarding lot/batch number has been requested.
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| 47 | 2021-03-30 | pain in extremity |
Very sore arm; Very tired; This is a spontaneous report from a contactable consumer (patient). A 47-...
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Very sore arm; Very tired; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 27Jan2021 at 08:00 (at the age of 47-years-old) as a single dose for covid-19 immunisation. The patient had no allergies to medications, food, or other products and other medical history was none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received allergy medicine within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, at 17:00 pm the patient had very sore arm and very, very tired. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Jan2021.
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| 47 | 2021-04-02 | burning sensation |
A mild rash developed on chin Within a week, the rash spread to neck, upper lip, nose, and eyebrows....
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A mild rash developed on chin Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened.; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day; This is a spontaneous report from a contactable Consumer (patient). A 47-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9264, Expiration date was not reported), via an unspecified route of administration, in right arm on 27Jan2021 15:30 as single dose for covid-19 immunisation. Relevant medical history reported as none. Concomitant medication included metronidazole (FLAGYL), levocetirizine dihydrochloride (XYZAL) and melatonin all are taken for an unspecified indication, start and stop date were not reported. It was reported that a mild rash developed on chin within 48 hours. Within a week, the rash spread to neck, upper lip, nose, and eyebrows. By two weeks, the rash worsened and developed red bumps and blisters with intense itching and burning 24 hours/day on 29Jan2021 05:00 PM. No changes in diet, facial products, cleaning/detergent products and have been wearing a mask since August with no issues. Patient did not have covid prior vaccination. Patient did not test for covid post vaccination. Patient received the treatment of adverse event was Prescribed Elidel, Montelukast, Allegra, Doxepin. The outcome of the events was not recovered.
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| 47 | 2021-04-03 | pain in extremity |
body aches; Fever 101 degree celcius; CHILLS; sore arm; This is a spontaneous report from received f...
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body aches; Fever 101 degree celcius; CHILLS; sore arm; This is a spontaneous report from received from a contactable consumer, the patient. This consumer reported different events after each dose of the same product for the same patient; This is the second of two reports. A 47-year-old adult female received the second dose of intramuscular BNT162b2 (solution for injection; Lot EL3249 expiry 31May2021) as a single dose in the right deltoid on 20Jan2021 at 14:00 (at 47-years-old) for COVID-19 immunisation. There was no medical history or concomitant medications reported. The patient previously received her first dose of intramuscular BNT162b2 (Lot EK5730) on 30Dec2020 (at 46-years-old) and donated blood seventeen days later and showed no antibodies. The patient reported that she received the second dose of vaccine on 20Jan2021 at 14:00 and by 21Jan2021 02:00, reported as within twelve hours, she had a sore arm, 101degree Centigrade fever, and body aches and chills. The patient denied any emergency room visit or physician's office visit and was not admitted to the hospital for the events. Post-vaccination antipyretic use on 20Jan202 included oral acetaminophen (TYLENOL) 1000mg, and oral ibuprofen (MOTRIN) 600mg. Treatment was received for the events. The outcome of the events sore arm, 101degree Centigrade fever, and body aches and chills was recovered on unspecified date(s) in 2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056901 PFIZER (Same patient/product; first dose, different event separated in time)
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| 47 | 2021-04-09 | pain in extremity |
About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up a...
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About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up as well as my hands. Then My right ankle swelled up. My face and hands had hives on them. My throat felt better, I thought but about 1/2 hr. Later I started wheezing and my right ankle and leg were swollen so, I went to the urgacare. They saw me but told me that I should've gone to the ER. I have a history of anaphylaxis. They gave me steriods and Benadryl via shots and sent me home with the same. I woke the next morning with a sore arm, a horrible headache and my face broke out into hives and was swollen again. Today is the 4th day after and my face still feels a little swollen, I have a headache and now an earache in my left ear. Today I also felt nauseous and couldn't eat.
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| 47 | 2021-04-11 | burning sensation | Severe reaction began with flu like symptoms and burning face to into head to toe severe body rash |
| 47 | 2021-04-13 | feeling hot |
hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat wa...
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hit the timer on my watch when the injection was given. By minute 2 my body was hot and my throat was starting to swell. Used Epi pen #1 . I did not get better. I felt even more on fire and my skin was hot to the touch. My tongue was really swollen and things get super fuzzy after the I might die feeling. Epi#2 Given around 5 minutes after Epipen 1. Medics took me to the ER and more rescue meds were given. I was admitted to the nuero trauma floor for 24 hrs and given meds and iv fluids. I got out the next afternoon. By the next day I was back in urgent care. They gave me meds and sent me home. By 9pm that night I was using epi#3 and going back to the ambulance. I have been to urgent care 2 times since for continued issues. I have zero appetite and my whole GI system hates me. I am alive and breathing but still feeling the impact of all of this.
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| 47 | 2021-04-17 | inability to speak, numbness |
while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken...
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while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken to hospital and given tests (MRI, CT scan, COVID test, echocardiogram, chest X-ray); numbness went away first day, MRI showed TIA/mini strokes on left side of brain and insula part of brain; had aphasia for two days; admitted to hospital for observation and released after 3 days; given Lipitor and aspirin and heparin shots for treatment; no lasting effects from stroke; doctor says cholesterol, blood pressure and family history normal;
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| 47 | 2021-04-20 | numbness, tingling, feeling cold |
1. injection site pain, swelling for ~7days ...
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1. injection site pain, swelling for ~7days 6. joints pain 2. unable to lift up arm pass 15-degree angle for days 7. fatigue 3. left arm got numb/tingling, cool to touch- required long sleeve shirt & gloves (resolve next day) 4. itchiness of throat for ~3-4 days 5. generalized body aches for @ least ~ 5 days
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| 47 | 2021-04-24 | cold sweat, weakness |
kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; col...
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kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; cold sweat; weak/did not have energy to talk; blood pressure was too low; This is spontaneous report from a contactable consumer reported for self. This 47-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8732) at single dose in left arm on 30Mar2021 01:45 PM for COVID-19 immunization. Medical history included nephrocalcinosis. Patient had allergies to contrast of iodine, had an anaphylaxis when they injected with iodine for checking her kidney, it was over 20 years ago. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, with a minute taken the covid vaccine, patient started feeling nausea and heart racing. Her blood pressure started going up. The facility kept checking blood pressure and oxygen. After a bit, patient had no idea of time she felt a cold sweat and very weak. Patient did not have energy to talk. However, patient saw the nurse with an epi pen and she was able to tell that she was breathing. Doctor said that her blood pressure was too low. It had dropped to low 80. Patient kept trying to relax and suddenly it went all the way up again. Her normal blood pressure was 110/70 or 120/80 and it was 150/98. Patient started getting heart pain was taken to the ER and an ECG was made and her heart was ok. Her blood pressure stayed high. Patient kidney disease. Specifically, nephrocalcinosis; however, her kidney function still good. In the second day after the vaccine, on 31Mar2021, her kidneys started hurting and she felt like she was having an UTI (urinary tract infection) what she did not have had in the last year or so. All the adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for all events was reported as unknown. The outcome of events was resolving.
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| 47 | 2021-04-26 | hot flush |
Bad headache; Stomach ache; Chills; Hot flashes; Aches all over; Fever; Nausea; This is a spontaneou...
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Bad headache; Stomach ache; Chills; Hot flashes; Aches all over; Fever; Nausea; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 18:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's disease, endometriosis, GERD (gastrooesophageal reflux disease). Known allergies were none. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL) received in two weeks for birth control. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) on 27Jan2021 at 18:00 as a single dose in left arm for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient has not tested for COVID post vaccination. The patient experienced bad headache, stomach ache, chills, hot flashes, aches all over, fever, nausea on 18Feb2021 at 06:00 AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment medication for the adverse events. The outcome of the events was recovering.
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| 47 | 2021-04-26 | nerve pain, bell's palsy |
diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/...
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diagnosed with Bells Palsy; fever; muscle aches; headache; throwing up; chills; swollen lymph nodes/swollen glands; swollen injection site; tired; mouth ulcers; extreme nerve pain; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 08Apr2021 15:00 (Batch/Lot number was not reported) at single dose (at the age of 47 years old) for COVID-19 immunisation. Medical history included "if covid prior vaccination: Yes". Concomitant medications included potassium, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cetirizine and chlorthalidone, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation. The patient reported, "fever, muscle aches, headache, throwing up, chills, swollen lymph nodes, swollen injection site, tired. After chills, fever, throwing up, mouth ulcers. On day 7 I have extreme nerve pain, swollen glands, and paralysis on left side of face. Went to DR and they diagnosed with Bells Palsy. Left side of face does not move at all", 09Apr2021 09:00. The patient received no treatment. The outcome of bells palsy, extreme nerve pain, mouth ulcers and swollen lymph nodes/ swollen glands were not recovered and other events was recovering. Information about lot/batch number has been requested.
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| 47 | 2021-04-27 | weakness |
chest pain; heart burn; chills; fever; body pains; terrible headache; tired; weak.; I had shortness ...
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chest pain; heart burn; chills; fever; body pains; terrible headache; tired; weak.; I had shortness of breath; This is a spontaneous report from a contactable consumer(patient). A 47-year-old non pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown) on 21Jan2021 at 04:00 PM via an unspecified route of administration in left arm at single dose for covid-19 immunization. Patient was 47 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient did not have any known allergies. Patient did not receive any other medications in two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination. On 21Jan2021 at 8PM patient had shortness of breath, chest pain, heart burn, chills, fever, body pains, terrible headache, tired, and weak. It lasted until 10AM the next day. Effects lasted for 12 hours. On 06Jan2021 patient tested for covid post vaccination with test name Saliva and result received was negative. The outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 47 | 2021-04-27 | numbness, tingling |
Tingling; Facial numbness on left side face; This is a spontaneous report from a contactable consume...
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Tingling; Facial numbness on left side face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number 588727) via an unspecified route of administration on 25Mar2021 at 08:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications include fexofenadine (reported as "generic ALLEGRA") from an unknown date for an unknown indication. The patient did not have any allergies to medications, food, or other products. In the afternoon on the day of vaccine on 25Mar2021 at 14:30, the patient experienced facial numbness on left side face. She felt it more in cheek. As of 28Mar2021 the patient improved by still had numbness and tingling. The event was reported as non-serious. The patient was not hospitalized for the event. It was unknown if the patient received any treatment for the event. The outcome of facial numbness on left side face and tingling was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 47 | 2021-05-04 | weakness |
fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spo...
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fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood. here were no concomitant medications. The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
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| 47 | 2021-05-04 | numbness |
numbness to the right of my face and body; numbness to the right of my face and body; This is a spon...
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numbness to the right of my face and body; numbness to the right of my face and body; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Batch/Lot Number: EN5318 via an unspecified route of administration in left arm on 28Jan2021 02:45 as single dose for covid-19 immunization. The patient was 47-years-old at the time of vaccination. The patient was not pregnant. Patient relevant medical history included prior to the vaccine about a month ago experienced the numbness in face and in body and currently consulting a neurologist. The patient's concomitant medications were not reported. Patient haven't taken other vaccine in four weeks and no other medications in two weeks. Patient have no known allergies. Patient was not tested to covid prior to vaccination and not tested post vaccination. On30Jan2021 at 19:00 the patient experienced numbness to the right of her face and body. AE resulted in emergency room/department or urgent care. No treatment taken for resulted adverse events. Outcome of the event was recovering. Information about Lot/Batch number is requested. Follow-up (08Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: [Query]: Dear Colleague, Please see attached which was submitted by you. Please kindly confirm the date you first aware of the info reported in the attached source, as this date was considered as PRD (Pfizer receipt date). This date provided as 01Feb2021 on the report, while the adverse event start date provided as 30Jan2021 [Response]: Yes, the adverse event occurred on 30Jan. Here's the lot #EN5318. Follow-up attempts are completed. No further information is expected.
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| 47 | 2021-05-04 | unresponsive to stimuli |
My wife (age 47) died on 14Apr2021 of a sudden death. She was found at home unresponsive and pulsele...
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My wife (age 47) died on 14Apr2021 of a sudden death. She was found at home unresponsive and pulseless. Her medical history is non-contributory for a sudden cardiac death. A full autopsy is pending.
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| 47 | 2021-05-07 | seizure |
had seizures; she fell; she was sleeping a lot; fever; fatigue; This is a spontaneous report from a ...
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had seizures; she fell; she was sleeping a lot; fever; fatigue; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 at 12:00 (Lot Number: ER2613) (at the age of 47-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6208) for COVID-19 immunization. The patient experienced fever and fatigue (on 12Apr2021) but then got better. On Monday 19Apr2021 she was sleeping a lot, she fell and then had seizures. The patient was taken to the emergency room and a CT scan was performed; she was there for 5-6 hours. The patient confirmed that she was not admitted to the hospital. The patient outcome of fever and fatigue was recovering, the outcome of the other events was unknown.
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| 48 | 2020-12-31 | pain in extremity, burning sensation |
Extreme left arm pain, left arm burning pain, traveling pain up to the neck, headache, low grade te...
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Extreme left arm pain, left arm burning pain, traveling pain up to the neck, headache, low grade temperature for 3 day..left arm still very sore on day 4
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| 48 | 2020-12-31 | pain in extremity, feeling hot, slurring, weakness |
After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, the...
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After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, then I headache started. A minute later fatigue hit and I was starting to fall asleep at the wheel. I live 1 mile away so I made it home. Now my head was getting fuzzy. Called a co-worker to tell her what was happening and she said my speech was slurring. I felt drunk and hungover at the same time. I went to bed and slept for an hour. I woke up and felt very fatigued. I finally went to bed for the night then was awoken with severe arm pain. My entire upper arm felt so tight but I it was soft upon palpation. I fell asleep and awoke to terrible arm pain again. I started crying in bed but fell asleep again. I woke up in the morning with severe upper arm pain and minor headache. I couldn't rotate my arm back to put my bra on so I took some ibuprofen. That had immediate relief for my arm and headache. I ran one errand and was wiped out. The fatigue hit again. The arm pain came back so I took another ibuprofen with relief. I had no energy so laid around for the rest of the day. I woke up on Sunday and finally felt normal with just pain at the injection site. The 2 other medical people that have had similar reactions like mine with dizziness and feeling light-headed have one thing in common with me...we are all vegetarians. I don't know if that makes a difference with protein metabolism or other enzymatic activity, but we are the only 3 that I know of out of all of our co-workers who have received the vaccine to react like this.
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| 48 | 2021-01-01 | numbness |
Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset ...
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Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset 12/27. Visit to dentist for worsening pain and mild body aches and chills - dentist felt the pain and swelling, + mild ulceration due to new toothbrush head causing abrasions on gums and hard palate - no treatment prescribed - 12/28. Worsening painful lymphadenopathy (now bilateral cervical), body aches, chills, joint pain, fevers, odynophagia, gum pain/swelling, malaise - visit to respiratory clinic - rapid strep negative; COVID negative, bacterial throat culture negative (VS: HR 120, SBP 168, T 100.7 on Tylenol) - no treatment prescribed - 12/29. Development of shallow, painful ulcers LEFT hard palate, gums and a RIGHT lip ulcer - 12/31. Photos of ulcers reviewed with previous dentist - prescribed acyclovir 400 mg TID and magic mouthwash. 12/31. Taking Ibuprofen and Tylenol regularly. As of today, 1/2, improvement in cervical lymphadenopathy, resolution of constitutional symptoms, and odynophagia. Ongoing mouth pain and ulceration. + left facial numbness/burning pain (V1-3) similar to previous episode of trigeminal neuralgia in 1999.
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| 48 | 2021-01-03 | pain in extremity, muscle spasms |
Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula...
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Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg). On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel. Information regarding lot/batch number has been requested.
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| 48 | 2021-01-03 | pain in extremity |
dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, craw...
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dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, crawl; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; arm sore day #1 and #2- not unexpected; This is a spontaneous report from a contactable Physician(patient). A 48-year-old female patient received first dose (BNT162B2, lot number EK5730) , intramuscular at Arm Right on 18Dec2020 14:15 at the 48-year-old at single dose for COVID-19 immunization. The medical history included elevated blood pressure , allergic to sulfa, hypertension and Covid. The concomitant products included alprazolam, diphenhydramine hydrochloride (BENADRYL), spironolactone, metoprolol for hypertension, colecalciferol (VITAMIN D 3). The patient previously took nubaine and experienced drug allergy. The patient also happened to be a physician in private practice and received the vaccine at her local hospital. The patient had hypertension which was under excellent control on metoprolol 25 mg. She took it as prescribed every day surrounding the vaccine. On day #1 at the vaccine she felt like her heart may be racing 10 min after vaccine was about 80 on 18Dec2020 14:25. nothing serious. The patient experienced arm sore day #1 and #2 and not unexpected. On about 7 pm the day after the vaccine 19Dec2020 she was tachy at rate of about 105. She took her metoprolol heart rate never came down. At about 9:30 pm on 19Dec2020 when her rate should have been about70- she got up from couch after falling asleep. Upon standing felt like she was very dizzy. Walked upstairs, started to feel faint, perspiring, heart felt off beat and like blood not getting to my head. She had to get on hands and knees, crawl and heart rate was 142 and sustained for almost a minute. It took over an hour for it to come back to 86 and stayed there all night. There was not treatment to all of the adverse events. The outcome of the events was Recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the palpitations, tachycardia and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-03 | tingling, flushing |
employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flush...
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employee getting Pfizer COVID19 vaccination. about 10 min post injection developed feeling of flushing and ?"prickliness" on skin. no resp distress no swelling or rash seen. VS taken and hypertension noted 170s/90s. normal O2sat and HR- NO prior medical hx of hypertension. Monitored for 30 min in vaccination clinic persistent hypertension. Referred to ED for ongoing monitoring-still hypertensive but eval neg referred to primary care provider for follow up
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| 48 | 2021-01-03 | tingling |
26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreas...
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26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-04 | burning sensation, hypersensitivity of all senses |
I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity...
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I was diagnosed with shingles on my left side on 12/31/2020, with symptoms (burning/skin sensitivity on my back (probably on 12/27, definitely by 12/28 progressing to waves of pain in my back to abdomen). On 12/30, a rash appeared on my abdomen starting below my navel and going around my left side to about an inch before my spine. I submitted a picture and it was diagnosed as shingles via a virtual visit. It is responding to antiviral therapy, although I still have a rash and pain (but improving). I did not go through the COVID vaccine side effect virtual visit route because I did not really think it was a side effect and knew I had a history of chicken pox and have been experiencing ongoing stress. The provider for the virtual visit told me to still report it for it to be investigated, but she too, thought it was likely unrelated, but still should be investigated.
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| 48 | 2021-01-04 | discomfort, pain in extremity, flushing |
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly...
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Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
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| 48 | 2021-01-04 | flushing |
15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throa...
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15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throat irritation. She states she feels " a bit shaky inside ". Given juice and crackers. BP 143/84. heart rate 89. O2 sat 99%. She was moved into another quieter observation area. She claims she felt better. Given H20 to drink. States she had a bit of chest discomfort but this was nothing new to her. She has been having chest discomfort for the past 1-2 weeks periodically. Upon observing patient for 40 minutes, patient states, she felt better. BP 115/78, heart rate 80. Patient was then released. She states this is the first time this has happened while taking an IM injection.
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| 48 | 2021-01-04 | hot flush |
Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from ...
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Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from a contactable Nurse (patient herself). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular, on 20Dec2020 at 18:15 at single dose for COVID-19 immunisation. Vaccine location was Arm Right. The patient was not pregnant. Relevant medical history included elevated rheumatoid factor, restless leg syndrome and depression. Past drug history included allergy to ferrous gluconate. Relevant concomitant medications included pramipexole dihydrochloride (MIRAPEX). The patient was vaccinated at hospital, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination COVID test was not performed. Post-vaccination COVID tests were performed: nasal swab on 28Dec2020 was negative; PCR in Dec2020 was negative. On 21Dec2020 at 18:30, the patient had headaches, muscle pain, body aches, low-grade fever and frequent hot flashes throughout the day at random moments, along with headaches and bod. The patient was not treated for the events. The patient had not recovered from the events.
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| 48 | 2021-01-04 | numbness |
numbness on left side of face, left arm and pain in different places on left side started for shortl...
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numbness on left side of face, left arm and pain in different places on left side started for shortly after vaccine. She has had all these symptoms prior but numbness never this bad. As of today, her symptoms are somewhat less. She has been able to work
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| 48 | 2021-01-04 | numbness |
numbness on left side of body including face, arm and leg Pain on left side in various places Starte...
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numbness on left side of body including face, arm and leg Pain on left side in various places Started soon after vaccine
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| 48 | 2021-01-04 | pain in extremity, numbness | numbness left side of body including face, arm, leg pain left side of body in several places |
| 48 | 2021-01-04 | pain in extremity | Sore Arm for 24 hours. Advil |
| 48 | 2021-01-04 | pain in extremity |
This caused immediate pain in the arm. The pain has continued for the past 20 hours.; This is a spon...
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This caused immediate pain in the arm. The pain has continued for the past 20 hours.; This is a spontaneous report from contactable Nurse reporting for herself via Pfizer Sales Representative. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #EJ1685), intramuscular into the right arm on 29Dec2020 11:15 at 0.6 mL, single for COVID-19 immunization. Medical history was none. There were no concomitant medications. The administer cleaned the arm with alcohol but didn't wait for it to dry. On 29Dec2020 the patient experienced immediate pain in the arm. The pain has continued for the past 20 hours. The outcome was recovered.
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| 48 | 2021-01-04 | tingling, numbness |
had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left s...
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had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left side of face; neck on left side felt like someone had hit it; injection site and whole deltoid was numb.; Left side of face, left foot and left ear all felt numb but with tingles; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), via an unspecified route of administration in Left arm on 28Dec2020 16:30 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at workplace clinic. Medical history included known allergies to food - vegetables, berries, shellfish, environmental. Concomitant medication in two weeks included desogestrel, ethinylestradiol (MIRCETTE), fluticasone propionate (FLONASE), iron, multi vitamin, elderberry w/z. The patient previously took benzoyl peroxide and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient waited 20min, went up to leave and while walking out had a little side step/unbalance moment. The patient thought nothing of it and went to car and was waiting in car for an extra 10 min. Her left hand started tingling, same tingling like if it was asleep and was waking up. Then she started to drive home, on the way home, noticed tingling in left foot and left side of face, neck on left side felt like someone had hit it. About 50 min after receiving injection, was at home, injection site and whole deltoid was numb. Left side of face, left foot and left ear all felt numb but with tingles. She had stopped timer after 2 hours. Tingling and numbness subsided sometime after 2 hours of receiving vaccine. Today (29Dec2020), everything felt fine. Injection site just felt like I got a shot, can barely notice it. Adverse event start date provided as 28Dec2020 05:15 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
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| 48 | 2021-01-04 | tremor, weakness |
I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still fee...
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I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still feel like very weak and achy; Pain/achy/aches; Teeth chattering; Shaking all night long and 102 fever; Shaking all night long and 102 fever/low grade fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, reason for no lot number: consumer stated, "I can't even read, it says EK or E something 5730. That's what it looks like."), intramuscular in arm in Dec2020 at single dose for COVID-19 immunisation. Medical history included low thyroid, have had thyroid cancer many years ago. Concomitant medication included levothyroxine sodium (SYNTHROID). Consumer stated, "I just have a question, I had a shot done on Wednesday and I have heard the second shot was worst so I was little concern we are all concerned about getting the first shot to begin with. So I had the shot on 11:30 at work at the hospital on Wednesday. I probably about 1:30 to 2 O'clock in the morning total like flu side effect. I thought I got a flu, aches, pain, teeth chattering, shaking all night long and 102 fever. I haven't been sick at all thank god in a while but it feels like I had, so, I have a new born grandson supposed to go there for Christmas so I'm concerned because I was running a 102 Wednesday night and I was so running a low grade so is it normal to have reaction like that?" Consumer stated, "Yes, let me just get a pen. I just don't want to be around the baby. I thought I was fit but I don't usually when your body gets the vaccination your body fighting against the vaccine so I don't think it is going to affect the baby. I just don't want to get this shot if they got affected and if they are on fever. I just want to make sure before I go over there for Christmas." When probed if calling for the first time in Pfizer drug safety department, consumer stated, "No, actually I was just thinking now before I had out I grab these side effects yesterday and I read it I have fever 102, I was like let me call the number from the paper that they gave me with the shot card, let me call you guys and try to figure out what the hell is going on here and why I'm so freaking sick from this shit." .Height and weight: Consumer stated, "I say about 130 and about 5'6.". LOT#: Consumer stated, "Let me see if I have the card, I know I have it somewhere. May be I'm just thinking I shouldn't get the second shot. I can't even read. it's Pfizer, I can't even read, it says EK or E something 5730. That's what it looks like."Manufacturer name: Consumer stated, "Covid 19 Vaccine and I'm pretty sure it's Pfizer.".Lab work: Consumer stated, "I had all my labs on like you know like regular labs CBC's like everything. I have bad thyroid it goes up and down, I didn't feel well so I went to you know I know when my thyroid is up or down so I went and got the whole blood panel done.".Date of administration of first dose: Consumer stated, "It was probably like December 8th. I had it done on 23rd of December." (Not further clarified).Event date: Consumer stated, "The same day I had the shot.".When probed if still experiencing the events, Consumer stated, "Yes. It's not totally improved but it is better than it was but I still feel like very weak and achy." .Treatment: Consumer stated, "Tylenol and Ibuprofen I keep alternating it."Consumer stated, "I just want to make sure I can go back to my grandson today because I went to my daughter last time she is leaving for (place name) tomorrow and she was nervous and now I'm like still running a low grade fever last night and I know my daughter is going to flip out if I show up. I told her it's okay because it's only vaccination but I just want to make sure with the Covid shot I got." .The outcome of events I still feel like very weak and achy and pain/achy/aches was not recovered. The outcome of events flu / like flu side effect, teeth chattering, shaking all night long and 102 fever, shaking all night long and 102 fever/low grade fever, I'm so freaking sick was Recovering. The outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 48 | 2021-01-05 | weakness |
Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested posi...
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Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020; Tested positive for COVID/positive via Nasal Swab test/fever/body aches/headaches/She was very very weak, almost lethargic/felt really bad/fatigued; gas; bloated; the weight last week she was 167 and this week she was 180; This is a spontaneous report from a contactable nurse reporting for herself. A 48-year-old female patient received her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) Lot #EH9899, via an unspecified route of administration on 16Dec2020 at single dose by injection in the right deltoid for COVID-19 immunisation. Medical history included borderline hypertension from 2018 and ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) from 2018 and ongoing for borderline hypertension. The nurse reported that she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020. She said this kinda weird. She received the COVID vaccine on 16Dec2020. She tested positive for COVID on 24Dec2020. Obviously she was exposed to COVID prior to the vaccine. She was scheduled to have the 2nd dose on 05Jan2021 but her hospital deferred it to 23Mar2021. She was asking if this was what's recommended.She said this was another weird thing, regarding the weight last week she was 167 and this week she was 180 (in Dec2020). She was very bloated in Dec2020, it was bizarre. He husband did not receive the vaccine and had symptoms on 24Dec2020. She had normal seasonal allergy symptoms. She did not think much of it. She took her Xyzal and her normal things.She took her husband to get tested and he tested positive, so she got tested, and was positive. She worked at (address withheld), and all of her patients were immunocompromised. She was shocked. She did not think this had anything to do with the vaccine. If anything, it has helped her fight the virus.By Christmas day 25Dec2020 her fever was 102, she had body aches, she went into overdrive. She had headaches and lots of gas in Dec2020.She went into overdrive from partial recognition from the vaccine.She was very very weak, almost lethargic. Her O2 saturation have stayed good around 98% in Dec2020. She has done really well. Yesterday or the day before she felt really bad again. She did a virtual visit with (name withheld), and the doctor started her on steroids and gave her an inhaler just in case she needed it. She felt better on 30De2020. On 29De2020 she was so bad and bloated, she only had one dose of the steroids, but had unusual weight gain. Then 2 pounds were gone this morning on 30De2020.She had no pitting edema or edema period. She was very fatigued, but had more energy this morning, probably because of the steroids. She had the vaccine, even though day 7 post-injection, instead of day 10, which was about 50%, her body reacted more so than her husbands because her body recognized it. The outcome of the events was unknown. She was unsure of the outcome. It was up and down. She has felt worse and she has felt better. The reporter considered the event Tested positive for COVID was Not serious and unrelated to the BNT162B2.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.
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| 48 | 2021-01-05 | feeling hot |
patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. ...
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patient received vaccine and shortly became warm and felt her arms were getting red and splotchy. Patient taken to ER and was given PO Benadryl 50mg and observed. Discharged 2 hrs later
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| 48 | 2021-01-05 | flushing |
c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable...
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c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable 138/91 HR105 no rash, no redness, no induration at site. no resp distress. vital signs recheck 134/91 pulse 97 at 1233, advised to go to ER if symptoms worsened, discharged at 1638. Patient called clinic at 1330 on 1/6/21 c/o continued headache, now improving, Temp 99.2, facial flushing, bilateral arm and leg swelling also now improving. patient advised to go to urgent care or ER however patient refused and said she will go to her new primary MD on 1/8/21 and will go to ER if symptoms worsen. Also patient stated had COVID-19 test by occupational health results pending.
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| 48 | 2021-01-05 | numbness, tingling |
After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness ...
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After ~30 minutes of receiving vaccine I developed tingling in my lips which progressed to numbness in my right cheek/jaw and cold, numbness and tingling in my right hand/forearm. Symptoms improved within 24 hours and were gone in 48 hours.
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| 48 | 2021-01-05 | numbness |
Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild h...
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Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild headache, numbness in both hands but more significant in the left hand, left foot numbness.
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| 48 | 2021-01-05 | night sweats, flushing |
fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache...
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fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache, fatigue, face feeling flush for 48hours beginning approximately 3 hours post second vaccination treated with acetaminophen, ibuprofen, fluids and rest
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| 48 | 2021-01-05 | pain in extremity |
Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual wor...
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Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual worsening pain and edema of the area and inner aspect of left upper extremity. Pain felt into the left axilla, Focal redness over ventral aspect of elbow. First, I did not relate it to vaccine and was not sure of etiology. Day 13: linear red indurated/ palpable ropy area , markedly tender in proximal forearm. Worse swelling and pain. Day 14: red Line extends upward towards axilla Day 15: Saw primary care physician Recommended antibiotics and Aspirin, warm compresses and ordered ultrasound. Findings were consistent with lymphadenitis and lymhpangitis
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| 48 | 2021-01-05 | pain in extremity |
they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis s...
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they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis should not be a part of these trials; Never felt this kind of joint pain in my life/these are hitting my every joint in my hand, I can barely move; I have never been in as much pain in my life; I am really bad nauseous; soreness in your arm; This is a spontaneous report from a contactable consumer (patient) (Food service worker in the hospital). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history included Meniere's disease (reported 'Meniere's disease in my left ear'). The patient's concomitant medications were not reported. Consumer stated, ''I just took the COVID 19 vaccine I work at (institute name), (city name), I took it yesterday around 1 and all through the night; they suspect that I have rheumatoid arthritis I got an injection in one of my hips, my right hip and both my shoulders I can inject in cortisone injection and I have never felt this kind of joint pain in my life, I can barely move, I had been calling and I let my director know and anybody that has any kind of arthritis on these trials, I have never been in as much pain in my life and I am really bad nauseous.'' When offered for the website consumer stated, ''I just wanted to report the side effects, I am really nauseous and I can barely move; this is like abnormal I mean anybody with arthritis should not be a part of these trials.'' When probed if vaccine was prescribed by Physician, Consumer stated, ''No it was voluntary, it was not mandatory it was given my hospital administration.'' Product details for vaccine (LOT#, Expiration date, NDC#, UPC#): Consumer stated, ''EH9894, I think for the last number.'' Treatment for adverse events: Consumer stated, ''I don't have anything for nausea, I did take, they told to me take Ibuprofen my doctor said that it would help with the soreness in your arm, I take my Ibuprofen every six hours because it is prescribed to me, but I could barely move my, I can barely move; these are hitting my every joint in my hand.'' Expiry Date of Ibuprofen: 16Jul2021. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
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| 48 | 2021-01-05 | tingling, flushing |
chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpit...
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chest tightness, flushing, swollen lips, tingling in the left arm, no shortness or breath, no palpitations, no lightheadedness, no dizziness, no nausea or vomiting, no rash, no redness, no cough, no tongue swelling Started within 20-30 minutes of receiving the vaccine Received 25mg of Benadryl with improvement
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| 48 | 2021-01-05 | tingling, flushing |
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at...
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left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
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| 48 | 2021-01-05 | tingling, numbness |
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i...
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C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
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| 48 | 2021-01-05 | tingling |
Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for ...
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Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for 30 minutes.
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| 48 | 2021-01-06 | weakness, tingling, tremor |
On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 a...
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On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 am on 12-23-2020, the associate suffered from a severe headache 8/10, tingling sensation, BP checked Systolic in 180s, Extremely weak and tired, Severe nausea and dry heaving. Rapid response called, and associate was sent to ER. Headache 7/10. 1 gram Tylenol. Associate states ?Shaking, and I experienced delayed response when questioned by staff. 1 liter saline. Hives treated with Benedryl. In ER from 8am to 11:30am. It was determined that this was not an anaphylactic response. Associate went home with a headache 4/10. Groggy all day from Benedryl. I still have headaches constantly in frontal lobe. The headache pain Can rise from 2 / 10 to 8 /10. The constant headache is in the left frontal lobe. When the headache increases, It radiates into the temporal area as well. Dec 31, I went to Patient First. I was given Toradol IM, but the headache didn?t go away. I was given Flexeril, but it doesn?t help the pain. I am now using Excedrin to take the edge off. Associate is awaiting physician?s return call, but Dr. is out of town. Another doctor in the clinic would not see associate, as they don?t cover other physician?s patients. No fever, no respiratory symptoms.
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| 48 | 2021-01-06 | hot flush, tremor |
Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking...
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Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.
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| 48 | 2021-01-06 | numbness |
numbness left arm to elbow and left upper cheek, denies shortness of breath, denies itching, no rash...
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numbness left arm to elbow and left upper cheek, denies shortness of breath, denies itching, no rash noted, Initially refused Benadryl po instead requested to stay for observation for an additional 15minutes. Symptoms persisted, denies shortness of breath, ithcing, denies swelling of tongue, At 1500 Benadryl 25mg given po, patient stayed for observation for 15 minutes and was ready to leave at that time.
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| 48 | 2021-01-06 | numbness |
left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneousl...
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left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneously
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| 48 | 2021-01-06 | numbness and pain in extremities |
anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report...
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anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0140) at single dose on left arm on 30Dec2020 at 09:00 for COVID-19 immunization. Medical history included asthma (controlled); hypertension diagnosis 1 year ago; allergies to medications, food and environmental. Concomitant medications in two weeks included antihypertensives - amlodipine and losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 9:15 AM, the patient experienced anaphylactic reaction within 10 minutes of administration, neuropathy in fingers, toes, roof of mouth/lips. Neuropathy continued to date. The adverse events resulted in emergency room/department or urgent care. The patient received treatment Epinephrine IM (intramuscular) and IV (intravenous) steroids. The outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of anaphylactic reaction and neuropathy peripheral due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including serum tryptase and nerve conduction studies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-06 | pain in extremity |
Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous ...
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Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm 02Jan2021 at 12:00 PM (at the age of 48-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, gastritis, and hypothyroidism. The patient had allergy to Sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, formoterol fumarate, mometasone furoate (DULERA), salbutamol (ALBUTEROL HFA), omeprazole (PROTONIX), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jan2021, at 12:30 PM, the patient experienced sore arm and fatigue after 30 minutes. The events were reported as non-serious. The patient did not receive any treatment for the sore arm and fatigue after 30 minutes. The clinical outcome of the events sore arm and fatigue after 30 minutes was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-01-06 | pain in extremity |
Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chill...
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Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chills ,fever ( on Wed 6th pm) fatigue
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| 48 | 2021-01-07 | weakness | Chills, generalized weakness, fatigue |
| 48 | 2021-01-07 | migraine, feeling cold, cold sweat |
about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going...
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about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated, BP dropped, HR wnl, After about 20 mins, I felt fine. Went to work, did develop a migraine afterwards, some body ache and fatigue.
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| 48 | 2021-01-07 | migraine |
Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved b...
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Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved but with occasional palpitations.
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| 48 | 2021-01-07 | pain in extremity, weakness |
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv...
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Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
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| 48 | 2021-01-07 | pain in extremity, tenderness |
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, mala...
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Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
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| 48 | 2021-01-07 | pain in extremity | Patient describes sore arm, |
| 48 | 2021-01-07 | tingling |
I started feeling achy (body aches) at night and took Tylenol and the next day at work I started hav...
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I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.
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| 48 | 2021-01-07 | seizure |
The patient reported shortness of breast and difficulty breathing. The patient's husband stated tha...
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The patient reported shortness of breast and difficulty breathing. The patient's husband stated that he witnessed the patient having a seizure. Patient advised to call EMS. EMS took the patient to hospital. The patient was stabilized after receiving emergency treatment.
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| 48 | 2021-01-08 | cold sweat, flushing, feeling hot, feeling cold, tremor |
Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " ...
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Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " I have asthma too too hard to tell the difference" Tearful, skin felt clammy.
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| 48 | 2021-01-08 | feeling cold |
Employee Health notified several days after first vaccination that she had a sore throat, felt cold,...
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Employee Health notified several days after first vaccination that she had a sore throat, felt cold, "brief asthma attack" one hour after being vaccinated. Did not seek medical care. Inhaler used and symptoms went away 15-20 minutes later.
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| 48 | 2021-01-08 | feeling jittery, flushing |
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s...
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Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
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| 48 | 2021-01-08 | pain in extremity | fever, chills, arm pain, muscle aches, severe headache, |
| 48 | 2021-01-08 | tingling |
Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter i...
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Employee called Employee Health Dept 12/28/20 stating she felt tingling in her face and a flutter in her chest shortly after vaccination done 12/22/20 (while being observed). States she informed staff, RNs in clinic state this employee did not report any reactions to clinic staff. Employee returned to work in ICU, states "felt better by end of day". 12/23/20 states swelling to both feet, reports 6+ (?) pitting edema. 12/24/20 states abdomen swollen. Called advice nurse who recommended she report to ED. Employee declined ED and took Benadryl instead. 12/26/20 states face swollen, joint pain, legs felt like they were on fire, could barely walk. 12/28/20 states feels better . Left foot a little swollen
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| 48 | 2021-01-09 | pain in extremity |
Received injection 1/8/2021 at 6:00 pm. 12 hours after injection experienced very sore arm, temp th...
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Received injection 1/8/2021 at 6:00 pm. 12 hours after injection experienced very sore arm, temp that peaked 101, aches and chills. Symptoms lasted about 15 hours. Upon waking on 1/10/2021 no fever, aches or chills. Sore arm continues.
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| 48 | 2021-01-09 | pain in extremity |
Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. T...
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Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. Tylenol taken with not too much relief. Slept most of the day. Second day arm is much better and can move more. Body is still achey.
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| 48 | 2021-01-09 | tingling |
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach quea...
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Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
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| 48 | 2021-01-10 | weakness |
Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea,...
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Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea, loss of appetite lasting approximately 72 hours
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| 48 | 2021-01-10 | feeling hot, nerve pain |
6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin...
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6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin daily. s/s today left shoulder nerve pain (had injection on right side) 6/10. No body ache, diarrhea, chills today. COVID 1/8 test negative.
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| 48 | 2021-01-10 | flushing, numbness |
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever...
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I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
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| 48 | 2021-01-10 | numbness |
Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine...
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Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions. Given diphenhydramine, famotidine, and prednisone in emergency department. During observation in ED, started having throat and chest tightness with hyperventilation. This improved with lorazepam. Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.
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| 48 | 2021-01-10 | night sweats, weakness |
Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and...
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Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
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| 48 | 2021-01-10 | unresponsive to stimuli |
After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, an...
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After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, and "didn't feel right". Patient was laid flat on a couch, but then passed out and was not responsive to sternal rub. After a code was called, the patient woke up. At no time was there a loss of pulse or SOB. Patient was transported to the ER and was subsequently discharged same day. Patient did report that prior to the vaccination, she ran 13 miles in the morning, which may have had something to do with the reaction.
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| 48 | 2021-01-11 | weakness, numbness |
I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt littl...
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I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt little bit sick and I picked up food and I started to feel sick. I went to work and my symptoms got worse and I sat in my desk and I felt like fainting. I just felt so sick and I thought it was my diabetes. A coworker saw me and told me i looked deathly pale and felt fainting and they took me to a ER room. They gave me Benadryl and IV fluids. I started seeing the floor and ceiling warped out, I was hallucinating. My legs felt numb as well. My eyes were twitching constantly. My blood pressure 147/95 and pulse was 112. I went home, ate and went to sleep. On Saturday I felt better and went back to work 12-28-2020, I felt weak and stayed working at my shift. On Tuesday I worked 1 hour and still felt super weak. Today I am starting to feel like myself again. I will not get my second dosage due to my symptoms I have experienced.
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| 48 | 2021-01-11 | burning sensation |
Patient states that she felt the vaccine go through her body. She says that after about 20 minutes s...
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Patient states that she felt the vaccine go through her body. She says that after about 20 minutes she developed dizziness and throat tightness. She developed erythema across her chest. BP 180/108. O2 sats 98%. No SOB or difficulty breathing
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| 48 | 2021-01-11 | seizure | Pt had a strong seizure |
| 48 | 2021-01-12 | weakness, tenderness |
The vaccine was administered too high on the shoulder. Within 2 hours a report was made. symptoms w...
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The vaccine was administered too high on the shoulder. Within 2 hours a report was made. symptoms were pain, weakness, tenderness of shoulder joint and upper arm
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| 48 | 2021-01-12 | burning sensation |
2nd shot, 12 hrs after body aches; 24 hrs after fevers high 102.5; rigors; felt I was burning up; Th...
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2nd shot, 12 hrs after body aches; 24 hrs after fevers high 102.5; rigors; felt I was burning up; This is a spontaneous report from a contactable other healthcare professional reporting for herself (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) intramuscularly at Left arm on 05Jan2021 12:00 at SINGLE DOSE for COVID-19 immunization. Facility type vaccine was Hospital. Medical history included allergies to Sulfa, mild ragweed. Concomitant medication included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC ALLERGY), estradiol (VIVELLE DOT). The patient received the first dose of BNT162B2 vaccine (Lot number EK5730) via intramuscular route of administration in the right arm on 15Dec2020 at 12:30 at single dose for COVID-19 immunization. On 15Dec2020 at 12:30, the patient experienced warm feeling throughout body and heart race which lasted 10 seconds. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination she had not been tested for COVID-19. Adverse events reported as "2nd shot, 12 hrs after body aches, 24 hrs after fevers high 102.5, rigors and felt was burning up". Adverse event start date was reported as 06Jan2021 06:00AM. No treatment received for the events. Outcome of the events was recovered in Jan2021. Information about Batch/Lot number has been requested.
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| 48 | 2021-01-12 | facial pain |
Episodic Severe facial pain, ? Trigeminal Neuralgia. ER visit with bloodwork. Office visit follow ...
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Episodic Severe facial pain, ? Trigeminal Neuralgia. ER visit with bloodwork. Office visit follow up. MRI pending
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| 48 | 2021-01-12 | migraine |
Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours ...
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Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours Still slight headache
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| 48 | 2021-01-12 | pain in extremity |
Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx....
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Increased pain, URE/axilla swelling, intermittent shooting pain in URE starting on 1/12/2021 approx. 1430, progressively worsened.
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| 48 | 2021-01-12 | tingling, flushing |
11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observa...
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11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observation post vaccine. No symptoms during 30 minute observation post vaccine administration. Approximately 12:45pm right hand, tongue, mouth started tingling, and felt tongue was swelling. Reported feeling flush with chills, headache, and generalized weakness in legs. Went back to vaccine clinic to report symptoms at 2:15pm.
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| 48 | 2021-01-12 | tingling |
Systemic: Tingling sensation in injection arm, went away then noticed on other side of body in leg, ...
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Systemic: Tingling sensation in injection arm, went away then noticed on other side of body in leg, then spread to right arm. Described sensation as 'what it feels like when you sleep on your arm funny'.-Mild
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| 48 | 2021-01-12 | tremor, pain in extremity | Woke up at 12:30 am with severe chills and shaking. Headache, muscle aches, sweating and sore arm |
| 48 | 2021-01-13 | weakness |
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi...
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Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
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| 48 | 2021-01-13 | flushing, tingling |
Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx wi...
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Facial Flushing, face tingling, tongue swelling, appx 5' after injection. transferred to ED & tx with Benadryl, Pepcid. solumedrol IV. : with sx resolution - observed for 4 hrs in ED & d/cd
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| 48 | 2021-01-13 | flushing |
Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at...
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Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at the reaction since she is ex-military and had received a full complement of vaccine for overseas deployment with no issues.
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| 48 | 2021-01-13 | numbness | Bilateral mild facial numbness. Intermittent. No weakness. |
| 48 | 2021-01-13 | tingling |
Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experience...
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Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experienced lightheadedness, nausea, bilateral hand tingling, hypertension after administration of her first COVID vaccination. No airway involvement. No rash, chest pain or SOB. Patient states that she thinks she had COVID in March though she tested negative. Patient has never had prior vaccine reaction. She was taken to ED, given PEPCID IV and liter of LR. Her vitals were stable throughout and she felt back to baseline and was released to go home after about 2 hrs.
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| 48 | 2021-01-13 | tingling |
pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of ...
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pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient). A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-01-13 | tingling | Reported heart rate of 108, a week of paresthesias. Symptoms resolved |
| 48 | 2021-01-14 | weakness, tingling |
severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness...
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severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness; fever; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), via Intramuscular at single dose in the arm left, first dose on 17Dec2020 08:15, second dose on 07Jan2021 08:15, both for COVID-19 immunisation. Medical history included Epilepsy. Concomitant medications included fluvoxamine maleate (LUVOX), oxcarbazepine (OXTELLAR XR), liraglutide (SAXENDA) and bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). On 07Jan2021 17:00, the patient experienced severe headache, severe nausea, severe vomiting, upper gi pain, tingling in hands and feet, weakness, fever. The patient underwent lab tests and procedures, which included Nasal Swab on 08Jan2021 with negative result. Therapeutic measures were taken as a result of severe nausea and severe vomiting and included treatment with Zofran. Outcome of events was recovering.
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| 48 | 2021-01-14 | weakness |
Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday...
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Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday morning, I was aching all over and still had a headache. The aches were so severe that I was unable to tolerate anything or anybody touching me. By that afternoon, I was weak and fatigued. I was sent home by my director and by that evening I had developed a temp of 101.0. Friday morning, I was not feeling any better so I went to Urgent Care at around 0800. COVID test was negative but possibly too early to detect. Here we are today and I am still having body soreness that has become unbearable. I went to the walk-in clinic here at the hospital and have now been told that I will have to be admitted based on my lab results that indicates rhabdomyolysis.
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| 48 | 2021-01-14 | flushing, pain in extremity |
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed...
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Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
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| 48 | 2021-01-14 | muscle spasms |
GI issues, severe cramping, diarrhea >10/day , dehydration, headache, tired Normal activities affec...
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GI issues, severe cramping, diarrhea >10/day , dehydration, headache, tired Normal activities affected
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| 48 | 2021-01-14 | night sweats, pain in extremity |
day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, w...
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day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, woke up in wet clothes from sweat, headache, runny nose Day 3- sore arem, red and swollen, warm to touch, felt lethargic day 3- arm just red and warm to touch. big red circle where shot was given day 4- sitting down and out of nowhere a sharp pain felt in back by neck and shoulders. could not move my neck. arm still a little red but not warm to touch. swelling went down. (went to ER on day 4. blood work and xrays were negative for anything. was given muscle relaxer.) day 5 sore muscles but on muscle relaxer to help day 6 until day 10 - just fatigue and sore muscles/joint pain but tolerable.
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| 48 | 2021-01-14 | pain in extremity |
"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have ex...
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"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have extreme fatigue. My arm was sore for a couple of days only. The first vaccine was on 12/17/20 and i had 11 days of nausea afterwards"
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| 48 | 2021-01-14 | tingling, numbness |
RRT called for numbness and tingling sensation report by patient (employee) after receiving Pfizer C...
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RRT called for numbness and tingling sensation report by patient (employee) after receiving Pfizer COVID-19 Vaccine. Vaccine administered at 10:48am and approximately 15 minutes later starting reporting numbness and tingling sensations. All VSS stable, neuro exam completed with no other findings appreciated. MDs at bedside encouraging patient to go to the emergency department but patient refused. Encouraged to go if symptoms persist and/or worsen. Patient endorses she will take Benadryl when she gets home.
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| 48 | 2021-01-14 | tingling |
Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a co...
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Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
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| 48 | 2021-01-14 | tingling | Sévère arthralgia, not able to walk. Facial paresthésie. Extreme fatigue, chills and fever |
| 48 | 2021-01-14 | tingling |
At 6 pm I started feeling tingling/prickly sensations around my body in different areas lasting abou...
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At 6 pm I started feeling tingling/prickly sensations around my body in different areas lasting about 1 sec each time.
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| 48 | 2021-01-14 | tremor | "11p that night I had a 101 -102 temp, chills, headache, hard shakes" |
| 48 | 2021-01-15 | difficulty speaking |
About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it ...
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About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it was deep and scratchy, The change in voice got worse as i was speaking to my friend so i went to the ED (building next to where I work). I had no problems breathing but was eventually treated for anaphylaxis with epi, prednisone, benadryl, and pepcid
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| 48 | 2021-01-15 | pain in extremity |
I have chronic neck pain that flared up pain level (4-6 on a 1-10 scale) that lasted 4 weeks. I exp ...
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I have chronic neck pain that flared up pain level (4-6 on a 1-10 scale) that lasted 4 weeks. I exp other side effects body aches, joint pain, nausea, sore arm.
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| 48 | 2021-01-15 | tingling |
L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation res...
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L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation resolved following benadryl. tingling still present at 14 hours but has improved.
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| 48 | 2021-01-16 | flushing, hot flush |
Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, t...
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Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, tachycardia.
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| 48 | 2021-01-16 | hot flush | Lips tingling, tongue/throat swelling, flushed, hot flashes, leg weakness, nausea, tachypnea |
| 48 | 2021-01-16 | pain in extremity | Temperature 102 Fatigue Sore arm Chills |
| 48 | 2021-01-16 | tingling, weakness | Dizzy, weakness, tingling in lips and fingers, increased heart rate |
| 48 | 2021-01-17 | burning sensation |
On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell an...
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On Tuesday (1/12/21) night face and neck started itching and burning. Face was starting to swell and neck was red and had small bumps on it. Took some Benadryl and went to bed woke up this morning and eyes were swollen and face was a little worse. No record that patient sought medical attention or visited the ED. Patient reported swelling and itching went resolved the weekend of 1/16/21.
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| 48 | 2021-01-17 | difficulty speaking |
Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, ...
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Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, throat swelling and hoarse voice. Symptoms started approximately 40 minutes post vaccination at 1320. Pt has hx of food allergies. Pt was treated with epinephrine 0.3mg IM, diphenhydramine 25mg po, and famotidine 20mg po and prednisone 40mg PO. Observed in ED until 1758 and was noted to have no worsening of symptoms and improvement in hoarse voice. Discharged with prescription for prednisone 40mg x4 days.
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| 48 | 2021-01-17 | face paralysis, tingling |
tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on ...
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tingling sensation in right eye and mid cheek area,Unable to wink, or scrunch right eye; muscles on the right side of my face were noticeably weaker; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), via an unspecified route of administration, on 23Dec2020 at 04:00 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at Public Health Clinic/Veterans Administration facility, age at vaccination was 48-years-old. No other vaccine was received in four weeks. Medical history included gastrooesophageal reflux disease (GERD). Known allergies included levofloxacin (LEVOFLOXACIN), pethidine hydrochloride (DEMEROL), phenobarbital, cefalexin monohydrate (KEFLEX), charithromycin (BIAXIN). Concomitant medications included dexlansoprazole (DEXILANT), estradiol, phentermine, ergocalciferol (VIT D), calcium. The patient was not tested for covid prior or post vaccination. On 23Dec2020 at 04:45 PM, after leaving the clinic, the patient felt tingling sensation in right eye and mid cheek area. Within 1.5 hours, muscles on the right side of her face were noticeably weaker. Unable to wink, or scrunch right eye. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with prednisone. Outcome was recovering.; Sender's Comments: Based on a close temporal relationship causality between events "tingling sensation in right eye and mid cheek area" and "muscles on the right side of her face were noticeably weaker" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-17 | feeling cold | Chills, muscle pain, tiredness, injection site pain, feeling malaise |
| 48 | 2021-01-17 | flushing |
On 1/14/21 I took ibuprofen at 400. By 9am I was starting to feel achy and had chills. The...
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On 1/14/21 I took ibuprofen at 400. By 9am I was starting to feel achy and had chills. The symptoms progressed throughout the day. I felt feverish and the symptoms worsened. Chills, flush, all over body aches including headache. I went to buy some ibuprofen since I forgot to bring any with me. I felt better after I took the medicine.
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| 48 | 2021-01-17 | numbness |
The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went ...
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The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went numb, and I became a little bit disoriented while driving home. I also noted a pain in the left side of my chest. I got feeling back in my lips in my face approximately half an hour to 45 minutes later. I did take an Allegra allergy pill when I got home. I had already taken one Allegra allergy pill that morning. I slept for 12 hours on the following Friday night and Sunday night, whereas I typically only sleep approximately 6 to 7 hours per night. I noted significant stuffy nose and fatigue for the 3 to 4 days following the vaccine continuing until today.
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| 48 | 2021-01-17 | muscle twitching |
Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she s...
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Reporter received the Pfizer Covid-19 vaccine on Dec 28 around 7:55 am. That afternoon ~12:55, she started experiencing tachycardia. EMS was called to her home. She was evaluated and transported by car to the ER. EKG and labs were done (normal). It could not be determine if the vaccine was the cause. Dec 29th she went back to the ER for tachycardia and shortness of breath. Once again labs and EKG performed (normal). She had an appointment with a cardiologist that evening; a Holter monitor and an echo were ordered. She continued to have bouts of shortness of breath, tachycardia, muscle aches, and intermittent twitching. Went back to the ER Dec 31st
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| 48 | 2021-01-17 | tingling, feeling hot |
I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a la...
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I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
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| 48 | 2021-01-17 | tingling |
At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard....
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At approximately hour 40 post vaccine my Axillary lymph node became very enlarged, painful and hard. It was causing a tingling in my arm, like a pinched nerve and was painful to keep my arm in a relaxed position. The node was visible if I lifted my arm above my head. With a dose of ibuprofen, the swelling reduced but it was still palpable and painful for the next 18 hours. By the 72 hour vaccine mark, all symptoms were gone.
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| 48 | 2021-01-17 | tenderness, pain in extremity |
2 weeks later and I am still having pain and tenderness in arm, arm feels heavy and sometimes I have...
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2 weeks later and I am still having pain and tenderness in arm, arm feels heavy and sometimes I have weakness. There is no rash or swelling
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| 48 | 2021-01-18 | inability to speak, tremor |
1. Nausea 2. Tremors 3. Lack of ability to speak 4. Lack of ability to sit EpiPen administered and ...
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1. Nausea 2. Tremors 3. Lack of ability to speak 4. Lack of ability to sit EpiPen administered and EMS called
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| 48 | 2021-01-18 | weakness, tremor, discomfort |
Approximately 1 and a half hour after received 2nd dose of vaccine, patient felt weakness, heaviness...
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Approximately 1 and a half hour after received 2nd dose of vaccine, patient felt weakness, heaviness and tremors in the legs, that needed attention at the ER. Patient received hydration with NaCL 0.45% 1 L. Started to fell well and was D/H. 2 days later started with another reaction that was reported at VAERS e-report 248300. (This was reaction #1)
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| 48 | 2021-01-18 | pain in extremity | Sore arm, headache. Runny nose Took Tylenol |
| 48 | 2021-01-18 | tremor, discomfort |
Patient had 2 adverse reactions with the same administration of vaccine (2nd dose). At the day of t...
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Patient had 2 adverse reactions with the same administration of vaccine (2nd dose). At the day of the vaccine, patient started with leg weakness and a sensation of "heaviness" and tremors. Received hydration at ER Room. But 2 days later, developed severe lymphadenopathy at axilla of the same arm (right) where received vaccine.
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| 48 | 2021-01-19 | weakness |
Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade feve...
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Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade fever and chills all over my body especially the head, extreme weakness. It lasted for 2 days.
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| 48 | 2021-01-19 | burning sensation |
HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, ...
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HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, WORSE IN ARMS, CHEST AND ABDOMEN. NOW NO HEADACHE/PAIN IN INJECTION SITE, BUT CONTINUES WITH RASH, BURNING SENSATION AND ITCHING DESPITE SOLUMEDROL INTRAVENOUS ON 10/13/2020 AT DOCTOR'S OFFICE, HYDROXYZINE 25 MG THREE TIMES A DAY, BETAMETHOSNE CREAM SINCE 01/13/2020 AND PREDNISONE 50 MG BY MOUTH DAILY SINCE 1/18/2020
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| 48 | 2021-01-19 | feeling hot, throat numbness, numbness |
10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. S...
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10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. She reported throat tightness. , nausea and dizziness. 2 MDs were in the Observation area. They assessed her, gave her 25 mg Benadryl IM and 3 puffs of Albuterol inhaler. Heart rate 110, Resp Rate 12, O2 sat 98% on room air. Pt continued to fell warm and "weird." MDs wanted her to go to hospital but pt refused. Her employer offered to drive her to the ER but she refused. The MDs remained with her, monitoring for another hour. Pt was feeling better and chose to have her husband pick her up.
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| 48 | 2021-01-19 | feeling hot |
Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, onl...
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Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
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| 48 | 2021-01-19 | numbness, burning sensation |
mild headache from Jan 11-16th, starting on the 16th __complete left facial numbness and burning fro...
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mild headache from Jan 11-16th, starting on the 16th __complete left facial numbness and burning from left shoulder to the top of the head and moderate to severe headache
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| 48 | 2021-01-19 | migraine |
Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, ex...
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Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, extreme fatigue. Lasted for 30 hrs. Fatigue remained another 24hrs. Felt like bad cold or mild flu. I treated with over the counter medication after my physician said that was appropriate. Still worth getting the vaccine! I?m thankful I could receive it.
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| 48 | 2021-01-19 | tremor |
Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheade...
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Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheadedness, dizziness, mild intermittent aches and neck pain. Approximately 12-13 hours post dose, reporter developed serious systemic aches and pains, uncontrollable shaking, chills, nausea, vomiting, and developed a fever of up to 103.1. These more severe symptoms lasted approximately 3 hours and were treated with acetaminophen and ibuprofen only.
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| 48 | 2021-01-20 | feeling cold |
Fever 37.3 C and 37.6 C Muscle pain Chills Headache Pain in the left arm at the site of injection Sy...
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Fever 37.3 C and 37.6 C Muscle pain Chills Headache Pain in the left arm at the site of injection Symptoms started 12 hours after the injection. They last about 12-14 hours. I took aspirin, ibuprofen and Tylenol.
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| 48 | 2021-01-20 | flushing |
Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heavin...
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Flushing accompanied by redness started about 25 minutes after shot while driving home. Chest heaviness without SOB or difficulty swallowing. Itching began starting with face then neck, chest and torso. Itching then spread to the whole body with a patina rash appearing on the face, neck and chest a few hours later. Immediately took dose of liquid Benedryl upon arriving home. Followed up by dose of Zyrtec. Continued monitoring sxs throughout the evening. Took additional 2 doses of Benedryl with a dose of Singular. Sxs severity lessoned though the night and into the next day. Mild itching and a few patches of the rash remained the next day 1/20/21. Continued taking antihistamine and allergy medication. All sxs have resolved as of 1/21/21
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| 48 | 2021-01-20 | numbness, tingling | left arm numbness and tingling |
| 48 | 2021-01-20 | pain in extremity |
Dizziness; brain fog; achy; chills; sore arm; This is a spontaneous report from a contactable other ...
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Dizziness; brain fog; achy; chills; sore arm; This is a spontaneous report from a contactable other HCP(patient). A 48-year-old female patient received first dose BNT162B2, via an unspecified route of administration at Arm Right on 30Dec2020 10:00 at the 48 years old at single dose for COVID-19 immunization. The medical history included Rheumatoid arthritis and Depression. The concomitant medications were hydroxychloroquine phosphate ( PLAQUENIL ), leflunomide(ARAVA), desvenlafaxine succinate(PRISTIQ). The patient previously took Methotrexate and experienced allergies. On 31Dec2020 11:00, the patient experienced Dizziness, brain fog, achy, chills, sore arm. Mild for maybe 6 hours and a couple hours were moderate. Woke the next day on 01Jan2021 feeling fabulous. There was no treatment received for all the adverse events. There was covid tested post vaccination. There was no other vaccine in four weeks. The patient underwent lab tests and procedures, which included Nasal Swab on 30Oct2020 Negative. The outcome of the events was recovered on 01Jan2021. Information about lot/batch number has been requested.
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| 48 | 2021-01-21 | bell's palsy, numbness, tingling |
Within the hour of having the injection , I was having a numbness sensation in my right eye and chee...
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Within the hour of having the injection , I was having a numbness sensation in my right eye and cheek area. Seen in the walk in clinic dx with Bells Palsy, seen in the ER, confirmed Bells palsy. Started prednisone. Symptoms within 3-4 days at 90%. Continued prednisone. Nausea, headache, aches on 1/4-1/6 felt better until 1/20- just had extreme back aches , 1/20 eye felt numb again, muscle movement remained the same. headache, body aches, pins and needles in 3 middle toes on the right side.
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| 48 | 2021-01-21 | numbness | Patient experienced numbness in left side of face |
| 48 | 2021-01-22 | muscle spasms, muscle twitching |
Around the 18 minute mark began having an odd facial sensation. There was intermittent tightening ...
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Around the 18 minute mark began having an odd facial sensation. There was intermittent tightening feeling at eyebrows and across forehead that would then flutter/spasm, subside, then repeat. The episodes would last 1-3 seconds intermittently for 25-30 mins. No treatment was sought, it did not affect any daily functions.
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| 48 | 2021-01-22 | tingling |
Day of vaccination: headache and right side face tingling. Followed by 2 days of fatigue. Day 9 pos...
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Day of vaccination: headache and right side face tingling. Followed by 2 days of fatigue. Day 9 post vaccination: raised redness, hard knotted area, pain and itching at injection site. And 2-3? diameter around injection site.
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| 48 | 2021-01-22 | tingling |
tingling/itching on back and neck, shoulders arms; pt denies SOB, wheezing, rash, hives, nausea, sta...
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tingling/itching on back and neck, shoulders arms; pt denies SOB, wheezing, rash, hives, nausea, states "it may be nerves"; recommended to take benadryl when getting home; info given
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| 48 | 2021-01-22 | tremor | Fever100.5, body aches, chills, shaking, headache, rapid heart rate |
| 48 | 2021-01-23 | tingling, pain in extremity |
Patient returned to clinic 3 weeks after her first dose of the Pfizer COVID19 vaccine to complete th...
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Patient returned to clinic 3 weeks after her first dose of the Pfizer COVID19 vaccine to complete the second dose in the series. When nurse asked regarding post vaccination response, patient reported expected muscle soreness at site (right deltoid) for 2 days, however expressed new localized symptoms at the site that began the evening of the second day. Symptoms included pain radiating down the length of right arm, tingling fingers, and weakness in right arm. Patient was able to manage pain with OTC analgesics, however expressed concern with length of the symptom's duration. After 21 days post vaccine administration, she expressed she continues to have pain in right arm when held in certain positions. Nurse took down information, notified supervisor and encouraged patient to follow up with her doctor. Nurse explained to the patient that a report would be completed and that further communication with her could be possible after reporting. Patient was in agreement with plan. Nurse completed assessment and education for second dose finding no contraindications. Patient consented to receiving her second Pfizer COVID19 vaccine in her left arm. Administration was completed in left deltoid with no immediate adverse effects.
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| 48 | 2021-01-23 | speech disorder, difficulty speaking |
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking....
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chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
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| 48 | 2021-01-24 | flushing, tingling |
Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness a...
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Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness approx 1.25-1.5 hours after injection. around 12:10 pm or so. Removed excess clothing, put head between legs and turned on fan. Symptoms improved within 15 minutes. Headache later Saturday evening. Face hot and flushed and bad headache around 6pm Sunday evening. Face hot and flushed still Monday 1/25 in am but is getting a little better (I think) at the time of report.
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| 48 | 2021-01-24 | migraine, pain in extremity |
Sore Arm within few hours after injection which went away after 2 days. The next day woke up with m...
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Sore Arm within few hours after injection which went away after 2 days. The next day woke up with migrane like headache, took 2 Advil and within an hour felt better. Also felt very tired for several days.
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| 48 | 2021-01-24 | pain in extremity | Left arm pain leading to chest wall pain with pmhx of angina. 6/10 pain radiating to left neck, SOB. |
| 48 | 2021-01-25 | weakness, pain in extremity |
extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which afte...
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extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which after the second dose remains a dull ache now at two weeks and 3 days after the second dose. Still have severe fatigue. I want to sleep all day.
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| 48 | 2021-01-25 | weakness | Sore Injection Site, Neck Pain, Nausea and Weakness |
| 48 | 2021-01-25 | weakness |
My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal B...
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My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time with it.
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| 48 | 2021-01-25 | burning sensation |
Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan...
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Red swollen face, swelling in hands fingers. Face was tight and felt as if it were burning. Claritan was provided, issue resolved in about two hours.
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| 48 | 2021-01-25 | burning sensation |
Within a hour and a half my throat was on fire, and I called a virtual care through my insurance and...
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Within a hour and a half my throat was on fire, and I called a virtual care through my insurance and saw a provider via telehealth. She gave me Augmentin and prednisone. My sinuses were irritated. I had flu like symptoms but no fever. I was treated for strep throat. I have had mild throat burning since and have not fully recovered. I have had a severe headache ever since and have had to rotate Tylenol and ibuprofen everyday. I went into the ER 01/22/2021 with severe chest pain and they said I had GERD.
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| 48 | 2021-01-25 | muscle spasms, pain in extremity |
I woke up early that morning and both of my legs were aching and cramping. It was very painful. Last...
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I woke up early that morning and both of my legs were aching and cramping. It was very painful. Lasted about a hour and stopped. I have burning in my throat still from the first injection.
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| 48 | 2021-01-25 | pain in extremity |
Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report...
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Left arm pain in armpit; swollen lymph nodes; led to whole left arm pain; This is spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm single dose for COVID-19 immunization on 10Jan2021, 09:30 AM, at 48-year-old. Medical history and concomitant medication were not reported. No known allergies. The patient did not have COVID prior vaccination. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 20Dec2020, 05:30 PM, at 48-year-old. On 11Jan2021, 05:00 PM, the patient had left arm pain in armpit with swollen lymph nodes, led to whole left arm pain. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
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| 48 | 2021-01-25 | tingling |
Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a con...
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Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 13Jan2021 10:15 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension (HTN). Concomitant medication included amlodipine besilate (NORVASC) and metoprolol tartrate (LOPRESSOR). About 8 hours after immunization, patient started to have pruritus and paresthesia across body, particularly extremities on 13Jan2021 06:00 PM. Therapeutic measures were taken as a result of the events which included Hydroxyzine Hcl (ATARAX). The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination. Information on the lot/batch number has been requested.
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| 48 | 2021-01-25 | tremor |
Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal ...
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Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal response with near syncope episode. Gave Diphenhydramine approximately 25 minutes after onset.
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| 48 | 2021-01-26 | bell's palsy |
Reporter received second COVID-19 vaccine on Wednesday 1/19 with no immediate side effects. On Frid...
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Reporter received second COVID-19 vaccine on Wednesday 1/19 with no immediate side effects. On Friday, 1/22, reporter began experiencing issues blinking. Saturday morning, 1/23, side effects expanded to her mouth. She called a 24/7 health hotline and was diagnosed with Bell's Palsy. She began prednisone Saturday afternoon (1/23). Symptoms persist, but do not seem to be progressing. Has been to her PCP who confirmed initial diagnosis and will schedule appt with endocrinologist to address change in blood sugars with prednisone. Received the vaccine in her right arm, which is the same side of her face affected.
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| 48 | 2021-01-26 | burning sensation |
My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experienci...
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My eyelids swelled and my face became red/itchy and burn. It's been a week and I'm still experiencing it all.
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| 48 | 2021-01-26 | feeling cold, tremor |
First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with...
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First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with burning pain. Was told is was shingles but wasn?t treated. Was told to get the second vaccine in the opposite arm to see if the same thing happens. Received 2nd injection in left arm and ended up with full blown symptoms of COVID. Uncontrollable shakes, cold, fever, severe body aches, cough, diarrhea and the rash still remains. As of today, I have an upper respiratory infection as well as the open rash, which the PCP listed has taken control of and deemed the cause side effects of the second injection.
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| 48 | 2021-01-26 | numbness | Systemic: cheek numbness, resolved with 25 mg of benadryl |
| 48 | 2021-01-26 | pain in extremity, numbness |
Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest...
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Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine
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| 48 | 2021-01-26 | pain in extremity | Sore Arm, Fatigue, General feeling of sick, Hives, |
| 48 | 2021-01-27 | flushing | Itching, vomiting, feeling flush, chest tightness |
| 48 | 2021-01-27 | hypersensitivity of all senses | headache, body aches, fatigue, loss of appetite, skin sensitivity |
| 48 | 2021-01-27 | pain in extremity |
Under my left arm was sore after each dose of the Pfizer-BioNTech COVID-19 Vaccine. I suspect swolle...
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Under my left arm was sore after each dose of the Pfizer-BioNTech COVID-19 Vaccine. I suspect swollen lymph nodes. The reaction occurred 7days after the first dose and the next day after the 2nd dose. While the armpit started to feel better before the 2nd dose I wouldn't say symptoms resolved before the 2nd shot.
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| 48 | 2021-01-27 | pain in extremity |
Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turnin...
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Arm was very sore couldn't move it started taking ibuprofen that night. On Sunday arm started turning red a size of a softball was extremely red swollen and hot to the touch, shoulder area and under arm pit was swollen and hurt to touch are move. Was informed by employee health to start taking antihistamines (which I already take) so she told me to increase the amount by taking Benadryl as well and icing it on and off for 30 minutes at a time, The people here at my work checked it regularly and slowly it is improving each day as long as I ice and take extra antihistamines.
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| 48 | 2021-01-27 | tingling, weakness, cold sweat |
severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weaknes...
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severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weakness; This is a spontaneous report from a contactable Other Health Professional. A 48-year-old female patient (not pregnant) received 2nd dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via intramuscular on 12Jan2021 13:30 at single dose on left arm for covid-19 immunisation. Medical history included mild asthma. There were no concomitant medications. Historical vaccine included 1st dose of bnt162b2 (lot: EJ1685) on 23Dec2020 left arm at single dose for COVID-19 Immunization (age at vaccination was 48 years old). Approximately 11 hrs after 2nd vaccine, patient developed severe rigors, severe arthralgias and myalgias as well as skin parasthesia, severe cold sweats and profound weakness. Symptoms improved with APAP (acetaminophen) plus ibuprofen alternating q3 hrs x24 hrs. Outcome of the events was resolving. This case was reported as non-serious.
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| 48 | 2021-01-27 | tremor |
rash on fash and I believe on scalp that is itchy, tried taking benedryl but it did not make a diff...
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rash on fash and I believe on scalp that is itchy, tried taking benedryl but it did not make a difference. shoulders and back also itchy but rash does not appear to have spread there. hands are trembling.
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| 48 | 2021-01-28 | numbness, tingling |
Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tinglin...
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Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tingling of left side of face; numbing and tingling of left side of face and left side of upper/lower lips; numbing and tingling of left side of face and left side of upper/lower lips; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included none. Patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced dry mouth, numbing and tingling of left side of face and left side of upper/lower lips, numb on left side of neck on 06Jan2021. Shot was in left arm. Concerned about getting second vaccine. No treatment received in response to the events. The outcome of the events was recovering. The patient was not pregnant. Facility type vaccine was Public Health Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 48 | 2021-01-28 | pain in extremity, tingling, feeling hot |
24 hours after vaccine, both arms began to hurt very bad, felt hot and tingly. Shooting pains in bot...
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24 hours after vaccine, both arms began to hurt very bad, felt hot and tingly. Shooting pains in both wrists and left knee. Became very dizzy. The pain lasted for about 8 hours then moved into both legs with shooting pains in both ankles. The leg and ankle pain lasted for about 8 hours. Now I am just very sore in all extremities and joints. Moving very slowly compared to my usual. Feel very run down. Also had very itchy arms about 8 hours in only for a few minutes, no rash.
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| 48 | 2021-01-28 | tenderness |
Total body joint pain, low grade fever, headache x 16hrs Injection site pain, axillary pain/tenderne...
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Total body joint pain, low grade fever, headache x 16hrs Injection site pain, axillary pain/tenderness x 1 week
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| 48 | 2021-01-29 | cold sweat, tingling, numbness |
Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and...
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Cough Throat tongue swell Dizzy Cold/ hot sweats Nausea Given 4 Benadryl immediately Numbness and tingling in vaccine arm Went to ER for monitoring Ten minutes after started the worst headache of my life and I get migraines Have had pulse racing and slight chest pains all afternoon Went home after 4 hours observing Got a steroid through IV Fever has started after 12 hours
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| 48 | 2021-01-29 | flushing |
with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood press...
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with dose 1given on 1/7/21 - within 5 mins -flushing, headache, chills, back pain., high blood pressure in 150's, fatigue. Headache and backache lasted for 4 days. Fatigue for a week. I was monitored for 2 hours after injection. With dose 2 on 1/29/21- immediate - nausea, headache, lightheadedness, chest discomfort, very sleepy like I just wanna go to sleep right away. I was monitored for 2 hours until Chest discomfort subsided. nausea took more than 3.5 hours. headache is still on today the next day. Midnight -I had severe severe joint pains like my bones were ripping apart. very sleepy. i slept 12 hours straight. still have headache.
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| 48 | 2021-01-29 | pain in extremity |
Malaise and severe joint pain, nausea, frequency in bowels, stomach pain, dizziness, headache that s...
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Malaise and severe joint pain, nausea, frequency in bowels, stomach pain, dizziness, headache that started about 12 hours post injection in the night. Arm pain radiating into axilla and down arm from injection site. A bit disoriented upon waking, pushed fluids and OTC meds with some relief of pain but GI symptoms persisted.
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| 48 | 2021-01-30 | pain in extremity |
Arm sore, headache, fever, myalgia stared about 12 hours after 2nd dose of vaccine. Reactions laste...
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Arm sore, headache, fever, myalgia stared about 12 hours after 2nd dose of vaccine. Reactions lasted one day.
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| 48 | 2021-01-30 | pain in extremity |
Around 5pm (12/28): chills, arm soreness on site of injection Trouble sleeping as sleep cycles inter...
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Around 5pm (12/28): chills, arm soreness on site of injection Trouble sleeping as sleep cycles interrupted by nightmares, also fever (101), chills and muscle/ joint aches 12/29: nausea/ vomitting with worsening joint/muscle aches. Sent home without finishing workday. Fever continue all day and all night with syncopal episode on friday night. My husband gave me ice bath to break the fever which was 102 ( according to him). *unable to got to the bathroom unassisted from Friday afternoon and all day Saturday* 12/30: fever, muscles, joiny aches and headaches persisted but lesser in severity 12/31: first day fever free ( last and only dose of tylenol at 6am). Mild headache at time of filling up this report(8:51pm) Able to go the bathroom unassisted all day.
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| 48 | 2021-02-01 | numbness |
Patient honked horn 10 minutes after receiving vaccine. C/o numbness in left side of face and in le...
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Patient honked horn 10 minutes after receiving vaccine. C/o numbness in left side of face and in left hand. No SOB. BP 110/64, HR WNL. 911 called at 3:54PM and 25mg of liquid Benadaryl given orally. Red rash on patient's chest appeared at 3:46 PM, continued numbness. EMS arrived at 3:59PM. Report given and patient transferred to Hospital with normal vital signs and no SOB.
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| 48 | 2021-02-01 | pain in extremity |
nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate ...
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nauseous; mild to moderate arm pain; injection site pain; Pain was from wrist to shoulder; moderate vasomotor symptoms; body aches; This is a spontaneous report from contactable nurse (patient herself). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:00 in right deltoid at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 19Jan2021, patient experienced mild to moderate arm pain in arm that had shot, more than just injection site pain. Pain was from wrist to shoulder. 2-3 hours later moderate vasomotor symptoms followed with body aches. She took celecoxib (CELEBREX)and paracetamol (TYLENOL), body aches got better. 7 hours post injection, she felt nauseous and took ondansetron (ZOFRAN). Outcome of events were unknown. Information on the lot/batch number has been requested.
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| 48 | 2021-02-01 | pain in extremity |
L upper arm, L shoulder and L side of neck pain. Treated with massage, stretching and Ibuprofen. Sym...
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L upper arm, L shoulder and L side of neck pain. Treated with massage, stretching and Ibuprofen. Symptoms are getting better but on-going.
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| 48 | 2021-02-01 | pain in extremity |
I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of ...
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I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of my 9 hour shift I was very stiff in all of my lower joints from the hips down as well as uncomfortable from the achiness. I walked slowly and stiffly as I was leaving work. I felt extremely tired that night and decided to work a shorter shift the next day - 8 hours rather than 9 hours. I took ibuprofen prior to my second shift. I was still achy and stiff but it was a little better witht he ibuprofen. The next day at home on the weekend I was again achy and stiff and took ibuprofen. I woke up on 1/25 with swollen hands that were painful and stiff. I have since had daily swelling of both hands and achiness in wrists non
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| 48 | 2021-02-01 | tingling, feeling hot |
This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT1...
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This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at the left arm on 13Jan2021 at a single dose to protect against COVID. Medical history included under active thyroid in Jul2019. There were no concomitant medications. The patient woke during the night feeling like she was on fire feeling prickly throughout her body/her whole body got really hot and she had to cool with a rag on 19Jan2021 03:00. Outcome of the events was unknown.
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| 48 | 2021-02-01 | tingling |
Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightn...
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Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightness in throat, difficulty swallowing and slight confusion begins - drank more water and began to suck on lollipop 5 minute marker - confusion, tightness in throat worsens and lump in throat begins - I alerted medical staff who attended to me and gave me a cold compress. 10 minute marker - Drank water, self administered 2 children's dissolvable Benadryl 20mg - remained at hospital for one hour under observation. 50 minute marker - throat still tight, lump subsided, difficulty swallowing persists, confusion lessens, extreme dry mouth persists, tingling in extremities comes and goes - self administered 2nd Benadryl 25mg 60 minutes - left clinic 90 minutes - called primary care physician and left a message 3 hours - primary care responded to take prednisone 20 - 40 mg every 6 hours for 2 days. 3 hours 20 minutes - all symptoms described above subsided. Prednisone was taken for 36 hours as tightness in throat, issue swallowing and lump came back when I tried to stop the Prednisone at 48 hours.
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| 48 | 2021-02-02 | feeling hot |
Patient felt light headed and hot. She then c/o scratchiness in her throat and a little shortness of...
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Patient felt light headed and hot. She then c/o scratchiness in her throat and a little shortness of breath. Patient was administered Benadryl 50mg IVP and was monitored at the site of vaccination. She refused transport. She stated that she felt much better.
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| 48 | 2021-02-02 | hot flush |
Client stated she felt a warm sensation going down her left arm. "almost like a hot flash, but just...
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Client stated she felt a warm sensation going down her left arm. "almost like a hot flash, but just in my arm". Client continued to be coherent. 4:20 pm B/P 122/90/98 pulse=78 Pulse Oximeter 98% 4:25 pm B/P 122/88 pulse=79 Pulse Oximeter 98% 4:30 pm B/P 128/88 pulse=80 Pulse Oximeter 99% Client stated she felt fine. Released from clinic site. Encouraged to contact medical provider if symptoms returned.
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| 48 | 2021-02-03 | burning sensation, numbness |
Headache; complete left sided facial burning; complete numbness starting from the neck to the top of...
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Headache; complete left sided facial burning; complete numbness starting from the neck to the top of the head; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included depression and metabolic syndrome from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (WELLBUTRIN SR), metformin hydrochloride (METFORMIN) and vitamin B complex (VITAMIN B). The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Jan2021 05: 00 PM, the patient experienced moderate to severe headache, complete left sided facial burning and complete numbness starting from the neck to the top of the head. No treatment was given to the patient for the events. The outcome of the events was recovering.
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| 48 | 2021-02-03 | cold sweat, cold extremities, feeling jittery |
she woke up her hands and feet were very cold; her hands and feet started feeling cold clammy and sw...
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she woke up her hands and feet were very cold; her hands and feet started feeling cold clammy and sweaty; hands and her feet have been sweating; feeling jittery; has not been able to sleep; feeling very nervous and anxious; feeling very nervous and anxious; she can feel cold air through her skin easier now/ under hot water her fingers and feet feel more sensitive to hot water; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on 11Jan2021 17:30 at a single dose on left arm for COVID-19 immunization (COVID-19 vaccination). The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 23Dec2020 at a single dose for COVID-19 immunization. The patient said that she got the second shot on Monday 11Jan2021 about 17:30 in the evening. On Tuesday 12Jan2021, when she woke up, her hands and feet were very cold. Her hands and her feet have been sweating. Her hands and feet started feeling cold clammy and sweaty the next day on Tuesday 12Jan2021 while she was working from home. She is also feeling jittery and she has not been able to sleep and she is feeling very nervous and anxious (onset date for feeling very nervous and anxious also reported as 13Jan2021, pending clarification). She said that she can feel cold air through her skin easier now it feels like, and also said that even under hot water her fingers and feet feel more sensitive to hot water than they did before. She has never had these symptoms (feel nervous and anxious) before. It made her nervous thinking that maybe the shot caused her hands and feet to feel cold and sweaty. The outcome of the events was not recovered.
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| 48 | 2021-02-03 | discomfort, tingling, flushing |
Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/di...
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Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/dizzy; lightheaded/dizzy like she was going to pass out; Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on; Had a heavy feeling in her chest; Tingling sensation on her lips; Tingling sensation on the right side of her face, and cheek; Severe burning in her right ear; Sore throat on the right side; When she was speaking it sounded like she had a thick tongue; Tongue feels swollen; Pain at the base of her skull on the right side; Pain on the right side of her forehead; Pinpoint pain that went down the right side of her spine; Metallic taste in her mouth; felt off; Pain at the injection site; It was so bad that it would wake her up if she rolled over; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3248), via an unspecified route of administration on 15Jan2021 at single dose (Once by injection in the right arm) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included Hepatitis B vaccine. There were no concomitant medications. On 15Jan2021, after 15 minutes of monitoring she was fine. 5 minutes later or so (after 20 minutes), she had a flushed feeling and was lightheaded/dizzy like she was going to pass out. She returned to her office. She had someone check her blood pressure which was fine. It was 110/60. Normally it runs low in the 90s. Again, she thought she looked flushed. It was reported she had a heavy feeling in her throat and chest and on her face. She had removed her mask but it still felt like she still had it on. She had brought Benadryl with her, as she has had a reaction to the Hepatitis B vaccine before. She took the Benadryl since she felt off. She thinks this first part of what she experienced triggered everything else. By the time she got home, she had a tingling sensation on the right side of her face, on her lips and cheek. She had severe burning in her right ear. She also had a sore throat on the right side. Heaviness in her throat and chest- resolved late Saturday to early Sunday (Jan2021). Her husband noticed on Friday evening (15Jan2021) when she was speaking it sounded like she had a thick tongue. Saturday morning it was more normal. Her tongue does feels swollen. She also developed pain at the base of her skull on the right side. This started about 2 hours after the vaccine. She had pain on the right side of her forehead. She had pinpoint pain that went down the right side of her spine. She also developed a metallic taste in her mouth. She had pain at the injection site. It was so bad that it would wake her up if she rolled over. On 17Jan2021, she slept all day Sunday and also had extreme fatigue. On 18Jan2021, her right eyelid feels heavy on 18Jan2021. She does not think any of these are serious, but stated they are concerning. Vaccination card does not have the NDC or expiration date on it. Patient asked is getting the second dose of the injection recommend. She is leaning towards no but wanted to see what was recommended. She has reached out to her primary care about this. Outcome of the events flushed feeling, lightheaded/dizzy, lightheaded dizzy, like she was going to pass out was recovered on 15Jan2021. Outcome of the events when she was speaking it sounded like she had a thick tongue was recovered on 16Jan2021; Outcome of the events pain at the base of her skull on the right side, pain on the right side of her forehead, pinpoint pain that went down the right side of her spine, extreme fatigue, pain at the injection site was recovered on 17Jan2021; Outcome of the events Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on, and Had a heavy feeling in her chest was recovered on Jan2021. Outcome of the events severe burning in her right ear, sore throat on the ride side, tingling sensation on her lips, tingling sensation on the right side of her face and cheek was recovering. Outcome of the events tongue feels swollen, metallic taste in her mouth, right eyelid feels heavy was not recovered. Outcome of the events it was so bad that it would wake her up if she rolled over, she slept all day Sunday, and felt off was unknown. The reporter considered the events as non-serious. Causality assessment for events for felt off, she slept all day Sunday, It was so bad that it would wake her up if she rolled over was not reported. Causality assessment for all other events was reported as related.
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| 48 | 2021-02-03 | feeling hot |
Patient states she was waiting in post vaccination area when she began to become very anxious. Her h...
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Patient states she was waiting in post vaccination area when she began to become very anxious. Her heart was racing, felt hot, rash on chest, and felt throat feel thick. EMS was on site and took vital signs. Transported patient to Emergency Department via ambulance. Benedryl and Prednisone were administered IV. Patient was monitored for 4 hours at Emergency Department. Followed up with patient today. She is continuing to take Benedryl. Feels much better.
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| 48 | 2021-02-03 | flushing |
C/O headache, became flushed in face BP, Pulse, respirations monitored for 1 hours and 45 minutes, c...
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C/O headache, became flushed in face BP, Pulse, respirations monitored for 1 hours and 45 minutes, cold compress to face and ice pack to left arm site
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| 48 | 2021-02-04 | hot flush |
Increase in hot flashes especially at night. I am perimenopausal and have had occasional hot flashes...
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Increase in hot flashes especially at night. I am perimenopausal and have had occasional hot flashes, but now I am having hot flashes every night and sometime during the day. Unsure if related to vaccine, but thought being it is a new vaccine I would report it.
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| 48 | 2021-02-04 | numbness, slurring, facial paralysis |
it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left ton...
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it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-04 | migraine |
bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a si...
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bad headache that felt like migraine; bad headache that felt like migraine; thought it might be a sinus headache; pain on the right side of the back of her neck that radiated behind her right eye; pain on the right side of the back of her neck that radiated behind her right eye; dizziness; sweating; swollen lymph nodes in her throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 15Jan2021 at 07:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced dizziness, sweating, and swollen lymph nodes in her throat. On 18Jan2021, the patient started to get a really bad headache that felt like migraine and thought it might be a sinus headache. On the same day, the patient also had pain on the right side of the back of her neck that radiated behind her right eye. The patient would like to know if she could take anything for her headache. The outcome of the event bad headache that felt like migraine was not recovered while the other events was unknown. Information about lot/batch number has been requested.
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| 48 | 2021-02-04 | pain in extremity, migraine |
Woke up the next morning with an extremely bad headache/migraine. Light sensitive to my eyes. I h...
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Woke up the next morning with an extremely bad headache/migraine. Light sensitive to my eyes. I had to take ibuprofen and acetaminophen around the clock, and I went back to bed and slept until 1pm that day. Headache remained dull the rest of the day, but I began feeling better. My left arm was also very sore and second day past vaccine now have armpit soreness/pain. Took ibuprofen again today for that.
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| 48 | 2021-02-05 | feeling hot |
I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a...
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I had a slightly elevated temp after the shot on 1-23. At 6:45 am on the 24th it was 99.9 . All of a sudden I felt a heat throughout my body and felt on fire while also feeling an urge of diarrhea and nausea. I tried to go to the bathroom, but kept passing out. I could not see, but was conscious. It took me 15 minutes to crawl to the bathroom. I did not vomit and passed watery stool x 2. The episode passed after about 40 minutes. I continued to have a slight elevated temp all day after that episode, but only 99.6 and below. There were no more issues after that brief, horrible reaction. I am 101 lbs.
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| 48 | 2021-02-05 | tremor |
Shot given 2-4-21 at 1236, woke up at 2-5-21 at 0130 with severe uncontrollable shaking that last ...
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Shot given 2-4-21 at 1236, woke up at 2-5-21 at 0130 with severe uncontrollable shaking that last approximately 2.5 hours. Joint pain was unbearable, felt like muscles were being torn apart, tried getting out of bed and hit the floor because of lack of muscle control.
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| 48 | 2021-02-07 | feeling cold, hot flush |
Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/c...
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Injection site rash; Swollen lymph nodes; Headache; Teeth hurt on left side; Hot/cold flashes; Hot/cold flashes; Nausea; Vomiting; Symptoms of perimenopause; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number=EL9262), via an unspecified route of administration at Left arm on 19Jan2021 15:00 at single dose for covid-19 immunization. The patient medical history included known allergies: penicillin. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0142), on 01Jan2021 12:00 PM at Left arm at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site rash, swollen lymph nodes, headache, teeth hurt on left side, hot/cold flashes, nausea/vomiting, symptoms of perimenopause on 20Jan2021 at time of 12:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-02-07 | pain in extremity | Pain in arm headache nausea fever body aches joint aches sensitive to light |
| 48 | 2021-02-08 | pain in extremity |
Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in t...
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Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse. A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose via an unspecified route of administration in right deltoid for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially. At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-09 | discomfort |
All over body / muscle aches - unable to sleep well due to extreme discomfort. Pain started around 8...
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All over body / muscle aches - unable to sleep well due to extreme discomfort. Pain started around 8pm and intensified through the night. Started to abate early afternoon next day. Did take extra strength Tylenol 4 times between 8pm 2/8/21 and 2pm 2/9/21. As of today, 2/10/21, still have joint pain in right hand knuckles and mid back / right shoulder blade and at injection site.
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| 48 | 2021-02-09 | tingling, discomfort |
swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm ...
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swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm tingling to fingers; very uncomfortable; Right armpit discomfort; This is a spontaneous report from a contactable healthcare professional (the patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), intramuscular in the right arm on 20Jan2021 at 10:00 (at the age of 48-years-old) as a single dose for Covid-19 immunization. Medical history included central nervous system disorder (CIS) from an unknown date. The patient did not have any allergies to medications, food or other products. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140) on 30Dec2020 in the right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021 at 18:00, the patient experienced right armpit discomfort. On 22Jan2021 the patient experienced swollen armpit lymph nodes and upper right arm leaving the right arm tingling to fingers and very uncomfortable. Therapeutic measures were not given for the events. The clinical outcome of the events axillary pain, lymphadenopathy, peripheral swelling, paresthesia and discomfort was not recovered. It was reported that since the vaccination (dose 1), the patient had been tested for COVID-19 via a PCR nasal swab on 19Jan2021 with a negative result.
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| 48 | 2021-02-09 | tremor, migraine |
migraines; blood glucose dropped below 80; severe shakes; nausea; This is a spontaneous report from ...
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migraines; blood glucose dropped below 80; severe shakes; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 14:30 at single dose at left arm for covid-19 immunization. Medical history included fibromyalgia, chronic migraines, degeneraive disc disease, spinal spinosis, celiac, arthritis, and type 2 diabetic, known allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks included prescribed medications. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient was a type 2 diabetic and the next day after the injection, on 05Jan2021 08:00 patient blood glucose dropped below 80 and patient usually run 128 and above. It was hard getting BG level up over 100 for over two weeks and patient had severe shakes, nausea, and migraines as an adverse effect from very low BG levels. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. Patient lowered insulin units as treatment.
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| 48 | 2021-02-10 | weakness |
Fever, severe body aches, chills, absolutely no energy, loss of appetite, hard to sit up to even dri...
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Fever, severe body aches, chills, absolutely no energy, loss of appetite, hard to sit up to even drink water. Similar to a horrible flu case. Worst I had felt maybe ever in my life. Took Tylenol and NyQuil. By Monday morning, about 30 hours later, was finally feeling some energy and able to go to work
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| 48 | 2021-02-10 | muscle spasms, pain in extremity | Lacy vascular rash on both calves. Calf pain and cramping. |
| 48 | 2021-02-10 | pain in extremity |
4 hrs after injection I had severe pain in shoulder and unable to move 1/2 inch without severe pain....
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4 hrs after injection I had severe pain in shoulder and unable to move 1/2 inch without severe pain. The pain compares to post op shoulder surgery or an injury and radiates thru arm into fingers. 24 hrs after injection. I spiked a fever of 101 degrees after taking ibuprofen 3 hrs prior. Also have severe fever and aches and pains accompanying the fever.
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| 48 | 2021-02-10 | pain in extremity |
1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was large...
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1/4 Vaccination. 12 hours later; arm pain, lump on arm with redness. Within 24 hours, lump was larger. Lymph nodes swollen. Lump was about size of a softball, all lymph nodes swollen. Symptoms about a week. Sought attention from NP. She stated to ice and Ibuprofen.
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| 48 | 2021-02-11 | muscle spasms, seizure |
Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, ra...
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Chills, fever, muscle spasms, convulsing, splitting headache, bone and joint aches, muscle aches, rash on neck, chest and back, itchy back, swollen lymph nodes (under jaw) really large lymph node in groin area appeared 10 days post vaccination, trouble breathing, exhausted, light headed, nausea, white chalky furry tongue., diarrhea.
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| 48 | 2021-02-12 | pain in extremity |
Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), bl...
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Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), blood in urine, pain in all major joints. difficulty walking and limited range of motion. Symptoms showed up after 7 days after vaccine was received. Presented to urgent care after test were don't I was hospitalized inpatient for 4 days. I was diagnosed with RHABDOMYOLYSIS, ABNL LIVER FUNCTION STUDY. CREATINE KINASE TEST OUTCOME WAS AT 41000.
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| 48 | 2021-02-14 | muscle spasms |
Fevers to 104 degrees with delerium, severe muscle contractures of neck, upper back, and left arm. S...
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Fevers to 104 degrees with delerium, severe muscle contractures of neck, upper back, and left arm. Severe rigors. Involuntary spasms of back and neck lasting 1-3 minutes. Severe headache -frontal location and behind eyes. Possible febrile seizures per husband (temp 104.5, not responsive, repeated jerking of neck- resolved after placing in ice bath) . Fevers refractory to ibuprofen/tylenol. Initially continued for duration of 12 hours, remitted for 2 hours, then resumed for additional 24 hours. Intermittent muscle spasms with chills continued for another 12 hours, along with muscle soreness.
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| 48 | 2021-02-14 | pain in extremity |
12 hours after second shot (1/29/2021): Chills for 5 hours, 101 fever; 24 hours after second shot (...
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12 hours after second shot (1/29/2021): Chills for 5 hours, 101 fever; 24 hours after second shot (1/30/21): 99 fever and throbbing pain in left and right forearms. Took 1 Tylenol on 1/30/21 that relieved the fever but not the pain in the forearms. Pain in forearms stopped on 1/31/2021.
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| 48 | 2021-02-14 | tingling, numbness |
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial are...
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Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
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| 48 | 2021-02-15 | cold sweat |
Patient started complaining of cold sweats, chills, and sweating. She states she suffers from anxiet...
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Patient started complaining of cold sweats, chills, and sweating. She states she suffers from anxiety and thinks she is having an attack. Patient then escorted to the post vaccination area and asked to remove jacket, and given water. After 10 mins of observation she states she is feeling better. Patient then escorted to her car without any incident
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| 48 | 2021-02-15 | pain in extremity |
Tiredness began upon return home from shot location. Severe bone pain in right hip, thigh, knee, bo...
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Tiredness began upon return home from shot location. Severe bone pain in right hip, thigh, knee, both shoulders, chest pain when taking a deep breath and headache began approximately 15 hours after injection and continue at 3pm on Tuesday the 16th of February. Just not the "happy camper, I usually am. :(
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| 48 | 2021-02-16 | weakness, pain in extremity |
Noted after first injection on 1/6/2021 within three hours, extreme fatigue, excessively sore arm an...
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Noted after first injection on 1/6/2021 within three hours, extreme fatigue, excessively sore arm and following morning significant brain fog and loss of energy. Noted after second injection on 1/27/2021, not much in the way of symptoms until about 3:15 a.m. on 1/28/2021 when was awakened from a sounds sleep with tremendous body aches, chills, fever, fatigue and headache. Took about 7 full days to completely recover. During weekly healthcare PCR testing, tested positive for COVID 19 on 2/10/2021. Two weeks later to the day. Week prior test was negative.
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| 48 | 2021-02-16 | weakness |
Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram ...
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Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath
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| 48 | 2021-02-16 | weakness |
Second vaccination given on the 02/12/2021 at 07:35. Began to have symptoms at 16:30 on 2/12/2021. B...
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Second vaccination given on the 02/12/2021 at 07:35. Began to have symptoms at 16:30 on 2/12/2021. Body aches, weakness, fever, chills, headache, and sore arm at injection site. These symptoms lasted until Monday 2/15/2021. I took Acetaminophen for the above symptoms. I left work early Friday night and called employee health Monday morning.
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| 48 | 2021-02-16 | numbness |
Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report...
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Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), intramuscular in the left arm on 06Jan2021 14:30 at a single dose for covid-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. On 06Jan2021 at 15:00, the patient experienced dysgeusia 20 min after exam lasting 1 min and left hemicranial numbness times 24 hrs. The patient still has mild residual numbness on left face. The events resulted in doctor or other healthcare professional office/clinic visit. The events were not treated. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events dysgeusia and numbness with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-02-16 | pain in extremity |
After getting 2nd Pfizer COVID 19 Vaccine, late that night I became achey, sore arm , tired and inte...
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After getting 2nd Pfizer COVID 19 Vaccine, late that night I became achey, sore arm , tired and intense headache on February 10th. The next day and until Sunday of same week I was tired with intense headache. The headache didn't subside even with taking something for it. February 16th I returned to work and felt better with a light headache. I am a teacher. After 2 hours of being at work I became extremely dizzy as I went to sit down. The classroom flipped and I was dizzy. I was dizzy and had a hard time with balance. Another teacher took me home. I went to Patient First and they said I had positional vertigo.
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| 48 | 2021-02-18 | numbness |
Employee received the second dose of the Pfizer COVID vaccine. Employee felt deep bone and muscle p...
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Employee received the second dose of the Pfizer COVID vaccine. Employee felt deep bone and muscle pain right after injection. The next day she was unable to move arm away from her body. Took Tylenol and ibuprofen and range of motion improved. Over time pain increased to a constant pain. On 2/14/21 the pain increased to 7 out of 10 while she was laying down and the pain would wake her up at night. Employee reports pain was bad regardless if she was sleeping on right arm or not. Employee reports one day (2/7/21) she experienced numbness in right arm down to fingers tips. Employee was seen on 2/18/21 and was diagnosed with rotator cuff tendonitis and prescribed physical therapy and given a steroid injection: methylprednisone acetate.
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| 48 | 2021-02-18 | tingling |
within 10-15 minutes post vaccination the recipient notified nurse she had difficulty in breathing, ...
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within 10-15 minutes post vaccination the recipient notified nurse she had difficulty in breathing, complaining of rapid heart rate, not feeling well, lightheaded, chest pressure, tingling. No LOC. Called 911 , Epi auto injection given 0.3 mg; reported improvement in chest pressure and breathing shortly afterwards, taken to local hospital via EMS in stable condition. Total time in clinic: approximately 40 minutes from vaccination to EMS leaving.
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| 48 | 2021-02-21 | numbness |
I have numbness on the left lower side of my face. It is faint, however, noticeably different from t...
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I have numbness on the left lower side of my face. It is faint, however, noticeably different from the right side with no symptoms.
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| 48 | 2021-02-21 | pain in extremity | swollen of the lymph node, pain on left arm that radiates to upper back |
| 48 | 2021-02-21 | pain in extremity |
Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old...
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Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and sore arm on 27Jan2021. The outcome of the events was reported as unknown. Information about Lot/ Batch has been requested.
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| 48 | 2021-02-21 | pain in extremity |
arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tende...
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arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-02-21 | pain in extremity |
I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Har...
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I had a sore arm and a raised bump for about 3 days, It went away. 10 days later it is back. Hard raised bump at injection site.
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| 48 | 2021-02-22 | breast pain, pain in extremity, hot flush |
Significant Left under arm swelling (area swollen approximately size of baseball in half) Significa...
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Significant Left under arm swelling (area swollen approximately size of baseball in half) Significant pain under left arm Redness along outside of left breast Pain in Left breast Pain Left shoulder to Left elbow Nausea and hot flashes - Mild
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| 48 | 2021-02-22 | numbness |
Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SO...
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Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SOB, wheezing, sweating, and numbness on left side from face to arm. Pt was given oxygen and 0.3mg of epinephrine was given intramuscularly at 12:05pm, followed by 25mg of diphenhydramine intramuscularly at 12:08, both administered by RN on site. Paramedics arrived at the scene at 12:05pm and took over monitoring of pt; pt was taken to ambulance at 12:10pm
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| 48 | 2021-02-22 | tingling | Itchy, tingley, throat. Itchy bottom of feet. Drank water. Lasted ~20 minutes. No visible rash. |
| 48 | 2021-02-23 | flushing |
Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Sh...
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Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Shoulder lymph and neck lymph on left side.
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| 48 | 2021-02-23 | numbness, pain in extremity | Headache and dizziness Diarrhea Nauseated Pain in arm and numbness from shoulder to elbow Fatigue |
| 48 | 2021-02-24 | feeling cold, tingling |
since about 3 days after the shot, my arm has been feeling a cold sensation in the deltoid area and ...
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since about 3 days after the shot, my arm has been feeling a cold sensation in the deltoid area and the forearm area. When I touch the arm, it is warm. I also have had a tingling in my left leg which comes and goes.
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| 48 | 2021-02-24 | flushing |
Patient reported feeling flushed during observation period. Pt. gets anxious with shots and has chr...
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Patient reported feeling flushed during observation period. Pt. gets anxious with shots and has chronic HTN. Pt. was hypertensive. Pt. stated she felt better and was advised to go home and relax, check BP when rested, and check with primary care provider. If needs emergent attention go to nearest ER.
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| 48 | 2021-02-24 | pain in extremity, muscle spasms |
Started 2/17/21 two days after vaccine shot. Left arm and shoulder pain upon waking. Intense burn...
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Started 2/17/21 two days after vaccine shot. Left arm and shoulder pain upon waking. Intense burning sensation across top of shoulder, down over shoulder blade and entire left arm, including hand. Sharp pain with cramping feeling. Difficulty finding a comfortable position because entire arm is tender, sore to the touch, as well burning feeling. Duration: 2/17/21 - still ongoing. 2 ER Visits. 2 PCP Visits
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| 48 | 2021-02-24 | tingling |
Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she bega...
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Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she began to look distressed and reported sensations of tingling in her elbows and behind her knees. No SOB, facial swelling, or heart palpitations. It was felt she may be nervous and she was given water and monitored closely. Vitals taken with O2 100%, HR 58, BP 134/89 Pt received Benedryl 25 mg when she began to note mild erythematous blotching on neck 10 min later vitals stable with bp 138/82 and pulse 62 Pt was given a second 25 mg dose to take if any symptoms worsened on way home- she was driving therefore I did not want to give her another dose at the time. She understands to call for emergency care if any SOB, facial swelling, or any distress Pt confirmed at 10 pm that she made it safely home with some improvement in her symptoms. I will follow up with her in the morning as well and will complete a VAERS report. I have educated her that at this time CDC would recommend not receiving the second vaccination, given potential allergic reaction within first 4 hours. We will review this again tomorrow I communicated with patient morning of 2/25/21- she states still mild tingling of arms but no new or worsening symptoms. She feels this is more consistent with anxiety and hesitant to not receive her second dose. I suggested she discuss with her primary care provider before her next visit and if she were to proceed with her second vaccination, I would suggest someone being with her to drive and she take 50 mg of benedryl 1 hr prior to vaccine. She was appreciative.
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| 48 | 2021-02-25 | burning sensation |
Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer....
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Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer. A 48-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176) via an unspecified route of administration in right arm on 22Jan2021 12:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, cough, diarrhea, swelling, burning on 22Jan2021 16:00. The patient didn't receive any treatment for events. The outcome of events was recovering.
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| 48 | 2021-02-25 | cold sweat | Perspiration all over body, clammy, warm, BM |
| 48 | 2021-02-26 | feeling hot |
Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at th...
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Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at the time. Subsequent readings: BP 160/110 O2 Sat 95% HR 119 BP 196/120 O2 Sat 96% HR 125 Patient was transported to the hospital.
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| 48 | 2021-02-27 | numbness |
Lymphadenopathy started approx 22 hrs after first dose. Tender left axilla, radiation to left breast...
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Lymphadenopathy started approx 22 hrs after first dose. Tender left axilla, radiation to left breast and left scapula with numbness noted 5th digit left hand approx 48 hrs after injection. Tenderness, pain increasing daily. Currently only second day post injection.
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| 48 | 2021-02-28 | flushing, feeling of body temperature change |
Pt. received second dose of Pfizer vaccine on 2/24/2021, on 2/25/2021 at 12:30 pm she stated she bec...
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Pt. received second dose of Pfizer vaccine on 2/24/2021, on 2/25/2021 at 12:30 pm she stated she became flushed and was nausea's. Went to put her head down on desk, head hit desk and she fell to her knees. Pt. unsure if she lost consciousness. She described going form extremely hot to cold. Ambulance called and taken to ER
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| 48 | 2021-02-28 | flushing |
I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad an...
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I waited in the holding area (mass vax clinic) for 20 min. No symptoms. The lights were very bad and bright flourescent so admittedly I was bothered by them or it could have been the beginning of the whooseyness from the shot. My husband picked me up in the car out front, we were driving and I began to get pressure in my sinuses and mostly the sides of my nose. I did have some head congestion but this feeling had never happened (it should be noted I had negative covid tests to make sure stuffy head was nog covid related). Then I felt pressure in my ears and my face began to feel flush as my cheeks. All of this began at about 35 minutes after the injection. Then my lips began to feel strange. It was a cross between tingly and numb. I made as many faces in the car makeup mirror to make sure my face muscles were moving properly And they were. But there was definitely numbness occurring in my mouth. Tingly-numbness. This all happened within about 10 min of the first onset. Then I noticed some splotchiness on my lower arms. Mostly my left (shot was given in right- no redness at the injection site). I also got some splochiness on my chest and neck. Cheeks were also ruddy and flush. I did NOT have any problem breathing or swallowing at anytime. Nor did my pulse race (other than from a pit of panic from nerves over the reaction). I didnt have a thermometer but don?t think I had a fever either. We pulled over and I called a nurse on call. She told me if things worsened to go to hospital. I did have a little bit of the feeling you get when you are about to pass out and you feel like things are closing in a bit. But it never got past about a 2 on a scale of 1-10. I decided I wanted something to eat (I HAD eatten before) and I went to get a sandwich. I still was a bit light headed but the symptoms did start to subside in about an hour. After that I was only tired and took a nap. Nothing else after those initial reactions.
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| 48 | 2021-02-28 | muscle spasms |
As anticipated, the day following the shot, I felt flu-like symptoms which subsided by late evening....
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As anticipated, the day following the shot, I felt flu-like symptoms which subsided by late evening. Monday morning, I still felt fine, but by the afternoon, complete exhaustion over took me, muscle pain and cramps began, headache returned and I've essentially been on the couch or in bed since Monday Feb 22.
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| 48 | 2021-02-28 | pain in extremity |
The vaccine was given on Tuesday, Feb 23, 2021, and on Wednesday 24, 2021 I had an awful headache, f...
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The vaccine was given on Tuesday, Feb 23, 2021, and on Wednesday 24, 2021 I had an awful headache, feelings of nausea, extreme tiredness, and arm pain. Wednesday 25,2021 most symptoms did not reoccur. Except now there is pain on my right side, back of the neck, shooting down the middle of the right shoulder blade. I took Midol for Wednesday's symptoms and went to bed before 8 pm. Woke up feeling better except for shoulder pain. Thursday I felt like I had a stiff neck so I took Ibuprophen and hubby massaged the area. Massage helped for about 30 min. The pain persisted on Friday still tried massage and Ibuprophen still very painful and now hard to be comfortable sitting and sleeping. Saturday morning I tried a warm shower and heat pad throughout the day pain still persisted. No ibuprofen and still massaged area. Sunday morning I soaked in the tub with Epsom salts and pain still continued throughout the day. Monday called dr. and she encouraged me to fill out a report and take vitamin C seems to think lymph nodes are clogged.
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| 48 | 2021-02-28 | pain in extremity |
Headache, chills, nausea, arm pain severe, tired. stared 24 hrs after Vaccination, Day after just pa...
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Headache, chills, nausea, arm pain severe, tired. stared 24 hrs after Vaccination, Day after just pain in Rt Arm.
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| 48 | 2021-03-01 | weakness | Dizziness tiredness headache nausea body aches no energy |
| 48 | 2021-03-01 | cold sweat |
2/26 9:30 am: cold sweats, nausea, stayed home from work 2/27, 2/28: unable to perform normal ellipt...
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2/26 9:30 am: cold sweats, nausea, stayed home from work 2/27, 2/28: unable to perform normal elliptical cardio, could only do a few minutes than had to lay down due to extreme fatigue and shortness of breath 3/1: too fatigued to shower, change, or cook a meal. Stayed home from work. 3/2: Went to work. Too short of breath to walk across campus without sitting and taking breaks. Went to urgent care at noon, took PCR test for Covid, was negative.
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| 48 | 2021-03-01 | tingling |
253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gav...
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253p 154/99, 139 HR, 24 RR, 100% O2 ? dizziness, itching on arms and face, R arm numbness ? gave diphenhydramine elixir 25 mg x1 307p 120 HR, trouble with BP cuff 313p R arm numbness, legs heavy, face and mouth tingling ? gave diphenhydramine elixir 25 mg x1 315p 142/89, 110 HR ? legs ?wonky?, R arm numbness remains, itching improving 330p symptoms significantly improved, ?feeling better?; family member with patient and able to drive patient at home and continue observation Telephone follow-up performed at 430p. No problems.
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| 48 | 2021-03-02 | cold sweat |
after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 ...
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after injection pt complained of dizziness and not feeling well. initial vital BP 66/52 HR 68 RR 15 spO2 97% RA. pt was in sitting position. became clammy, diaphoretic, blurred vision, and feeling worse and passed out. pt assisted to floor. MD called to bedside, 0.3 epi pen given to left thigh. no respirstory distress noted. fire and EMS on scene to transfer to ED. pt now a&ox4. VSS now.
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| 48 | 2021-03-02 | pain in extremity | Sore arm, headache, stiff neck |
| 48 | 2021-03-02 | cold extremities, tingling |
mild tinging in her left arm; tingling in her feet; tingling in her feet and they also feel cold; Th...
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mild tinging in her left arm; tingling in her feet; tingling in her feet and they also feel cold; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on the left arm, on 31Jan2021 13:30, at single dose, for covid-19 immunization. Medical history included penicillin allergy. Concomitant medications included temazepam; spironolactone and; silybum marianum (MILK THISTLE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received the vaccine in the hospital. It was reported that shortly after the vaccination, on 31Jan2021 the patient experienced mild tinging in her left arm that went away; but when she woke-up she noticed tingling in her feet and they also feel cold on 31Jan2021. The outcome of the event mild tingling in her left arm was recovered on 31Jan2021. The outcome of the events tingling in her feet and they also feel cold was unknown. The patient has not been COVID-tested post-vaccination.
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| 48 | 2021-03-04 | discomfort |
It started out as an itchy area under the band aid. I took the band aid off and the itching got wors...
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It started out as an itchy area under the band aid. I took the band aid off and the itching got worse and went down my arm. A minute left after waiting 15 minutes I let the nurse know the reaction I was having ( bad itching), she looked at it and was red. She said it could be a site reaction and gave me an ice pack. Another nurse came to check on, and I told her I was really thirsty. By the time she got back my lips were feeling very heavy, lips itching and difficult to swallow, then my whole chest was covered in a red rash. With in a couple minutes there was a paramedic there and was more difficult to swallow, they tried to give me Benadryl thru an IV and blew my vain. So he asked me for a IM shot of Benadryl, I said yes and took me to the ER. By the time got there the Benadryl wore off and my lips got itchy and they took me right to the room and Dr gave me IV Solumedrol and Benadryl. They watched me for two hour sin the ER , they released me with 3 days of prednisone, Epipen, Benadryl. I went to the pharmacy (15 minute drive from ER) and both my eyes starting swelling, so I took 50mg of Benadryl capsule and the next day I started the prednisone, I had to take Benadryl every 3 hours for the next couple days because my eyes would start swelling.
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| 48 | 2021-03-04 | feeling hot | hot, dizzy, redness, headache |
| 48 | 2021-03-04 | flushing |
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injecti...
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Error: Wrong Route (SC, IM, etc.)
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| 48 | 2021-03-04 | muscle spasms | DIZZINESS, NAUSEA, CRAMPS, DIARRHEA, HEADACHE, FATIGUE. |
| 48 | 2021-03-04 | pain in extremity, numbness |
A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJ...
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A SHARP PAIN AND NUMBNESS IN INJECTED ARM IMMEDIATELY AFTER THE INJECTION, 25 MINUTES AFTER THE INJECTION I EXPERIENCED A HEADACHE, CHEST PAIN, DIZZINESS, THROAT SWELLS UP AND IT'S HARD TO SWALLOW, AND BLURRY VISION.I TOOK SOME BENADRYL AND MY THROAT STOPPED CLOSING UP. I WENT HOME AND LAID DOWN. MY ARM IS STILL NUMB BUT THE PAIN HAS RECEDED. MY ARM ALWAYS SWELLS UP WHENEVER I RECEIVE AN INJECTION. 2 HOURS LATER THROAT IS STILL A LITTLE SWOLLEN, AND I HAVE A SLIGHT HEADACHE. CHEST STOPPED HURTING. LEFT ARM IS STILL NUMB.
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| 48 | 2021-03-04 | pain in extremity |
Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h pos...
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Arm Pain - onset 6h post injection Body aches - 24h post injection Arm pit pain & swelling - 34h post injection Headache -34h post injection Injection site swelling/lump - 38h post injection Lightheaded - 44h post injection
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| 48 | 2021-03-04 | pain in extremity |
Around 2/13/21: Right Hand second finger with rash, swelling, mottled color with redness on knuckle ...
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Around 2/13/21: Right Hand second finger with rash, swelling, mottled color with redness on knuckle and dorsal side of skin from knuckle to nail. Same day I developed a growth on right hand middle finger similar to a cyst or nodule. 2-3 days later I developed a reddened raised lesion on my left hand 4rth finger dorsal side near the joint. Doctor looked at it over zoom but not in person and thought it was contact dermatitis or allergic dermatitis from hand sanitizer or glove use. Steroid cream triamcinolone and cloberasol have been tried for 1.5 weeks but not working. After second dose of vaccine I developed pain and redness to left hand 4th finger knuckle near where the previous lesion had been. And the cyst on my right hand middle finger is growing and taki bf on a weird shape, its surface area has increased and these creams are not helping.
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| 48 | 2021-03-05 | flushing | Flushing, history of anxiety. BPs 148/80 (pulse 84), 140/90 (pulse 74). O2 sat 97%. |
| 48 | 2021-03-05 | muscle spasms, tingling, numbness, pain in extremity |
Patient's symptom log: 1/21/2021: 1st dose of COVID-19 vaccine (Pfizer); just sore arm 1/27/2021: N...
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Patient's symptom log: 1/21/2021: 1st dose of COVID-19 vaccine (Pfizer); just sore arm 1/27/2021: Numbness felt in front left thigh 1/27/2021 - present: - continued numbness in legs that comes and goes - numbness in arms; both but more in left - pins and needles in both hands, feet - hands fall asleep during night - back spasm overnight; left side of back - numbness in back; both left and right sides - middle and upper back - in back, stiffness/achiness, not quite pain - back sensations feel like a radiating spasm that comes and goes - new this week - pins and needles (slight) in trunk - at work, have felt slight difficulty typing with left hand Areas Affected: - neck (slight soreness) - shoulders (stiffness and achiness/numbing) - back (achiness, stiffness, spasms, numbness) - arms (stiffness, achiness, pins and needles, numb) - hands (pins and needles, possible muscle loss) - buttocks (numbness) - legs (pins and needles, stiffness, numbness, soreness) - feet (pins and needles, numbness) - face (slight numbness on right slide)
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| 48 | 2021-03-05 | muscle twitching, tingling |
Acute onset of fatigue approximately 48 hours after receiving the vaccine on 30/Jan/2021. Fatigue ha...
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Acute onset of fatigue approximately 48 hours after receiving the vaccine on 30/Jan/2021. Fatigue has worsened and persists to this day. Acute onset of palpitations 48 hours after vaccine and lasting approximately 20 min., headaches lasting 3 days and severe heartburn lasting 3 days. Coarse fasciculations of left pectoralis muscle onset 50 hours after vaccine. This progressed over ensuring days to involve other muscles both above and below the diaphragm including gluteals, gastronemius muscles, abductor hallucis longus, left first dorsal interosseous, deltoids, triceps, various abdominal and spinal muscles, and more recently the left masseter. The fasciculations persist to this day. Muscle pains started 2 days after onset of the fasciculations and are moderate-severe and worsened by exercise. I experienced tingling at the lower limbs on 6 occasions and transient disorientation one day on my way to work. My vision has been a bit blurry at times. i have been moody and short-tempered at times.
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| 48 | 2021-03-06 | pain in extremity |
Dizziness, nausea, fatigue, fever, chills, muscle soreness, pain in left hand, swollen and painful a...
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Dizziness, nausea, fatigue, fever, chills, muscle soreness, pain in left hand, swollen and painful armpit.
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| 48 | 2021-03-06 | pain in extremity |
Upon receiving vaccine I immediately had severe arm pain. The injection itself was extremely painfu...
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Upon receiving vaccine I immediately had severe arm pain. The injection itself was extremely painful and immediately afterwards pain worsened from elbow to top of shoulder and has not let up. I have zero mobility and the severe pain is not responding to over the counter pain relief medicine.
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| 48 | 2021-03-07 | pain in extremity, feeling hot |
fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable hea...
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fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3248 and expiry date: unknown), via an unspecified route of administration on the left arm, on 02Feb2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 12Jan2021 11:00 on the right arm (lot number: ej1656). Medical history included cancer. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and no other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, warming feeling, sore arm, joints sore on 02Feb2021 15:00. No treatment was received for the events. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. Covid test was on 03Feb2021 with unknown results. The reporter considered the events non-serious.
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| 48 | 2021-03-08 | migraine |
Severe headache, nausea, malaise, migraine ( 2 weeks), and fatigue. Took excedrin and imitrex for 2 ...
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Severe headache, nausea, malaise, migraine ( 2 weeks), and fatigue. Took excedrin and imitrex for 2 weeks. Intake of lots of fluids and bed rest. Telehealth visit with doctor.
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| 48 | 2021-03-08 | muscle twitching |
at 6 am this morning I felt that the muscle on my left arm on the injection site is twitching and it...
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at 6 am this morning I felt that the muscle on my left arm on the injection site is twitching and it continues to twitch off and on up to the time I am writing this note at 2:20 pm
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| 48 | 2021-03-08 | nerve pain, numbness, pain in extremity |
Covid arm developed last night and is getting worse at the injection site. I have extreme dizziness...
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Covid arm developed last night and is getting worse at the injection site. I have extreme dizziness like vertigo, extreme fatigue, throwing up and nausea and my arm symptoms are huge welt that is burning hot at the injection site, cannot lift my arm without pain, numbness and nerve pain running down the arm down to the elbow. I feel faint. I am at home laying down with ice on it, Tylenol and Benadryl. I cannot make it to the doctor as I live alone and have epilepsy.
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| 48 | 2021-03-09 | weakness |
Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakne...
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Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakness Requires emergency room visit or hospitalization Shortness of Breath, Myalgia
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| 48 | 2021-03-09 | cold sweat |
excess phlem; Exhaustion; Body aches; fever; chills; cold sweat; This is a spontaneous report from a...
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excess phlem; Exhaustion; Body aches; fever; chills; cold sweat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3247), via an unspecified route of administration on right arm on 04Feb2021 10:00 (at age of 48 years old) at single dose for COVID-19 immunization. Medical history included spinal stenosis, liver hemangiomas, uterine fibroids, parapelvic and renal cysts, complex left ovarian cysts, PTSD (Post-traumatic stress disorder), pap smear atypical cells of undetermined significance, endometrial cells, bacterial vaginosis, HPV (Human papilloma virus infection), osteopenia, anemia, patellar tendenitis, right hip impingement, left shoulder impingement syndrome, microscopic hematuria, hiatal hernia, cricopharyngeal spasms and allergies to contrast die. Concomitant medication included pregabalin (LYRICA), sertraline hydrochloride (ZOLOFT), colecalciferol (VIT.D3) and glutathione. The patient previously received first dose of BNT162B2 (Lot number=EL3247) on 15Jan2021 at 10:45 AM on right arm for COVID-19 immunization. The patient experienced excess phlem, exhaustion, body aches, fever, chills, cold sweat on 04Feb2021 17:00. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment from events. The outcome of events was recovered in Feb2021.
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| 48 | 2021-03-09 | migraine | Rash around injection site Rash around neck Migraines Nausea Fever Ache |
| 48 | 2021-03-09 | tremor |
At 11:30pm on 3/9/2021 over 12 hours after my 1st COVID-19 vaccine , I awakened from my bed and went...
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At 11:30pm on 3/9/2021 over 12 hours after my 1st COVID-19 vaccine , I awakened from my bed and went into my bathroom to urinate. As I was using the restroom, I noticed my arm where I got the vaccine was very sore, and raised it slightly. Immediately after raising my arm, I became very dizzy and passed out, fell off of the toilet and hit the left side of my temple and eye on the marble ledge of my shower. As I came to, my whole body had chills and I was shaking. I applied a cold compress and took 2 Tylenol. I alternated between sweating and chills for the rest of the night. The next morning I had a headache and felt fatigued, but the dizziness had subsided and I rested.
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| 48 | 2021-03-10 | discomfort |
4:39 pm - Client complained "heaviness in neck region". There was no rash or tingling sensation. Cl...
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4:39 pm - Client complained "heaviness in neck region". There was no rash or tingling sensation. Client was alert and oriented and left at 4:53 pm.
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| 48 | 2021-03-10 | facial pain | Severe left ear pain and pain on the left side of the face, including the neck. |
| 48 | 2021-03-10 | numbness, tenderness |
Angioedema of the right side of the patient's face from the inferior orbit down, sparing the upper l...
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Angioedema of the right side of the patient's face from the inferior orbit down, sparing the upper lip, and involving the lower lip. Accompanied by numbness for a few hours which then subsided, with lingering tenderness upon palpation.
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| 48 | 2021-03-10 | pain in extremity |
Severe leg pain (both), overall muscle soreness, diarrhea, nausea, vomiting, coughing, and tiredness...
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Severe leg pain (both), overall muscle soreness, diarrhea, nausea, vomiting, coughing, and tiredness.
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| 48 | 2021-03-10 | pain in extremity |
COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat;...
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COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.
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| 48 | 2021-03-11 | weakness | chills, body aches, extreme fatigue, could not use/move right arm, weakness |
| 48 | 2021-03-11 | flushing, weakness |
Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Im...
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Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Immediately afterwards, patient was dizzy, flushed feeling, tingling of my lips, and swelling of the right side of my face. These symptoms were not enough to seek medical attention but were there. After that, I had swelling down my arm and into my right hand, up my neck and face, up and down the right side of my back. I have been extremely tired and weak feeling. Some improvement but I am still really sore and the RSD is starting to act up. I have called into work, been eating well, drinking a lot or water, moving as much as I can, and using Advil and Tylenol for pain management. Called into work for three days.
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| 48 | 2021-03-11 | numbness | Immediate numbness of left arm. After 2 days left face numbness |
| 48 | 2021-03-11 | pain in extremity |
My arm has been hurting since I had the 1st doce. When I lift up, it hurts so much. There's no swole...
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My arm has been hurting since I had the 1st doce. When I lift up, it hurts so much. There's no swolen or rashes. Just pain. Why is that so after so long?
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| 48 | 2021-03-11 | pain in extremity |
Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. ...
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Terrible pain and swelling under my left arm (arm pit area) with pain shooting into my left breast. Pain at the injection site that traveled through my arm to the joints in my wrist.
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| 48 | 2021-03-11 | tingling |
I woke up with a rash on chest tingling and burning. On Friday I had a Telehealth appt was diagnose...
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I woke up with a rash on chest tingling and burning. On Friday I had a Telehealth appt was diagnosed with Shingles.
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| 48 | 2021-03-12 | unresponsive to stimuli, tingling, numbness |
Person noted to be drowsy and minimally responsive. Epinephrine 0.3mg IM and diphenhydramine 25mg I...
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Person noted to be drowsy and minimally responsive. Epinephrine 0.3mg IM and diphenhydramine 25mg IM administered and within two minutes of the epinephrine the patient started talking and saying she was feeling a little better. Reports that she started feeling numbness and tingling in her lower extremities which progressed to her upper body (bilateral). Also reports hx of hypoglycemia and states she ate and drank approx 90 minutes before the event. Reports this happened one other time when she was exposed to smoke in her classroom and that she was admitted to a local hospital for three days. VSS 124/72, 90, 100% ORA. Apple juice given after patient became more responsive. Transported via EMS to ED for eval, alert, oriented, stable, and in no apparent distress.
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| 48 | 2021-03-13 | pain in extremity | arm soreness, very mild dizziness, fatigue |
| 48 | 2021-03-13 | pain in extremity |
Headache w nausea started in 5 min. At about 15 min chest was tight. By 45 min neck muscles were e...
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Headache w nausea started in 5 min. At about 15 min chest was tight. By 45 min neck muscles were extremely tight. By about 90 min slight wheezing and all over joint pain. Skin itching in various places. Took Benadryl. At night my whole body was tight muscled. Felt much better next day other than continued fatigue , sore arm and mild flu feeling. No fever or rash. The form
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| 48 | 2021-03-14 | feeling cold |
On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch soun...
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On 3/13/21 I started to notice a buzz sound in ny head when trying to take a nap. A High pitch sound like static. It hasn?t gone away since then. Im seeing an ENT on 3/16/21 to have this checked. About 25 minutes after my covid shot I felt a strong cold feeling on the top of my head for about 30 -60 minutes . It went away. Now I wonder if this was also related.
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| 48 | 2021-03-14 | migraine | Sever two day migraine starting the day after injection, fever, chills, myalgia in lower back |
| 48 | 2021-03-14 | tingling, hot flush, pain in extremity |
pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore...
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pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore R arm; LOSS OF TASTE; partial throat swelling 90 min after 2nd injection; drowsy; This is a spontaneous report from a contactable health care professional. A 48-years-old female received 2nd dose, bnt162b2 (BNT162B2) Lot number= Lot EL3247 , intramuscular in right arm, on 29Jan2021 at 15:30 as a single dose for COVID-19 immunization . Medical history included sjogren's syndrome, irritable bowel syndrome , raynaud's phenomenon, fibromyalgia , food allergy to peanuts, honey, oranges, strawberries, lobster, molasses, brown sugar, cinnamon. She had the first dose of COVID-19 on 08Jan2021 at 1545 in the right arm. There were no other vaccinations given in the past 4 weeks. She was not tested for Covid prior to vaccination.Concomitant medication included collagen (COLLAGEN), medium-chain triglycerides (MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]), ergocalciferol (VIT D), fish oil (FISH OIL). The patient previously took gluten and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. Course as follows: On 29Jan2021: partial throat swelling 90 min after 2nd injection. Took 50mg Benadryl. Became very drowsy and went to bed at 7:30pm. 30Jan2021: Woke at 5am w/chills, headache, body aches, sore R arm, temp of 101.3, dry mouth & LOSS OF TASTE. By 11:30am, fever went up to 103.5. Took 400mg ibuprofen. Went and got a Rapid Covid test (It was negative/undetectable). 4pm diarrhea. Took 400mg Ibuprofen at 6pm and 11:30pm. 31Jan2021: fever 100-101, headache, body aches, sore R-arm, diarrhea, loss of taste, sore throat. 01Feb2021: fever 99-100, headache, body aches, sore R-arm, dry mouth, loss of taste, sore throat. Went to get a 2nd Covid Rapid Test to r/o a false negative (It was negative/undetectable again). 02Feb2021: Fever 99-100, headache, dry mouth, loss of taste. 03Feb2021: temp normal, headache, dry mouth, loss of taste. 04Feb2021- 07Feb2021: temp normal, headache, dry mouth, weird continuous hot/cold flashes, pins & needles tingling all persist. Appt w/PCP scheduled for 17Feb2021. The patient was not hospitalized for the events. The patient was tested for Covid-19 on 01Feb2021 and was negative. The outcome of the events was recovering.
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| 48 | 2021-03-15 | numbness |
Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes...
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Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes of injections.
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| 48 | 2021-03-15 | tremor, tingling, cold sweat |
2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via ...
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2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via adult face mask sat 100%. vitals; 139/82 HR 98. 2:30 felt, cold & clammy, shakey and tingling body & nausea vitals 125/70 HR 95 O2 sat 100% . By 3:00 previous symptoms subside , new symptoms dry mouth, headache 7/10 and nausea vitals 145/85 HR 105, taken of 2L 02. Called 911, emergency transport to AV emergency room. Patient choose to be driven to AVH emergency room by daughter who was at her mothers bedside during observation.
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| 48 | 2021-03-16 | feeling hot, tingling | Feet were red and hot, tingly No interventions other than monitoring reaction dissipated |
| 48 | 2021-03-16 | hot flush |
After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. ...
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After receiving the first dose of the Pfizer vaccine, my face immediately went all red and got hot. I stayed at the pharmacy for 30 minutes to ensure I didn't have an allergic reaction like a breathing issue. I had my epi pen with me just in case. It was loud in the pharmacy so I didn't notice it at first but once I got outside and was in the car, my ears were ringing. When we got to the restaurant to eat, we were the only family in there and it was pretty quiet. The ringing was really high pitched and loud. For the following two weeks it did not stop, day and night. I contacted my primary and had a telehealth appt and also went physically in to my ENT's office. I also tried acupuncture to see if that would take away the ringing. The acupuncture seemed to lower the pitch in my ear but it was still present. 2 hours after I left the office the pitch was back to a high pitch ring again. I cancelled my appointment today for 3/18 for the second dose because no one can assure me that this ear ringing will go away and the doctor's are unsure of whether the second dose will trigger a worse condition. I had a hearing test on 3/16 at my ENT's office and I couldn't hear some of the sounds because of the ear ringing but I did pass the test at the very line of baseline normal. My ENT is unsure if I will lose hearing due to this vaccine.
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| 48 | 2021-03-16 | numbness, burning sensation, pain in extremity |
Got vaccine at 9:00 AM and had no problems, and started to feel pain towards the end of the day, wen...
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Got vaccine at 9:00 AM and had no problems, and started to feel pain towards the end of the day, went to bed. On 3/9/21 had pain right below the injection site and above the elbow/forearm there is a burning sensation/pain in the bone and the whole arm below the injection site on 3/9/21. She has been applying heat/cold, which has helped but feels heavy pain into the bone. On 3/10/21 she could feel a numb tingling sensation on her index finger like a Lidocaine injection numbness. This has extended the middle finger and thumb as well on the left side. She works for Cardiologists which she consulted and they told her that it looked like a hematoma, and they looked at her injection site a week after the injection and advised her to keep taking Benadryl. She then spoke with another doctor and he wrote her a prescription for Gabapentin which she took yesterday at 7:00 PM and then again at 2:30 AM, and also gave her a Medrol dose pack, which she has not started yet. He also felt that they injected her way to deep and hit a nerve. Today she felt as if her pain is much better from a 9 to a 5/6, but still feels the heaviness pain, and also still has the numbness on the index and middle finger. On Saturday 3/13/21 she got a Salon patch and covers her whole arm other than the injection site, around the elbow area to her hand, which h as cooled the area but not improved the sensation a lot. The area under her arm from the injection site also has a burning pain as well.
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| 48 | 2021-03-17 | feeling hot |
Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: Fludrocort...
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Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: Fludrocortisone 0.1mg (pt took med prior to vaccine) No current outpatient medications on file. Allergies: Pt reports anaphylaxis x2 as a child after receiving vaccine (varicella and MMR) Not on File Medical history: "low blood pressure" per pt No past medical history on file. This was vaccine dose 0.3ml Pfizer Lot# ER2613 given @ 2:55pm Describe adverse reaction: Per pt "itchy throat" and "knot in my throat" Tachycardia to 110's Hypertension 120-150/80' Employee was monitored for 30minutes. Vaccine @ 1455 and pt started to c/o "itchy throat" @ 1515. Pt requested water and was able to swallow w/o difficulty. C/o feeling dizzy and warm. VS continued to be taken while pt sat on gurney. MERT called @ 1527 and arrived @ 1534. Pt taken to ED. AOD present @ 1530 and escorted pt via gurney to ED w/ MERT @ 1540. A/O x3, following commands, RR 20's. No difficulty breathing. 15:21 128/86 100% RA HR107 RR20 15:27 157/84 100% RA HR100 RR20 15:33 125/85 100%RA HR114 RR20 Anaphylaxis symptoms: Per pt "itchy throat" and "knot in my throat" Tachycardia to 110's Hypertension 120-150/80' Anaphylaxis plan: Anaphylaxis kit within reach. Pt also brought her own Epi pen. Not used. MERT called. Vasovagal symptoms: Dizziness Vasovagal plan: Pt remained seated and gurney brought to clinic. Administration error: NONE MERT called YES @ 1527 Transferred to ED VAERS report number: Email sent to OHS and patient documented in adverse reaction log.
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| 48 | 2021-03-17 | feeling hot |
loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with...
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loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with swelling; severe pain under arm in armpit with swelling; hot feeling on skin; extreme fatigue; had some itchy skin and redness an hour after shot, especially on both arms; had some itchy skin and redness an hour after shot, especially on both arms; Extremely nausea/Often nauseous; insomnia; mild diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809; expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 09Feb2021 18:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drug both from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date not provided) on 19Dec2020 02:30 pm (vaccination location: left arm) and experienced dizziness, extreme itchy skin, headache, and fatigue reported as 'After 1st shot had dizziness and extreme itchy skin 1 hour after shot for approx 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone'. The patient experienced spontaneous bleeding under skin by right eye on 14Feb2021. Patient's clinical course is as follows: After 2nd shot, patient had some itchy skin and redness an hour after shot, especially on both arms that lasted a couple hours (started at 7PM and stopped at 9PM). Patient also had extreme fatigue everyday since 11Feb2021, as well as insomnia especially during the first 48 hours. Also had total loss of appetite the past 8 days (17Feb2021), extremely nauseous and mild diarrhea everyday since immediately after 2nd shot until now (8 days later) with no improvement. Often nauseous until close to the point of vomiting. 2 days after 2nd shot started having severe pain under arm in armpit area with swelling and hot feeling on skin. Developed some spontaneous bleeding under skin by right eye about 5 days (14Feb2021) after shot which has now gone away. Fatigue and health is poor with no improvement; most effects seem to be getting worse instead of improving each day. Patient was not COVID tested post vaccination. It was reported that no treatment was provided for the events. Outcome of the event 'had some itchy skin and redness an hour after shot, especially on both arms' was recovered on 09Feb2021; outcome of the event 'spontaneous bleeding under skin by right eye' was recovered; outcome of the remaining events was not recovered.
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| 48 | 2021-03-17 | tingling |
Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the le...
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Within 30 minutes of receiving the first dose of the COVID vaccine, I ban to feel tingling on the left side of my face. Within another 30 minutes, I had multiple blisters in the same spot. Within another 2 hours, the lymph nodes on the left side of my neck were swollen.
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| 48 | 2021-03-18 | feeling hot |
As soon as I received my vaccine my face, specially cheeks felt very hot, I was wearing a face mask ...
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As soon as I received my vaccine my face, specially cheeks felt very hot, I was wearing a face mask so not sure f that had anything to do with that feeling. I sat down in the wait area for the required 15 minutes and left. while walking towards my car I was nauseous and drank some water to help ease my stomach. When I got home my stomach felt like if I had a nod at the top of it as well as it got a little upset. I noticed I had blotchy arms the following morning.
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| 48 | 2021-03-19 | pain in extremity, migraine, muscle spasms, weakness |
Approximately thirty minutes after the injection, i started having right leg muscular pain and spasm...
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Approximately thirty minutes after the injection, i started having right leg muscular pain and spasms. The next morning I woke up with with full body spams, extreme fatigue and severe migraine. The left side of my face has continued spasms that has not stopped and under my left eye continues to spasm and has spasmed non stop. I'm feeling very weak. My symptoms have not improved and it has been over a week.
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| 48 | 2021-03-19 | pain in extremity |
2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip...
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2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip, sore 1st rt finger 2/19/21, 2/20/21: sore under rt upper arm 2/21/21: greater pain under rt upper arm, took acetaminophen 2/22/21-3/7/21: pain extending from rt underarm to rt wrist upon extension/reaching 2/24/21-2/26-21: rt carpal tunnel ache 2/28/21: lymph nodes not as sore 2/28/21-3/11/21: puckered skin, rt upper arm
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| 48 | 2021-03-20 | nerve pain | Metallic taste in mouth, severe fatigue, muscle, joint, and nerve pain, nausea |
| 48 | 2021-03-21 | pain in extremity |
Right arm pain that continued to worsen as the day went on, progressing across my back and then legs...
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Right arm pain that continued to worsen as the day went on, progressing across my back and then legs. Felt the worst about exactly 24 hrs after the injection. Felt like a truck ran over me. Took ibuprofen and felt much better the next day.
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| 48 | 2021-03-21 | tingling |
3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and n...
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3/18: Upon receiving the injection, nerve tingles began in my left arm, wrist and hand. My jaw and neck became very sore and two small bumps appeared on the back of my neck. The bumps became very sore and my lymph nodes began to swell. All symptoms were on the left side of my body, which is the side I received the injection. 3/19: The two bumps multiplied and I had them behind my ear, in my hairline, on the back and front of my neck, trailing to my shoulder and a patch on my back. The bumps were painful and hot. I vomited 4 times that day, ran a 100 temp for a short period of time, had chills, body aches, very swollen lymph node, mild headache, and a very stiff, sore neck. All of this occurred on the left side of my body. 3/20: The bumps continued to increase in size, pain and number. The swollen glands, sore and stiff neck persisted. I was very tired and felt nausea at times. 3/21: I woke with an extremely sore and stiff neck, sore throat and new patches of bumps. I sought medical treatment and was diagnosed with Shingles. I was 100% healthy prior to the shot. I've never had Shingles before. I am now on medication to treat the outbreak.
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| 48 | 2021-03-21 | tremor, paralysis |
I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactab...
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I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, brain injury (doesn't have a good memory), menopause and menopausal problem. The patient is on a lot of medications (unspecified medication) for her Brain injury. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient had her second dose on 06Mar2021 and had been having bad like chills and shaking too but not fever. The patient was shaking bad (not clarified) there but she doesn't know if it's part of her menopausal problem from my menopause (as reported) but she was shaking. The patient mentioned that she was paralyzed. The patient stated that she was taking some Ativan for anxiety, she has been so anxious; and she had been taking Benadryl. The outcome of the events was unknown.
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| 48 | 2021-03-22 | weakness |
I received my first dose on 3/3/21 and the adverse reaction occurred from 3/10/21 through 3/19/21. ...
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I received my first dose on 3/3/21 and the adverse reaction occurred from 3/10/21 through 3/19/21. My side effects included: headache, fatigue, congestion, dizziness, nausea, diarrhea, chills, myalgia(lots of muscle pain), joint pain and swelling, overall weakness throughout body.
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| 48 | 2021-03-22 | pain in extremity |
Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarr...
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Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarrhea, chills, disorientation, difficulty breathing
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| 48 | 2021-03-22 | tingling |
The patient was in observation and complained of a sudden headache and left arm tingling. The patie...
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The patient was in observation and complained of a sudden headache and left arm tingling. The patient was assessed and the patient refused transport. The patient signed out against medical advice. See paramedic PCR for further detail.
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| 48 | 2021-03-22 | seizure | Non-provoked first time seizure |
| 48 | 2021-03-22 | tremor, seizure | Seizure the next day plus headaches, tremors and vomiting. |
| 48 | 2021-03-23 | facial paralysis, numbness, tingling |
30 minutes after my vaccine I started to feel tingling and numbness on my face, mouth and nose. The ...
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30 minutes after my vaccine I started to feel tingling and numbness on my face, mouth and nose. The bottom part of my face was numb. I was also nauseous and I had a metal taste in my mouth. Today is the 5 day since my vaccine and the numbness is less. I did not have facial droop.
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| 48 | 2021-03-23 | feeling hot |
Within 10 minutes of receiving the vaccine, my skin broke out in hives, was itchy and hot. I took o...
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Within 10 minutes of receiving the vaccine, my skin broke out in hives, was itchy and hot. I took over the counter Benadryl about an hour later. The hives subsided but the itching lasted approximately 24 hours after injection. I called the clinic and spoke to a nurse who in turn recommended my primary physician contact me. My primary physician and I spoke by phone the next day. No office visit was scheduled.
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| 48 | 2021-03-23 | flushing |
Patient reported at about 25 minutes after 1st dose of pfizer covid vaccine she began to feel facia...
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Patient reported at about 25 minutes after 1st dose of pfizer covid vaccine she began to feel facial itching and flushing, similar to what she felt with previous anaphylaxis due to allergy immunotherapy. She was brought to the medical tent and given 50mg benadryl po and observed x 1 hour. No progression of symtpoms, vitals stable. No angioedema, throat or tongue swelling, difficulty breathing or speaking, sob, or wheezing. Symptoms had completely resolved prior to discharge. She was driven home by her husband.
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| 48 | 2021-03-23 | flushing |
About 25 minutes after 1st dose of Pfizer covid vaccination the patient noted facial itching and flu...
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About 25 minutes after 1st dose of Pfizer covid vaccination the patient noted facial itching and flushing and this was similar to previous anaphylaxis she had from allergy immunotherapy. No angioedema, throat swelling, tongue swelling, sob, wheezing, difficulty speaking or swallowing. She was brought to the medical tent and given benadryl 50mg po and observed x 1 hour. Symptoms completely resolved. She was discharged home with her husband.
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| 48 | 2021-03-23 | migraine |
Day after vaccine: Bad migraine, fever, chills, body aches Day 3: arm swollen/red at injection site...
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Day after vaccine: Bad migraine, fever, chills, body aches Day 3: arm swollen/red at injection site and armpit is sore. Day 4: went to the ED due to worsening symptoms from vaccine injection including a rash
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| 48 | 2021-03-23 | night sweats |
Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lym...
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Unusual Thirst Tiredness Chills Low fever 100.3 Achy all over Sweated all night Swollen armpit lymph node Headache
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| 48 | 2021-03-23 | pain in extremity |
Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; ...
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Swollen lymph glands; Headache; Arm Pain; Fever; First dose on 02Feb2021, second dose on 19Feb2021; First dose on 02Feb2021, second dose on 19Feb2021; This is a spontaneous report from a contactable healthcare professional reported for herself. This 48-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El9262) on 19Feb2021 at 08:45 AM single dose at left arm for COVID-19 immunisation. Medical history included known allergies: Penicillin, sulfa and Pre diabetic. Historical vaccine was 1st dose of BNT162B2 (lot number El3247) for COVID-19 immunisation on 02Feb2021 at 08:00 AM at left arm. Concomitant drugs included semaglutide (OZEMPIC), pravastatin sodium (PRAVASTINE), metformin and losartan potassium (LOSARTIN). On 19Feb2021 at 06:00 PM, the patient experienced headache, arm pain, fever and worst part was the swollen lymph glands. The patient had visible swollen under arm into breast and down side of her arm, almost looks like a half a baseball sticking out of her arm. The patient saw doctor on 22Feb2021 and received treatment. The outcome of the events was resolving.
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| 48 | 2021-03-23 | tremor, feeling hot |
Client received 1st Pfizer Covid Vaccine (Lot # ER8732, Exp 3/24/21) approximately 1545. Client was ...
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Client received 1st Pfizer Covid Vaccine (Lot # ER8732, Exp 3/24/21) approximately 1545. Client was sitting in post vaccine waiting area when she alerted EMT she was feeling lightheaded and dizzy. RN joined and began to assess client. Vitals at 1600: blood pressure 126/80 pulse 84, respirations 18. Alert and oriented. No swelling noted. Client denied shortness of breath. Per client no history of allergies or reaction to vaccines in the past. Client asked for water. PHN joined team, client instructed to take small sips of water. Client mentioned she had not ate yet and thought maybe it was related to that. Client informed she would be observed another 15 mins due to current symptoms. 1608 client stated feeling warm, anxious, and still lightheaded. PHN offered client benadryl and client accepted. Per client husband came with her and was going to drive her home. Benadryl 50mg was given orally at 1609. Vitals: blood pressure 144/90, pulse 76, respirations 18. Client informed staff she felt hands were shaky and body was warm. Client alert and oriented, no swelling noted. Vitals at 1616: 140/90, pulse 60, respirations 16. At 1622 client stated feeling better, did not want to wait rest of remaining time. Client was advised to consult primary provider prior to receiving second dose Pfizer. Client also given ER precautions. Husband was waiting in parking lot and was going to drive client home. Client left facility with a steady gait at 1630.
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| 48 | 2021-03-24 | burning sensation |
Injection given at 4 p.m. by 4:03 p.m. my tongue started to tingle and then turned into a burning se...
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Injection given at 4 p.m. by 4:03 p.m. my tongue started to tingle and then turned into a burning sensation by 4:10 my tongue had began to adversely swell to twice its size. I inform the nurses and was immediately taken to the ER where they noticed that my tongue was extremely swollen my throat was beginning to swell and that I had raised up bumps and lesions starting to form on the back side of my tongue. ER staff admitted me and began me on a IV steroid treatment accompanied with Pepcid and Benadryl After 2 hours in the ER under close observation my tongue was still swollen and my windpipe was in danger of being closed off so I was transported via ambulance to Hospital and admitted to Intensive Care Unit where they continued to administer steroids and Benadryl. By 2 a.m. my condition had not improved and I was given an EpiPen in my arm. The EpiPen did help but by 6 a.m. my tongue swelling had returned but not as severe. On march 24th The hospital then moved me from the ICU to the cardiac wing to be placed on a heart monitor as they continue to administer steroids, Benadryl, and Pepcid. I was given another Epi Pen by 11 a.m. in the cardiac care unit due to my tongue beginning to severely swell again. As of today, March 25th My tongue continues to swell and they still have me admitted to the hospital as they continue to observe me and continue to administer steroids and Benadryl all via my i.v. port. Today they are going to begin me on an oral Prednisone.
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| 48 | 2021-03-24 | burning sensation |
Pt reports: "feeling of itchiness across her entire body and 'burning on the inside.'" "Itchiness an...
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Pt reports: "feeling of itchiness across her entire body and 'burning on the inside.'" "Itchiness and a tightness in her throat"
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| 48 | 2021-03-24 | feeling hot |
I feel itchy all over from head to toe. There is a slight warming sensation and tightness of my skin...
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I feel itchy all over from head to toe. There is a slight warming sensation and tightness of my skin. There are no bumps or rash. It feels like a similar reaction I have to penicillin before the hive appear.
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| 48 | 2021-03-24 | migraine |
The following morning I woke up with severe migraine, fever (99.5), severe body aches, severe fatigu...
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The following morning I woke up with severe migraine, fever (99.5), severe body aches, severe fatigue and slightly nauseous. I ran a fever the entire day and felt like I was in a car accident. I could not do my normal activities. I laid in bed all day and had to cancel the appointments I had. Luckily I did not have to work that day. I wouldn't been able to make it. The next day I was fine. I've run a little fever off and on since then (it's been 1 week and 4 days), but I've felt so much better.
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| 48 | 2021-03-24 | pain in extremity |
My arm was sore and the rash started. It has been present since 01/07/2021 and it is not going away....
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My arm was sore and the rash started. It has been present since 01/07/2021 and it is not going away. The only thing different is the vaccine. I've had IV antibiotics twice that seems to help so that it's not quiet as bad. It has never gone away.
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| 48 | 2021-03-24 | tingling |
A few minutes after receiving vaccine patient reported with itchy throat and tingling of neck and fa...
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A few minutes after receiving vaccine patient reported with itchy throat and tingling of neck and face. Previous history of anaphylaxis to bee stings. Gave 50mg Benadryl and bottle of water. Patient did not want Epi-pen until absolutely necessary because she said previously it took her down for 2 days. She had us call husband and sister and asked for EMS to be called. Still declined Epi-pen. EMS took her to (hospital).
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| 48 | 2021-03-24 | tremor |
Injection site pain, injection site swelling, injection site redness, shaking, chills, tiredness, he...
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Injection site pain, injection site swelling, injection site redness, shaking, chills, tiredness, headache, muscle pain, joint pain, nausea, feeling unwell, fever of 103.6
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| 48 | 2021-03-25 | burning sensation |
Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and...
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Rash around the neck area that spread to chest and back of the neck later in the day. Very itchy and have a burning sensation. The lymph node in the left neck area where the rash is, feels swollen.
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| 48 | 2021-03-25 | feeling hot |
Severe hives over entire body 2 hours after injection, especially bad on face and neck. Felt extrem...
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Severe hives over entire body 2 hours after injection, especially bad on face and neck. Felt extremely hot from the inside out. Seen at Urgent Care, given shot of Benedryl and a dose of Prednisone Symptoms continued into the next day and evening, took Benedryl every 4 hours Symptoms improved by 03/26, though not completely gone.
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| 48 | 2021-03-25 | feeling hot |
Patient received vaccine at 14:15 and was in the observation room when at 14:30 reported feeling diz...
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Patient received vaccine at 14:15 and was in the observation room when at 14:30 reported feeling dizzy, warm, hear raising and not feeling right. A team alert was called and at 14:30 healthcare team arrived to provide assistance. Patient's blood pressure was up and was taken by team to medical office for further evaluation.
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| 48 | 2021-03-25 | flushing |
Facial flushing, slight chest tightness. BPs 155/103 (pulse 90), 98-99% O2 sat; 156/97 (pulse 79), 9...
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Facial flushing, slight chest tightness. BPs 155/103 (pulse 90), 98-99% O2 sat; 156/97 (pulse 79), 99% O2 sat.
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| 48 | 2021-03-25 | numbness, tingling |
Patient woke up in the middle of the night due to her chin quivering and then noticed facial numbnes...
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Patient woke up in the middle of the night due to her chin quivering and then noticed facial numbness, specifically the left side of her chin and lip. The left side of her jaw was numb and tingling. When she woke up this morning, she noticed that her arm felt heavy, numb, and somewhat tingly. As of late morning today, her arm is still a little tingly and numb. This sensation goes from the top of her arm to her fingertips, specifically her 4th and 5th fingers. She does not notice any facial paralysis or drooling and she was able to suck out of a straw this morning. She will notify her doctor and seek follow-up care if it does not improve.
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| 48 | 2021-03-25 | muscle spasms | Blurring in right eye that comes and goes, constant muscle spasms in stomach |
| 48 | 2021-03-25 | pain in extremity |
Fever >102.4, congestion, sore arm, difficulty breathing, severe asthma, malaise, headache. Minor te...
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Fever >102.4, congestion, sore arm, difficulty breathing, severe asthma, malaise, headache. Minor temp started around 10pm, woke up 3:30am with extreme cough and SOB, asthma, wheezing; fever rose throughout day greater than 102, continued shortness of breathe, coughing, congestion, wheezing, sought treatment in Emergency Room
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| 48 | 2021-03-25 | pain in extremity |
I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, a...
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I have a headache, fever, chills, exhausted. Now I have covid arm. My arm is itchy, swollen, pain, and have slight rash.
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| 48 | 2021-03-25 | tingling, pain in extremity |
40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of...
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40 minutes after receiving the shot my face felt like it was swelling. It felt like my left side of my face swelled first and then 3 minutes later if felt like it generalized to the entire face. (I received the shot on my left side) I also felt some faint tingling in my mouth. Looking in the mirror, I couldn't tell if it was swollen but my sensation of my skin was swollen & tight. After about 10 minutes it felt like it was easing off. A hour later my face felt a little tingly like a Novocain shot had almost worn off. After 3 hours, I felt normal. Then day 2 & 3: a sore arm. Then day 4: muscle aches, fatigue & headache.
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| 48 | 2021-03-26 | muscle spasms, hot flush |
I had a reaction within the 15 minute observation period. I had a hot flash, increased HR, and muscl...
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I had a reaction within the 15 minute observation period. I had a hot flash, increased HR, and muscle spasms near my right ankle. I was examined by the Physician and EMT on site. The following day, I experienced body and head aches. Naproxen and Tylenol
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| 48 | 2021-03-26 | numbness and pain in extremities, breast pain |
I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, sympto...
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I received Vaccine No. 2 at 5:45 p.m. on 03/19/21. Beginning at around 2:30 a.m. on 03/20/21, symptoms started to gradually surface that progressed throughout the day, such as: - intense pain at the site of the injection that spread to my underarm and left side of ribcage/breast - chills - low grade fever - aching joints - painful skin surface on my whole body - headache - shortness of breath - neuropathy - nausea - loss of appetite - loss of taste - stuffy nose
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| 48 | 2021-03-26 | pain in extremity, feeling hot, weakness, hot flush |
03/23/2021 - injection given and within 2-3 minutes after injection I had heart palpitations and flu...
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03/23/2021 - injection given and within 2-3 minutes after injection I had heart palpitations and flush of heat over my body. After about 3 minutes heartbeat regulated and flush of heat dissipated. About 45 minutes later I got a headache last about 15 minutes. Then came back about an hour later lasting same time before stopping. This occurred again about 3 hours later, same as before. 03/24/2021 - arm was sore and injection site was slightly itchy and hot but stopped by 03/25/2021, no hunger. 03/24/2021 - woke up feeling nauseous and overall crappy feeling (not achy, not in pain). nausea lasted throughout the day, but no vomiting. headache often throughout the day but not lasting more than 10-15 minutes, no hunger. 03/25/2021 - again woke up feeling nauseous lasting off/on thru day, no vomiting, no headache, feeling overall more energetic wanting to eat when nausea went away. 03/26/2021 - woke up NO nausea, not hungry so ate later in afternoon. Within 20 minutes of me eating I became extremely fatigued, dizzy and could barely stand up. I started to feel like I was going to faint and got to a couch and laid down. I started sweating and felt like my body was on fire. My scalp and face were wet with sweat, I felt dizzy and extremely nauseous before I vomited (3) times. After vomiting the dizziness, nausea and weakness dissipated. After about 30 minutes I just felt tired and my chest hurt from the convulsions of vomiting. After about 2 hours I felt better and just tired. 03/27/2021 - woke up no nausea, no headache and slightly fatigued.
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| 48 | 2021-03-26 | pain in extremity | headache, sore arm, dizziness, nausea, fatigue |
| 48 | 2021-03-27 | pain in extremity, tenderness |
March 8th. Almost 0 pain at injection site for first 3 hours then a little soreness Three hours lat...
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March 8th. Almost 0 pain at injection site for first 3 hours then a little soreness Three hours later a few minor sx began:- chills on my skin starting at hands, then pain across bottom of rib cage, then stabbing pains throughout torseau and legs-worsened at night time and joined by severe chills-shivering. All next day felt like I had flu-waking up most every hour-level 5-6 headache also developed. March 9th felt like I had the flu most of the day-flushing, then getting chills. still stabbing pains and indigestion-very tender around ribcage (tender to the touch). Took peptobismol tablet. Good 11-12 hour sleep 2nd night. Next morning:
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| 48 | 2021-03-28 | migraine |
On Saturday, March 27 at about 8:00 p.m. I had a severe migraine headache that caused vomiting. I do...
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On Saturday, March 27 at about 8:00 p.m. I had a severe migraine headache that caused vomiting. I don't usually have headaches. The only time I could remember having a similar experience of such a severe headache was the one time in July of 2019 when I had drunk too much water in too short a time span and washed all the sodium from my system. I was treated at the Hospital at that time for that incident, Having had that previous experience, I was concerned for my health and safety having another similar headache on Saturday night. By 11:00 p.m. the pain had intensified and I went to the Hospital for treatment. The doctor ordered a blood panel and a ct scan of my head. All the results came back normal.
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| 48 | 2021-03-30 | discomfort |
With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area...
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With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; This is a spontaneous report from a contactable nurse. This 48-year-old female nurse reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EH9899) intramuscularly from 18Dec2020 at 12:00 pm to 18Dec2020 at 12:00 pm at single dose (dose number; 1) on left arm, then second dose, lot number; EL1283 from 07Jan2020 to 07Jan2020 (dose number; 2) at single dose on right arm for covid-19 immunization. Patient was not pregnant at the time of vaccination. Vaccine facility type was reported as hospital. Patient's medical history (If covid prior vaccination, If covid tested post vaccination; no) was not reported. Past drug included allergy; sulfa. Other vaccine in four weeks was reported as no. Concomitant medications (other medications in two weeks) included ESTRADIOL (Estrogen), progesterone and multivits. Nurse reported that on 18Dec2020 at 12:00 pm with both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area. Treatment was not given for the AE. Outcome of event was not recovered.
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| 48 | 2021-03-30 | feeling hot |
Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like i...
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Date of start of drug 06Jan2021/ Date of start of drug 29Jan2021; 2nd dose Roof of mouth felt like it was swelling; My tongue and lips started tingling; Both ears red and felt very warm; Both ears red and felt very warm; Slight headache; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration in left arm on 29Jan2021 at 09:15 as a single dose for covid-19 immunization. Medical history included Allergies to medications, food, or other products: Penicillin, amoxicillin and codeine. Concomitant medications included esomeprazole magnesium (NEXIUM), ibuprofen (IBUPROFEN) and nature's bounty on unspecified date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). The patient experienced second dose roof of mouth felt like it was swelling, y tongue and lips started tingling and both ears red and felt very warm and slight headache for the second dose on 29 Jan2021 at 09:15 AM. The outcome of the events was recovered on an unspecified 2021. Information on the lot/batch number has been requested.
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| 48 | 2021-04-01 | numbness, hot flush, pain in extremity, breast pain |
The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain beca...
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The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain became severe by day 3. Pain spread to my right breast, neck, back, and right scapular area. I have had numbness in my fingers on right side. Today is 16 days. The pain increased every day for about 10 days. Decreases slightly and is now holding. I'm am in terrible pain. I didn't sleep for 6 days when the pain was at is peak and still can barely sleep. It's the worst pain of my life. It feels like my arm is in fire and in a meat grinder. My arm and neck pain worsens when I use my arm or change positions. I am also getting flushed heat feelings on my face intermittently. Since this vaccine I have had allergic reactions to ibuprophen and prednisone which sent me to the ER. Two medications I have received before with no problem. I also felt I was reacting to gargling with listerine which I have used before without issue. I eat eggs regularly and got a small sensation of throat swelling with that too and have not eaten them again. My doctor is having trouble treating me since I am now having so many allergy symptoms to different things. I have been advised by my doctor not to continue with this vaccine or any vaccine in the future. I am still in terrible pain that is limiting me from participating i. my normal life activities. I did not develop any rashes or obvious swelling at the injection site. Twenty minutes after receiving the shot I did get a bit flush feeling and some redness in my face and my ears felt hot and then cold. That resolved within about 45 minutes.
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| 48 | 2021-04-01 | numbness and pain in extremities |
brachial neuropathy; This is a spontaneous report from a contactable consumer. A 48-years-old femal...
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brachial neuropathy; This is a spontaneous report from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 16:00 (Batch/Lot Number: Pfizeren6206) as single dose for covid-19 immunisation (age at vaccination: 48 years) . Medical history included asthma, drug hypersensitivity (allergy to Penicillin). Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient experienced brachial neuropathy on 12Mar2021 with outcome of not recovered. The reported event was considered an Important Medical Event. (IME). Course of the event: Initial pain subsided in 3 days, then returned with right shoulder joint pain, burning sensation in right side of neck, limited mobility in shoulder joint and severe pain. Dr. Diagnosed as brachial neuropathy. Its 2 weeks now, and still in severe pain. The patient is being treated with Pain meds No follow-up attempts are possible. No further information is expected.
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| 48 | 2021-04-01 | pain in extremity, seizure, tremor |
Seizure that lasted about 10-15 minutes the next day; Headache; throwing up; arm tremors; not feelin...
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Seizure that lasted about 10-15 minutes the next day; Headache; throwing up; arm tremors; not feeling well; sore arm; This is a spontaneous report from a patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 16Mar2021 09:30 at single dose for COVID-19 immunization. The patient's medical history included Epilepsy. The patient was not pregnant at time of vaccination. The patient's concomitant medications included oral levetiracetam (KEPPRA) for epilepsy at 4000 mg, daily, valproate semisodium (DEPAKOTE) for epilepsy at 500 mg, daily, and valproate semisodium (DIVALPROEX) for epilepsy at 500 mg. The patient stated that she got the vaccine on 16Mar2021. The patient had a a seizure that lasted about 10-15 minutes the next day on 17Mar2021 at maybe 11pm-1130pm. The patient was out with someone and he took her back to her house and she wasn't feeling like, not normal, and he told her she needed to go to the hospital and it took her awhile as she doesn't realize she had a seizure and it sometimes takes a while to convince her she did. States sometimes with seizures you don't remember. The patient was advised to go to the ER to get checked out and he was really worried. States immediately after the seizure she threw up and was not feeling well at all. States she was not admitted to the hospital. States they did a Ct scan of her head and she had bit her tongue a little bit, which is normal with seizures. States she is improved but she still has the medical condition of epilepsy. The patient stated that after she drove home she noticed when she stretched her arm out she was still having tremors and these for lasted about an hour and then she went to sleep. Caller clarifies that after the hospital she went home and went to sleep. States she had been given Ativan at the hospital to ward off additional seizures and that makes you very tired. The patient also had headaches and still gets them, states they are getting less and less frequent. States the headaches started that same evening, that it was weird she had gone out to dinner and was talking with her friend and she thought I have a headache and he is normally fun and she was not feeling so good. Relays that she thought maybe it was a problem with the food she ate, but states they ordered the same meal and she in confident it is not the food as he did not have any troubles. The patient hasn't had a seizure since age 14 and had she known the vaccine would likely cause one she would not have taken it. States she will not take the 2nd one. She said that this was ridiculous. States her arm was sore like from the flu shot or a little worse, but not a big deal. . States her main concern is the seizure. States she is a CPA and it is her busy season for tax returns and saying her arm being sore is eh maybe she wasn't waving it around as much as normal, she is like a praying mantis at her computer typing away. States the soreness started by the end of the work day or that afternoon. States it was no big deal and the next day she did work around the house and was using that arm more and then working from home that day thank God and it was St. Patrick's day and she went out to dinner. States she only noticed the arm soreness/sore arm 16Mar2021 and by the morning of 17Mar2021 she didn't notice it anymore. States she wasn't told she was at risk for a seizure and that would have been helpful as if she had known there was a chance of a seizure she would, like any medication, if there is a chance of seizures she doesn't take it. The outcome of the event Seizure was not recovered. The outcome of the event headache was recovering. The outcome of the event Pain in extremity was recovered on 16Mar2021. The outcome of the remaining events was unknown. Information about the lot/batch number has been requested.
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| 48 | 2021-04-03 | pain in extremity |
Onset of symptoms was 24 hrs after vaccine. First symptoms were fatigue, abdominal discomfort, loss...
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Onset of symptoms was 24 hrs after vaccine. First symptoms were fatigue, abdominal discomfort, loss of appetite, mild dizziness, swollen injection site, arm soreness. Starting 48 hours after the vaccine: jaundice symptoms, including: itchiness on the feet and palms, large patchy bruises on the legs, clay-colored stools, extreme fatigue, yellowing of the eyes, dark-colored urine. Later, small, round, skin lesions emerged and spread , starting around March 11, 2021. By the 23, red, itchy, patches had expanded over the chest, abdomen and groin areas.
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| 48 | 2021-04-15 | weakness |
About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both...
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About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both arms, hands and right legs, dizziness, pins and needles, extreme fatigue, lethargy, feeling the pulse of my heart rate in various part so my body in an opressive kind of way like in my throat, under my right breast, in my back on the ribs usually. All these symptoms never subsided and became noticeably worse a few days after my second dosis on April 8th. My arms are always numb when I get up and become worse when hanging down, of course, but with different intensity. I am feeling extremely dizzy as I walk around and unstable. Walking feels like the ground is further than it is in a way. I do notice a slight shortness of breath but more of an oppression in the rib cage than panting. I have been avoiding walking far or walking my dogs all together. I am not seeing any improvements even after my visit to the Urgency Care where nothing wrong was found on blood work and EKG. I was told to reduce inflammation with dietary supplement and some vitamins. I cannot work of course and what is a bit frightening now is that I am not improving on day 8 of my second dosis! Same rotation of weird symptoms all day (feeling my blood not circulating normally if that can be described even, numbness, pins and needles in arms, and right leg. Sometimes it affects my right cheek. Dizziness and unstability to walk around. Vision is lower as well. Too weak to do anything constructive. My legs feel like they are not reliable (never have had that feeling at my age). It is more than feeling like a zombie, it is feeling too weak to do anything and my head is sometimes spinning. The numbness can be painful as a sudden thrust in an arm ( this does not last more than a few seconds). It has now been going on since week 3 of my first dosis and today is day 7 of my second dosis! I had 0 symptoms on the first 2 weeks of my vaccine, dosis one. Now, I don't see any progress, rather a slight worsening of all the symptoms above. It is freakish not knowing what I have, of course. One can imagine, so stress adds to the mix sometimes during the day. I would not dare to even go walk my dogs now. A short grocery store visit at the most.
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| 48 | 2021-04-15 | feeling of body temperature change, tremor |
Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t qu...
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Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t quench my thirst dry mouth unsteadiness
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| 48 | 2021-04-15 | pain in extremity |
DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week lat...
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DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week later with persistent pain. Diagnosed by ultrasound. Confirmed by hematologist and started on Xarelto same day.
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| 48 | 2021-04-17 | muscle spasms, weakness |
Widespread muscle spasms, pain and weakness over about 1/2 hour. I had a similar, yet more severe re...
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Widespread muscle spasms, pain and weakness over about 1/2 hour. I had a similar, yet more severe reaction to chemo and neulasta.
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| 48 | 2021-04-18 | unresponsive to stimuli |
?ti Patient became unresponsive, no pulse was able to be found, CPR initiated immediately and EMS ...
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?ti Patient became unresponsive, no pulse was able to be found, CPR initiated immediately and EMS arrived to transfer patient to hospital. Patient was first taken to community Hospital and later was sent to Hospital.
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| 48 | 2021-04-20 | facial pain |
became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin...
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became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
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| 48 | 2021-04-23 | pain in extremity |
ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and b...
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ulcers on the side of her tongue and on the inside of her lips; rash with blisters on her hand and back; Blister of lip; Swollen lips; sore arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on right arm on 12Jan2021 at single dose for covid-19 immunization (to not get symptoms from Covid). Medical history included typically had a strong local reaction to bees or insect bites. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL) for Birth control 1 by daily (had been taking for 15 years and is ongoing). On 12Jan2021, the day patient received the vaccine, she had sore arm which resolved on 13Jan2021. Ten days later on 23Jan2021, she developed a rash with blisters on her hand and back, had blisters/ulcers on the side of her tongue inside her lips and her lips were also swollen and cracked. She states that she treated these symptoms with Benadryl and the rash and swelling resolved. She cannot attribute it to the vaccine. The ulcers in her mouth were better in about a week. She was calling to see if she should receive the second dose of the COVID-19 vaccine and would like to know how effective the Pfizer COVID-19 vaccine is after one dose. Everything that she had seen, this was not a typical reaction. She was wondering if it was safe to get the second dose. She went to the site where she received the vaccine and was unable to get any information. She does not have a physician. The rash has improved. Redness on her skin still can be seen. The blisters on her lips were white places like a canker sore but it was not a canker sore. Her lip was split like mouth ulcers. She took Benadryl and it helped. The outcome of the event ulcers on the side of her tongue was unknown. The outcome was recovered for the events sore arm on 13Jan2021, blister of lip on 31Jan2021 and swollen lips on 01Feb2021. The outcome of the event rash was recovering. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
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| 48 | 2021-04-24 | flushing |
Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic sho...
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Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.
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| 48 | 2021-04-26 | numbness, tingling |
I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and...
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I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and right foot; I felt numbness/tingling in right hand and right foot; This is a spontaneous report from a contactable consumer patient. This 48-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 08:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:48 years.Facility type vaccine: Hospital.No other vaccine in four weeks. Medical history included hypertension , well controlled . Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B COMPLEX) taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient stated "I felt numbness/tingling in right hand and right foot when I woke up at 5:00 am on 19Apr2021. On 20Apr2021 around 8:00 AM I felt numbness on right side of face. On 20Apr2021, I went to ER, was admitted to hospital, was diagnosed with TIA (mini stroke). I was discharged on 21Apr2021. I was given aspirin, Plavix, and Lipitor which I will take for the next three weeks and will follow up with family doctor and neurologist. I still have the numbness". The patient was hospitalized for the events for 2 days. Treatment received for the events (hospitalized 2 days, tests, prescription drugs). No COVID prior vaccination. The patient had COVID tested post vaccination (Covid test type post vaccination= Nasal Swab). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021.Outcome of the events was recovering.
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| 48 | 2021-04-28 | numbness, tingling | Tingling and numbness in left arm all the way down to fingers |
| 48 | 2021-04-28 | nerve pain, tingling |
Nerve pain, tingling. Felt like bee stings. Started in left quad area and spread through out body. ...
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Nerve pain, tingling. Felt like bee stings. Started in left quad area and spread through out body. Still happening but getting better 2 months later. Also , after second dose experienced extreme brain fog and memory issues.
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| 48 | 2021-04-29 | pain in extremity | Extremely sore arm for 36 hours |
| 48 | 2021-04-30 | seizure |
Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and ...
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Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and drove slowly and hit a pole; "positional vertigo"; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP8737) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient developed positional vertigo after the first dose. On 06Apr2021, the patient apparently had seizure with no history of seizures. The patient also had lost consciousness and drove slowly and hit a pole. They had to break the window to get the patient out of the car. The patient did not remember any of it. The patient stated that it was less than an hour that she was out; from the time recorded on the incident report and waking up in the emergency room (ER) and looking up at the clock in the room, it was under an hour. On an unspecified date, the patient experienced dizzy. The patient lab work and stuff done when she was in the ER after she had the seizure. The outcome of the events was unknown.
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| 48 | 2021-05-03 | muscle spasms |
Very heavy period since second vaccine, extremely painful cramps. Very unusual and not what i am use...
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Very heavy period since second vaccine, extremely painful cramps. Very unusual and not what i am used to. Definitely feels different.
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| 48 | 2021-05-04 | weakness |
This is a spontaneous report from a contactable physician. A 48-year-old female patient received BNT...
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This is a spontaneous report from a contactable physician. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 48-year-old, dose 2 via an unspecified route of administration on 17Mar2021 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included Huntington's disease diagnosed in 1995, due to this her voice crackles a bit. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EL9263) at the age of 48-year-old, for COVID-19 immunisation and she experienced 4 days of severe nausea, vomiting, couldn't get out of bed, couldn't eat, and diarrhea. The patient got her second dose on 17Mar2021 and had worsening of nausea, vomiting and fatigue on an unspecified date. The patient couldn't keep food down, can't sleep and keeps falling down, and he states "that really concerns me, she's going to knock her teeth out or bleed in her brain, that's not good". She's barely able to get around, doesn't leave unless she has a doctor's appointment. The problem is this, it's not the vaccine, it's the genetic modification this patient has Huntington's disease she was told it was safe, but don't think they took into consideration that it's a genetic modification and she has Huntington's which was also the genetic modification, don't know what to do at this point. He mentions that her nausea and dizziness was getting worse now that were a month out. She's falling down more than before. He wants to help her keep down food because she lost approximately 10% of her body weight. She's dizzy and weak, he states "she's wiped out, not sleeping". He also mentions that she's had hospitalizations. The reported was asking what do to next and if there was an on-staff physician for special cases. Patient reports going to the hospital 8 days after the second shot, she wasn't eating or sleeping. The second shot of Pfizer COVID vaccine was on 17Mar2021, patient began having severe vertigo, falling down, breathing hard, afraid she was going to knock her teeth out or break a bone, insomnia on an unspecified date. Patient reports she took a sip of water and threw up all over the side of the car today 20Apr2021. The Doctor states that this was not normal for her. Patient and reporter stated that the patient has lost between 10-15 lbs, about 10% of body weight. Reporter states that Ivermectin comes in custom lozenges and that it gets rid of inflammation so that it doesn't hurt the whole body. Ivermectin can make the GI upset. Caller states that it was not actually a vaccine that Pfizer was offering, reporter explains that Huntington Disease was when there was a repetitive code in the DNA, to the point it effects muscles and nerves and renders you. What Pfizer and Moderna was offering was a genetic modifier, mRNA was a genetic modifier, not a vaccine. In a Vaccine, they take a piece, make sure its dead, expose it to you and your body makes an antigen, that's a typical vaccine but this is not. Patient says Friday Saturday and Sunday she was stuck in the house. She cannot do anything. Reporter says the patient needs professional help. Her voice fluctuates so people take her seriously. (institute name), told the patient it would be ok to take the Pfizer COVID vaccine, but they didn't take into consideration is it was a genetic modifier. This was not a typical vaccine. Reporter states that he needs help escalating this please help with escalating this, needs help to know what to do for this patient because of the MRNA genetic modification. The mRNA may have affected the Huntingtons. The events resulted to hospitalization except for vertigo and breathing hard. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-05-07 | tingling |
Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling i...
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Got really inflamed and everything again; Brown-Sequard syndrome; Brown-Sequard syndrome; Tingling in both legs; legs getting swollen; whole left side of body swelling only from under the breast down; muscles tightening on the whole left side of body only from under the breast down; continued discomfort in left leg; Swelling makes it to where her joints can't like she can't bend her knee really well; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Apr2021 at 10:15 (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history included ongoing Brown-Sequard syndrome, ongoing diabetes mellitus, COVID-19 from 14Feb2021 to 2021 (for about 3 weeks), ongoing immunodeficiency. Concomitant medication included semaglutide (OZEMPIC) for diabetes mellitus. The patient experienced Brown-Sequard syndrome exacerbation (medically significant) on 01Apr2021 with outcome of unknown, tingling in both legs (non-serious) on 01Apr2021 with outcome of unknown, legs getting swollen (non-serious) on 01Apr2021 with outcome of unknown, whole left side of body swelling only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, muscles tightening on the whole left side of body only from under the breast down (non-serious) on 01Apr2021 with outcome of unknown, continued discomfort in left leg (non-serious) on 01Apr2021 with outcome of unknown, swelling makes it to where her joints can't like she can't bend her knee really well (non-serious) on 01Apr2021 with outcome of unknown, got really inflamed and everything again (non-serious) on 21Apr2021 with outcome of unknown. Patient reported that had swelling in the areas that normally, like the left side of her back, her stomach, all the sites that basically the Brown-Sequard Syndrome that she has problems with, it just exacerbated it. Follow-up attempts are completed. No further information is expected.
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| 48 | 2021-05-10 | pain in extremity |
swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was ...
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swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling.; she got like three balls on the right arm; pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm; the lymph nodes in left armpit got swollen; swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow; This is a spontaneous report received from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:30 (Batch/Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling on 15Apr2021, swelling behind the knees and swelling of the veins, swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow on 12Apr2021, the lymph nodes in left armpit got swollen on 13Apr2021, pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm on 14Apr2021, she got like three balls on the right arm on 15Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: unknown results.She was calling because she got her shot on 12Apr2021 and then she ended up having swelling behind her knee, then she had swelling under her armpit and swelling on her right arm below her elbow. She stated that they weren't lymph nodes, and she went to the ER (EmergencyRoom) had to check and see if they were blood clots. She stated that it turns out that her veins were swollen underneath her arm. She said that was what happened after the shot and that was her first shot. She states so that's her report on what happened. She stated she got the shot in the morning so her symptoms at 6 or 7 pm that evening. She stated she went to the doctor first and then went to the hospital. She went to the doctor on the 16Apr2021 and the hospital on 16Apr2021. She stated that the swelling behind her knee went away on 20Apr2021.Tuesday, 13Apr2021 the lymph nodes in left armpit got swollen. On Wednesday, 14Apr2021, there was a pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm. On Thursday, 15Apr2021 she states she got like three balls on the right arm, on her elbow on the right side. She went to the doctor on Friday 16Apr2021 she went to the ER (emergency room) because they couldn't figure out if it was some kind of clotting because of the position of the areas of swelling. She got an ultrasounds for them to check her blood flow. She stated that the pain in her left arm was going down but didn't resolve until the 22Apr2021. For the little balls on her arm, the MD (Medicne Doctor) gave her a medication for the swelling of her veins but she forgot the name and she doesn't have the paper with her. She states the balls of fluid went away between the 20Apr2021 and 22Apr2021. Everything starting going away that week.She states it had to do with blood clot warnings, and swelling under her skin had to do with the veins. Outcome of with blood clot warnings was unknown, like three balls on the right arm and pain in her left arm from the armpit to the elbow was recovered, remaining events was recovering.Therapeutic measures were taken as a result of swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow, she got like three balls on the right arm.
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| 48 | 2021-05-12 | discomfort, feeling hot, pain in extremity, numbness and pain in extremities |
stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and le...
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stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and left arm pain/legs hurt/hands were also hurting; not as hard of a pain but it is in the muscles below the knee and in the back of the calf.; neuropathy; whip lash in shoulders and neck; feel radiation or heat; uncomfortable; shoulders became sore; tired; Eyes hurt; vasculitis pain flare up; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in right upper arm, at age 48 years, on 12Apr2021 13:00 (Batch/Lot Number: 9R8732) as second dose, single, for COVID-19 immunization. Relevant medical history includes two autoimmune diseases and two lung diseases further reported as ongoing Post-traumatic stress disorder (PTSD) diagnosed in 2017 because of trauma from vasculitis because both her arms looked like sleeves of nothing but broken blood vessels; Chronic obstructive pulmonary disease (COPD) from unspecified dates; ongoing bronchiolitis from unspecified date that does not go away; ongoing Hepatitis B contracted after vasculitis had gotten back together with her baby daddy and contracted it that way; ongoing small cell vasculitis (CSVV) from Oct2017 is her main disease; immune system weaker than her mom; body is weak; has weak muscles; generalized anxiety disorder; depression; she had fell on both arms, she's had a knee surgery; and she can barely walk because she pulled a back muscle before, her back and her having an injury from 2 years ago in 2019. Patient also usually gives blood at her primary care. Family history includes arthritis, her mom has it. Concomitant medications included tenofovir alafenamide fumarate (VEMLIDY) taken for antibiotic therapy from an unspecified start date and ongoing; meloxicam taken for joint swelling from an unspecified start date and ongoing; alprazolam (XANAX) taken for generalised anxiety disorder from an unspecified start date and ongoing; quetiapine fumarate (SEROQUEL) taken for post-traumatic stress disorder from an unspecified start date and ongoing; pantoprazole taken for ulcer from an unspecified start date and ongoing; sertraline taken for depression from an unspecified start date and ongoing; promethazine taken for prophylaxis of nausea and vomiting from an unspecified start date and ongoing; albuterol sulfate taken for an unspecified indication from an unspecified start date and ongoing; and budesonide taken for lung disorder, start and stop date were not reported. Patient historically took first dose of BNT162B2 (injection, Batch/lot number: EN6202) in the left upper arm at age 47 years on 19Mar2021 at 1:40pm at a clinic for COVID-19 immunization and experienced no adverse event; and an unspecified flu shot last Oct2020 (also reported as last winter). Patient has some 5 or 6 doctors there as specialists or prescribers. She has a liver specialist and a vasculitis specialist, whom she has not seen since the flare up because of her insurance, a main primary that saved her and brought her into remission is not covered with her insurance, and a GI doctor as well. She also reported that her immune system is probably weaker than her mom's because of her own 2 diseases. She also said that she was supposed to be in lung therapy but her body is weak. She stated that every time something hurts, it may be neuropathy. She has weak muscles and they haven't been this weak. She could move around and do things before. Patient was tired from the autoimmune and lung disease, she has had to stop and rest. Patient clarified that she had these prior to COVID coming. Patient wanted to get the vaccine to have more immunity so she could go out. She didn't want to get the Corona virus. The doctors said she wouldn't make it. It was her choice but the doctors recommended it. It was reported that patient has completed vaccination. About a week ago (13Apr2021), started experiencing a lot of pain from a vasculitis flare up. It is as if it just happened and was having a lot of pain in various parts of the body. Patient stated that it didn't start until like the second day (13Apr2021). Patient was not disgruntled, believes in the vaccine. She has an appointment with the tele doc this week and with another doctor at the same office since doctor was not in this week, because of her back and her having an injury from 2 years ago, X-rays, and can't walk right now, is in a lot of pain. She did not know if she can take pain pills, with all her other stuff. Patient stated that both her legs hurt and she can't walk. Her hands were also hurting with it in Apr2021. Patient had knee pain on 19Apr2021, leg pain was still there but getting better and was still hurting when she walks. It is not as hard of a pain but it is in the muscles below the knee and in the back of the calf in Apr2021. On 21Apr2021 or 22Apr2021, right and left arm just hurts all the way down started. They are the same and are still hurting and staying persistent. On 26Apr2021, back pain was added and stated that she got it for complaining about her arm. It started About 3 days after the shot, around 14Apr2021 or 15Apr2021, patient had whiplash in shoulders and the neck. It started in the back of the head and was like she could feel radiation or heat. It would be so uncomfortable, her shoulders became sore. When she looked left or right, it felt like whip lash. It has gotten better. For her arm, she wanted to revert to ice/heat but she hasn't done anything yet. Patient called her primary in hopes that he would give her something for the pain, she was not in pain management but it is hurting so bad. Since the injection, she has been so tired, so she has not been taking her XANAX. She takes them as needed for generalized anxiety disorder and her anxiety has not been up. A lot of the time she does not have to take them. The diseases make her tired and fatigued. If her mind is too racy, she will take to keep as calm as possible, especially with the small cell vasculitis or then she could have a flare. Her main objective is to keep calm. She was already taking 1 XANAX a day when diagnosed with PTSD but they just raised it because then came her PTSD and depression from the vasculitis. Has muscle relaxer cyclobenzaprine hydrochloride (FLEXERIL) at 100mg once a day which she doesn't take. Did not normally take these but has been taking them since this happened. She is in so much pain. Does not generally have high tolerance for pain. Does not like taking opioids because they make her throw up. She can only take them with Phenergan. Does not take if she does not need them because they do not sit well with the liver. She has an inhaler that keeps the lungs dilated for 10 hours, is not Pulmicort but something else. Eyes hurt on Apr2021 and can't read the label because its so little. She has bronchiolitis which is another rare disease with the airways in her lung and medication keeps the lungs dilated. Haven't seen the doctor yet so no tests yet. Since this happened, she can't walk. On 26Apr2021, when she went back down she couldn't walk since. It is her lower back on the right side, above her hip. She had pulled it 2 years ago (2019), above the hip on the right side. She recognized this feeling from a couple of years ago. It seems to be the place where she feels over winded. It may be neuropathy problems, wondering if it's not neuropathy since it's not her muscles (Apr2021). Everything that was wounded has come back and hurts as bad as it does. For can't walk, the pain just hurts. She didn't sleep at all last night (26Apr2021). Tries to turn and get up and if she is on either of her arms. Other than the neck, shoulders and back of her head, she never got a fever. When it started she thought that it was normal. Then, it started hitting in all of these other places and she was barely moving. Patient had the normal feeling like when she would breathe. On an unspecified date, she was having stiffness of the joints, as if they were traveling, then taking a vacation to every place that she has ever hurt itself. She had fell on both arms, she's had a knee surgery and its like going to that. The knee surgery was on the right knee. Like right now its in her back, and she can barely walk because she pulled a back muscle before. She stated that she will enjoy it if she can walk again and she just wanted to make it through this. The adverse events did not require emergency room visit or physician's office visit but was definitely at the point where she will go see the primary or go to the ER. The outcome of the event vasculitis pain flare up, right and left arm pain/legs hurt/hands were also hurting, and ?can't walk was not recovered; for knee pain, whip lash in shoulders and neck, feel radiation or heat, uncomfortable, and shoulders became sore, it was recovering at the time of report; for the other events, it was unknown. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-05-13 | bell's palsy |
This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 01:00 (Batch/Lot Number: EW0164) (at the age of 48 years old) at 1st dose, single for COVID-19 immunization. Medical history included low iron, Bell's palsy in Jan2020 and patient had no known allergies. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications within 2 weeks of vaccination. On 25Apr2021 08:00 (after receiving the vaccine 2 days later), the patient had Bells Palsy symptoms started along with a head ache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The outcome of the events was not recovered.
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| 49 | 2020-12-31 | weakness |
mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1...
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mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1 day); 3 says after injection: nausea, dizziness and weakness, headache, tiredness, feeling unwell.
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| 49 | 2020-12-31 | hot flush, tension headache |
12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tig...
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12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tightness(headache), rigors, hot flashes.28th feeling off and fatigued, continued to feel better as the days went on and on the 31st had diarrhea, rigors, temp of 99.3F, hot flashes, muscle aches now.
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| 49 | 2021-01-01 | numbness |
12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , ...
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12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead with mild erythema including eyelids, mild circumoral numbness with occasional burning/stinging sensation.
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| 49 | 2021-01-03 | weakness, night sweats |
Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. S...
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Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
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| 49 | 2021-01-03 | weakness | headache, weakness, brain fog, confusion, dizziness. weakness in limbs |
| 49 | 2021-01-03 | facial paralysis, numbness |
On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste li...
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On 1/3 around 2 am , I got up to get something to eat and drink. The taste of food , feels/ taste like cotton on the left side of my mouth/ tongue. As the day progress, I noticed I am having numbness left side of my face and mouth, unable to sip from a straw on the left side of my mouth, I am having facial droop that prompted me to to the ER . At ER same day my left eye is not blinking as my right eye. I was prescribed to take antiviral , steroids and eye meds. TODAY- 1/4/21, I am still having same symptoms and my left eye , feels grainy/ needle pricking inside. Left eye vision more blurry.
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| 49 | 2021-01-03 | flushing, tingling |
Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mou...
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Tachycardia and flushing immediately after shot given, followed by fullness (slight swelling) in mouth, prickly feeling to tongue.
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| 49 | 2021-01-03 | flushing |
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around ...
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I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
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| 49 | 2021-01-03 | hot flush, feeling hot, tremor |
10 min after initial injection, I experienced a brief flush of heat that resolved after a few minute...
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10 min after initial injection, I experienced a brief flush of heat that resolved after a few minutes. 6 hours later, I had a sudden onset of intense heat, diaphoresis, and a rash to my arms/legs, along with intense muscle tremors, nausea, vomiting and stomach cramps.
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| 49 | 2021-01-03 | numbness |
Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency,...
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Patient is a 49 y.o. female with a PMHx of AAT deficiency, HPV infection, DVT, Vitamin D Deficiency, Hypercholesterolemia and Anxiety with complaints of acute left arm numbness that radiates into her left digits and chest tightness that began 12-13 min after receipt of the COVID-19 vaccine. She noted numbness radiation into the left side of the neck and the bilateral ears. She voices she has also developed chest tightness and wheezing. Evaluated in the emergency department treated with diphenhydramine 25mg, epinephrine 0.3mg and dexamethasone 10mg
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| 49 | 2021-01-03 | pain in extremity |
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ...
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12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
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| 49 | 2021-01-03 | pain in extremity |
pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at tim...
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pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at time of injection. Nausea started on 1/4 around 930am. overall fatigue
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| 49 | 2021-01-03 | pain in extremity |
Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigu...
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Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigued. Nausea the first two days, with diarrhea.
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| 49 | 2021-01-03 | pain in extremity | Very sore arm, required Tylenol Moderate fatigue Sore are resolved next day Fatigue continues |
| 49 | 2021-01-03 | tingling |
Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved ...
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Right wrist rash, 4cm x 2.5cm, with vesicles that drained clear fluid after severe itching relieved by scratching. Left hand rash, of the webbing between the thumb and forefinger, raised. Not as severe as the wrist. Numbness or tingling of the lips, intermittent, first occurred an hour after the vaccine and has been infrequent since then. Gradually reducing in frequency; described as an awkward sensation of tingling. Has contacted her PCP for an appointment. Local Pharmacy would not sell or recommend medications due to the patient's history of Pfizer vaccine without her having been diagnosed first.
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| 49 | 2021-01-04 | weakness, muscle spasms |
throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it ...
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throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
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| 49 | 2021-01-04 | weakness |
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ...
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difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-04 | breast pain, pain in extremity |
ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO...
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ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO HER LEFT BREAST. ON 1/4/21, STATES THAT THE SWELLING IS RESOLVED AND THE PAIN IS IMPROVING, BUT STILL PRESENT IN THE LEFT BREAST.
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| 49 | 2021-01-04 | facial pain, numbness |
Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue are...
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Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue areas. Affects similar to receiving a Novocain shot. No treatment, went away on its own Lasted four hours-was closely monitored
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| 49 | 2021-01-04 | hypersensitivity of all senses, facial pain |
left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some p...
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left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.
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| 49 | 2021-01-04 | numbness, tingling |
I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes af...
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I experienced my heart racing as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted till about 3:30 pm and then went away. Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
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| 49 | 2021-01-04 | migraine, pain in extremity |
swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle an...
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swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
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| 49 | 2021-01-05 | feeling cold |
I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itch...
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I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itchy, I left at 3pm by 3:15 my head started hurting, mild. at 7pm I had a pounding headache, chills, body aches on the 24th AM I could not warm up my body was shivering I went to work at 8 am I thought I had a fever and I checked it was 100.2 when I got home my temp was 101 and 102.9 and my body aches were horrible I couldn't move nausea no appetite, shortness of breath, I did a telemed and talked to my primary and she said this was all related to the vaccine, she prescribed something for the nausea was asked to get a covid test and it came back negative, I started getting better Dec 27th .
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| 49 | 2021-01-05 | feeling hot | THROAT TIGHTNESS, FINGERS WARM. EPI GIVEN. TRANSFERED TO ER |
| 49 | 2021-01-05 | flushing, pain in extremity, numbness, tingling |
After receiving the injection in the right arm, the patient began to feel pain and burning at the in...
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After receiving the injection in the right arm, the patient began to feel pain and burning at the injection site in the right deltoid with spreading down to her hand along with localized redness at the injection site. She was given 50 mg of diphenhydramine and subsequently developed facial flushing and a feeling of numbness/tingling in both arms and hands. At this time, about half an hour had elapsed after the injection, so she was referred to the hospital emergency department from the hospital vaccine pod for additional monitoring. No additional interventions were given in the emergency department, she was discharged home after 3 hours of monitoring. Symptoms had improved with time.
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| 49 | 2021-01-05 | flushing |
A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and i...
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A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and in my other arm, back. I became extremely fatigued and felt lethargic. I felt flushed and slightly nauseated, but mostly I felt body pain and extremely tired. This continued through the evening and night. In the morning of 1/6/21, I felt better, but today I still have severe muscle pain in both arms and shoulders and back and neck and I am still fatigued, with some loss of appetite.
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| 49 | 2021-01-05 | migraine, tingling, hot flush |
UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to...
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UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to a previous flu vax reaction 2 years. She did consequently have a migraine headache upon awakening this AM which prevented her from working. Treated with Benadryl 25mg PO in the ER, monitored via cardiac monitor and then she was discharged with 25mg of Benadryl that she took when she got home at 1630.
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| 49 | 2021-01-05 | night sweats |
Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM...
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Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM on 1/5/2021 to 0730 1/6/2021. Massive headache still lingering.
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| 49 | 2021-01-05 | pain in extremity, tremor, cold extremities, flushing, feeling hot |
I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was si...
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I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
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| 49 | 2021-01-05 | pain in extremity | Chills,joint pain,muscle aches,nauseated, headache, sore arm |
| 49 | 2021-01-06 | weakness, tingling, pain in extremity |
Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, g...
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Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, generalized weakness Narrative: employee considered response mild, needed a heat pack for pain relief, staying in bed on Jan 5. Taking 800 mgm ibuprofen every eight hours, has not recovered yet.
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| 49 | 2021-01-06 | weakness, cold extremities |
Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02...
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Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02 or 03 sleeping clothes all wet-she had to change her clothes, Sunday-she feels drained, She laid in bed Saturday & Sunday drank water and took Motrin. Monday-too weak to work. Body aches, headache. Monday severe ABD cramps-heating pad to help/nauseated. Tuesday diarrhea starts. Wednesday-left side of her back-pain-diarrhea & Tired. No SOB. Drinking Pedialyte and taking Motrin-she said IF she gets worse she will go to the Urgent Care-near her home.
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| 49 | 2021-01-06 | weakness |
Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad...
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Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)
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| 49 | 2021-01-06 | weakness | Patient reported weakness and pain in neck and back |
| 49 | 2021-01-06 | cold sweat, feeling hot, migraine |
This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vacci...
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This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vaccine recipient reported that after 10 minutes of receiving the 2nd vaccine they developed a headache that felt like a migraine. The vaccine recipient took Advil, then a few minutes later started sweating, felt clammy, and hot. The symptoms started to pass 15 minutes later. That night they reported that their chest felt tight but it went away before bedtime. This morning 1/7/2021, vaccine recipient reported feeling tired and mind felt foggy. They were able to continue to go to work.
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| 49 | 2021-01-06 | feeling hot |
Patient sitting for about 20 minutes and feet felt hot/on fire; no shortness of breath. BP 118/84; p...
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Patient sitting for about 20 minutes and feet felt hot/on fire; no shortness of breath. BP 118/84; pulse 84; p ox 99%. Has had same sensation when had allergic reaction to bactrim. Monitored for another 15 -20 minutes; took gatorade. Wanting to go home and take liquid benadryl.
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| 49 | 2021-01-06 | feeling hot |
Today was my second dose of the COVID vaccine and just a few short minutes after the injection the i...
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Today was my second dose of the COVID vaccine and just a few short minutes after the injection the injection site start itching. At just about the 15 min wait time after ionjection a nurse asked if i was feeling ok. I told her i was feeling gine but my arm was very itchy. She checked the site and I had redness all around the site and welt size hives around the site. She asked me to stay 15 min longer and I agreed. Shortly after that the hive started to spread to my neck and chest area and I became lightheaded and faint feeling. I became very hot. They gave me and injection of benadryl and since my BP was high and my syptoms were not going away completly I was taken to the ER for monitoring and IV fluids. There I was given more Benadryl, steroids, Pepcid and IV fluids and monitored. I felt much better and was released to go home with a RX for 4 days of steroids.
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| 49 | 2021-01-06 | flushing, feeling hot |
a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This ...
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a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.
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| 49 | 2021-01-06 | flushing, feeling hot |
she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Ta...
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she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 6th of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter did not know if the patient received any other vaccines at the same time as the COVID-19 Vaccine, and if had received any other vaccines within the last 4 weeks. The patient works at a hospital but doesn't believe that she received any medical attention. she believed just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported whole body heat, flushing, tachycardia and palpitations, and the administration of BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
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| 49 | 2021-01-06 | flushing |
SkinRash flushed face noted with rash around neck Narrative: @1348 noted face flushed and rashes aro...
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SkinRash flushed face noted with rash around neck Narrative: @1348 noted face flushed and rashes around neck. BP 132/80, P 96, R 18, O2 sat 100%, T 98.6 Given Cetirizine 10 mg po and observed for 30 minutes. @ 1405 BP 123/65, P 65, R 18. Resolved and d/c'd at 1410. Updated in employee record on database
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| 49 | 2021-01-06 | flushing |
12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed...
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12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed headache, 3pm developed nausea, vomiting and dizziness, flushing of skin. Rapid Response called at 3:52pm and patient sent to Emergency Room at 4pm. VS on arrival were BP 144/105, HR 146, RR 22, T 97.9, O2 sat on Room air 98%. ED treatment included IV of 0.9NS (1L), EKG, IV Zofran 4mg, IV Benadryl 25 mg, IV Ativan 0.5mg, IV Compazine 10mg. Also had CT head.
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| 49 | 2021-01-06 | numbness, tingling |
Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient ...
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Patient reports arm became numb right after receiving the COVID-19 vaccine. Two hours later patient reports the numbness being limited to the bottom of the arm and hand. Patient states to being able to use hand but reports there is numbness and tingling.
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| 49 | 2021-01-06 | migraine |
About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills. All sympt...
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About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills. All symptoms lasted about 22 hours. I still have a minor headache and fatigue
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| 49 | 2021-01-06 | pain in extremity | Headache, Myalgia, ARM PAIN,CHILLS,LIGHT HEAD Narrative: |
| 49 | 2021-01-06 | pain in extremity | 9 x 5 cm area of raised redness and pain left arm starting on on day 8 |
| 49 | 2021-01-06 | pain in extremity |
Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm...
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Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm soreness, chills, and hives/welts on her face, neck, back, and thighs. The associate is taking Benadryl and self-monitoring her symptoms currently from home. The associate was instructed to seek medical attention if symptoms worsen.
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| 49 | 2021-01-06 | tingling, flushing, numbness |
felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, al...
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felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, also hands flushed feeling over neck facial numbness on the left check headache dizziness neck pain throat pain numbness and tingling on right arm fatigue feels unwell
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| 49 | 2021-01-06 | tingling, numbness |
Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dos...
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Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl. Patient reported feeling better and was sent home.
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| 49 | 2021-01-06 | tingling, numbness |
Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of ...
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Patient reported numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine. Monitored for 45 min and given 50 mg of Benadryl.
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| 49 | 2021-01-06 | tingling, numbness |
Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the l...
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Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the lft side, especially on the cheek, coming from neck. Back of head. numbness and tingling feeling on the back of the head and both arms and the hands. Patient reports headache as well. Also feeling fatigued
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| 49 | 2021-01-06 | tremor | Fever, chills, shaky |
| 49 | 2021-01-07 | weakness |
Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after inject...
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Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after injection and progressively worsened over 24 hours, ~40 hours after injection symptoms were gone. -took advil, increase fluids and went to bed to sleep ~ 7 hours
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| 49 | 2021-01-07 | feeling hot, discomfort, pain in extremity |
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ...
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EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
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| 49 | 2021-01-07 | feeling hot | Throat hurting , really hot Neck Swollen , back of Neck hurt really bad Joint Pains Headache |
| 49 | 2021-01-07 | flushing, tingling |
developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-1...
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developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-19 vaccine. By the time of assessment in ED, sxs have resolved other than residual numbness of lips.
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| 49 | 2021-01-07 | flushing |
Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12...
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Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12 hours. All symptoms resolved. Patient Included the following information: 1 st dose Phizer EH 9899 2nd Dose Phizer EK 9231
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| 49 | 2021-01-07 | numbness, tingling |
Left sided parentheses and numbness sensation which then spread to right side. Strong headache initi...
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Left sided parentheses and numbness sensation which then spread to right side. Strong headache initially then resolved, rapid heart rate, confusion, dizziness, high blood pressure,
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| 49 | 2021-01-07 | migraine, feeling hot |
100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is ver...
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100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is very painful; migraines; she felt warm; joint pain; dull headache; tenderness at the injection; chills; as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it; fatigue/joint pain and fatigue are getting worse; This is a spontaneous report from a contactable consumer. A 49-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on the left arm on 30Dec2020 10:40 at single dose for covid-19 immunisation. Medical history included from Feb2020 and ongoing she is currently a breast cancer patient/she had breast cancer, has lymphedema in the right due to breast cancer and on 31Oct2020, she tested positive for COVID and that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. Had joint pain and fatigue ever since her COVID-19 diagnosis in October. There were no concomitant medications. The patient previously took H1N1 shot and her arm got really big and they watched for cellulitis discomfort. The patient stated on Dec2020, "received the COVID-19 vaccine on 30Dec2020 and is reporting 100.7 temperature, dull headache, tenderness at the injection, chills, joint pain and fatigue. She reported that she has had joint pain and fatigue ever since her COVID-19 diagnosis in October. The patient contacted COVID, she tested positive on 31Oct2020, and still has no taste or smell, and the biggest thing right now, that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. She wants to know, where it has gone into the joint, the arthritis has flared from it, from her testing positive, it will be 9 weeks tomorrow since she had COVID, and she is not 100%, and yesterday she had the COVID vaccine, her first dose, and she was up all night, her joints and muscles were in a lot of pain, but she had been like that, and this morning she took her temperature and it was 101.7. Does it mean can't have the shot in 3 weeks? She has had health issues this year, she had breast cancer, and her oncologist wanted her to have the vaccine, but it concerns her with all the pain in her joints swelled, and wanted to know if it is a side effect due to COVID. States she is still coughing, she wants to know if Pfizer thought this was a side effect of COVID, since she tested positive in October, will she have to live like that? It is very painful. Her shot went fine at 10:40 yesterday morning, fine, but she has been experiencing stiffness and joint pain, and she contacted COVID in October, thinks this doesn't have to do with the shot, this has been this way since October, and her husband said to ask- will it be like this since she contacted COVID, and the only thing, this morning she had a headache, but she didn't sleep and she gets migraines it she doesn't sleep, and she took her temperature, she felt warm and it was 101.7. Her temperature was 101.7 about a half hour ago (31Dec2020), she takes her temperature now, states it is now 100.8. Stated that she probably needs to speak to her doctor for her questions. Got up a 1am and took Ibuprofen. Her joints were so sore from when having COVID and so she went back to sleep and slept off and on. Got up at 4am this morning with the dull headache, it was not enough to be considered a migraine, so she took another 800mg Ibuprofen. Headaches: states it is just a dull headache, she hasn't taken Ibuprofen yet this morning, she is not a big medicine person, she is trying to see if it will go away, but if it is worse she will take migraine medicine". The outcome of "as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it", "she was up all night/she didn't sleep", "It is very painful", "migraine" and "she felt warm" were unknown. Other events was not recovered.
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| 49 | 2021-01-07 | pain in extremity |
fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhaust...
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fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhausted; sore arm; woke her up briefly; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included spending 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. The patient has no known allergies. The patient has no covid prior vaccination, and she was not tested for covid post vaccination. The patient's concomitant medication included multivitamin. The patient did not receive other vaccine in last four weeks. The patient was vaccinated on 31Dec2020 at 10am for her 1st Pfizer vaccine. No symptoms for 6-8 hrs. By bedtime at 06:00 PM, she experienced headache, achey, tired, and sleeping on her sore arm woke her up briefly. Next day on 01Jan2021, more achey, exhausted, fever of 2-3 degrees, slept most of the day and didn't feel well at all. She could tell that her body was fighting something, but she is much better 48 hours out. The patient did not receive any treatment for the reported adverse events. She stated she had no regrets. She stated that she loves Pfizer, because it has given hope. She just wasn't expecting any side effects after the 1st vaccine, only for the 2nd. Anecdotally, it seemed her hospital coworkers who have had Covid react more to the 1st vaccine, possibly for them, 1st vaccine is like the 2nd. She doesn't know if she has had Covid, but as an Acute Care PT on Covid units, she spends 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. She stated that possible her immune system already recognizes Covid. She is curious. No complaints, only curious. Again, she said thank you. She stated that she has seen too many good people die this year, thus, she didn't hesitate on the vaccine. The outcome of the events was recovered in Jan2021. The report was considered non-serious. Information on the lot/batch number has been requested.
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| 49 | 2021-01-07 | pain in extremity |
01/08 sent email to cancel the second dose. I called her and she states after the first dose after ...
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01/08 sent email to cancel the second dose. I called her and she states after the first dose after about 1.5 hours started getting tachy and palpations for about 6 hours following her shot. She states her resting HR was HR 130 for about an hour but she just sat and waited it out. She denies going to ER or calling she stated she had this happen about 6 years ago and just waitied it out. She stayed and worked stating she just did inservices and after about 6 hours felt better before she states she felt fine the next day except for sore arm.
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| 49 | 2021-01-07 | pain in extremity |
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ...
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I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
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| 49 | 2021-01-07 | pain in extremity | Nausea, Headache, Fever, Sweats, Sore Arm |
| 49 | 2021-01-07 | tingling |
Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/1...
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Patient c/o generalized tingling 35 minutes after receiving vaccine. BP taken and was elevated 169/112. tachy at 101. patient brought to ED for further evaluation.
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| 49 | 2021-01-07 | tingling |
Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the...
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Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the inside of her left wrist; "Needle pokes" on the inside of her left elbow & left wrist. She said what she was experiencing was like pins & needles, but with just the needles.; This is a spontaneous report from a contactable consumer (ophthalmic technician, also patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 29Dec2020 11:44 at single dose on her left upper arm (non-dominant arm) for COVID-19 immunization. Medical history included ongoing lupus from 1993. The patient had no concomitant medications were received. No additional vaccines administered on same date. No emergency room and physician office were visited. The patient had no prior vaccinations (within 4 weeks). The patient took part in a COVID-19 Vaccine program and had fatigue as a side effect. She received the COVID-19 Vaccine on 29Dec2020 at 11:44AM. Reported she started experienced fatigue at around 7:00-8:00PM. She said she all of a sudden became really tired, like she hit a brick wall. She said she could still do stuff, but was really tired. She said the fatigue lasted about 24 hours. She said she generally experiences fatigue in winter, but this fatigue was more than the usual fatigue. Reported she also experienced "needle pokes" on the inside of her left elbow and the inside of her left wrist. She said what she was experiencing was like pins and needles, but with just the needles. She said it felt like painful poking, but the pain was not severe and only lasted a half hour. Reported she recently had full blood work done with her primary care doctor, and all was fine. She said she also had some testing done with her gynecologist, and all was fine, saying there was nothing weird. The patient declined any treatment. The outcome of the event fatigue was recovered on 30Dec2020. The outcome of the event She said it felt like painful poking was recovered on 29Dec2020. The outcome of the rest event was recovered in Dec2020.
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| 49 | 2021-01-08 | weakness, inability to speak |
Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphor...
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Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
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| 49 | 2021-01-08 | weakness |
01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills...
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01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills, headache. Needed pain medicine to alleviate pain. Fatigue. 01/09:21: AM: Less body pain , but feeling of heaviness in head; weak. PM: Had onset of lower GI symptoms: painful abdominal/cramps, stomach pain, nausea. No vomiting, but had several episodes of diarrhea. Feeling like passing out but never did. Loss of appetite. Slowly resolving.
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| 49 | 2021-01-08 | feeling cold |
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ...
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After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
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| 49 | 2021-01-08 | feeling hot | Headache chills, feels hot (no fever), body aches, stuffiness, and headache |
| 49 | 2021-01-08 | flushing, feeling hot | Heat/flushing from injection site to neck to face to upper body x 20 minutes; sweating |
| 49 | 2021-01-08 | migraine |
Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into...
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Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into migraine and severe exhaustion. Chills, diarrhea and nausea. Day 10 woke up in the middle of the night with fever 99.6. At this point I went and got tested for Covid and it was negative. Finally on 09/09/2021 woke up without a headache but it came back later on.
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| 49 | 2021-01-09 | migraine |
Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had...
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Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had swelling and a red lump at site of injection, with pain and soreness around injection site.
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| 49 | 2021-01-09 | pain in extremity |
Approx 10 hrs after injection severe left arm pain, progressed to all over body aches about 12 hrs p...
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Approx 10 hrs after injection severe left arm pain, progressed to all over body aches about 12 hrs post vaccination. Approx 24-30 hrs post vaccination chills and slight headache added and remained until approx 48 hours post. Took Motrin for aches and rested with restricted movement
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| 49 | 2021-01-09 | paralysis, pain in extremity |
The patient received the vaccine in the left deltoid at 07:45 on 1/7/21. The patient reports that o...
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The patient received the vaccine in the left deltoid at 07:45 on 1/7/21. The patient reports that on 1/8/21 at around 0200, she was awoken with a sharp pain in her left arm followed by complete paralysis of her left hand for about 15 seconds. Did not re-occur. Did not seek treatment. Reported to Dr. and no further issues seen.
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| 49 | 2021-01-10 | feeling cold, speech disorder |
her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all ...
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her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown. Information on lot number/batch number was requested.
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| 49 | 2021-01-10 | feeling cold | chills exhaustion, headache |
| 49 | 2021-01-10 | feeling hot |
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte...
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Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
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| 49 | 2021-01-10 | muscle spasms | ABDOMINAL PAIN, CRAMPING |
| 49 | 2021-01-10 | tenderness |
Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injecti...
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Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injection administered. Fatigue and headache occurred by the same afternoon and low grade fever of 99.6° that evening at 8:30 PM. Right armpit tender and swollen lymph nodes remain present 2 days post 2nd IM injection and right arm injection site is warm to touch with redness and firmness to touch.
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| 49 | 2021-01-10 | tenderness |
After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mi...
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After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent. I had malaise and fatigue. I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day. It was painful to touch and tender once the lymph node decreased in size. The only other reaction was the site pain and tenderness and warmth. That lasted a few days.
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| 49 | 2021-01-11 | weakness |
doesn't feel good; her body is hurting/her left side hurts/her body hurts/it's like somebody hit her...
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doesn't feel good; her body is hurting/her left side hurts/her body hurts/it's like somebody hit her hard; headache; so weak; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date: unknown), via an unspecified route of administration on 06Jan2021 at 12:30 at a single dose for Covid-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine the day before (06Jan2021) and doesn't feel good in the morning, her body is hurting, and she has a headache. The patient is a CNA and she got the vaccine the day before at around 12:30 and she just got up in the morning, so weak, and her left side hurts. Her body hurts and she doesn't feel good too, reportedly "all the body hurts now, it's like somebody hit her hard". The patient asked if she can take Tylenol or pain medication. After receiving a verbal response, the patient added that she would take Tylenol and pain medication together and hopefully get some sleep. The patient then asked if headache and body ache are normal side effects of the vaccine. The outcome of the events was unknown. Information about batch/lot number has been requested.
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| 49 | 2021-01-11 | feeling hot, hot flush, burning sensation |
99 yo obese DMII smoker reported during post-vaccination monitoring for Pfizer COVID 19 that she wa...
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99 yo obese DMII smoker reported during post-vaccination monitoring for Pfizer COVID 19 that she was experiencing a burning sensation without pain in her neck, hips and along the spine area of her lower back. She reported feeling warm but stated it was likely a hot flash. She reported that when she has a flu shot she has localized arm burning sensation similar to this burning. Denies difficulty breathing, or swelling of any portion of her body. Patients states she is comfortable self-monitoring and plans to go to work. Patient released to self after monitoring for 1 hour. If patient later seeks medical care, we requested she inform us of the outcome.
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| 49 | 2021-01-11 | pain in extremity |
Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other ...
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Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other HCP (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Vaccine location was right arm. Patient is not pregnant. Patient received the first dose on 17Dec2020 05:45 PM also at right arm for covid-19 immunization. Lot number was also EJ1685. The facility type vaccine was hospital. Medical history included Celiac. Concomitant medication included pregabalin (LYRICA), celecoxib (CELEBREX), escitalopram oxalate (LEXAPRO), spironolactone. Known allergies: Penicillin, morphine, lactated ringers. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient experienced Sore arm, headaches at 05Jan2021 06:00 PM with outcome of recovered in Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. No follow up attempts are possible. No further information is expected.
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| 49 | 2021-01-11 | pain in extremity |
Pain in left arm began within 30 min. of injection and has lasted over 24 hours with radiation down ...
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Pain in left arm began within 30 min. of injection and has lasted over 24 hours with radiation down into elbow, wrist, hand and fingers.
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| 49 | 2021-01-11 | tenderness |
Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sou...
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Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.
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| 49 | 2021-01-11 | tremor |
The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness...
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The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness, sweating, and shakiness. The ambulance was called just to be on the safe side. She was taken to the hospital via ambulance and was later discharged that same night as symptoms improved.
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| 49 | 2021-01-12 | flushing | Reported feeling flushed and experienced chest pressure. Transferred to ED |
| 49 | 2021-01-12 | hot flush |
My adverse reaction was a hot flash for about 10min on 12/31/2020 and on 01/01/2021, I found a small...
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My adverse reaction was a hot flash for about 10min on 12/31/2020 and on 01/01/2021, I found a small pea size lump on my right collar bone area that has now increased in size to a quarter size lump that's mildly tender.
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| 49 | 2021-01-12 | numbness, tingling |
Covid-19 given at 0845, @ 0855 client complained of left arm numbness and tingling on fingers. Provi...
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Covid-19 given at 0845, @ 0855 client complained of left arm numbness and tingling on fingers. Provider onsite: NP evaluated the client, advised to wait for another 15 minutes. @0932 per client she is feeling better. Provider onsite advised client to see her PMD if the reaction will get worse. Client left the clinic in Ambulatory stable condition.
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| 49 | 2021-01-13 | weakness |
Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling ...
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Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling good; awful stomach ache; could not eat/she can't eat; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included ongoing overweight. Concomitant medications were not reported. The patient experienced sick to her stomach/super sick stomach on 03Jan2021 with outcome of unknown, not feeling good on 03Jan2021 with outcome of unknown, awful stomach ache on 03Jan2021 with outcome of unknown, could not eat/she can't eat on 03Jan2021 with outcome of unknown, body ache on 07Jan2021 with outcome of unknown, fatigue on 07Jan2021 with outcome of unknown, weakness on 07Jan2021 with outcome of unknown, abdominal noises on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown on 05Jan2021. Therapeutic measures were taken as a result of sick to her stomach/super sick stomach (nausea) and included treatment with Pepto-Bismol.
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| 49 | 2021-01-13 | flushing |
15 minutes after im shot, patient experienced itchy feeling and then flushed face patient was admin...
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15 minutes after im shot, patient experienced itchy feeling and then flushed face patient was administered diphenhydramine 25mg orally and observed . No additional side effects occurred
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| 49 | 2021-01-13 | flushing |
SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she beg...
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SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she began feeling her throat was scratchy, mouth tasted metallic and a flushed felling over her entire body. SM attached to VS machine. Initial set of vitals were HR 77 bpm, spo2 100% on RA, and left arm blood pressure 158/84.
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| 49 | 2021-01-13 | numbness |
Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with t...
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Right arm numbness occurred within the 15 minute waiting period. It did not start immediately with the injection but rather 5 minutes after. Lasted about 3 minutes before completely resolving. The right arm numbness returned on 01/01/2021 and persisted through 01/03/2021. Went away and returned on 01/06/2021 then migrated to the left arm. Waxes and wanes and added numbness to bilateral lower legs and feet. Improved with less frequency by 01/14/2021.
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| 49 | 2021-01-13 | numbness |
-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on...
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-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain
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| 49 | 2021-01-13 | numbness |
c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other sympto...
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c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other symptoms noted. Monitored for 30 minutes.
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| 49 | 2021-01-13 | pain in extremity | Patient describes nausea, fatigue and headache. Also has arm soreness, but very mild |
| 49 | 2021-01-13 | pain in extremity |
Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site p...
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Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site pain
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| 49 | 2021-01-13 | pain in extremity |
felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of ery...
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felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
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| 49 | 2021-01-14 | weakness |
FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAI...
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FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAIN JOINTS,FEVER,NAUSEATE,FEELING BAD.
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| 49 | 2021-01-14 | bell's palsy | Bell's Palsy left side |
| 49 | 2021-01-14 | feeling cold, burning sensation, feeling hot |
Burning and itching at site, increased blood pressure, redness and burning down both arms, redness i...
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Burning and itching at site, increased blood pressure, redness and burning down both arms, redness in face, hot, sweaty, and cold
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| 49 | 2021-01-14 | feeling hot, pain in extremity |
the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face...
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the skin overlying the injection site has an intense prickly "itchy" sensation; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face; I had a short episode of disequilibrium; awoken by intense bilateral leg pain; my legs felt weak the following day; This is a spontaneous report from a contactable Physician who reported for herself. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK9231) for COVID-19 immunisation on 07Jan2021 at 15:30 at single dose in Left arm. Medical history included allergy to penicillin , clindamycin, azathioprine (IMURAN) (known allergies: penicillin, clindamycin, Imuran) , allergy to glove powder and autoimmune disorder (unspecified). Concomitant medication (received within 2 weeks of vaccination) included hydroxychloroquine sulfate (PLAQUENIL), methotrexate, mycophenolate mofetil (CELLCEPT), folic acid and magnesium. On 07Jan2021 at 17:30 , approximately 2 hours after she received the vaccine, she had a short episode of disequilibrium, then an hour after that (at 18.30) the left side of her face felt heavy, stiff and was palpably warmer than the right side of her face. There were no visible changes to the appearance of her face, and she had normal motor control. This episode lasted for approximately 1-2 hours then gradually diminished. In Jan202, approximately 36 hours after the vaccine, patient was awoken by intense bilateral leg pain. The pain gradually diminished after approximately an hour, but her legs felt weak the following day. Legs were fine on 10Jan2021. In the evening of 09Jan2021 though 10Jan2021, the skin overlying the injection site had an intense prickly "itchy" sensation, there was no rash. Events were all non serious. No treatment administered and final outcome for all the events was reported as recovering.
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| 49 | 2021-01-14 | pain in extremity |
immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and move...
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immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and movement, then flu like symptoms 1/11-14/21: aches, fatigue, malaise, head ache; on 1/12/21 in the afternoon I noticed right axilla pain in axilla, same level at the upper back/ribcage under the shoulder blade and corresponding pectoralis muscles and swell in axilla and upper pectoralis muscles, I could also palpitate multiple firm and tender lymph nodes at the right axilla.
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| 49 | 2021-01-14 | pain in extremity |
She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm sorenes...
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She stated: I received my 2nd dose of vaccine on 1/11 24hours after I experienced severe arm soreness which progress to body aches and tongue swelling. I took 50mg of Benadryl and 40 mg of prednisone that I had at home and my symptoms resolve gradually and I felt better the next day
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| 49 | 2021-01-14 | pain in extremity |
left arm pain, generalized body aches, chills and fatigue. Treatment included Tylenol the next day....
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left arm pain, generalized body aches, chills and fatigue. Treatment included Tylenol the next day. Outcome: Moderate improvement has continued c/o of mild fatigue and generalized body aches that does interfere with ADL's currently working.
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| 49 | 2021-01-14 | tingling |
After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated s...
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After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated she has 2 bowel movements, denies diarrhea. She felt very tired. Both her hands felt tingly. BP 117/75 - 85bpm - 98% RA. She was not pale or diaphoretic. No medication given. She slept for ~90 minutes in the vaccination room on the gurney. She felt well upon awaking. Drank water and ate crackers. She left in stable condition.
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| 49 | 2021-01-15 | pain in extremity |
Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Diz...
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Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Dizziness Lightheadedness Fatigue Chills Sneezing Sore arm (first 3-4 days). I had a negative COVID test on 1/12/21.
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| 49 | 2021-01-15 | pain in extremity |
dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued a...
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dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued arm sore, did call out of work 1/14 took Tylenol and motrin
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| 49 | 2021-01-16 | pain in extremity, hot flush |
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. ...
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Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities. Treated with meclizine
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| 49 | 2021-01-16 | pain in extremity |
Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Fe...
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Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Felt Strange just not well. Ran a fever through the night into the next morning., Friday 1/15/21 had a fever of 100.5 taken by ear. Fever subsided. Began having a slight headache that lasted through Sunday. Also had Nausea that started Friday and continued through today. Sunday. Injection arm has been very sore. I also have a very sore enlarged lymph node under my left arm pit. Markedly swollen.
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| 49 | 2021-01-17 | difficulty speaking |
Patient received Pfizer 1st dose and asked the patient to wait for 30 minutes post vaccination to ob...
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Patient received Pfizer 1st dose and asked the patient to wait for 30 minutes post vaccination to observe for any sort of adverse reactions. 30 minutes later patient complained of having sore throat and her voice sounded hoarse. Patient asked to wait to see if symptoms improved. 15 minutes later patient complained of short of breath and throat tightness. Given albuterol nebulizer and benadryl. Patient further monitored and vital signs were stable. 5 minutes later patient remained short of breath and rapid response was called and patient was taken to ER. Given Benadryl 25 mg IV and famotidine 20 mg IV. In ER, given 125mg methylprednisolone and 0.3mg of epinephrine. Patient discharged from ER.
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| 49 | 2021-01-17 | feeling cold |
headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp...
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headache, chills ( all day of Jan.17) feels icy cold around my ears and face temp. 97, warm/hot temp 98.9, nausea, blurry vision, pass out once 2-3 mins, feverish at night 99.9
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| 49 | 2021-01-17 | hot flush |
palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on ...
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palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on my arms and abdomen; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), intramuscular in the left arm on 06Jan2021 16:00 (at the age of 49 years old) at a single dose for COVID-19 immunization. Medical history included psoriasis, microscopic colitis, allergies to shellfish, and coconut. The patient's concomitant medications were not reported. The patient previously took estrogen patch, etanercept (ENBREL) and sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies to all. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medications with 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 16:15, the patient experienced a very warm flush feeling, nausea started and by 15 minutes, she had swelling of the throat and rash on her arms and abdomen and the palms of her hands were bright red. The events resulted in Emergency room/department or urgent care visit. The patient was treated with diphenhydramine hcl (BENADRYL), steroids (unspecified), famotidine (PEPCID) and ondansetron (ZOFRAN) in response to the events. The patient assessed the events as non-serious. The outcome of the events was recovered with sequel on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-01-17 | numbness, tingling |
*eyelid area on both sides of face felt tingly/numb for about 20 minutes which started about 40 minu...
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*eyelid area on both sides of face felt tingly/numb for about 20 minutes which started about 40 minutes after the shot was administered. *42 hours after administration of vaccine, I woke up with a metalic taste in my mouth which has laste for 6 hours
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| 49 | 2021-01-17 | pain in extremity, tingling |
1. Tingling in left ring finger immediately 2. Left arm burning and soreness starting at injection ...
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1. Tingling in left ring finger immediately 2. Left arm burning and soreness starting at injection site and traveling down arm worse within 48 hours with continued pain left arm with on and off altered sensation left ring finger currently (3 weeks post injection) 3. Early fatigue left arm 4. Significant body/bone aches for 6 days
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| 49 | 2021-01-17 | pain in extremity |
I woke up with hills, body aches 12 hrs after 2nd dose. My arm was hurting I expected that was one o...
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I woke up with hills, body aches 12 hrs after 2nd dose. My arm was hurting I expected that was one of the symptom as 1st dose. The following day chills, body ache fever 99.6 took Ibuprofen slept most of the day. On 1/17 started exp stomach cramps (described as the muscles in stomach).
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| 49 | 2021-01-17 | tingling |
49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. ...
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49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction. Patient states that she got her first Covid vaccine yesterday afternoon and states that she has noted some swelling in her hands and also feels as though she has burning pain and pins-and-needles in her hands. She denies any weakness in her distal extremity. She states the sensation extends from her fingertips to her mid forearm. She also states that she has noted some lymph node pain in her groin and neck. She denies any fevers or chills. She denies any throat tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting or rash associated with her symptoms. Patient is alert and oriented ×3, cranial nerves II through XII intact bilaterally, no pronator drift, paresthesias in glove like distribution from hand to mid forearm bilaterally. Sensation intact in bilateral lower extremities, 5/5 strength in upper and lower extremities, cerebellar function intact with finger to nose bilaterally. No visual field deficits by confrontation. Discussed laboratory findings with patient. She did also does have a mildly elevated creatinine outside of kidney injury however suspect may be source for mildly elevated phosphorus. Given 1 L of fluids. Recommended close follow-up with PCP for laboratory recheck and further evaluation. No signs of acute anaphylaxis or angioedema. Discussed return precautions with patient if she were to have worsening symptoms
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| 49 | 2021-01-17 | tenderness |
swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout t...
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swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
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| 49 | 2021-01-18 | weakness, pain in extremity, migraine |
Took Wednesday, by Friday under left arm was swollen, chills, body aches, migraine, low energy, tire...
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Took Wednesday, by Friday under left arm was swollen, chills, body aches, migraine, low energy, tiredness, couldn't get up, Sunday felt same way and called in to work, Monday weakness in both legs, went to work, today under arm is still sore. When i rub on deodorant underarm is very sore, left arm feels funny. Today still have migraine, i started Tylenol on Thursday, by Friday evening i was taking tylenol every 6 hours until yesterday. I used medicated over the counter pouch, put hot cloth under arm for swelling and it did go down some, but is still not back to normal. Everything i was feeling was on my left side, by Saturday whole body was aches, continued taking tylenol but now just left arm is sore. Migraine comes and goes. My doctor told me this morning she experienced everything i told her.
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| 49 | 2021-01-18 | weakness |
Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my...
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Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my temp it was 104. Took Tylenol, held cool compress on my forhead, the next day had bad chills, throbbing headache, and temp never dropped below 100. I was very weak, every muscle in my body ached, couldn't eat, yet my blood sugar was high all day. Kept checking my temp. It was avg. 102 . Read about the side effects, seemed like I just had it worse than others. Then into Monday morning, still felt awful, but had woke up in a pool of sweat, temp finally fell to 99 . Seemed like the worst was past, was able to eat a little breakfast, but then the diahrea started! I called in sick again, and went to Urgent care. The Dr. said I had a severe adverse reaction to the second vaccine. I asked for a Covid test just in case. Now Tuesday, felt better today, still a bit tired, temp has been avg. of 98 today, got results from test, negative.
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| 49 | 2021-01-18 | cold sweat, tremor, weakness |
Following my 2 dose of the Phizer Covid Vaccine I experienced a temperature of 101.0 spiking over th...
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Following my 2 dose of the Phizer Covid Vaccine I experienced a temperature of 101.0 spiking over the course of 2 days, sever body shaking, dizziness, weakness, and cold sweats. These symptoms lasted for approx. 2 1/2 days. 3-4 days following my severe symptoms I was extremely sore in my neck muscles and fatigued. My balance felt "off".
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| 49 | 2021-01-18 | flushing | Rash, Anxiety, Flushed |
| 49 | 2021-01-18 | flushing |
10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl...
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10 mins after first dose - Flushed, heart racing and head pressure. BP 139/89 - HR 115 Took Benedryl 25 mg P.O. Denied ER visit Released home.
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| 49 | 2021-01-18 | flushing |
Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a ...
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Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies. On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 49 | 2021-01-18 | numbness |
Pfizer C19 vaccine given, Patient was a staff member at facility, felt unwell, blood pressure was ta...
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Pfizer C19 vaccine given, Patient was a staff member at facility, felt unwell, blood pressure was taken by observer, pt ultimately felt well enough to go back to her office. At some point she contacted her doctor by phone and came back to observation reporting numb tingly lips and cheeks (covered by mask). Requested a diphenhydramine 50mg, which was given at 1400. rated reaction feel as level 5. After 25 minutes asked again and rated level 1. Contacted doctor. He cleared her to go home and would follow up in 2 hours to see how she was doing.
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| 49 | 2021-01-18 | pain in extremity |
Dose #1, Day 2-Approx 24hrs after IM injection started with finger joint swelling/pain/limited ROM a...
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Dose #1, Day 2-Approx 24hrs after IM injection started with finger joint swelling/pain/limited ROM and difficulty grasping items by end of day. Day #3 Fingers improving. Day 4 Knees swollen and difficulty bending or climbing stairs, resolved by Day 5. Dose #2, Day 1- 12 hrs after injection started with joint stiffness in hands. Day #2 Finger joint swelling/pain. Day #3 finger,hand,shoulder,hip,knee and metatarsal pain/swelling/limited ROM. Day #4 (same as Day 3), DAY 5,6,7 symptoms improving: able to complete 12 hr shift at work. Day 8 finger/hand joint swelling/pain/stiffness
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| 49 | 2021-01-18 | pain in extremity |
Later in day intense headache and now two days later still intense headache, muscle aches/soreness(m...
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Later in day intense headache and now two days later still intense headache, muscle aches/soreness(mostly arms neck back), very tired, chills, low grade temp. flu like). Even had to miss work.
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| 49 | 2021-01-18 | pain in extremity |
Could not raise it above shoulder, when turning steering wheel pain with up and over motion, could n...
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Could not raise it above shoulder, when turning steering wheel pain with up and over motion, could not lift anything; patient's left arm was very sore, achy; Bruise on injection site; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration, lot number: EH9899, from 23Dec2020 11:00 at a SINGLE DOSE for COVID-19 immunization. Medical history included obesity, hyperthyroid and vit d deficiency. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included topiramate (TOPAMAX), bupropion, darifenacin (ENABLEX) and levothyroxine. On 23Dec2020 15:00, the patient's left arm was very sore, achy, could not raise it above shoulder, when turning steering wheel pain with up and over motion, could not lift anything. Pain was described as worse than flu shot which lasted 24 hours. She also had bruise on injection site that lasted two weeks. Outcome of events was recovered. No treatment was received/required due to events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
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| 49 | 2021-01-19 | weakness, muscle spasms |
I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level ...
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I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level was 8 out of 10. When I tried to get out of bed, I was dizzy and had to hold to the walls to make it to the bathroom. I had severe dry mouth, nausea, muscle weakness, loss of appetite and chills. I was unable to go to work. The symptoms did not begin to subside until later in the evening the next day around 6:30pm. Today I am still weak but making it. Still having chills, and some minor muscle aches and spasms.
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| 49 | 2021-01-19 | numbness, tingling |
generalized numbness and tingling down both arms extending from shoulders to fingers, transient sens...
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generalized numbness and tingling down both arms extending from shoulders to fingers, transient sensation of bandlike chest tightening across rib cage, BP 156/94 with pulse oximetry 98, pulse 111. Observed one hour without allergic signs or symptoms and no wheezing.
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| 49 | 2021-01-19 | numbness |
Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard t...
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Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard time catching my breath, throat became itchy. This lasted for around 35 minutes.
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| 49 | 2021-01-19 | pain in extremity, weakness |
I awoke with severs chills, fever at 5 am. I have muscle/joint pain, very fatigued, slight headache...
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I awoke with severs chills, fever at 5 am. I have muscle/joint pain, very fatigued, slight headache, fever of 101.2, arm soreness on first day. Today (2nd day) temp of 100, body fatigue/weakness, slight headache, arm soreness, but overall feeling better.
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| 49 | 2021-01-19 | pain in extremity |
: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and ...
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: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and fatigue following the vaccination. Those symptoms lasted a few days and resolved. On 1/17 she noticed a sore area under her left arm. she has a small firm painful lymph node under the left arm. She also noticed that she has a slight " fullness" in the neck area. She feels like her thyroid gland is more pronounced. than it was prior to the vaccine. She denies any dysphagia or odynophagia. No SOB or tachypnea. No fever or chills. No hx of thyroid dysfunction.
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| 49 | 2021-01-19 | pain in extremity |
Sore arm, moderate body aches, fatigue, mild headache 14 hrs post 2nd vaccine First vaccine zero sid...
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Sore arm, moderate body aches, fatigue, mild headache 14 hrs post 2nd vaccine First vaccine zero side effects except arm soreness
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| 49 | 2021-01-19 | pain in extremity |
Patient reports acute pain at the injection site immediately after vaccination that lasted for an ho...
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Patient reports acute pain at the injection site immediately after vaccination that lasted for an hour and a half, she also had pain up and down her arm and into her neck. She reports numbing/tingling in both cheeks for half an hour after receiving the vaccine. 9 days later she continues to experience pain up and down the injected arm from wrist to shoulder and into her neck. The pain is somewhat relieved by NSAIDs.
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| 49 | 2021-01-19 | pain in extremity |
"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I starte...
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"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I started with severe pain in my left leg. The pain worsened through the day and my leg began swelling. No other symptoms at all. This morning my leg was twice the size of my right leg so I went to the ER. I live in so I'm at ED. I have a massive blood clot running the the length of my leg - from my thigh to my ankle. I'm very lucky I got here so fast! I?m a very healthy 49 year old with no history of DVT or blood clots so they dug further to find out why. A cat scan showed I have a congenital condition called May Thurner Syndrome. I?m so relieved to have an answer and it?s fixable! The vascular doctors are not 100% convinced that?s not all that was going on as I was born with the syndrome and I?ve gone this long without a clot. So they are doing lots of labs to see if anything else shows up. This is where we are at. I?m being admitted to take care of the clot."
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| 49 | 2021-01-19 | tingling |
Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been go...
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Pt entered observation @ 1645. @ 1704 states prickles felt on back and arm. States s/s had been going on about 10 mins before she said anything. Benadryl 25mg given @ 1705. Does have allergies to Flu Vaccine, MRI Dye, Vicodin, Buspar, Lisinopril, Suchycin. Celexa, Prev Pack, Lexapro, Penicillin, Hydrocodone, and Fluoxetine. Remains to voice s/s @ 1729. Red Blotchy areas noted to face and neck. Pt states this is normal for her when her anixety level is high. V/S were taken @ 1733 BP-193/105, P-74, R-18, 02-100% on L arm. V/S obtained on R arm @ 1731 BP-193/111, P-76, R-18, O2-100%. States that takes BP meds daily @ night, in which she hasn't taken her meds all day. Takes Amlodipine 5mg, Klonopin 0.5mg, Vit D 1000, MVI, Clartin 5mg, and Zantac 150mg. Stil continues to voice s/s @ 1739. BP remains elevated. Patient sent to ER @ 1740. Pt entered registration @ ER @ 1745. Pt continue to voice s/s of prickling noted to body. Denies SOB nor trouble w/ breathing.
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| 49 | 2021-01-19 | speech disorder, tingling, numbness, discomfort |
29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my...
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29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my lips. i informed nurse and she began taking blood pressure and oxygen levels while asking if i was breathing ok. i said yes. i then felt the right side of my lips go numb. i felt a faint tightness in my throat but after about two minutes it felt like my right side of the lips started to feel normal and my throat. then all at once i felt the blood rush from my body and tingling all over. i told the nurse i didnt feel good. she layed me down on the floor and put my feet up. she asked what i was feeling and i said i felt like i was going to faint. i was aware that my tongue felt heavy and i wasn't talking clear. another nurse got the allergist or doctor on standby and she asked me what i was feeling. i just rubbed my throat and my cheeks and lips and felt numbness and my throat tight and my tongue very thick. she asked if i was having a hard time swallowing. i nodded so she said they were going to sit me up because they needed to give me an Epipen. i nodded, tgey brought a wheekchair for me and as they helped me stand because i had no strength, a nurse stabbed me with the Epipen then they took me to the emergency room and observed me until 2:30pmish to make sure i didnt have another episode. then i wss discharged and was told to follow up with my primary care doctor within 3 days. An allergist will also see me to do a skin test.
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| 49 | 2021-01-20 | weakness, tremor |
Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vo...
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Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vomited at 5am on jan 18; Jan18 fever and chills continued, no apetite all day; dizzy; weak; severe body aches; confined to bed all day; severe head ache; very sensitive to light; could not sleep for more than 15-45 minutes at a time; food tasted like chemicals or sickeningly sweet; only rice tasted normal; very sensitive to and repelled by odors. Jan 19: nausea abated, started to eat a few things but eveything still tasted terrible except for rice; got tested: covid negative, flu A &B negative, RSV negative; body aches were much worse; difficult to walk due to shooting pain in feet and back; stayed in bed all day; Jan 20 fever broke, now have right side sore throat; still achy and dizzy; Jan 21 still have headache and mild body aches, not confined to bed but too weak and achy to work
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| 49 | 2021-01-20 | feeling cold, tingling |
All of my symptoms occurred later in the evening: Very cold (lasted 1 night) nausea (lasted 2 days) ...
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All of my symptoms occurred later in the evening: Very cold (lasted 1 night) nausea (lasted 2 days) light headed (lasted 1 night) tingling sensation in hands, feet, legs, and arms (this is still happening as of today)
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| 49 | 2021-01-20 | hot flush, feeling hot, flushing |
Hives; legs were feeling itchy; red blotches to back of thighs/red blotches to both inner arms/red b...
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Hives; legs were feeling itchy; red blotches to back of thighs/red blotches to both inner arms/red blotches mostly to both calves; redness to right leg/redness to right thigh/she had redness, flushed and warmth of face; stated that all the flushed areas were hot to touch; redness to face (flushed)/she had redness, flushed and warmth of face; she had redness, flushed and warmth of face; moderate allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the right arm, on 07Jan2021 at a single dose, for COVID-19 immunization. Relevant medical history included right eye surgery on 06Jan2021, severe allergies, environmental and drug allergies. The patient has no concomitant medications. The patient stated that she had first dose of COVID vaccine on Thursday. Stated that she has sent V-safe reporting updates. Stated that she had a moderate allergic reaction to the vaccine on an unspecified date in Jan2021. She had noticed hives when she woke up on Friday morning (08Jan2021) that her legs were feeling itchy. She stated that she has hives, red blotches on back of thighs, arms and mostly on calves. The area was hot to touch. She then clarified that all the flushed areas were hot to touch. She was feeling a little better. She stated that they looked like they were trying to dry up and she has new ones. She had redness, flushed and warmth of face that started the day of vaccine that night (07Jan2021). She had red blotches to back of thighs Friday evening and they were starting to fade. Stated that the blotches to her left leg started Friday and that evening redness started to right leg and thighs. The blotches to both calves are still warm but starting to improve. The redness to her right thigh is more pink than red now. The patient was Benadryl around the clock and using Aveeno cream as treatment for the events. She has always had severe allergies but has not had an allergic reaction in over year. She also has history of environmental and drug allergies. Patient was trying to determine if should go back for second vaccine due to the reaction. She had asked for a consult from the immunization doctor before receiving the vaccine because she has history of severe allergies. Outcome of the events hives, and redness was not recovered, for events flushing, hot flushes, and red blotches was recovering, while for the remaining events was unknown.
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| 49 | 2021-01-20 | migraine | Migraine Swollen axilla lymph nodes Low grade fever 100 Chills |
| 49 | 2021-01-20 | migraine | Fever, body aches, chills, migraine excessive tiredness |
| 49 | 2021-01-20 | muscle spasms, numbness, tingling |
Severe leg muscle cramps all the way to feet. Numbness and tingling. Lasting well over an hour at th...
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Severe leg muscle cramps all the way to feet. Numbness and tingling. Lasting well over an hour at this time
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| 49 | 2021-01-20 | pain in extremity, muscle spasms |
Severe leg cramps. Temporary paralysis of both legs. Intense pain in both legs and feet. Several epi...
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Severe leg cramps. Temporary paralysis of both legs. Intense pain in both legs and feet. Several episodes lasting approximately 10 minutes
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| 49 | 2021-01-20 | pain in extremity |
A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was g...
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A lot of pain in arm; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy; This is a spontaneous report from a contactable other hcp (patient). A 49-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose bnt162b2 on 18Dec2020 for Covid-19 Immunization and experienced a lot of pain in arm which was normal. On 10Jan2021, the patient's arm was completely swollen with hard ball underneath where the injection was given. It's extremely hot and it's extremely itchy and on an unspecified date the patient had a lot of pain in arm. She had not taken anything other than acetaminophen (TYLENOL) 650 mg. The patient thought it was due to the vaccine (COVID-19 vaccine) she got the reaction. The outcome of the events was unknown.
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| 49 | 2021-01-20 | pain in extremity |
Sore arm day of. Next day: Headache, extreme fatigue, nausea, low grade fever of 99 these symptoms l...
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Sore arm day of. Next day: Headache, extreme fatigue, nausea, low grade fever of 99 these symptoms lasted until 1/15/21 at 1300.
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| 49 | 2021-01-20 | pain in extremity |
Swelling very red painful growing spot at injection site, beginning a few hours after injection, sor...
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Swelling very red painful growing spot at injection site, beginning a few hours after injection, soreness in entire arm beginning the morning after the injection more severe than with the flu vaccine, nausea two days past vaccination
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| 49 | 2021-01-20 | pain in extremity | Sore and heavy arm after an hour. The next day i felt body ache. |
| 49 | 2021-01-20 | tingling, pain in extremity |
fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches...
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fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included hashimoto thyroiditis and hypertension. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020. On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches. The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020. There was no treatment given for any of the events. The outcome of the events was recovered in Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 49 | 2021-01-20 | tenderness, pain in extremity |
Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot bu...
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Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot but not as severe.; Left below knee pain and discomfort. Some to the right leg as well.; Left below knee pain and discomfort. Some to the right leg as well.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort; This is a spontaneous report from a contactable nurse reporting for herself. A 49-years-old female patient started to receive bnt162b2 (BNT162B2; Lot: ECO142) vaccine , intramuscular in the left arm on 29Dec2020 15:45 at single dose for Covid-19 immunisation . Medical history included hypertension, anaemia, blood cholesterol increased , depression, food allergy (whey casium) (taking doxepin for it with relief). Concomitant medication included doxepin (DOXEPIN), metoprolol (METOPROLOL), calcium ascorbate (VITAMIN C [CALCIUM ASCORBATE]), tocopherol (VITAMIN E [TOCOPHEROL]), cyanocobalamin (VITAMIN B-12) , atorvastatin (ATORVASTATIN), sertraline (SERTRALINE). The patient experienced felt like a restless leg or blood clot but not as severe. on 30Dec2020 07:00 with outcome of recovered , left below knee pain and discomfort. some to the right leg as well. on 30Dec2020 07:00 with outcome of recovered , checked back of leg for warmth or bruising lasted day 2 and day 3. on 30Dec2020 07:00 with outcome of recovered , did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort on 30Dec2020 07:00 with outcome of recovered. The event blood clot was considered serious (Important Medical Event). Course of the events The patient reported left below knee pain and discomfort. Some to the right leg as well. She checked back of leg for warmth or bruising lasted day 2 and day 3. She felt like a restless leg or blood clot but not as severe. She felt better to stand instead of sitting. Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort. No shortness of breath, no nausea, no dizziness, no increased fatigue (baseline - not enough sleep - working 3 jobs).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported leg thrombosis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-01-21 | weakness | Fever-around 101.7 had lasted for 36 hours. Chills and extreme muscle pain Weakness |
| 49 | 2021-01-21 | flushing |
Patient called for encounter: She received Pfizer COVID-19 Vaccine 07JAN2021. 08JAN2021 developed fl...
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Patient called for encounter: She received Pfizer COVID-19 Vaccine 07JAN2021. 08JAN2021 developed flushing on face, lower extremities and hives on left leg. Hives progressed to both legs and arms. She then developed swelling on the left side of the roof of her mouth. She started taking benadryl every 4-5 hours for 7 days. She did not use the EpiPen. Simultaneously patient developed vasculitis flare - pain involving ankles and lower legs. No hx of allergy to polyethylene glycol. Prior to vaccine - no changes in exposure other than eye surgery the day before vaccine which utilized the same medications that have been used for prior eye surgeries
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| 49 | 2021-01-21 | pain in extremity |
Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over bod...
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Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over body aches, severe right ankle/heel pain, headache, fever 101, chills, sweats. 1/22/2021 left axillary lymph node swelling and soreness.
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| 49 | 2021-01-21 | pain in extremity |
My left arm was sore and second day I felt very fatigued. I had really bad headaches. My muscle pa...
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My left arm was sore and second day I felt very fatigued. I had really bad headaches. My muscle pain was mild but my headaches have not gone away they are usually mild to moderate.
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| 49 | 2021-01-21 | throat numbness, numbness |
At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied...
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At 0847 patient reported numbness to face, lips, and throat. No SOB nor difficulty breathing. Denied pain. No antidote nor supportive treatment given. After ~40 minutes of observation, minimal numbness and no SOB. Patient left clinic.
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| 49 | 2021-01-21 | unresponsive to stimuli |
Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We ...
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Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We sat her down and then she said her chest felt tight and said she felt as if her heart was racing. Went unresponsive, still breathing, for almost 1 min. Came to and then began to dry heave. Her breathing became wheezy and rapid and her bottom lip began to turn blue. We administered an EpiPen about 5:03pm and the rescue squad took her to the hospital. They administered Benadryl and Ativan in the ER and sent patient home that evening.
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| 49 | 2021-01-23 | tremor |
fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tyleno...
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fever of 103 degrees with chills, uncontrollable shaking, vomiting beginning around 8:00 PM, Tylenol did not reduce fever, went to ER and was admitted post chest x-ray, CT scan, dopplers. While admitted was treated for adverse reaction and pneumonitis diagnosed in ER. Treatment included iv fluids, iv antibiotics (Rocephin), magnesia, potassium, anti-nausea mediation, breathing treatments, Lovenox injections, blood draws for labs multiple times per day.
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| 49 | 2021-01-24 | feeling hot |
I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face ...
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I had the first dose on Friday afternoon and on Monday morning when I woke up it feels like my face has been sunburned. It is red and slightly puffy. No new skin products or foods. No difficulty breathing or other symptoms. I am also a nurse practitioner.
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| 49 | 2021-01-24 | numbness |
Facial numbness that started at the hard palate then across cheekbones then upper lip. Numbness pers...
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Facial numbness that started at the hard palate then across cheekbones then upper lip. Numbness persisting but is better when taking vitamins. Seems worse in afternoon
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| 49 | 2021-01-24 | tenderness | Swollen lymph node/gland w/ tenderness in the left arm Pitt |
| 49 | 2021-01-25 | inability to speak |
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat...
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? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
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| 49 | 2021-01-25 | weakness |
ON 1/21/21 DEVELOPED NAUSEA, BODY ACHES AND WEAKNESS. SHE CALLED HER DOCTOR, WHO TOLD HER TO WAIT OU...
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ON 1/21/21 DEVELOPED NAUSEA, BODY ACHES AND WEAKNESS. SHE CALLED HER DOCTOR, WHO TOLD HER TO WAIT OUT THE SYMPTOMS OR GO TO THE ER IF THEY GOT WORSE. SHE DID NOT GO TO THE ER.
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| 49 | 2021-01-25 | weakness |
11:00 am feeling pain and could did not have any upper body strenght, severe body aches, nausea, chi...
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11:00 am feeling pain and could did not have any upper body strenght, severe body aches, nausea, chills, second day felt feverish and third day 100.2 fever low grade fever, head arce .
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| 49 | 2021-01-25 | burning sensation | Tightness in right jaw and neck; Burning sensation all over |
| 49 | 2021-01-25 | feeling hot | I have a sudden "hot feeling" in arms and legs that started 2 days ago. |
| 49 | 2021-01-25 | numbness | Facial numbness that started at the upper palate then progressed across the middle of the face |
| 49 | 2021-01-25 | migraine |
migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a con...
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migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142 and expiry date unknown) via unspecified route of administration at the left arm on 08Jan2021 13:45 at single dose for Covid-19 immunization in a hospital. Medical history included vestibular migraines, allergies to ragweed, and allergies to PCN (penicillin). The patient was not pregnant. The patient has no covid prior vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), propranolol hydrochloride (INDERAL), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC), riboflavin (VIT B2), and colecalciferol (D3) and multivitamins; all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On day 1 (08Jan2021), the patient experienced sore arm injection site. On day 2 (09Jan2021), the patient experienced diarrhea once. On day 3 (10Jan2021), the patient experienced migraine, vertigo attack. On day 4 (11Jan2021) and 5 (12Jan2021), the patient was still little dizzy. The patient did not receive treatment due to the events. The outcome of the events sore arm injection site, diarrhea, migraine and vertigo was recovering, while dizzy was not recovered.
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| 49 | 2021-01-25 | tenderness |
First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.;...
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First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.; swollen lump nose; swollen lump nose; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular in right arm on 07Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included valley fever treatment for 4 months. No known allergies. Concomitant medication included fluconazole. On 07Jan2021 18:00, the patient experienced first day-headache, second day feeling unwell, and third day tenderness/ swollen lump nose, lymphadenopathy, right underarm. Patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Treatment received for the events included TYLENOL tabs. The outcome of the events was not recovered.
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| 49 | 2021-01-26 | weakness, night sweats |
I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I w...
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I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I woke up sweating profusely and had major chills. My body ached all over and had a hard time sleeping due to all of this the entire evening. I woke up and tried to get ready but quickly realized I was weak, my joints hurt, body ached, headache and couldn't do it. This continued throughout the morning and part of the afternoon. Then around 2pm, I was still tired and achy but my joints didn't hurt as bad and I was able to manage the headache with ibuprofen. The body aches continued through most of the next day (Jan. 23) as well. By Jan. 24th I was perfectly fine and back to normal. I had covid early in the year on Nov. 6 which kept me out of work for almost 3 weeks. These few days were very similar to how I felt when I had covid but not as intense.
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| 49 | 2021-01-26 | pain in extremity, weakness, numbness |
Severe shoulder and arm pain, weakness, numbness finger tips. Diagnosed with Parsonage Turner Syndro...
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Severe shoulder and arm pain, weakness, numbness finger tips. Diagnosed with Parsonage Turner Syndrome
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| 49 | 2021-01-27 | weakness, numbness, pain in extremity, tingling |
Received 2nd dose vaccine on 1/22/21; woke up on 1/23/21 with mild headache by later in afternoon wi...
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Received 2nd dose vaccine on 1/22/21; woke up on 1/23/21 with mild headache by later in afternoon with generalized body aches. By early evening left arm tightness radiates to shoulder/shoulder blade/left chest and arm tingling sensation (as if pulled muscle) requiring icing area and Motrin; felt tired and lethargic; woke up Sunday with headache, ate breakfast and went back to bed till 2pm. Felt better as day progresses Sunday. Wednesday 1/27/21 left arm sore as if I received injection that morning. as day progresses soreness radiates to the shoulder and chest area, tingling resumes and by evening with numbness and nausea. Thursday 1/28/21 still with the tingling sensation and whole left upper arm and shoulder area tight with some weakness.
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| 49 | 2021-01-27 | discomfort, feeling cold, tremor |
Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable...
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Everyday-fatigue 25th Jan 2021-HA @1500, pain at injection site 26th Jan-0930-shaking uncontrollable-she states, COLD, body aches, HA, nauseated, sweating, muscular & joint pain 27th Jan-decreased symptoms some, intermittent SOB, chest pain, rt & left sides 28th Jan-SOB-continues, -she has a history of seasonal allergies, Told to go to the ER if her SOB & chest pain gets worse. Took Tylenol & Motrin for the body aches, HA, joint pain and discomforts Can't walk-gets fatigued-even short distances
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| 49 | 2021-01-27 | feeling hot, tremor |
Feels hot; Fevers/Her temperature is currently 102 degrees; Shakes; Vomiting; Diarrhea; This is a sp...
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Feels hot; Fevers/Her temperature is currently 102 degrees; Shakes; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer reported for self. This 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142) via unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunization. The patient worked front line in the emergency room (ER). The patient medical history included stage 4 metastatic melanoma from 2013. The patient concomitant medications included nivolumab (OPDIVO) for stage 4 metastatic melanoma. The patient previously received first dose of BNT162B2 (Lot: EJ1685) on 22Dec2020 at single dose for COVID-19 immunization and she didn't feel anything with that dose. The patient experienced shakes, fever, diarrhea, vomiting on 13Jan2021. The patient reported that she had been having shakes and fevers that started at 2:00 AM this morning 13Jan2021. Her temperature is currently 102 degrees on 13Jan2021. It was better but she let herself go 5-6 hours without taking anything. She had been alternating paracetamol (TYLENOL) and ibuprofen (MOTRIN). When it wore off she instantly felt hot and shaky. She also had started having diarrhea and vomiting. The outcome of the events was unknown.
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| 49 | 2021-01-27 | muscle spasms, hot flush, numbness, tingling |
I had headache that night, hot flashes, left arm, legs, and fingers had spasms and tingled, felt ver...
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I had headache that night, hot flashes, left arm, legs, and fingers had spasms and tingled, felt very tired. The next day my throat was a little sore and I felt tired. On the 20th I awoke to my face feeling like pins and needles, neck numb. I felt like my mouth was pulling down and I was drooling on my left side of face. The pins and needles stopped on the 27th after prednisone and Valacyclovir was prescribed on the 22nd. I still feel like I am drooling some but today the feeling is back in my jaw.
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| 49 | 2021-01-27 | pain in extremity |
Headache; body aches; fever; dizziness; sore arm; drowsiness; loss of balance; agitation; skin ach; ...
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Headache; body aches; fever; dizziness; sore arm; drowsiness; loss of balance; agitation; skin ach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 15Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID, and allergies (unspecified). The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included unspecified medication. The patient experienced headache, body aches, fever, dizziness, sore arm, drowsiness, loss of balance, agitation, and "skin ach" on 15Jan2021 21:00. Treatment was not provided in response to the events. The patient has not undergone COVID test post vaccination. The outcome of the events was recovered with sequel on an unspecified date in Jan2021.
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| 49 | 2021-01-27 | tingling |
c/o receiving her second vaccine today and notice there was now a rash on her chest and she states s...
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c/o receiving her second vaccine today and notice there was now a rash on her chest and she states she is starting to feel tingling in her throat and bilateral arms Transferred to ED. Treated with epinephrine, solumedrol, benadryl and pepcid with resolution of symptoms
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| 49 | 2021-01-28 | weakness, feeling cold |
Unusually cold, very lethargic, achy(mostly in legs), generalized weakness within 12 hours of vaccin...
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Unusually cold, very lethargic, achy(mostly in legs), generalized weakness within 12 hours of vaccination. The majority of these symptoms resolved by 11:00 PM EST on 1/28/21. Around this time head became stuffy with a headache. Headache and stuffy head are continuing to the present moment on 1/29/21. Some lethargy also noted.
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| 49 | 2021-01-28 | cold sweat |
BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse ...
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BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKS730), via an unspecified route of administration on the right arm on 20Dec2020 11:15 at a single dose for Covid-19 immunization. Medical history included allergic rhinitis and atopic dermatitis both from an unspecified date. Patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), doxycycline, prednisone, and diphenhydramine hydrochloride (BENADRYL); all were taken from an unspecified date for an unspecified indication. The patient received the second dose of other vaccine (unspecified, Pfizer product, lot number: EK9231), via an unspecified route of administration on the right arm on 14Jan2021. On 20Dec2020 11:45, the patient had headache, cold sweats, shivering, and BP (blood pressure) 218/116. The patient called Rapid Response Nurse, and she was wheeled to the hospital E.R. The patient was seen by a doctor and opted to just monitor her BP, no medication or IV line started. The patient was discharged with SBP of 159. The outcome of the event BP (blood pressure) 218/116 was recovering while the rest of the events was unknown.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 11:15. On 20Dec2020 11:45, the patient had blood pressure high, 218/116 mmHg. Based on information available, the reported high blood pressure was probably causally related to the first dose of BNT162B2, considering the plausible temporal relationship, and clinical course. However, the concomitant medications, especially prednisone, for unspecified indications, could be confounding factors. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-28 | pain in extremity |
Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my enti...
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Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.
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| 49 | 2021-01-28 | pain in extremity |
At night on the day of the vaccine I started with a headache, a dull headache, nothing sharp, really...
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At night on the day of the vaccine I started with a headache, a dull headache, nothing sharp, really tired and my body was achy. My left arm was sore. The next day roughly the same symptoms throughout the day, really tired and just kinda achy. On a Holiday after I had the vaccine, when I took the ibuprofen, my husband realized he lost his sense f taste and smell and he realized he was the same way the day before. He got tested Saturday the day after the Holiday and since I was still achy on Saturday I called employee health and they told me to get tested. I was tested through Employee Health ( employee only testing site). I still get tired really quick, I get winded really quickly even after doing chores at the house, like laundry and even if I am sitting still, I still sometimes am short of breath. The dull headaches are still present. I had lost my sense of taste and smell but those came back.
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| 49 | 2021-01-30 | flushing |
My bp went up to 182/101 a couple hours after vaccine., had a bad headache, tired and flushed feelin...
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My bp went up to 182/101 a couple hours after vaccine., had a bad headache, tired and flushed feeling. Had to take BP meds again n lay down, seemed to go down after an hour of taking BP meds to 140/89
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| 49 | 2021-01-31 | feeling hot, pain in extremity |
woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; head...
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woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; headache 6/10 /My head hurt so bad 10/10; thought I would throw up; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; muscle and bone aches; muscle and bone aches; I was just crying; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3302, intramuscular in the left arm on 18Jan2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included hyperthyroidism from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Levothyroxine, Liothyronine, CoQ10, McIntyre Vit D, and Probiotics all from unspecified dates for unspecified indication. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscular in the left arm on 28Dec2020 at 09:00 as a single dose for COVID-19 vaccination. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021 at 12:30, the patient experienced writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch. This morning just muscle and bone aches and headache 6/10. The patient did not receive treatment for the events. The clinical outcome of the events writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 49 | 2021-01-31 | migraine |
I had severe headaches for the first 5 days that Tylenol would not help. One day, I had what I woul...
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I had severe headaches for the first 5 days that Tylenol would not help. One day, I had what I would consider a migraine (light and sound were painful). I also had bubbly feelings in my stomach that came in waves. The headaches have gotten better in the last 2-3 days.
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| 49 | 2021-01-31 | pain in extremity | Lymph Node swelling under right arm pit and arm. Pain the radiated from there down to fingertips. |
| 49 | 2021-01-31 | pain in extremity |
Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees ...
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Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees Fahrenheit; arm pain; sweating; she was really tired; This is a spontaneous report from a contactable nurse. This 49-year-old female nurse reported for herself that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982) at single dose for Vaccination on 14Jan2021. The vaccine was injected to left deltoid/shoulder about 2:15 pm. Relevant medical history included ongoing uterine fibroids since Dec2019, ongoing obesity since Oct2000 and COVID-19 from Dec2020 to Dec2020. Relevant concomitant drug was unknown. The patient had surgical procedures when she had her first child. No Family Medical History Relevant to AE(s). Her mother got the shot a couple of days before caller did and she had no problems. The patient was administered her first dose of Pfizer BioNTech COVID-19 Vaccine on 14Jan2021. She reported that she became sick (Medically significant) about 12 hours later on 15Jan2021. The patient Went to sleep and woke up about 12 hours after she got the Pfizer-BioNTech COVID-19 Vaccine with a body temperature of 102 degrees Fahrenheit and arm pain. She could not really go back to sleep. When she got up it went away. She tried to go to work that day, and did go to work but she was really tired. When she finally got home she got in the bed and really had not been out of bed since then except for today she was sitting in a chair; so she thought maybe she had improved a little bit at on the reporting day. She had maintained a constant fever since 15Jan2021 that had gotten as high as 103 degrees Fahrenheit. At the reporting time her temp was 100.5. She had alternated Tylenol and Motrin for the fever. She was sweating profusely so it may be the temperature trying to break, but she had been struggling since she had it. This was so unlike her, she did not just stay in bed. She could not kick it. She had been unable to work since 15Jan2021 and she had to work tomorrow. She believed this was medically significant because she cannot work. The patient did not have vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Additional Vaccines was administered on Same Date of the Pfizer Suspect. Relevant Tests was None. The patient did not visit the emergency Room nor Physician Office due to the events. The outcome of event being sick was resolving. The outcome of event temperature had gotten as high as 103 degrees Fahrenheit was not resolved. The outcome of other events was unknown. The patient thought the causality was yes 100% because her COVID-19 symptoms were not even this bad; she never had a fever with COVID-19; and she had never before had a fever this high for this long.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the event; causality therefore cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-01-31 | pain in extremity |
My arm got sore; Body ache; Low grade fever; I kind of lost my appetite; Extreme fatigue; This is a ...
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My arm got sore; Body ache; Low grade fever; I kind of lost my appetite; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283, Expiration Date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Patient had second Pfizer vaccine last Wednesday morning (13Jan2021) and went to work that day and was fine. Her arm got sore but that was fine and that night around like 10:00 pm, patient got like body ache and low-grade fever and patient was kind of lost appetite and that went on for about a day and a half. But patient had continued extreme fatigue and patient was wondering if that was part of the (sentence incomplete), several days later, it was four days later. Patient just expected it, but it was a little way more. Patient received paracetamol (TYLENOL) as treatment. Outcome of extreme fatigue was unknown. Outcome of other events was resolved after about a day and a half.
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| 49 | 2021-01-31 | pain in extremity |
Severe arm pain; unable to move arm without excruciating pain; This is a spontaneous report from a c...
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Severe arm pain; unable to move arm without excruciating pain; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231, expiry date not reported), via an unspecified route of administration on the left arm on 15Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included was not reported. Concomitant medication included ibuprofen, vitamin D NOS, magnesium and fish oil. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on the right arm on 25Dec2020 for COVID-19 immunization. The patient experienced severe arm pain; unable to move arm without excruciating pain on 15Jan2021 15:00. The outcome of the event was unknown.
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| 49 | 2021-01-31 | tremor |
I started out feeling light headed with a little bit of a headache. As the day went on my legs and m...
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I started out feeling light headed with a little bit of a headache. As the day went on my legs and my back started to ache. My legs were so bad that you could not touch the back of them. I had a low grade fever. I also had the shakes and a runny nose. This lasted 24 hours. The fever and headache lasted 36 hours. After that all I was left with was a runny nose. My job all made me get a COVID test and that came out Negative.
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| 49 | 2021-02-01 | migraine |
COULD NOT LIFT LEGS TO GET INTO BED, OR HARDLY WALK IT WAS SO PAINFUL AND LOW BACK PAIN, MIGRAINE, F...
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COULD NOT LIFT LEGS TO GET INTO BED, OR HARDLY WALK IT WAS SO PAINFUL AND LOW BACK PAIN, MIGRAINE, FUZZY HEAD, DIZZY, LACK OF APPETITE, FATIGUED (SLEPT ALL DAY STARTING AT 3 PM DAY OF VACCINE TO ALL WAY NEXT DAY AND NIGHT), VERY ACHEY, COULD NOT LIFT MY RIGHT ARM, BRUISE WHERE INJECTION WAS GIVEN ALONG WITH A KNOT. TODAY IS 2.2.21 AND STILL FEEL FUZZY HEAD AND ACHEY.
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| 49 | 2021-02-01 | tingling |
Vaccination day was Sunday. Sunday evening developed chills and malaise which lasted thru Monday mid...
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Vaccination day was Sunday. Sunday evening developed chills and malaise which lasted thru Monday mid-day. Monday night noticed canker sore on the gums in the mouth which gradually resolved over the course of the next few days. On Thursday I noticed a small rash on the left side of my upper back. Within next 48-72 hrs multiple blistery patchy rashes developed on the left lower back, hip and groin. The rash is painful and tingly. Dr. visit on Tuesday (2/2/21) diagnosed/confirmed shingles. Valacyclovir was prescribed by MD.
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| 49 | 2021-02-02 | feeling hot, muscle twitching |
When the vaccine was administered, I felt a warm sensation move up my neck and then approx 3 hours l...
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When the vaccine was administered, I felt a warm sensation move up my neck and then approx 3 hours later I started having left sided facial muscle twitching. Then I started having muscle twitching all over my body. To this day (3 weeks after vaccine) I am still having muscle twitching. It has improved some.
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| 49 | 2021-02-03 | weakness, tenderness, night sweats |
Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painf...
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Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painful lymph nodes-to neck and groin and around sides; low grade fever; abdominal pain one day; all days lymph nodes pain /neck lymph node aches/ severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness, especially around the side rib cage and waist area; tenderness especially around the side rib cage and waist area/ severe tender and painful lymph nodes-to neck and groin and around sides; feeling really bad like i want to cry; slight headache; night sweats; rapid heart rate; increased blood pressure; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness to flank area; difficult to turn in bed and lie on right side; Itchiness but no visible rash; first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration at the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included taking medication for focus (adult adhd?); perimenopausal. She also has known allergies: sulfa; shrimp, strawberry/raspberry flavored foods or candies. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for focus, perimenopausal. The patient previously received the first dose of bnt162b2 intramuscularly at the right arm on 28Dec2020 at 2:30 PM at the age of 49 years for COVID-19 immunization (Lot number: EL3249). On 15Jan2021, the patient experienced weakness, fatigue, small breathes like slightly short of breath/ short of breath, body aches, low grade fever, abdominal pain one day, all days lymph nodes pain and tenderness especially around the side rib cage and waist area, more on right side then left, neck lymph node aches, feeling really bad like the patient wanted to cry, slight headache, night sweats. Lymph node pain and tenderness is the worse along with body aches and weakness. Also, on 15Jan2021, patient experienced rapid heart rate, increased blood pressure, severe tender and painful lymph nodes-to neck and groin and around sides, under ribs and tenderness to flank area. Mainly right below right ribs and right waist, right flank painful and difficult to turn in bed and lie on right side. There were also Itchiness but no visible rash. According to the reporter the events started on 15Jan2021 at 1AM. The patient received the first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021. The patient had nasal swab, rapid on18Jan2021 result was negative and nasal swab on 20Jan2021 result was negative. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering except for abdominal pain one day which recovered on 16Jan2021.
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| 49 | 2021-02-03 | facial paralysis |
was supposed to get the second dose yesterday 19Jan2021 but location is closed/ could get it up to ...
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was supposed to get the second dose yesterday 19Jan2021 but location is closed/ could get it up to the 26Jan2021; paralysis of the chin and half of the face; and around the mouth; This is a spontaneous report from a contactable consumer report for self. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 29Dec2021 20:00 PM for COVID-19 immunization. Medical history included ongoing severe migraines. None family history. There were no concomitant medications. No Prior Vaccinations within 4 weeks. After an hour she had paralysis of the chin and half of the face; and around the mouth. It only lasted a few minutes, like 10 minutes and then it went away, she was fully recovered. She did not got to a doctor or the ER. Adds she was supposed to get the second dose yesterday 19Jan2021 but she has to go to another location as that location is closed. They told her she could get it up to the 26Jan2021 and then it would be more problematic to get. The event outcome was recovered on 29Dec2020. Information on the lot/batch number has been requested.
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| 49 | 2021-02-03 | feeling cold |
Feeling like I have a bad cold. Exhausted, headache, lethargic, stomach ache, no fever. Started the ...
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Feeling like I have a bad cold. Exhausted, headache, lethargic, stomach ache, no fever. Started the morning after I received the first vaccine
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| 49 | 2021-02-03 | numbness, burning sensation |
numbness for an hour; burning sensation; joint pain; This is a spontaneous report from a non-contact...
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numbness for an hour; burning sensation; joint pain; This is a spontaneous report from a non-contactable consumer reporting on behalf of the patient. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness for an hour, and subsequently burning sensation and joint pain which subsided with Tylenol use. The patient was recovering from the events burning sensation and joint pain, while unknown outcome for the remaining event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 49 | 2021-02-03 | pain in extremity |
Difficulty swallowing, swollen uvula, rash in ~15-20 minutes Benadryl (self administered), Epinephri...
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Difficulty swallowing, swollen uvula, rash in ~15-20 minutes Benadryl (self administered), Epinephrine & steroids (ED) 4 hours post epinephrine observation Headache, arm pain and lethargy the following day
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| 49 | 2021-02-03 | pain in extremity |
Received Pfizer vaccine on 2/2/2021, noticed that left hand was achy and swollen on 2/3/2021 and on ...
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Received Pfizer vaccine on 2/2/2021, noticed that left hand was achy and swollen on 2/3/2021 and on 2/4/2021, she noticed that her right hand was swollen.
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| 49 | 2021-02-03 | pain in extremity |
Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like ...
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Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; This is a spontaneous report from a contactable healthcare professional (patient herself). A 49-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 at 0.3 ml, single for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced arm pain on 08Jan2021, fatigue on 09Jan2021, nausea on 10Jan2021, left lower quadrant pain on 11Jan2021. The patient said that she felt like she caught "a bug" or "flu-like symptoms" after her first dose of the COVID vaccine. She would like to know if she should get the 2nd dose of the COVID vaccine after experiencing flu-like symptoms after her first dose. Therapeutic measures were taken as a result of nausea and left lower quadrant pain that included ciprofloxacin and metronidazole. Clinical outcome of arm pain was not recovered; for fatigue and nausea was recovering; for left lower quadrant pain was recovered on an unspecified date; while for the other events was unknown.
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| 49 | 2021-02-03 | tingling |
feel prickly; both arms broke out in raised hives and rash; both arms broke out in raised hives and ...
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feel prickly; both arms broke out in raised hives and rash; both arms broke out in raised hives and rash; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 14Jan2021 at 13:00 at a single dose for COVID-19 Immunization. Medical history included severe asthma, depression, anxiety, sinus problems, and known allergies with Penicillin and intravenous (IV) iodine. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and aripiprazole (ABILIFY). The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. About 15 minutes after the shot, on 14Jan2021 at 1330 hours, the patient started to feel prickly and both arms broke out in raised hives and rash. Treatment for the events included intramuscular (IM) 50mg Benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab: negative on 14Nov2020. The events resolved in Jan2021. Information on the lot/batch number has been requested.
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| 49 | 2021-02-03 | seizure | Systemic: Anaphylaxis-Severe, Systemic: Fainting-Severe, Systemic: Seizure-Severe |
| 49 | 2021-02-04 | breast pain |
about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Wok...
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about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Woke up feeling better. Appx 3 days later ( 1/15/2021) from shot, soreness in both breasts. This symptom lasted for about a total of 1 week from date of noticing. 1/22/2021.
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| 49 | 2021-02-04 | breast pain |
A little over an hour after shot: Numbness on back of tongue, lasted about 1 hour after shot 3.5 hou...
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A little over an hour after shot: Numbness on back of tongue, lasted about 1 hour after shot 3.5 hours after shot: Swelling and small lump formed on left wrist, last appx 16 hours 2 days after shot: Small lump and soreness along the left collar bone area, lump, soreness still ongoing (as of 2/5/2021, date of this report) 2 days after shot: Soreness in both breast, still ongoing (as of 2/5/2021, date of this report)
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| 49 | 2021-02-04 | feeling cold |
discomfort in her chest vs the burning/ chest discomfort; discomfort in her chest vs the burning/whi...
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discomfort in her chest vs the burning/ chest discomfort; discomfort in her chest vs the burning/while the chest discomfort had subsided the burning was back; burning in her lungs; coldness/ all over body coldness; fatigue; chills; This is a spontaneous report from a contactable consumer (patient herself, a medical assistant) via Medical Information team. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration on the right deltoid on 13Jan2021 at 12:30 at a single dose for COVID-19 immunization. The vaccination facility was the clinic. Vaccine was not administered at a military facility. Relevant medical history included sleeping (problem). Concomitant medications included ongoing trazodone as a sleeping pill and an unspecified multivitamin. The patient had no previous immunizations with a Pfizer vaccine as this was the first dose. She had no prior vaccinations within 4 weeks. The patient was having concerns about the side effects was experiencing after her first dose. The patient received the first dose on 13Jan2021 and afterwards she felt fatigue on 13Jan2021; coldness on 14Jan2021 at 07:30; and chills on an unspecified date in Jan2021. On Tuesday, on 19Jan2021, she started having "burning in her lungs" then the day prior reporting, on 20Jan2021 was a vigorous day at work and she had discomfort in her chest versus (vs) the burning." She stated that at the time of the report (21Jan2021), she was working at home and while the chest discomfort had subsided, the burning was back. The patient was asking if this was normal or expected and she didn't call her doctor; she was asking what should she do. The patient further reported that she did have some common side effects and the some of them were the normal ones such as: fatigue, chills, and feeling cold for a few days. The patient further reported that all over body coldness occurred at 7:30 AM on 14Jan2021; she noticed it shortly after she woke up. She actually noticed it after drinking coffee and then it was like the coldness kicked in. It would get worse as she drank things. It did not matter if it was hot or cold things. It was like the hot things intensified the cold feeling. At the time of the report she was having more concerning symptoms. On Tuesday (19Jan2021), she started to have burning in her lungs and the day prior reporting (20Jan2021) at work, she had chest discomfort. It was a little busy day at work running around on the floor. The chest discomfort was nothing significant, but it was a discomfort, especially on the left side. She confirmed she did not have that discomfort at the time of the report. However, she was having the burning again. She was having concerns and wanted to speak to someone about this. She went on to explain she noticed the fatigue during the night on the day she got the vaccine. It resolved around 16Jan2021. She added she had all over body coldness. She confirmed this was the same as the chills and feeling cold. This feeling comes and goes. She added, it was also winter so it was really hard to tell what it was from. The first two days, she had this chills, cold feeling for two days straight. However, at the time of the report it was better. The chest discomfort started the day prior reporting; however, she was doing a lot of activity and she did not have it today. At the time of the report, she was sitting all day working from home. However, the burning was back. The adverse events did not require any visit to an emergency room or a physician office. She stated she thought about calling the doctor's office, but she had not called them yet. She knew they probably won't be able to help or tell her anything. The patient had no investigation assessment and no relevant test. The patient recovered from the event "fatigue" on 16Jan2021; she was recovering from the events "coldness/ all over body coldness and chills," she was not recovered from the event "burning in her lungs," while the outcome of the events "discomfort in her chest vs the burning/ chest discomfort /while the chest discomfort had subsided the burning was back" was unknown.
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| 49 | 2021-02-04 | flushing |
Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after CO...
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Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after COVID vaccine she experienced SOB, throat and tongue itching, flushing, very anxious, her BP 144/102, HR 120s, RR 20. She had Epi-pen and we injected it for her per her request. She transferred herself to a wheel chair and went to ER with Crisis Nurse. Symptoms resolved. Patient discharged from ED.
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| 49 | 2021-02-05 | weakness |
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt prese...
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pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
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| 49 | 2021-02-05 | numbness |
Developed numbness of the right side of face about 20 minutes after receiving her vaccine. She went ...
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Developed numbness of the right side of face about 20 minutes after receiving her vaccine. She went to the ED to e evaluated. Symptoms resolved on their own after 2.5 hours and no other symptoms developed.
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| 49 | 2021-02-05 | tremor, feeling hot, flushing |
Five minutes after receipt of vaccine, patient c/o dizziness, hot, flush, shaking, nausea. Gave Be...
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Five minutes after receipt of vaccine, patient c/o dizziness, hot, flush, shaking, nausea. Gave Benadryl 25 mg PO @ 1214. 1215 Shaking and other s/s resolved. 1220 All symptoms resolved and decline ambulance nor visit to the hospital. 1237 All s/s resolved and left site.
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| 49 | 2021-02-06 | pain in extremity |
Pt. reports intense right shoulder pain within 4 hours of receiving the vaccine and inability to mov...
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Pt. reports intense right shoulder pain within 4 hours of receiving the vaccine and inability to move her right shoulder properly. The pain extends into the neck bilaterally, right trapezius, and into the right hands. Pt. reports she feels like she can't grasp things properly with her right hand.
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| 49 | 2021-02-07 | facial paralysis |
Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old fema...
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Bells Palsy; This is a spontaneous report from a contactable Other HCP(patient). A 49-years-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular on 05Jan2021 19:00 at the 49 years old at Arm Right at single dose for COVID-19 immunization. The medical history was not reported. The concomitant medications were none. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient experienced Bells Palsy on 20Jan2021 15:00. The event caused Physician Office Visit. The patient received Steroids and viral antibiotic as treatment for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. There were none known allergies. The outcome of the event was not recovered. The information on the batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event Bell's palsy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-08 | pain in extremity |
1st dose vaccine 1/7/21; 2nd dose vaccine 1/28/21; developed low back pain radiating to left leg wor...
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1st dose vaccine 1/7/21; 2nd dose vaccine 1/28/21; developed low back pain radiating to left leg worse with movements no injuries onset 2/8/21; was seen in same day 2/8/21.
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| 49 | 2021-02-08 | pain in extremity | Sore arm and slight headache. |
| 49 | 2021-02-09 | burning sensation |
Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The ras...
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Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The rash it blistery kind of looking, little bit blister and they would open and bleed and then close back up. It was also burning. It start continually spread more. I went yesterday 02/09/2021to a Dermatologist he treated me for a contact kind of dermatitis as if he was unsure if it was linked to vaccine or not. He gave me two steroid injections in the office and prescribed a cream Elidel 1% . The medications seem to be clearing up my face today.
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| 49 | 2021-02-09 | hot flush, feeling cold, flushing |
Very Flush; hot/cold flashes; hot/cold flashes; mild headache; sore at injection site; This is a spo...
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Very Flush; hot/cold flashes; hot/cold flashes; mild headache; sore at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, lot number=EL9261), via an unspecified route of administration on 23Jan2021 14:45 at single dose at left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included allergies to sulfa, mold, asthma, multiple sclerosis, anemia. Concomitant medication included dimethyl fumarate, chorionic gonadotrophin (PROVIGIL), clonazepam, modafinil and Fl. The patient previously took Wellbutrin and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced very flush, hot/cold flashes, mild headache, sore at injection site on 23Jan2021 17:00. The outcome of the events was recovered in Jan2021. No treatment received for the adverse events.
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| 49 | 2021-02-09 | pain in extremity, tingling, muscle spasms | Headache, fatigue, tingling in hands, pain and spasms in hands, pain in left leg. |
| 49 | 2021-02-09 | tingling |
severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; severe nausea and vomiting...
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severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; Chills; body aches; tired and slept all day; Tingling at fingertips; This is a spontaneous report from a contactable consumer(patient). The 49-year-old female patient(not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3247), via an unspecified route of administration at left arm on 11Jan2021 16:30 at single dose for covid-19 immunisation. Medical history included hashimotos disease, allergy to penicillin and sulfa, tree nut intolerance. There was no COVID-19 Prior to vaccination. Concomitant medication included levothyroxine sodium (UNITHROID), ethinylestradiol/levonorgestrel (ENPRESSE). There was no other vaccination within 4 weeks prior to the COVID vaccine. On 22Jan2021, 04:00, The patient woke up with severe nausea and vomiting/diarrhea, lasted for the morning, she also experienced chills and body aches. By noon she was fine but tired and slept all day. She also experienced tingling at fingertips. That was all done by night. There was no treatment. Outcome of events was recovered in 22Jan2021. Events were assessed as non-serious. Since the vaccination, the patient had not been tested for COVID-19.
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| 49 | 2021-02-10 | weakness, tremor |
I woke up about 4am on the 8th I had fever and chills and shaky, temp was 100.5 nauseous, weak, diz...
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I woke up about 4am on the 8th I had fever and chills and shaky, temp was 100.5 nauseous, weak, dizzy, I called into work, I assumed the shot was working. I called my physician to let her know I was having a reaction, I diarrhea for 3 days . I just took some tylenol and after the 3 days I started feeling better
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| 49 | 2021-02-10 | feeling cold, numbness |
Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation...
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Shortly after I felt very dizzy, light headed and felt numb all over. I developed heart palpatation. I was laid down and was very nauseous, cold, had a headache and got cotton mouthed. I had an elevated HR and BP as well. I laid there for about 30 minutes and finally the all symptoms except the headache subsided and it finally went away after day 3.
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| 49 | 2021-02-10 | feeling hot |
Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels ...
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Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels yucky all of sudden. My tongue and throat feel fat and weird. Exactly like when she eats shrimp
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| 49 | 2021-02-10 | night sweats, weakness |
That evening after my 2nd injection of the vaccine I became extremely weak and achy. I went to bed ...
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That evening after my 2nd injection of the vaccine I became extremely weak and achy. I went to bed and had chills, fever, and night sweats. I woke up with a bad headache that lasted 24 hours and the weak, achy feeling was still present for a couple more days. Those feelings eventually went away but I still felt very tired and drained for the next several days.
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| 49 | 2021-02-10 | tremor, feeling cold, pain in extremity |
Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to t...
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Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to temp 101.8, shaking chills, EXTREME arm pain, upper back pain, chest pain, wheezing, SEVERE headache, nausea, vomiting, diarrhea, EXTREMELY swollen axillary lymph nodes enlargement. Symptoms started approx 2 hours after injection and proceeded for 6 days then started to slowly improved then resolve.
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| 49 | 2021-02-10 | tremor | Shaking chills Low grade fever Fatigue |
| 49 | 2021-02-14 | muscle twitching |
At around noon 2/11/21 i began getting a headache and took prescription strength Tylenol, by 730pm I...
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At around noon 2/11/21 i began getting a headache and took prescription strength Tylenol, by 730pm I started having chills and couldn?t get warm, eventually just going to bed. Through out the night I was sweating and experienced awful body aches and twitching. I woke up on 2/12/21 at 6:00am with a 100.4 temperature and slept until about noon at which time I had 101 temperature and then continued to sleep until 5p, still having a fever of about 100. I then slept until around 830am 2/13/21, still experiencing twitching, body aches and sweating. When I woke on 2/13/21 I had no fever, but still achy and in a ?fog?.
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| 49 | 2021-02-15 | tingling, migraine, feeling of body temperature change |
Woke up to a severe migraine, felt like vomiting but couldn?t (dry heaves), chills...no fever althou...
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Woke up to a severe migraine, felt like vomiting but couldn?t (dry heaves), chills...no fever although felt hot/cold, upset stomach (diarrhea), and tingly face
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| 49 | 2021-02-16 | numbness |
About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very ver...
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About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very very dizzy. I got up and showered and my feet swelled very bad. I did not feel well but I went to work but the feelings never got better. So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well. The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days. The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date. On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work. On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.
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| 49 | 2021-02-16 | migraine |
Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. Th...
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Soon after shot my lips tingled and I got really tired so I knew I was having a slight reaction. That was it until later that night I started getting a really bad headache/migraine. I started taking Tylenol but that didn't help much. I got chills and I'm sure a slight fever because I was sweating. I started throwing up also.. After taking Tylenol every 4 hours my headache finally went away and I started to feel better. This was around 2:30 pm the following day. I would say my symptoms lasted for about 22 to 24 hours.
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| 49 | 2021-02-16 | muscle spasms |
I had muscle spasms and trouble walking before I got the vaccine. I gave it some time. The morning b...
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I had muscle spasms and trouble walking before I got the vaccine. I gave it some time. The morning before I had a light headache. After the vaccine my headache, and muscle spasms got worse. It lasted for days. Yesterday the headache was a little less. As of this morning my neck was hurting. Thursday and Friday the headache did not go away at out. Saturday it was coming and going. I was trying to put ice on it and run the water from the shower on it. Thursday , Friday and Saturday I was vomiting. Friday I went to Urgent Care, the doctor said a lot of patients were complaining about headaches. She gave it a few days. On the 15th of this week I seen my primary doctor, she said the same thing.
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| 49 | 2021-02-16 | pain in extremity | Severe arm pain lasting almost two weeks |
| 49 | 2021-02-16 | tremor |
Muscle aches & pain to the bone; chills so bad I couldn't stop shaking for three hours no matter how...
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Muscle aches & pain to the bone; chills so bad I couldn't stop shaking for three hours no matter how many covers; full-head headache to the point I could barely open my eyes; lasted approximately 12-15 hours overall
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| 49 | 2021-02-18 | bell's palsy, tenderness, facial paralysis |
Patient reported to the ER on Feb. 16th with onset of right-sided facial droop today about 1400. P...
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Patient reported to the ER on Feb. 16th with onset of right-sided facial droop today about 1400. Patient has no other weakness symptoms, bilateral extremity strength is equal. No forehead sparing on facial droop along with some tenderness and rhinorrhea. Symptoms are consistent with a Bell's palsy. Patient recently had Covid which fits with viral syndrome causing Bell palsy. Discharged with valacyclovir and prednisone burst. Follow-up and strict return precautions to the ED were discussed and patient verbalized understanding.
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| 49 | 2021-02-18 | numbness |
approximately 5 minutes after the injection my upper lip went numb along with my left side of my fac...
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approximately 5 minutes after the injection my upper lip went numb along with my left side of my face, primarily my upper cheek below my eye. Then it slowly moved to the top of my head and the top of my left hand. My heart was racing a bit, but that could be due to me being nervous about my face going numb. An attendant stayed with me until it started to subside, approximately 15 minutes later. Other side effects were mild the following day. A bit of a headache, fatigue and chills. Fatigue lasted a couple days but all minor.
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| 49 | 2021-02-18 | tingling |
tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of ...
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tingling and pins and needles on the left side of face, slight numbness on bottom lip and bottom of the mouth. Slight swallowing problem. High blood pressure, dizziness, shivering. Got some Benadryl ( chewing tablet) from the paramedic on site. Went to the ED got more Benadryl, steroids and pepsid IV. Tingling subsided after 2 hours and numbness in the mouth too. Next day had major vertigo and heart rate was high and heart palpitations . Had some PVC which is still there. headaches come and go
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| 49 | 2021-02-19 | weakness |
High fever (up to 103 degrees) for three days, extreme muscle pain, joint pain, fatigue, brain fog, ...
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High fever (up to 103 degrees) for three days, extreme muscle pain, joint pain, fatigue, brain fog, nausea, joint pain, weakness
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| 49 | 2021-02-21 | facial paralysis |
Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey....
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Facial drooping, watering of the right eye, twitching of the right eye. Diagnosed as Bell's Palsey. Rx for prednisone.
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| 49 | 2021-02-21 | pain in extremity, tingling |
RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/21/21 & 02/11/21. ON 02/21/21 REPORTED TO ER WI...
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RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINE ON 01/21/21 & 02/11/21. ON 02/21/21 REPORTED TO ER WITH COMPLAINT OF LEFT ARM PAIN (TINGLING, HEAVY SENSATION). DIAGNOSED WITH PARESTHESIA OF LEFT UPPER EXTREMITY, GOITER, AND DEGENERATIVE DISC DISEASE. DISCHARGED TO HOME SELF CARE.
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| 49 | 2021-02-22 | pain in extremity |
Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic S...
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Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic System
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| 49 | 2021-02-22 | tremor | Tremors in arm afterward |
| 49 | 2021-02-23 | migraine | Body aches, chills, migraine, 102 fever, nausea, vomiting. |
| 49 | 2021-02-24 | bell's palsy |
Numbness and tingling on R side of the face with drooping of eyelids and face currently on day7 diag...
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Numbness and tingling on R side of the face with drooping of eyelids and face currently on day7 diagnosed Bells Palsy
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| 49 | 2021-02-24 | muscle twitching |
12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red...
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12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red. Felt like burning from the inside, out. Lightheaded and dizzy. Got puffy. Was NOT anaphylactic. 2 Benadryl. I didn't feel good for a couple weeks. 14-20 days, same experience with redness/burning. I took pictures. That happened every day for 4-5 more days. I went to doctor after doctor; ER after ER. About 6-7 times I have been to the ER; SOB, dizzy all the time, panic attack/anxiety, Stomach is not emptying correctly (NOT diabetic), eye keeps twitching, hurting behind my eyes, all my muscles are shrunken now. Blood panel, stress test; gastroparesis; positive; ringing in my ears; SOB; *COVID; negative.
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| 49 | 2021-02-24 | pain in extremity | Pain and swelling in. arm Fever, low-grade Chills Achiness Fatigue Headache |
| 49 | 2021-02-24 | speech disorder |
Severe asthma attack, shortness of breath, unable to speak, wheezing. Patient given albuterol neb, e...
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Severe asthma attack, shortness of breath, unable to speak, wheezing. Patient given albuterol neb, epi pen, placed on cPAP and transported to hospital.
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| 49 | 2021-02-24 | tenderness | Lymphadenopathy, neck tenderness + stiffness, even painful in places. |
| 49 | 2021-02-24 | unresponsive to stimuli |
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypert...
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypertension-Medium
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| 49 | 2021-02-25 | flushing |
No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate...
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No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate, insomnia, body pain, joint pain, lower back pain, severe chills, upset stomach, nausea, headache. Within 36 hours, most of the side effects were gone, except headache. 3 days later - still have headache, and flush feeling all over body with mild sore throat (as of 2/26/21 @ 11:27 a.m.)
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| 49 | 2021-02-26 | flushing, feeling hot |
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: she mentioned that thi...
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Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: she mentioned that this is a common reaction after vaccinations. she felt hot, sweat, nausea symptoms. nurse practioner on duty monitored her while she waited in the wait area for abour 20mins. she was feeling fine before she left. Rph called her about an hour and half later and she was back to normal.
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| 49 | 2021-02-26 | flushing | Throat tingling, flushed, diaphoresis, increased blood pressure to 160's, |
| 49 | 2021-02-26 | flushing |
15 minutes after injection, I felt whole body flushing with tachycardia and palpitations that lasted...
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15 minutes after injection, I felt whole body flushing with tachycardia and palpitations that lasted for 5 minutes. The symptoms resolved and then 15 minutes later, the same symptoms occurred and lasted 10 minutes.
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| 49 | 2021-02-26 | numbness | Systemic: Numbness (specify: facial area, extremities)-Medium |
| 49 | 2021-02-26 | muscle spasms |
Mild fever, tiredness and loose bowel which cleared up after 12 hours. Vaccine also seemed to provok...
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Mild fever, tiredness and loose bowel which cleared up after 12 hours. Vaccine also seemed to provoke an MS-related response with pain in back, leg spasms and difficulty walking. Symptoms began to clear about 24 hours after onset (36 hours after vaccine injection). First vaccine was tolerated well with only mild and normal side effects (mild cough, soreness at injection site, etc.).
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| 49 | 2021-02-26 | pain in extremity |
Fever and body aches for one day the day after. Then 2/26 got large swollen area in underarm of arm...
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Fever and body aches for one day the day after. Then 2/26 got large swollen area in underarm of arm where got shot and it is extremely painful.
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| 49 | 2021-02-26 | tremor, seizure, feeling hot |
came to the vaccination appointment with no current illness or cough. Within less than 5 minutes af...
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came to the vaccination appointment with no current illness or cough. Within less than 5 minutes after the injection started with a cough that is similar to asthma attack onset. As talking with the nursing staff on site after waving them over I began to get worse very quickly. Within minutes I heard one of the staff say "she's crashing, move it". At that point I could not breathe, audible wheezing, shortness of breath, throat was closing, entire body felt like it was on fire, extreme itching on back (especially upper back), shaking/convulsing, incoherent. Paramedic staff was put into place and i was ambulanced to the hospital across the street from the vaccination site. Everything is a whirlwind at this point and treatment from what I can remember was albuterol svn, atrovent svn, use of cpap, epipen administration in the parking lot, benadryl via iv, solumedril, oxygen and pepcid. Once arrived at E.R. I was aggressively treated. Once stabalized began to wheen off the oxygen onto room air. I am a rare asthmatic and my oxygen sats usually do not drop, although I am in distress. At one point I heard oxygen sats were at 96, which is low for me. I was discharged from the hospital to my husband's care. In the next days now I am expriencing fever (100), itching, red rashy skin, severe headaches, joint pain, body ache, diarehha and extreme fatigue
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| 49 | 2021-02-27 | hot flush | Fever 100, chills, hot flashes, nausea, splitting headache, low ringing in ears, upset stomach |
| 49 | 2021-02-27 | pain in extremity | Headache, eyes sensitive to the light, nausea, soar arm. |
| 49 | 2021-02-27 | pain in extremity |
I received the first dose of my vaccine at 4:20 pm. My left arm was sore at the injection site prett...
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I received the first dose of my vaccine at 4:20 pm. My left arm was sore at the injection site pretty quickly as I would have expected. At about 9:30 pm, I noticed that both of my hands were painful and achy (I assumed the cause was flu-like symptoms from the vaccine). Upon examination of my hands, I noticed that my veins were significantly enlarged and bulging from partway down my forearms through my hands. When I raised my hands in the air, the veins became smaller and the pain subsided. I took 2 advil and went to bed with my hands slightly elevated. When I woke up in the morning, the veins were back to normal.
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| 49 | 2021-02-28 | feeling of body temperature change |
The side effects after the first of the two vaccinations (01/23/21) resulted in the side effects sta...
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The side effects after the first of the two vaccinations (01/23/21) resulted in the side effects starting same night and resolving by 01/25/21 of headache, fatigue and localized soreness at vaccine injection site. The side effects from tge 2nd vaccination administered on 02/13/21 resulted in the side effects beginning later the same night of moderate site soreness, severe fatigue, headache, feeling hot and cold, loss of appetite and pain in muscles. All of the side effects resolved by 02/18/21 except the fever and chills which has happened every night since the second vaccination and had not been experienced prior to tge vaccination.
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| 49 | 2021-02-28 | migraine, pain in extremity |
dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; t...
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dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; turn off the lights in the office/has to have the lights low, still sensitive; arm hurt worse with second dose; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EK9231, expiry date Apr2021), via an unspecified route of administration on 19Jan2021 at a single dose, administered left arm at 4:10-4:15pm, as a coworker came down with Covid (COVID-19 immunization). The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm hurt with first dose of bnt162b2 given intramuscularly in the left arm (Lot number EL1284) on 29Dec2020 for COVID-19 immunization. Patient had her second Covid vaccine last Tuesday, 19Jan2021. She had a really bad migraine Friday, 22Jan2021 and had to turn off the lights in the office. On Saturday, 23Jan2021, her head was sensitive, but on Sunday, 24Jan2021, later in the evening she had this dull achiness on the right side of temple area that went down behind the right eye down to the temple. The dull and achiness was just enough to where she couldn't function and been like that ever since. She was prone to headaches and migraines, this was just different and so she took Tylenol and Aleve (both with believed dose was 200mg, 2 tablets by mouth since Jan2021), and another medication for migraines, Ubrelvy (lot number: 1084537, expiry Jan2022, dosage text: 100mg, 1 by mouth at first sign of headache, started in Jan2021). She took the Tylenol and it maybe of help, but the migraines/headaches are almost constant all day long. She took the Tylenol early Friday and when the migraine got really bad that was when she took the Ubrevly. She took the Aleve only yesterday, but she still has to have the lights low, still sensitive. Patient knew that the headaches are a sign of Covid, but when she had her first dose her arm hurt. This second arm hurt worse, arm hurt worse with second dose (Jan2021), and she did fine the first few days and Friday was when all of a sudden she had the migraine and had to turn off the lights in the office. She sits at a computer. The events did not require emergency room or physician office visits. Therapeutic measures were taken as a result of really bad migraine, "turn off the lights in the office/has to have the lights low, still sensitive", and "dull achiness on the right side of temple area/headaches". The patient had not recovered from really bad migraine, head was sensitive, and "dull achiness on the right side of temple area/headaches". The outcome of the events "turn off the lights in the office/has to have the lights low, still sensitive" and arm hurt worse with second dose was unknown.
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| 49 | 2021-02-28 | night sweats |
Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120...
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Fever 103.0 F, Chills, Muscle Pain, Headache, Night Sweats, Dizziness/near-syncope, tachycardia (120's bpm), nausea, severe fatigue, severe soreness at injection site (but mild swelling, mild itching). Starting from 3:30 am on 02/21/21 until about 3 pm on 02/22/21. Milder headache and fatigue throughout rest of that week. Back to normal now.
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| 49 | 2021-02-28 | pain in extremity |
2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil...
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2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser; it feels warm at the injection site; arm was initially sore and that was all/a sharp pain in her arm/it was very sore/arm hurt; I didn't realize if a 'lesion' (not clear over the call) kind of formed overnight; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration in left arm on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. It was reported that patient had her 1st Pfizer vaccine dose on Monday, 25Jan2021, her arm was initially sore and that was all. Then sometime today (on 28Jan2021) she has developed 2 blisters around the injection site in her left arm. Blisters were approximately the size of pencil eraser. She was driving home from work and felt a sharp pain in her arm. She pulled her car over because it was "very sore". "she was glad that she was close to home when this happened. It was kind of freaked her out." Patient also stated that she got the vaccine on Monday and today (on 28Jan2021) she was driving home. She hadn't had any issues other than her arm hurt but it feels warm at the injection site and she just got in to her house, she wanted to stretch, she didn't realize if a 'lesion' (not clear over the call) kind of formed overnight in Jan2021, it hurts, her arm hurts." No lab work was done. No treatment was received for the events. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 49 | 2021-02-28 | pain in extremity |
arm pain/soreness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old fe...
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arm pain/soreness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EK9231), intramuscular at the left upper arm on 05Jan2021 10:20 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 05Jan2021, the patient experienced arm pain/soreness she took some Tylenol, not that she needed too much. She recovered from the arm pain/soreness within a day or two days. It was not a big deal. The patient weight was 157-158lbs on an unspecified date. The outcome of the event was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.
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| 49 | 2021-02-28 | tremor, weakness |
Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport t...
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Painful site Weakness and shaking Tingling sensation in mouth EMS called and recommended transport to the hospital - patient declined
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| 49 | 2021-03-03 | pain in extremity |
Patient was vaccinated by EMT. Provider was not present for time of vaccination. Immediately followi...
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Patient was vaccinated by EMT. Provider was not present for time of vaccination. Immediately following vaccination, patient complained of sharp, left sided arm pain. No other symptoms were reported by the patient. Patient reported that vaccinator had administered the dose too high on the arm and was concerned with long-term affects. Patient was examined by provider and found that injection site was highly-placed in on upper arm. Patient was able had intact FROM in both arms and shoulders. Patient was advised to follow up with PCP if nerve like pain persisted for more than 5 days and to follow up sooner with PCP if she developed difficulty moving her arm, shoulder or developed concerning symptoms.
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| 49 | 2021-03-04 | feeling hot |
Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observa...
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Patient arrived to obversation area stating she felt hot and ?not normal.? She was guided to observation by field ops and received by nurse. Nurses alerted immediately and made available to patient. Patient stated she went to the restroom because she ?felt hot and I needed to cool off? but returned to be observed. Vitals taken @ 1:56 pm BP 177/96, Pulse 104, O2 Sat 95%, Temp 99.4 F. Red Rash noted on bilateral arms and chest. Nurses made available to patient. At 2:16 pm vitals reassessed with patient positioned on the floor. BP 144/90, Pulse 78, Temp 97.1, Respirations 20. At 2:19 patient continued to state she felt ?hot?, nauseous, dry mouth and some tightness in the chest. Nurse offered additional help to the patient by calling EMS, but patient refused. Nurses continued to monitor patient. Vitals reassessed with patient upright on chair @ 2:30 156/82, 97.4 Temp, 95% O2 Sat, Pulse 85, Respirations 18. At 2:38 patient stated she is starting to feel less hot and it is easier to breath. Patient requested to use the restroom to refresh herself. Patient accompanied by Nurse. At 2:48 patient states she is feeling better and only feels slightly nauseous. No reports of chest tightness. Rash on arms cleared. Rash on chest significantly improved. Patient refused to stay for additional observation. Patient educated to consult with health care provider prior to receiving second dose. Earlier, patient stated she has had instances where she had to take Benadryl when taking NSAIDS, and also carries EPI Pen. Patient also educated to call 911 if ?chest tightness,? respiratory issues occur. Patient accompanied out by brother-in-law.
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| 49 | 2021-03-04 | tingling, bell's palsy, burning sensation |
She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling ...
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She is worried it might be Bell's Palsy; had a knot at the injection site of her left arm; Tingling sensation on her upper back which went up to her neck and head/tingling in my neck, face, lips and eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; Burning and tingling in my neck and in my face and in my lips and in my eyes; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EH9899, Expiration date: not provided), intramuscular on the left arm on 19Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-year-old for COVID-19 immunization. The patient was worried it might be bell's palsy (medically significant) on an unspecified date. she experienced side effects on 22Jan2021 after receiving the vaccine on 19Jan2021. She had a knot at the injection site of her left arm on the first day. After 3 days, she experienced a tingling sensation on her upper back which went up to her neck and head. It was not excruciating pain but had presence to be noticed. It had been there since that day and was not going away. She had been feeling it around her eyes and on her lips. She was worried it might be Bell's Palsy. She was asking for advice and if this had been reported. As soon as she get the second Covid Shot at the 19Jan it was about 2-3 days afterwards, it was on the Friday and it was about 2' O'clock, well she had the knot in my arm, her left arm where she received the IM (Intramuscular) vaccination (Covid Shot) and she had started having the symptoms of like burning and tingling in my neck and in my face and in my lips and in my eyes and that is not gone away and I still have that knot in my arm, I still have the burning and tingling. she had some blood work done like last Thursday to see if she had any kind of like rheumatoid problems to see arthritis or something but other than that no. Consumer stated, "Well I work in the doctor office and the Physician the one he told me to get the blood work and it goes to the doctor office because I work in one. For treatment consumer stated, she had only been taking an Advil and it did not seem to help her. The outcome of the events was not recovered. Comments/Narrative: Patient will follow up with Physician next week. She is currently on vacations.
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| 49 | 2021-03-04 | tingling |
After receiving the medication, the patient stated that she felt tingling in right arm. She states t...
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After receiving the medication, the patient stated that she felt tingling in right arm. She states that she had a headache. It subsided in 20 minutes. Blood Pressure was very high 5:13PM 175/102 P94 O2 100: 5:19 PM 183/109 P96 O2 100 5:23PM 173/101 P99 O2 100 5:53 PM 162/98 P92 O2 99
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| 49 | 2021-03-05 | pain in extremity |
Pain at injection site, soreness in right arm, Abdominal cramps and diarrhea lasting throughout the ...
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Pain at injection site, soreness in right arm, Abdominal cramps and diarrhea lasting throughout the night
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| 49 | 2021-03-05 | tingling |
24 hr post vaccine: fever, headache, chest pain 48 hr post vaccination: tingling sensation in arms a...
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24 hr post vaccine: fever, headache, chest pain 48 hr post vaccination: tingling sensation in arms and legs (bilateral), rash on chest, face, back
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| 49 | 2021-03-05 | tingling | Pins and needles tingling and feeling of weakness in right shoulder/arm area. |
| 49 | 2021-03-06 | migraine |
I received my shot at 1pm on Monday, March 1. Forty five minutes after the shot was administered, I ...
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I received my shot at 1pm on Monday, March 1. Forty five minutes after the shot was administered, I started to have a metallic taste in my mouth. Five minutes after that, my lips and tongue started to tingle. Five minutes after that my tongue started to go numb and then a few minutes after that my throat felt sore. Around 3pm, I took two Benadryl. By 5:30pm, my tongue was no longer numb, but my mouth didn't feel right all night. I don't know if this was related, but on Wednesday morning I woke with the start of a migraine. I took something right away and was able to avoid it. I have only had 4-5 migraines in my adult life. I started to feel like I was getting a cold by Friday, but I'm not sure if this is related either.
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| 49 | 2021-03-07 | weakness |
Began feeling dizzy 20 hours after receiving vaccine. This progressed to fever of 102.7, chills, we...
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Began feeling dizzy 20 hours after receiving vaccine. This progressed to fever of 102.7, chills, weakness, and fatigue within 2 hours. These symptoms lasted until 4am the following day, when I began feeling better; fever and other symptoms resolved by 8am on 2/26.
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| 49 | 2021-03-07 | bell's palsy | Bells Palsy |
| 49 | 2021-03-07 | bell's palsy | I developed Bell's Palsy 13 days after injection. |
| 49 | 2021-03-07 | migraine | Migraine, body aches, fever, fatigue |
| 49 | 2021-03-07 | tingling, numbness, flushing |
facial hives, left arm numbness and tingling, facial flushing w/ parenthesis. Evaluated by EMS-Clea...
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facial hives, left arm numbness and tingling, facial flushing w/ parenthesis. Evaluated by EMS-Cleared
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| 49 | 2021-03-08 | pain in extremity |
Joint pain in both shoulders, elbows, wrists, fingers, knees, ankles, and feet, as well as muscle so...
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Joint pain in both shoulders, elbows, wrists, fingers, knees, ankles, and feet, as well as muscle soreness. Two days after the first shot on February 15th, the pain in my arms, joints and muscles, was awful. The pain lasted for two days. After yesterday's shot, the soreness and pain came on within 12 hours. So far, the pain is manageable.
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| 49 | 2021-03-08 | tingling, numbness |
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he...
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hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-03-09 | pain in extremity |
Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropp...
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Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropped to 99.6 for a day. I had chills, joint achiness, fatigue, foggy headed feeling, a runny nose, sinus pressure, headache, chest tightness and pain, arm pain, stomach pain, lymph nodes in my left armpit are sore (after 10 days), and I now seem to have a worsened allergy to dairy and a new allergy to nuts - I get very phlegmy, cough, and have chest pain and tightness. These symptoms lasted for 5- 6 days and the allergies with their symptoms and sinus pain and sore lymph nodes have continued.
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| 49 | 2021-03-09 | tingling, numbness |
No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extrem...
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No current pregnancy. Hives, itching, shortness of breath, light headed, numbness/tingling in extremities, thick/numb feeling in tongue, coughing. taken to ED and given IV Benadryl and oral prednisone. Given prescription of for prednisone and Zyrtec for home use. At home, shortness of breath with coughing, lightheadedness, numbness/tingling in extremities, itching persisted for the next 5days. Took prednisone as prescribed for 3 days. Did not take allergy medication. Three days later on Thursday 2/22, I fell while going down stairs and suffered a badly sprained ankle. I feel the fall is a result of lingering symptoms of the vaccine.
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| 49 | 2021-03-10 | weakness, feeling cold |
I experienced an inability to get warm in the afternoon and extreme fatigue, then after going to be...
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I experienced an inability to get warm in the afternoon and extreme fatigue, then after going to bed, I woke up with my heart racing, intense headache, head spinning, weakness, and sweating.
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| 49 | 2021-03-10 | hot flush, tremor, pain in extremity, throat numbness |
20 minutes after receiving the vaccine I got a hot flush and a numb throat. I felt dizzy and medical...
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20 minutes after receiving the vaccine I got a hot flush and a numb throat. I felt dizzy and medical staff gave me 25mg of Benadryl and apple juice. I waited another 15 minutes and I felt tingling in the tongue. Dr observed me Pulse and Bp were low to start and became elevated. I received another 25mg of Benadryl and I was observed for another 20 minutes. I woke up that evening feeling tired. I woke up in a few hours feeling like I was beaten up joint pain and muscle pain. Muscle tremors were worse than normal it was difficult to walk. Low grade fever and headache. This lingered for a few days. I developed mouth sores after days and still had a headache. Arm pain and aches and pains. Total time feeling poorly was 9 days. I visited an allergist on the advice of facility, allergist advised Zyrtec before next dose. Second dose caused similar symptoms with severe aches and pains. I had trouble getting up or moving. Tremors on the right side leg and arm were markedly worse than normal. Instability and fatigue lasted three weeks. Mood swings were unusual.
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| 49 | 2021-03-10 | pain in extremity |
sore arm for 1st 24 hours it subsided. then had a low grade 99.9-100.4 temperature and body aches fo...
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sore arm for 1st 24 hours it subsided. then had a low grade 99.9-100.4 temperature and body aches for next 48 hours.
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| 49 | 2021-03-10 | tremor |
I felt flushed but had taken double dose of Zyrtec. Second dose caused similar symptoms to first dos...
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I felt flushed but had taken double dose of Zyrtec. Second dose caused similar symptoms to first dose with more severe aches and pains. I had trouble getting up or moving. Tremors on the right side leg and arm were markedly worse than normal and I was unstable on my feet. Instability and fatigue lasted three weeks. Mood swings and brain fog were unusual and persisted for no reason for 2-3 weeks. For one day I had inflammation of glands on the right side of my throat. Phone contact with doctor to report that allergy did not occur.
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| 49 | 2021-03-11 | weakness, feeling cold |
About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - ...
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About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - each wave lasted about 2 minutes. During that time - I felt a wave/rush of lightheaded/disorientation feeling/ a cold sensation was rushing throughout my body internally/weak-shaky/ dry mouth/ and one of the waves I felt like I had to make myself swallow/like a rush of adrenaline. These subsided - and started again with a couple minutes between each wave. I took a Benadryl once I arrived home - only 2 very minor waves that morning. No other treatment but now afraid and need guidance if I should get the 2nd injection in case the 2nd reaction is worse.
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| 49 | 2021-03-11 | weakness |
Dizzy, weakness, rapid heartbeat, splitting headache, nausaus, all while still at the vaccine clinic...
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Dizzy, weakness, rapid heartbeat, splitting headache, nausaus, all while still at the vaccine clinic. I remained there for 90 minutes and the symptoms did not change. Still have splitting headache and some dizzyness here we are two days later . . .
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| 49 | 2021-03-11 | flushing | Patient became flushed, chest discomfort, hypertensive |
| 49 | 2021-03-11 | flushing |
Flushing (Chest and face) - gave 25mg PO diphenhydramine and sent her to the Emergency room for furt...
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Flushing (Chest and face) - gave 25mg PO diphenhydramine and sent her to the Emergency room for further care.
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| 49 | 2021-03-11 | numbness, tingling |
Patient stated that starting 1 week post vaccine, she experienced numbness & tingling starting at in...
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Patient stated that starting 1 week post vaccine, she experienced numbness & tingling starting at injection site, and went down to thumb.
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| 49 | 2021-03-11 | numbness |
Chest pain with left arm numbness for 10 min duration. BP 110/80, HR 63, O2 99% RA. ASA 325 given an...
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Chest pain with left arm numbness for 10 min duration. BP 110/80, HR 63, O2 99% RA. ASA 325 given and 911 called
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| 49 | 2021-03-12 | cold sweat |
02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the...
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02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the restroom and almost fainted (lightheaded, nausea, black vision, cold sweat). Blood pressure was 84 over 44. In the afternoon had muscular pain and a low grade fever of 100F for about 2 hours. A little sore at the injection site but all symptoms disappeared on day two 03/13/2021
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| 49 | 2021-03-12 | pain in extremity, hot flush |
At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out...
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At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out of bed. I had an increase in hot flashes, which lasted through the 2nd day and I was back at work. On the 2nd day, the arm pain and swelling worsened. I had a 2 in x 2 in area of redness by the injection site. With the 1st one I had a lot of hot flashes, but nothing to where I was unable to work.
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| 49 | 2021-03-12 | tingling, feeling hot, pain in extremity |
Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blist...
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Bilateral swelling of big toe, 2nd toe, and 3rd toe on left/right feet. began with swelling. blisters, then developed. inflammation, heat, and pain also present. became difficult and painful to wear socks. shoes were also uncomfortable. swelling and sensitivity were present all day, but flare ups occured in evening which included further swelling, pain, redness, and tingling sensation. PCP diagnosed anti-fungal and said would improve. after 7 days on anti-fungal ointment, no improvement. Referred to dermatologist. Dermatologist diagnosed Pernio/Chilblain, likely related to 2nd Vaccine. prescribed topical steriod and suggested keeping toes and feet warm at all times.
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| 49 | 2021-03-12 | tingling |
5:05pm chest pain, itching, paresthesia, sweating. gave patient 50mg benadryl. chest pain resolved...
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5:05pm chest pain, itching, paresthesia, sweating. gave patient 50mg benadryl. chest pain resolved and itching and paresthesia decreased. bp = 124/64. patient reports resolution of symptoms. Monistored until 5:30pm and allowed to leave.
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| 49 | 2021-03-13 | numbness |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium
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| 49 | 2021-03-14 | weakness, pain in extremity, discomfort |
Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I w...
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Pain & stiffness: injection site within an hour of dose 3/12. The next morning, (3/13) 9:30 am, I woke with severe pain all over my body. The worst pain was left arm, neck, back, buttocks, calves. Moderate pain throughout the rest of my body, notably my torso and my jaw. I had terrible headaches throughout the day. I was fatigued/exhausted and slept for several hours intermittently throughout the day. By 9PM I started to feel less fatigued, but the pain was very bad in most of my muscles. I felt like my muscles were battered and beaten, bruised and weak. The next day (3/14) I started to have energy, but not a lot, around 11am, and was still very sore, but the pain had subsided, and no more headaches. Today is 3/15, I am still very tired, but wouldn't call it fatigue, rather less energy than I am used to. I have noticed that my back is still very sore, especially the intercostal muscles. My legs and buttocks are still very sore today. I would not call it pain, but definitely notable and uncomfortable soreness.
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| 49 | 2021-03-14 | electric shock sensation |
All symptoms on the side effect list... 101.4 fever, pain, chills, headache, joint pain, muscle pain...
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All symptoms on the side effect list... 101.4 fever, pain, chills, headache, joint pain, muscle pain, brain buzz.
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| 49 | 2021-03-15 | facial paralysis | Fever, left side face swelling and drooping |
| 49 | 2021-03-15 | numbness | PT c/o numbness to bilateral arms and face |
| 49 | 2021-03-15 | tingling |
numbness and tingling in both hands, pain in muscle at injection site, worse at night, unable to sle...
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numbness and tingling in both hands, pain in muscle at injection site, worse at night, unable to sleep
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| 49 | 2021-03-16 | flushing |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All E...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All Expand All by Default COVID VACCINE CLINIC 3/16/2021 Patient: DOB: Date: 3/16/2021 MRN: Subjective Patient is a 49 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. She had stayed her 15 minute waiting period after the injection and asked to stay another 5 minutes. She felt fine until she reached the front doors, she started to feel short of breath, nausea, flushed. She denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, increased swelling, rapid progression of symptoms and respiratory distress. Past Medical History: Diagnosis Date ? Asthma ? Concussion without loss of consciousness 8/27/2019 ? Depressive disorder ? Esophagitis, reflux ? Hepatic steatosis 12/7/2018 ? HX OTHER MEDICAL ? Hyperlipidemia, mixed ? Hypothyroidism (acquired) ? Insomnia, unspecified type ? OSA on CPAP ? Pulmonary hypertension (HCC) Noted on CT, echo was normal. ? Pulmonary nodules 3/28/2015 Follow up with Pulmonary in 3 months for a CT scan ALLERGY REVIEW OF SYSTEMS: Patient complains of malaise/fatigue and shortness of breath Patient denies chills, fever, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches +lightheaded: SOB resolved by time arrival to ED medical bay. Previous Reactions: none Objective Vitals Vitals: 03/16/21 1158 03/16/21 1207 BP: 117/83 (!) 141/91 Pulse: (!) 103 86 Resp: 18 18 SpO2: 96% 97% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is morbidly obese. She is diaphoretic. Comments: Flushed HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Improved in observation bay. Monitored for approx 15 minutes. Pt ambulated but developed chest tightness. Albuterol inhaler provided (2 puffs) via inhalation. Pt reports immediate improvement of symptoms. She was able to ambulate w/o difficulty afterwards. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) VS stable. Resolution of diaphoresis and flushed appearance. Pt symptoms resolved with use of albuterol. Suspect exercise induced asthma. Recommend that she use albuterol if needed for wheezing or 30 minutes prior to exercise. Follow up with her pcp otherwise as needed. Pt voiced appreciation of her care today. APRN Electronically Signed 3/16/2021 11:52 AM
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| 49 | 2021-03-16 | muscle spasms |
I started having cramping on the 11th, and then that got better. On the 14th, I started having blood...
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I started having cramping on the 11th, and then that got better. On the 14th, I started having bloody stools. I ended up in the hospital starting on 15th - 18th. GI Bleed - It was a lower one. Treatments - Put me on antibiotics and I had to get two or three units of blood. Had a follow up with doctor - roughly, Feb 5.
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| 49 | 2021-03-16 | pain in extremity | Headache nausea sore arm lethargic |
| 49 | 2021-03-16 | tingling |
Within 10 minutes got blurred vision and felt like going to faint. happened 3 times during first ...
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Within 10 minutes got blurred vision and felt like going to faint. happened 3 times during first 30 minutes happened 3 times. Felt like throat was tight when swallowing . Face started to tingle and numbness lips and tongue for about 5 minutes , Tightness in throat for 2 hours . went back to Cvs and stayed for a an hour . Felt like swelling of throat for the first night . 2 days had a sore throat , little by little went away. took 3 days to swallow normal. Called her doctor for advice on second short
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| 49 | 2021-03-17 | weakness, tingling, inability to speak |
Difficulty breathing, weakness, dizziness, couldn?t stand on my own, tingling of my hands and feet, ...
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Difficulty breathing, weakness, dizziness, couldn?t stand on my own, tingling of my hands and feet, inability to speak, tiredness and feeling unwell
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| 49 | 2021-03-17 | cold sweat, feeling hot |
Member observed to be lethargic. Member stated just feels hot, clamy and feels overheated. Not obs...
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Member observed to be lethargic. Member stated just feels hot, clamy and feels overheated. Not observed to be diaphoretic. Member also reports feeling dizzy. symptoms lasted approximately 10 mins. 911 called , triage completed and member declined to be transported to emergency room
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| 49 | 2021-03-17 | pain in extremity |
Developed a splitting headache, back of head, right side, minutes after vaccination. Also, arm was v...
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Developed a splitting headache, back of head, right side, minutes after vaccination. Also, arm was very sore 1 hour later, sore spot was over 3" wide at largest point, resolved overnight
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| 49 | 2021-03-18 | tingling, burning sensation |
Progress Notes Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID...
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Progress Notes Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC Date: 3/17/2021 Subjective Patient is a 49 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience tingling sensation along recent surgical incision and along both sides (had full knee replacement on March 9th). She also has "burning" going down the left leg from her knee down to foot. She denied all other symptoms. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , increased swelling, rapid progression of symptoms, respiratory distress and skin changes. Of note, she had not taken her medications this morning, which includes lisinopril. She had physical therapy this morning as well. She states that they iced her knee at the end of her session. ALLERGY REVIEW OF SYSTEMS: All other systems negative Left knee bandaged, wrapped with ace bandage. She also has compression socks on.: Tingling sensation along surgical incision on left knee and down both sides of same incision. Burning pain down left leg from knee to foot.: Previous Reactions: None to first covid vaccine. Objective Vitals Vitals: 03/17/21 1113 03/17/21 1129 BP: (!) 129/90 126/70 Pulse: 81 72 SpO2: 97% 100% Physical Exam Vitals reviewed. Constitutional: Appearance: She is obese. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Head: Normocephalic. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: Cervical back: Normal range of motion. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Symptoms likely related to ice therapy done at physical therapy prior to coming into vaccine clinic. Symptoms were resolving, back to her baseline when she left. Encouraged to notify surgeon or primary care provider if symptoms return or become worrisome. Electronically Signed 3/17/2021 11:30 AM
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| 49 | 2021-03-19 | tingling, hot flush |
Immediately after vaccine, felt tingly through arm and down leg (L side both). A few minutes later, ...
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Immediately after vaccine, felt tingly through arm and down leg (L side both). A few minutes later, she got hot on l side of face, like a hot flash.
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| 49 | 2021-03-20 | weakness | Fever, aches, joint pain, headache, weakness, nausea, aftertaste, indigestion |
| 49 | 2021-03-20 | burning sensation |
I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, M...
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I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, March 15th, I noticed a small rash on my right side upper eye lid and the side of my eye but thought it may just be an allergic reaction to something. No pain or itching. I had a couple of similar spots on my scalp but didn?t think much of it. On Thursday, I had a headache but I do get headaches now and then. When I woke up on Friday morning, March 19th, I found my eye lid completely swollen and saw the rash had turned to blisters, and there was a new one by the inner corner of my eye and a very faint rash on my forehead. Still no fever, pain or fatigue but had a lingering headache and a burning sensation on the rash. Saw my opthalmologist right away who diagnosed it as shingles and did a complete eye exam. Luckily no shingles in the eye as that can lead to glaucoma or even blindness in severe cases. I was prescribed Valtrex (1000 mg x 7 days) and prednisone (60 mg x 5 days) by my PCP. Hoping that I was still in the 72 hour window when the antiviral med is effective, I started on the meds immediately. Today is the third day of treatment and the blisters seem to be crusting away and healing faster. Luckily, no new blisters as of now. The prednisone caused my eye area to swell up further so I am gradually tapering off the dosage from 60 mg prescribed to 40-30-20 mg. Keeping a watch for any complications such as ear pain or numbness in the face. Have a follow up appointment with ophthalmologist who will be dilating my eyes for further checks. I was glad to have found the Reddit board and see that there are over 50 cases of people reporting shingles after the first or second covid vaccine. I plan to delay or skip my second Pfizer vaccine for now.
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| 49 | 2021-03-20 | numbness |
03:40 pm..Numbness in right cheek into lower jaw. similar to when you are coming out of novicane fr...
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03:40 pm..Numbness in right cheek into lower jaw. similar to when you are coming out of novicane from dental appt. Lasted about 15 minutes but subtle feeling for 24 hours. Friday morning: reaction to my BP meds of heavy head, weak hands that other meds caused me in past. Never had previously. Been on this med brand for over 3 years. The symptoms passed after 5 hours when med wore off. My BP seems lower than before shot. So reduced med to half dose 2x day and full dose once a day. Seems to have helped reduce symptoms, but they reappear less intense now. Also have heartburn and much more gas than ever had in past.
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| 49 | 2021-03-20 | pain in extremity | The vaccinated arm was sore for about 24 hours. Dose 1. |
| 49 | 2021-03-20 | tingling, pain in extremity |
pt c/o of left arm pain after vaccination of the vaccine. and tingling of the left fingers. sympto...
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pt c/o of left arm pain after vaccination of the vaccine. and tingling of the left fingers. symptoms was resolved and patient went home
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| 49 | 2021-03-21 | flushing |
she experienced throat swelling, difficulty breathing, itching, flushing. she self-administered Epi...
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she experienced throat swelling, difficulty breathing, itching, flushing. she self-administered Epi-Pen which she brought with her. EMS was called.
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| 49 | 2021-03-21 | pain in extremity |
I had soreness on my shoulder that progressively extended to all of my upper arm and became more pai...
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I had soreness on my shoulder that progressively extended to all of my upper arm and became more painful. I had difficulty raising my arm or moving it (it reminded me of the pain I felt when I had a case of bursitis on my other shoulder years prior). When lying down I could not sleep on that side and had difficulty sleeping on my right side as I could not find a comfortable position for my left arm that would not cause shooting pain. This lasted for 2-3 days. It subsided after 5 days. However, 10 days later, sometimes I get a softer pain on that arm when I move it. I did take extra strenght Tylenol, as recommended by the person that provided the shot. It did not help a lot, to be honest.
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| 49 | 2021-03-22 | cold sweat |
Woke at 6am feeling dizzy. By 7:30, I was vomiting, lose stool and cold sweats. Lasted until approxi...
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Woke at 6am feeling dizzy. By 7:30, I was vomiting, lose stool and cold sweats. Lasted until approximately 1:00pm. Still feeling lethargic and have slight headache
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| 49 | 2021-03-22 | pain in extremity |
3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head p...
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3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head pain. As the day progressed, experienced pain/inflammation in leg muscles and body. Headache worse. Brain fog. Slow to focus eyes.
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| 49 | 2021-03-22 | tingling |
Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the ...
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Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the patient reported feeling ?funny?. She described symptoms including itching/tingling, sweating and increased heart rate. She was immediately ushered into the counseling room of the pharmacy and a blood pressure monitor was attached to her arm. At 2:09 p.m. her blood pressure was 166/78 and heart rate was 98 BPM. At this time 25mg of diphenhydramine was given to the patient orally. In addition to the subjective symptoms, the patient?s complexion had turned from neutral to red, and her face was covered in what appeared to be hives. EMS was called, and while on the phone with a dispatcher, a subsequent reading found the patient to have a BP of 140/122 and HR 121 BPM (2:15p.m.). As instructed by the EMS dispatcher, 0.3mg was administered to the patient via auto-injector into the left thigh. Paramedics arrived several minutes later and the patient was helped onto a stretched and subsequently escorted from the building for further observation and treatment.
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| 49 | 2021-03-23 | numbness |
Patient presents to ED w/ chief complaint of numbness. Symptoms started as back pain with numbness...
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Patient presents to ED w/ chief complaint of numbness. Symptoms started as back pain with numbness to R middle finger. Symptoms progressed to Numbness of bilateral legs and face. +fatigue, exhaustion, weakness in fingers, mild SOB.
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| 49 | 2021-03-24 | feeling hot |
she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous r...
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she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration on 08Mar2021 at age of 49 years old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received her first Pfizer Covid vaccine on 08Mar2021. Within 15 minutes she experienced tachycardia (157 BPM) and a warm sensation in her chest and ears. The symptoms resolved in 45 minutes. She would like guidance on if she should receive the second dose. The outcome of events was recovered on 08Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tachycardia due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-03-24 | pain in extremity |
Began feeling as if someone had punched me in the upper arm terribly around 11:30pm. Hurt arm to lif...
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Began feeling as if someone had punched me in the upper arm terribly around 11:30pm. Hurt arm to lift it. NO redness, NO swelling, just intense muscle pain. Had pain following day, so took Advil to help alleviate tense feeling in muscle. Also rubbed painful area to try to "work out" the stiffness. It seemed to help somewhat. Now around 35 hours later, the muscle is still feeling a bit "stiff", but much better. I'm sure I'll be back to normal two days after my vaccine.
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| 49 | 2021-03-24 | tremor, flushing |
flushing, mouth/lips trembling, and felt a little woozy. Lasted maybe 5-10 minutes, then wooziness w...
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flushing, mouth/lips trembling, and felt a little woozy. Lasted maybe 5-10 minutes, then wooziness went away and the trembling/chattering turned into tingling lips. Hours later, my lips still feel weird. Treatment is nothing - it's not a big deal, I just wanted to report this to be helpful. I will call my doctor if this doesn't go away in a few days.
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| 49 | 2021-03-25 | difficulty speaking |
Patient reports throat swelling and lips slightly swollen. 10 minutes later patient feeling like thi...
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Patient reports throat swelling and lips slightly swollen. 10 minutes later patient feeling like things are worsening. Epinephrine 0.3mg given x 1. VSS. Symptoms improved and patient discharged feeling normal. Left with hoarse voice and HA.
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| 49 | 2021-03-25 | flushing, hot flush |
I received the vaccine at 9:15a and was told to wait 30 min instead of 15 due to my anaphylactic all...
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I received the vaccine at 9:15a and was told to wait 30 min instead of 15 due to my anaphylactic allergy history. At 9:21a, while in the waiting area, I felt a flushing sensation through my body and felt my face grow hot. I got very light-headed even though I was sitting down and thought I was going to be sick, and my heart rate as noted on my watch became elevated. It went from low 70's to high 90's. My throat did not close up and I did take my regular allergy medicine and inhalers prior to the vaccine. After 30 minutes, I went to the facility restroom and noted my face was still red. I called my sister (a hospital doctor) who told me to immediately take Benedryl. After taking Benedryl, I was feeling better after about another hour and the nausea and light-headedness subsided. In total, the symptoms lasted about an hour and 45 minutes. I did not notify staff at Med.Centerl at that time as my throat didn't close but did contact my PCP and now have an appointment scheduled with an allergist at Med. Center for next week and have put my 2nd vaccine on hold until I see the allergist.
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| 49 | 2021-03-25 | numbness |
On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth ...
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On same side as vaccination I experienced burning knuckles on middle finger and ring finger, warmth on side of neck, the cheek on the left side of my face was numb, my lips tingled, and my heart rate increased to 105 bpm. The facial numbness went away after a few hours and felt like I had received Novicane for dental work. The burning knuckles took 8 days to go away. I called my doctor's office and spoke to the on call nurse who said the reaction was likely due to the vaccine.
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| 49 | 2021-03-26 | weakness |
Arm pain I pain around midnight the night of injection continuing through next day. Night sweats ...
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Arm pain I pain around midnight the night of injection continuing through next day. Night sweats Fever and chills March 27th all day StIff and painful joints and muscles everywhere Slight headache Energy drain was almost immediate and ongoing.
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| 49 | 2021-03-26 | hot flush, weakness |
I have felt extremely weak and fatigued since i got my First dose. It has not subsided at all and it...
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I have felt extremely weak and fatigued since i got my First dose. It has not subsided at all and it's been 8 days. I feel shaky and get hot flushing every time I exert myself. I feel like I have the flu.
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| 49 | 2021-03-26 | pain in extremity |
headache (not migraine) and ear ringing began about 20 hours after my second shot, had extreme arm p...
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headache (not migraine) and ear ringing began about 20 hours after my second shot, had extreme arm pain as well with both shots. The ear ringing is constant and loud and hasn't stopped since the day after shot 2. The headache seems to come and go.
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| 49 | 2021-03-26 | pain in extremity | Fatigue, sore arm, achy, chills, |
| 49 | 2021-03-27 | weakness |
Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, ...
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Minor injection site pain followed by chills, high fever, SOB, dizziness, weakness, blurred vision, severe muscle pain, and large swollen lymph node (size of golf ball under left arm/near injection site) 12 hours after second shot. Adverse events diminished 12 to 48 hours later.
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| 49 | 2021-03-27 | burning sensation |
I had a high level of normal body aches, but I am filling out this form because I had a high level o...
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I had a high level of normal body aches, but I am filling out this form because I had a high level of pain at past surgical incision sites. One at a hysterectomy incision from 19 years ago, at three of the nine incisions from a heller myotomy in Dec. 2019, and one internal at the point of what I assume must be esophageal scar tissue from the Heller myotomy. The internal pain was at the vert same point of pain post surgery. The pain presented as "burning" and aching that lasted approximately 12 hours. This morning, the pain is completely gone. The nurse I spoke with said that I should contact my physician within 24 hours, but that it did not sound like an emergency. Neither the nurse nor I could locate information about surgical site pain as a side effect of the civic 19 vaccination, so it was disconcerting. I am submitting this as it might be helpful to others who experience this to know that others have as well.
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| 49 | 2021-03-29 | muscle twitching |
Extreme fatigue; nausea; muscles aching; muscle twitching; sweating; This is a spontaneous report fr...
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Extreme fatigue; nausea; muscles aching; muscle twitching; sweating; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Mar2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included myasthenia gravis, undiagnosed autoimmune disorder, non-alcoholic fatty liver disease, hypertensive heart disease and allergy to mushrooms. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 12:45, the patient experienced extreme fatigue, nausea, muscles aching, muscle twitching and sweating. No treatment was given for the events. The outcome of the events extreme fatigue, nausea, muscles aching, muscle twitching, and sweating were not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 49 | 2021-03-30 | feeling hot, flushing |
severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; hear...
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severe flushing and hot feeling; severe flushing and hot feeling; lightheaded; severe headache; heart pounding; funny feeling in throat; throat tightening; hacky cough; itchy throat; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: E19264) on 10Feb2021 08:00 AM at Right arm as single dose for covid- 19 immunisation. The patient medical history included Hypothyroidism and hypertension. The patient concomitant medication included Nifedipine, Levothyroxine, Vitamin D, started on unspecified date at an unknown dose and unknown if ongoing. The patient had allergies to bee stings and latex. On 10Feb2021, 09:00 AM, approximately 35-40 minutes after vaccine the patient experienced severe flushing and hot feeling, lightheaded, severe headache, heart pounding, funny feeling in throat. 1 hour after vaccine throat tightening, hacky cough, itchy throat. The patient was treated with allergy medication and famotidine. The outcome of the events was recovered. No follow up attempts are possible. No further information is expected.
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| 49 | 2021-04-06 | bell's palsy |
face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowi...
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face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowing; difficulty breathing & swallowing; nausea; metallic taste in mouth; double vision; This is a spontaneous report from a contactable consumer. A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 18Mar2021 at 08:15 (Batch/Lot Number: EP7534) as a single dose at the age of 49, for Covid-19 immunisation. Medical history included juvenile- als, and a sulfa allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 18Mar2021, after use of product patient developed Acute pain in base/spine of neck, dizziness, difficulty breathing & swallowing, nausea, metallic taste in mouth, face felt like plastic, double vision. The patient was not hospitalized nor was treatment received for the events. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. Additional Information has been requested.
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| 49 | 2021-04-15 | numbness, bell's palsy | Bell?s palsy, numbness, headache |
| 49 | 2021-04-17 | speech disorder, facial paralysis |
My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure wa...
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My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure was high; I was disoriented and I could not move my arms or legs; they were not able to understand my speech; I could not move my arms or legs; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in right arm on 26Mar2021 08:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Graves Disease (in remission), papillary necrosis of kidney, Raynaud's, fibromyalgia, breast cancer survivor. Allergies to medications, food, or other products: Morphine, Sulfa, Aspirin, Ibuprofen, Bactrim, Escitalopram. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)), gabapentin, tizanidine, paracetamol (TYLENOL). Patient experienced: Less than 10 minutes in the waiting area (reported as 26Mar2021 08:15 AM), began to feel a wired dizziness that got worse and she was able to signal a nurse who was attending to another lady having a reaction in the same seating area. Blood pressure was high, she was disoriented and she could not move her arms or legs. According to the doctor and nurse, they were not able to understand her speech. Her mouth on the right side droops slightly. Patient was admitted on 26Mar2021 and discharged from hospital on 28Mar2021. Events resulted in Emergency room/department or urgent care, Hospitalization. Treatment included testing, IV. Covid test post vaccination on 26Mar2021 (nasal swab) was negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 49 | 2021-04-18 | weakness |
STARTING FEELING SLUGGISH/ TOOK A NAP/ THEN WHEN AWOKE COULD NOT MOVE LEFT SIDE OF BODY/ WENT TO ER ...
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STARTING FEELING SLUGGISH/ TOOK A NAP/ THEN WHEN AWOKE COULD NOT MOVE LEFT SIDE OF BODY/ WENT TO ER AND WAS DIAGNOSED WITH MINI-STROKE WITH POSSIBLE MS ---STILL FEELING WEAK
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| 49 | 2021-04-21 | burning sensation |
Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore t...
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Extreme non stop aching. Nausea Temperature that ranged from 99 to 103 Chills Headache Very Sore throat Burning when taking a deep breath
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| 49 | 2021-04-21 | numbness |
Immediately after getting the shot, I felt a heaviness on the arm (left) that was given the shot. T...
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Immediately after getting the shot, I felt a heaviness on the arm (left) that was given the shot. Then, that heaviness moved to my left leg, thighs, and calf. My joints (knees, elbows, etc.) are stiff and sore. My left calf feels numb and stiff like after getting a nasty leg cramp.
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| 49 | 2021-04-22 | one side paralysis |
All this on the right side of the body. Injection site was on the right arm. Dizziness and weaknes...
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All this on the right side of the body. Injection site was on the right arm. Dizziness and weakness, swollen/painful lymph nodes (axillary, cervical, epitrochlear, under jawline and chin). Parotid gland swollen and painful. Entire right arm swollen with rash, Right check swelled. Right ear pain.
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| 49 | 2021-04-23 | weakness |
At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98...
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At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98,At 10:24 BP 164/102, At 10:27 BP 167/99; Unable to work after the 2nd dose; I wasn't able to go back to work because of severe weakness; Dizzy; my BP went down to 90/60, 80/56; This is a follow-up spontaneous report from a contactable Nurse in response to HCP letter sent in cross referenced case. A 49-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in deltoid right on 14Jan2021 at 09:00 (at age of 49 years old) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration on 20Dec2020 as single dose for Covid-19 immunization. On 14Jan2021, the patient was placed on close monitoring after receiving the second dose for continuous pulse oximetry, O2 saturations ranged from 98%-100%. At 09:50 BP 157/98, HR 73, 99% O2 sat, then 09:51 BP 161/101, HR 100, SpO2 100%, at 08:58 am 167/80, HR 85, SpO2 94%. The PCP prescribed clonidine 0.1 mg as needed for SBP>160. The patient took 1 tab clonidine 0.1mg. At 10:13 BP 181/93, HR 63, SPO2 100%, at 10:22, BP 165/98, HR 59, 100% SPO2, at 10:24 BP 164/102, HR 77, 99% SPO2, at 10:27 BP 167/99 HR 74, 100% SPO2. Later the patient took 2nd dose of clonidine 0.1mg and at 10:36 BP 134/86, HR 65, SPO2 100%, at 10:47 BP 124/81, HR 65. The patient was released by employee health nurse. She was dizzy when she got home, her BP went down to 90/60, 80/56. The patient was unable to work after second dose because of severe weakness. The patient stayed in bed for 5 days. The patient went back to work on 19Jan2021. Treatment for the event blood pressure fluctuation was two dose of tab clonidine 0.1mg. The patient provided information regarding the reported adverse events with the use of the suspect product to the nurse and the nurse considered that the Pfizer product had a causal effect to the adverse event. The outcome of the events was unknown. Information on the batch number has been requested.
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| 49 | 2021-04-24 | burning sensation, pain in extremity, numbness, bell's palsy |
Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pa...
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Before the Bell's Palsy diagnosis she felt like she was getting a cold; dry eye and eye watering; pain in her feet; dry eye and eye watering; Bell's palsy; Legs went numb; Feet burning; Arms went numb; Nausea; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:45 (Batch/Lot Number: ERG213) as a single dose for covid-19 immunisation. The patient's medical history included ongoing systemic lupus erythematosus diagnosed 17 years ago. The patient's concomitant medications were not reported. On 30Mar2021, the patient experienced headache and nausea, arms went numb on 31Mar2021, legs went numb and feet burning on 01Apr2021. On 05Apr2021, the patient was diagnosed with Bell's palsy. It was also reported that before the bell's palsy diagnosis she felt like she was getting a cold. It was further reported that on the first day the patient had a headache and nausea. The second day her legs went numb for 3 days, on 05Apr2021 she got Bell's Palsy. Patient cannot talk, symptoms were not treated in any way. Patient had numbness in her arms first and then it went to her legs. She later clarified her arms and legs are still numb. The headache started soon as she got the vaccine. Her nausea started 2 hours after the vaccine and lasted 8 hours. Her legs still bothering her. She still has pain in her feet. Before the Bell's Palsy diagnosis she felt like she was getting a cold. She had a headache on the right side of the face. Her tongue was numb 3 days ago. She can't close her eye all the way, it was causing headache, dry eye and eye watering. It was going into her nose. Her lip was moving, she cannot talk. She went to urgent care last night after her daughter asked why she was winking. Her lip was sagging and thought it was a stroke. They said the Bells Palsy was definitely from the vaccine. The outcome of the event nausea was recovered on 30Mar2021, Bell's Palsy legs went numb, arms went numb, feet burning was not recovered and unknown outcome for the event before the Bell's Palsy diagnosis she felt like she was getting a cold.
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| 49 | 2021-04-24 | numbness |
she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weak...
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she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weakness in her left arm; losing her balance; vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone; less range of movement in her left foot; trouble walking; like someone who had a stroke; numbness; legs felt heavy climbing stairs; immediate pain when needle went all the way in and worse when vaccine went in; pain in shoulder joint; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ep6955), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 18:00 (at the age of 49years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included anemia that is treated, living kidney donor, gastric bypass in 1999, gallbladder removal, hysterectomy, intussusception x2, migraines, high heart rate, and smoking. Concomitant medications included omeprazole (OMEPRAZOLE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously received Flu vaccine and Tetanus vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. She got the shot on 25Mar2021 on Thursday evening at 1800. She is 49 years old and has had all the flu shots and tetanus shots. She has never had one hurt so bad. She stated that the vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone. It was reported that the patient experienced immediate pain when needle went all the way in and worse when vaccine went in. The whole time it hurt really bad and her arm hurt severely for 2 days from 25Mar2021. She still has pain in shoulder joint. That aside wasn't a big deal, it went away even though the joint is sore. The following Monday 29Mar2021 in the evening, her legs felt heavy and she had trouble going up the stairs. Then she had complete numbness of her left leg, from her hip or butt crack to the tip of her toes. It was on the same side she had the shot. It was further reported that the patient's legs felt heavy climbing stairs then she woke Thursday morning with her left leg numb. She couldn't feel herself starting to have a bowel movement because the numbness went all the way up to that area. She went to the ER (emergency room) on Saturday night (03Apr2021) because she was afraid of a blood clot. An ultrasound was done on her left leg, CT of head and neck, and blood work with nothing found. She has numbness and less range of movement in her left foot with trouble walking and have had no improvement with calf being numb. It was further clarified that when she was Easter shopping, there was numbness in her foot was causing her to drag her foot around the store. It was like someone who had a stroke, with slight impairment on one side. Her foot slaps the floor. She doesn't have control of it, she can't flex her foot up and down at all and she has little movement in her toes, even now. When she went to the emergency room, she thought she had a blood clot. She is a kidney donor and is healthy over all except for anemia that gives her tingly toes since she was 30, off and on. She never had a body part felt so numb, other than when she sits on her leg wrong. They did a bunch of tests there. They did a doppler, CT scan, and an EKG (unspecified date) which was abnormal. Her EKG has never been abnormal before. It said possible septal infarct undetermined time. The doppler showed no deep or superficial blockages noted from her groin down to her toes/ankle. The doppler was to check for blood clots. They referred her to her primary care provider who said that she will do a neurological exam. She has weakness in her left arm as well. The weakness in her left arm was only told by the neuro touch test. The patient further clarified that she doesn't have less range of motion, it is really just pain (arm). She can still move her arm all the way. Her left side is weaker or less sensitive as far as the neuro test. She wasn't aware she had less feeling on her arm until the nurse said she did. Her arm pain is nothing significant, it can hurt when moving her arm. She had no leg pain or anything like that until later in the week. She still had symptoms of losing her balance. Getting in and out of the chair she almost fell down. She didn't realize the numbness. Monday, she felt heaviness going up the stairs. For 2 days she had the worst pain ever in her arm. She had the tetanus shot and didn't have anything like that. It went away, when she raises her arm off from the side, she still has pain in the joint. She has migraines, it is nothing that is causing difficulty. She is more concerned something else happened. Patient thought maybe it is MS (multiple sclerosis) and asked if it is peripheral artery disease. She did smoke half a pack every other day. She is 49 but didn't start smoking till she was 36. It is a terrible habit and her doctor is aware. She also had her good and bad cholesterol which was just over 100. She is just reporting it because it happened on only the left side and she is a healthy person. She never had high blood pressure and never been treated for it, but she has had high heart rate before. It is not something that has ever caused any issue. She doesn't have something like peripheral artery disease, when she (software company name withheld) that is said plaque in the arteries. The doppler showed no signs of blockage superficial or deep on that side. She doesn't have an appointment until 29Apr2021. She doesn't know what to do to get more urgent care. The pain in her arm was better after the first 2 days. It is like a tooth ache, a dull ache. It is not all the time, just when moving her arm. Her legs were worse to where Thursday, she woke, and she was numb from the top of her leg to the tip of her toe. She can still lift her leg, but when she walks the tip of her second toe which is longer will drag on the ground. When she walks it is hard to hold her shoe on the left foot or put her shoe on. She can't maneuver her foot. When her foot hits the ground, the ball area of her foot smacks the floor because she doesn't have control over it. It is laboring to walk and is hard. She was kind of limping and pulling that leg on the left side. Her laboratory tests were BMP, CBC auto diff, CBC with diff, CT, angiogram of the head and neck, EKG 12 lead, and they did a venous doppler of the left lower extremity. It all came back good except the EKG which says septal infarct undetermined date, which has never come up on any tests before. The events resulted in Emergency room/department or urgent care, Disability or permanent damage. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.
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| 49 | 2021-04-24 | pain in extremity, weakness |
Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a c...
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Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date (at 49-years of age) for Covid-19 immunization. Patients medical history and concomitant medications were not reported. She had an allergic reaction to CAT scan contrast dye in the past. It was reported that after the first dose of the vaccine, within several minutes, she felt dizzy and it passed quickly. 4-5 hours later patient got severe dizziness and her family had to walk her to her bed. She was very weak and very dizzy so she laid down. She was dizzy in the morning and then was only mildly dizzy for a number of days. She also had chills and her arm hurt. She stated she saw dizziness at the bottom of the sheet as a more serious reaction and wanted to know if she should get the next dose of the vaccine? Patient also stated she heard that one dose of the vaccine is over 80% effective. No PQC was present. It was reported that patient did a report. Patient was guided to read form PI section 4. Read from Fact sheet under "WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?" regarding the description of serious allergic reactions. Referred to HCP for further discussion. PI: LAB-1457-7.0/ Revised: 06Apr2021 Fact sheet: LAB-1451-4.0/ Revised: 06Apr2021. The patient has a question if she is still considered vaccinated with just one dose? Is it 80% effective? Patient was asked to read from attached document. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 49 | 2021-04-27 | cold sweat |
This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-o...
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This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158 and expiration date not provided), via an unspecified route of administration administered in the right arm on 11Apr2021 14:00 as a single dose for COVID-19 immunization. Medical history included Crohns Disease. The patient is not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 12Apr2021 01:45, about 12 hours after the first dose, the patient passed out and then broke out in a cold sweat, multiple times. No treatment was given in response to the events. The outcome of the events was recovering. The patient has not been tested for COVID post vaccination.; Sender's Comments: Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-04-28 | migraine |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach pains; nausea; diarrhea; migraine; dizziness; body aches; faint; This is a spontaneous report from a contactable consumer reporting for self. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:00 (Batch/Lot number was not reported) at the age of 49 years old, as single dose for covid-19 immunisation. Medical history included allergies to penicillin, codeine, Bactrim, sulfa drugs. Concomitant medications included alprazolam; sumatriptan succinate (IMITREX); amitriptyline. The patient experienced Chills, Fatigue, stomach pains, nausea, diarrhea, migraine, body aches, dizziness, faint from 01Apr2021. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient had Nasal Swab on 07Apr2021 with negative result, and on 13Apr2021 with Positive result. Outcome of event COVID-19 virus test positive was unknown, of other events was not recovered. Information about lot/batch number has been requested.
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| 49 | 2021-04-28 | tingling |
This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old fem...
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This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.
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| 49 | 2021-04-30 | weakness |
Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day aft...
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Felt weakness and lethargic all day long; developed neck pain on the same side as injection. Day after injection (Saturday), neck pain was severe; severe major joint pain; Also, muscle and skin pain all over my body; Also, muscle and skin pain all over my body; Overall feeling of malaise; Felt weakness and lethargic all day long; Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did; The day of the injection (Friday), pain at sight was very strong.; That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); That night, developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms); This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021 (Batch/Lot Number: ER8732) as single dose in left arm at the age of 49-year-old for COVID-19 immunisation, administered at healthcare facility. Medical history included Heterozygous Factor 5 Leiden, narcolepsy, total knee replacement 13 months before in 2020, arthritis, chronic low vitamin D levels, sites of previous injuries from years earlier that had healed. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received Effexor and experienced drug hypersensitivity. The past vaccination history included the 1st dose of bnt162b2 (Lot number EN6199) as single dose in left arm on 05Mar2021 for COVID-19 immunisation. No other vaccine in four weeks. On 26Mar2021 03:45 PM, the day of the injection, pain at sight was very strong. That night (26Mar2021), developed deep cough that sounded and felt like someone with fluid in the lungs (although had no prior symptoms), and also developed neck pain on the same side as injection. On 27Mar2021, day after injection, neck pain was severe, and developed severe major joint pain throughout body. Also, muscle and skin pain all over my body. Overall feeling of malaise. Sites of previous injuries from years earlier that had healed and presented no pain prior to injection, hurt more than other joints did. Felt weakness and lethargic all day long. All of these symptoms were gone by 28Mar2021 except for the neck pain which remained sever for 10 days, but has subsided slightly more for the last 5 days leading up to today (still suffering from neck pain today). No treatment received. Covid was not tested post vaccination. The outcome of pulmonary edema, cough, vaccination site pain, lethargic, joint pain, muscle pain, skin pain, malaise and weakness was recovered on 28Mar2021, of neck pain was not recovered. No follow-up attempts are needed. No further information is expected.
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| 49 | 2021-04-30 | burning sensation |
her symptoms started as a couple of dots at the injection site; The rash started growing all over he...
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her symptoms started as a couple of dots at the injection site; The rash started growing all over her body; Rash growing all over body was worsened; It is still burning and itching; It is still burning and itching; Neither of them can sleep; This is a spontaneous report from a contactable consumer (Patient husband) via Medical Information Team. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 01Apr2021 (at the age of 49-years) as single dose for COVID-19 immunisation. It was reported that the patient received vaccine 22 days ago. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, patient experienced symptoms that started as a couple of dots at the injection site that got worsen and started growing all over her body, it is still burning and itching, neither of them can sleep. There is no relief for her rash even after ten days. Patient visited the emergency room four times and has been to her primary doctor and her pain management doctor where she received six different prescriptions, of which three are from a hospital which prescribed over-the-counter medicine and asked to come back after seven days. But nothing helped and the rash is still growing like poison ivy. Reporter described that patient back looks like the surface of Mars as seen on a television channel. Nothing else was different in her diet or medications outside of the vaccine. Later, patient visited another hospital where she was prescribed with another medication. Patient received treatment with an unspecified intravenous (IV) medication which helped her to sleep. Reporter stated that none of the medication helped except the IV medication, considered so because it helped her sleep. Reporter was upset and thought that Pfizer vaccine gave the patient that rash. The outcome of the event insomnia was recovered and the outcome of the event condition aggravated was unknown while for all the other events, it was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 49 | 2021-04-30 | numbness |
Allergic reaction; itching from head to toe; rash; broken vessels in cheeks, turned red; difficulty ...
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Allergic reaction; itching from head to toe; rash; broken vessels in cheeks, turned red; difficulty breathing; arm went numb; was not feeling good; blotchy; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 25Mar2021 14:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were none. No prior vaccinations within 4 weeks. The patient experienced itching from head to toe on 25Mar2021 with outcome of not recovered, rash on 25Mar2021 with outcome of not recovered, broken vessels in cheeks, turned red on 25Mar2021 with outcome of not recovered, difficulty breathing on 25Mar2021 with outcome of recovering, allergic reaction, arm went numb, was not feeling good and blotchy on 25Mar2021 with outcome of unknown. The events itching from head to toe, rash, broken blood vessels in cheeks and difficulty breathing require a visit to Emergency Room. No relevant tests. Clincial course reported as follow: Patient received her first dose 25Mar2021 and within 3 hours she was in the Emergency Department. She had an allergic reaction. She has had itching and rash since receiving the shot. The allergic reaction wasn't even 5 minutes of getting the shot her arm went numb and she thought she's in trouble and was this normal. She asked people running the clinic and asked if this was normal and they said no never heard of that. After that itching started. Itching started at her head and moved to her face and then her entire body. She had a rash on her face, neck and chest. The blood vessels broke in her cheeks. She knew she should have some diphenhydramine hydrochloride (BENADRYL) and the emergency department didn't have any there. The staff made her wait for 30 minutes after her injection. She was not feeling good. It was hard for her to take a deep breath, and to catch her breath after 30 minutes of waiting there. Then she drove herself to store and got diphenhydramine hydrochloride, and drove herself home, she was not feeling any better and took the diphenhydramine hydrochloride. She called her doctor's office. It was like an hour after the shot and she told them at the doctor's office she was blotchy, itchy, and having trouble breathing. She talked to the nurse and was advised she must got to the Emergency Department. The nurse told her that the staff should not have let her leave the facility where had shot administered and should have called an ambulance and did not. The staff did not even have diphenhydramine hydrochloride. She went to the Emergency Department and she was still itchy. It had been since 25Mar2021. The rash was mainly on both sides of her neck and under her ears. It comes and goes. She confirmed outcome as persisting. The broken vessels, turned red, under her eyes were no better. She would get spells of difficulty breathing. She couldn't get a deep breath for about a week after the shot and it has gotten better. No follow-up attempts are needed. No further information is expected.
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| 49 | 2021-05-03 | migraine, feeling hot |
1st Vaccine shot-FRI APR 23, 0900 9hrs later, shot area sore, next morning SAT approx 330am woke up ...
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1st Vaccine shot-FRI APR 23, 0900 9hrs later, shot area sore, next morning SAT approx 330am woke up to migraine that lasted till noon SAT. Afternoon fatigue /tired / dizzy; *started weezing , nose felt stuffy-took 1 puff inhaler. Sun 25- breathing normal, no inhaler, but by mid day both hands-ALL fingers tight / stiff/ bones sore - pain lasted approx 1 day, stiffness in joints lingering. Mon 26- bone joint / stiffness somewhat subsides, constant Left hip bone pain, intermittent heat sensation / like hot flashes- ongoing until current. May 2-3-weezing is back, stuffy nose - 1 puff inhaler per day. May 3- approx. 0500am bright red blood found in stool. Stool normal size / color, blood in feces, no blood when I wipe. No odd smell, no difficulty in moving bowls, no stomach pain. Appetite & sleep pattern is normal, no fever.
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| 49 | 2021-05-04 | numbness, nerve pain |
Developed unilateral neuropathic pain in one thigh, progressing to both thighs; posterior arm numbne...
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Developed unilateral neuropathic pain in one thigh, progressing to both thighs; posterior arm numbness; skin feels sunburned but no skin findings; lower abdominal burning sensation; This is a spontaneous report from a contactable physician. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 11Jan2021 (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, allergies: shellfish. Historical vaccine included 1st dose of BNT162B2 (lot number=59267-1000-1 Lot EJ1685) via intramuscular on left arm on 21Dec2020 for COVID-19 immunization. Concomitant medications included semaglutide (OZEMPIC), atorvastatin, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and enalapril, all taken for an unspecified indication, start and stop date were not reported. Patient developed unilateral neuropathic pain in one thigh, progressing to both thighs. Patient also had posterior arm numbness, skin feels sunburned but no skin findings, also now with lower abdominal burning sensation. The events onset on 22Jan2021. Patient received treatment for the events included prednisone. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.
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| 49 | 2021-05-04 | tingling, pain in extremity, numbness |
Pt (Patient) started feeling confused; She had numbness and tingling on R side; She had numbness and...
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Pt (Patient) started feeling confused; She had numbness and tingling on R side; She had numbness and tingling on R side; pain in R leg; headache; This is a spontaneous report from a contactable Physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration in left arm on 27Jan2021 at 10:45 AM as single dose for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was allergic to penicillin. The patient medical history included TIA, angina, and restless leg syndrome. Concomitant medication included Asprin 81mg daily. On 29Jan2021 at 09:00 PM, the patient started feeling confused, had numbness, and tingling on right side, pain in R leg and headache. AE resulted in emergency room/department or urgent care. Treatment was received for AE. The outcome of the events was unknown.
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| 49 | 2021-05-07 | tenderness |
2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clo...
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2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.
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| 49 | 2021-05-10 | numbness, slurring |
Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet;...
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Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; Slurred speech an difficulty swallowing; Slurred speech an difficulty swallowing; Feet felt super heavy and awkward; Significant urination; muscle aches; low-grade fever; very tired; Slight headache; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; blood sugar plummeted; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:45 (Batch/Lot Number: CR8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Type 1 diabetes, Some allergy medications like zyrtec, topamax, Nortriptyline, allergic asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG); bisoprolol (BISOPROLOL); fexofenadine hydrochloride (ALLEGRA). Historical Vaccine included product=COVID 19, brand=Pfizer, lot number=EP7533, administration date: 04Apr2021, administration time =04:00 PM, dose number =1, vaccine location =Left arm for covid-19 Immunization. Reported Event: About 3 hrs after 2nd dose, lower back pain for 20 minutes followed by numbness in tongue, throat, lips, cheeks, hands, feet, slurred speech an difficulty swallowing. Extreme difficulty thinking. Feet felt super heavy and awkward, like they were bricks. She was a type 1 diabetic and her blood sugar plummeted. She had to stop her basal delivery for an hour, then she halved her basal rate for several hours. After laying down for a few hours, symptoms improved, but worsened when standing. Significant urination every 40 - 60 mins for several hours. In the morning, muscle aches throughout body, low-grade fever, very tired. Slight headache. Adverse event start date: 25Apr2021, Adverse event start time: 06: 30 PM, No treatment for AE. Lab data included blood sugar: plummeted on 25Apr2021. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
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| 49 | 2021-05-10 | muscle spasms |
Post-menopausal menstruation: I have been in menopause since December 2019, which is to say that I h...
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Post-menopausal menstruation: I have been in menopause since December 2019, which is to say that I have not had a menstrual period in almost a year and a half. However, some time after receiving my first dose of the Pfizer COVID19 vaccine , I experienced familiar symptoms of ovulation and PMS (tender breasts, vaginal discharge, and cramping). Then on May 8, 2021 (approx 2 weeks after receiving my second dose of the vaccine), I began menstruating heavily. Very heavily. On May 9 and 10, I continued to menstruate heavily. And, at the time of this writing (May 11), I continue to menstruate.
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| 49 | 2021-05-11 | pain in extremity, weakness, feeling cold |
was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really h...
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was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really hot and dry; slight fogginess; achiness; I tested positive for COVID; Restless body; Nausea; Weakness; Fast heartbeat; Headache; Chills; Muscle pain; Feeling unwell; high fever couldnt shake it at all; got congested/ Stuffy nose; facing joint ache; extremely tired/ Tiredness; Pain in arm/ whole hand just felt achy; Heart hurt when laying on side; Dizziness/ lightheadedness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 15:00 (Batch/Lot Number: EW0164) (at the age of 49 years old) at 1st dose, single for COVID-19 immunisation. Medical history included asthma and hypersensitivity (allergies). Concomitant medications included montelukast sodium (SINGULAIR) taken for hypersensitivity; formoterol fumarate, mometasone furoate (DULERA) taken for asthma; beclometasone dipropionate (QVAR); and levosalbutamol hydrochloride (XOPENEX). On unspecified date in Apr2021, she got pretty sick and swollen lymph nodes. On 23Apr2021, the patient experienced heart hurt when laying on side, high fever couldn't shake it at all, extremely tired/tiredness, headache, chills, muscle pain, feeling unwell, joint pain/ facing joint ache, dizziness/lightheadedness, fast heartbeat, pain in arm and got congested/ stuffy nose. On 24Apr2021, the patient experienced nausea and weakness. On 25Apr2021, the patient experienced restless body, her body also got extremely restless like she had restlessness lesions on whole body. On 26Apr2021, the patient tested positive for COVID-19. On unspecified date, the patient experienced chest pain, she wakes up freezing and her eyes felt really hot and dry and was exhausted, whole hand just felt super achy, slight fogginess and achiness. The patient had vaccination on Friday. On Friday night, she started not feeling well and then was like full blown all the Saturday all the Sunday (as reported). The patient got vaccination last Friday and had a severe reaction to the vaccination. She was extremely upset about it because now she tested positive for COVID. She was not really showing any symptoms and whatsoever before of any COVID like symptoms. Allergy was bothering her but no fever, no chills, no tiredness, no achiness and no nothing. She was nervous because she did realize that it wasn't FDA approved and now she was suffering positive, she started feeling a little better but still tested positive. It was reported that the event started at the time of report, 26Apr2021. The patient had a severe reaction. She had every symptom except that her arm didn't swell. She didn't have any rash in her body. She got pretty sick. She had a high fever couldn't shake it at all, got congested, facing joint ache and extremely tired. Her body also got extremely restless like she had restlessness lesions on whole body she couldn't lay down. The patient reported that it was hurting her so bad and she had to keep moving like she couldn't relax fall free. She had a severe reaction and doctor said she could have COVID knowing it and then got a shot and then came out full blown. The patient stated she was taking Tylenol (50mg, Not clarified), Tylenol Cold and sinus (325mg) for like a flu and Motrin (500mg). She had some time to shake the achiness and the fever was just coming back. She took Tylenol to help rid of fever and achiness, it didn't help and then she tried Tylenol cold and flu that help the little bit then she tried Motrin the Motrin help more with achiness but not hundred percent. The outcome of the events heart hurt when laying on side and fast heartbeat, both recovered on 26Apr2021; events high fever, tiredness, chills, muscle pain, feeling unwell, swollen lymph nodes and dizziness were recovering; events nausea, restless body and stuffy nose were not recovered; and unknown outcome for the other events. No follow-up attempts are needed. No further information is expected.
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| 49 | 2021-05-12 | pain in extremity |
extreme fatigue; malaise/feel sick; the bottoms of my feet hurt so it's hard to walk; the bottoms of...
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extreme fatigue; malaise/feel sick; the bottoms of my feet hurt so it's hard to walk; the bottoms of my feet hurt so it's hard to walk; This is a spontaneous report from a contactable other hcp (Patient). A 49-year-old female patient received bnt162b2 (Pfizer), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 13:15 (Lot Number: er8733) as single dose for covid-19 immunisation at the age of 49-year-old. The patient was not pregnant at time of vaccination. Medical history included herniated disc (l5-s1) and back pain from an unknown date. No known allergies. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced extreme fatigue and malaise/feel sick, the bottoms of feet hurt so it's hard to walk on 28Mar2021 with outcome of not recovered. The events were considered serious as disability. The events resulted in Doctor or other healthcare professional office/clinic visit. The clinical course was reported as follows: I am having extreme fatigue and malaise. Prior to receiving the vaccine I had NO health issue other than back pain, but now I have extreme fatigue, the bottoms of my feet hurt so it's hard to walk, (and I'm fit) and I feel sick ALL OF THE TIME. Follow up needed, further information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-02 | pain in extremity |
Moderate to severe left arm pain. for 12 days now post first covid vaccine shot. Mild neck stiffnes...
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Moderate to severe left arm pain. for 12 days now post first covid vaccine shot. Mild neck stiffness also noted. The worse pain on left arm felt on first day, then slowly got better after. However still with Limited mobility (my left arm movement very guarded due to feeling of soreness on the affected arm), stiffness on left arm. Ice pack, advil and tylenol, and sometime with cyclobenzaprine, which I thought would help, but did not help.
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| 50 | 2021-01-03 | feeling cold |
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to ...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.
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| 50 | 2021-01-03 | pain in extremity |
Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortne...
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Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortness of breath. Sore left arm all the way down arm. Rested and took ibuprofen. Today I returned to work still having headache
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| 50 | 2021-01-03 | pain in extremity |
After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was e...
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After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was extreme pain, I couldnt lay on it. Then about 3-4 days later, the color is blue and black. Then I started having cold symptoms. Like a head cold. On my left side, my arm and my leg is sore. In addition, my face broke out too. I did not go to the ER. I let Employee health examine my arm . No ER visit
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| 50 | 2021-01-04 | weakness |
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her l...
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allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
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| 50 | 2021-01-04 | feeling hot |
5 MINUTES AFTER INJECTION FELT WARM ALL OVER. HEART RATE 99 BP 180/101. SENT TO ER. GIVEN BENADRYL A...
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5 MINUTES AFTER INJECTION FELT WARM ALL OVER. HEART RATE 99 BP 180/101. SENT TO ER. GIVEN BENADRYL AND DISCHARGED TO HOME STABLE. EMPLOYEE REPORTS HER HR INCREASED THAT NIGHT AND NEXT DAY FOR A FEW MINUTES AND THEN COMPLETELY RESOLVED BY THE THIRD DAY.
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| 50 | 2021-01-04 | flushing |
After vaccine she felt flushed, heart rate 99 bp 181/105. Sent to ER. She reported chest tightness a...
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After vaccine she felt flushed, heart rate 99 bp 181/105. Sent to ER. She reported chest tightness and palpitations while in the ER. Given Benadryl and discharged stable. She reported that her heart rate went up again for a few minutes that night at home and next day and then she was fine.
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| 50 | 2021-01-04 | hot flush |
BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase flui...
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BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase fluid intake, and extra Valsartan x 1.
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| 50 | 2021-01-04 | numbness | left sided numbness |
| 50 | 2021-01-04 | migraine |
Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Naus...
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Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Nausea; This is a spontaneous report from a contactable Registered nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: E10140), via an unspecified route of administration on 23Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included ongoing Diabetic for at least 7 years, ongoing hit in the head (She was a psych nurse and was hit in the head at work maybe a month to two months ago in 2020. She did have headaches from that incident). There were no concomitant medications. The patient experienced headache on 23Dec2020, fever on 24Dec2020 14:30, nausea on 23Dec2020, cough on 24Dec2020, really lazy on 24Dec2020, chills on 24Dec2020 14:30, body aches on 24Dec2020, sometimes her headaches were migraines on an unspecified date. Specifically, it was reported that when she first got the vaccine, she didn't have anything but a headache and a little bit of nausea. She had worked the night before and didn't sleep before the shot. So maybe that had a part in it. She was a diabetic. It was fine, and no big deal that night. Then, the next day on 24Dec2020 at 2:30 pm she woke up and she was freezing and couldn't get warm. She had chills and a fever of 102.1 on 24Dec2020. She took Tylenol, and it came down to 101 on an unspecified date in Dec2020. All weekend long, she has had a fever. It has been controlled by Tylenol. She had chills so bad she had to use her heated blanket. She has had a cough. She has been really lazy. She has had chills and body aches. She has had nausea here and there. She has had a headache. She received the vaccine on the 23Dec2020, which was Wednesday. She had to stay 15 minutes after. That is when she developed the headache and nausea. Sometimes her headaches were migraines. She developed the fever on 24Dec2020 14:30. Or noticed the fever when she woke up. Her fever was 101.2 this morning on 28Dec2020. Within the 15 minutes of getting the vaccine, she developed the nausea. It has gotten better. Her body aches are getting better. She still has chills when she is running a fever. She has gotten better overall. Thursday (24Dec2020), Friday (25Dec2020), and Saturday (26Dec2020) it was awful. Sunday (27Dec2020) the symptoms lightened up. Today (28Dec2020) she was better. She still had a headache and fever this morning, but nothing like she had been feeling. She felt like dying those days. She was a Psych nurse, and she got hit in the head. So she did get headaches from that incident. They are about the same as these headaches so she didn't know if it was related. It just went along with the flu like symptoms. But sometimes these headaches were migraines. Therapeutic measures were taken as a result of fever and chills. The outcome of the events headache, chills was not recovered. The outcome of the event really lazy was recovered on 27Dec2020. The outcome of the events fever, nausea, cough, body aches was recovering. The outcome of the event migraines was unknown.
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| 50 | 2021-01-04 | pain in extremity, feeling of body temperature change |
headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, som...
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headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,
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| 50 | 2021-01-04 | pain in extremity | The patient reported ankle, leg and hip pain for which she is taking Motrin |
| 50 | 2021-01-04 | pain in extremity |
underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting he...
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underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting her; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH5730), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunisation. There were no medical history nor concomitant medications. The consumer received the vaccine on the 28Dec2020. She doesn't have a prescribing doctor. During the night after receiving the vaccine, her body was hurting her on 28Dec2020. She started to develop side effects 4-5 hours after receiving the vaccine. The side effects started during the evening the same day she got the shot. On 29Dec2020, the side effects were worse, she had a headache, and her arm hurt a little bit more. She then realized under her armpit was swollen a little bit / underneath her armpit was a little bit swelling on 30Dec2020. She talked to someone earlier about this and they told her to call her doctor. She had a lot of headaches. Everything is hurting her. The outcome of under her armpit was swollen a little bit was not recovered, of her arm hurt a little bit more was unknown. The outcome of the other events was recovering.
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| 50 | 2021-01-05 | weakness |
Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115...
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Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115; she was not feeling right, so she took the day off from work today; Lightheadedness; wobbly; she felt weak; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, expiration date: Apr2021), via an unspecified route of administration at right deltoid on 29Dec2020 17:45 at a single dose for Covid-19 immunization. Medical history included asthma from 2003 and ongoing, tachycardia and major surgery. Concomitant medication included maintenance inhaler (unspecified) for asthma. Patient was officially diagnosed with asthma in 2003. She said her asthma was controlled, and she takes a maintenance inhaler every day. She said she has been taking the same maintenance inhaler since she was first diagnosed with the asthma. She said she rarely uses a rescue inhaler. Reported she was prescribed the Metoprolol Tartrate 25mg for her tachycardia that she had after her major surgery, but she did not take the full 25mg dose during that time. She said she hasn't had taken the Metoprolol Tartrate 25mg in almost a year, clarifying it was last Jan2020 that she used the Metoprolol Tartrate. The patient previously received a flu shot in Oct2020, and felt rundown for a day afterwards, but that she always does after she receives a flu shot. She said she had no heart issues after receiving the flu shot in Oct2020. The patient who is a registered nurse reported she received the COVID-19 vaccine last night at work, on 29Dec2020, at 5:45PM, and had experienced some tachycardia after receiving the vaccine. Reported the COVID-19 Vaccine was offered through her employer. She said the COVID-19 vaccine was optional and offered to all employees if they work at the hospital. She experienced the tachycardia at 11:00 PM last night, 29Dec2020. She said her normal resting heart rate is between the high 60s to low 70s. She said her heart rate at 11:00PM last night was at around 100, clarifying she was not running a fever at that time. She stated after she received the COVID-19 vaccine, she was not feeling right, so she took the day off from work today, and slept in. She said when she woke up this morning (in Dec2020), she still didn't feel right, saying she felt weak and wobbly, and when she checked her pulse it was 115. She said she does have a past history of tachycardia. She said a year ago she had major surgery, and she had tachycardia after the major surgery. She said the tachycardia eventually went away, but she did have to see a cardiologist and take a beta blocker. She said she took a tiny dose of the beta blocker this morning, and called the cardiologist to let him know what was going on. She said she has not heard back from the cardiologist yet. She said the tachycardia went away once she took the beta blocker this morning. She said she took the beta blocker because her heart rate was going higher, and higher. She said she didn't want to end up like last year after her major surgery with a heart rate in the 170s. She said the tachycardia she was experiencing after receiving the COVID-19 Vaccine was not normal for her. She said once she got over the major surgery last year, her heart rate was fine. Reported her employer was making employees wait around for 15 minutes after the employees received the COVID-19 Vaccine to make sure no one had a major reaction to the COVID-19 Vaccine. She said after she received the COVID-19 Vaccine, she waited around longer than the 15 minutes. She said she felt weird after she received the COVID-19 Vaccine and thought maybe she was experiencing anxiety. She said she was lightheaded on 29Dec2020 after she received the COVID-19 Vaccine and completed a report right then on the website. She said the website is for reporting adverse events, and she was sent a website link to complete the adverse event reporting. She said she signed into the website link while she was still at the hospital. She said one of the website's first questions asked was how she was feeling. She said the question made her wonder if her lightheadedness was due to her heart rate being up because she becomes lightheaded when that happens. She clarified she reported only the lightheadedness on the website, and not the tachycardia. She said her lightheadedness got better and she was fine, and then at 11:00PM the tachycardia hit her like a switch. Reported this morning she felt fine, and then all of sudden she wasn't fine. Tachycardia Treatment: Reported she took a 8.5mg dose, or one quarter of a 25mg tablet (as provided by the reporter) of the beta blocker Metoprolol Tartrate 25mg tablet this morning and called her cardiologist to let him know. She said she split the Metoprolol Tartrate 25mg tablet this morning, and only took a quarter of the 25mg tablet (reported as a 8.5mg dose by the reporter). Reported she believes 100% that her tachycardia was caused by the COVID-19 Vaccine, saying she has been fine up until receiving the COVID-19 Vaccine. She said she got the COVID-19 Vaccine because she was afraid of getting the COVID-19 Virus with her asthma. She said she has no other preexisting conditions besides the asthma. Reported she is not going to get the second COVID-19 Vaccine dose. She said it was scary when her heart rate shot up out of nowhere. She said the COVID-19 Vaccine is the only thing different she has done. She said before the COVID-19 Vaccine, she was completely fine. Patient asked if the Pfizer DSU agent had heard of anyone else who has experienced tachycardia after receiving the COVID-19 Vaccine. The outcome of the event tachycardia was recovered in Dec2020, event lightheadedness was recovering and unknown for the other events. The reporter assessed the event 'tachycardia' as Serious (Medically Significant).; Sender's Comments: Based on the close temporal relationship, the association between the event tachycardia with BNT162b2 can not be fully excluded. The medical history of tachycardia and asthma medication may be contributory as well. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-05 | facial pain |
. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the...
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. Woke up in the middle of the night with acute facial pain on the left side. From the scalp to the jaw line including the roof of my mouth. I took 3 Advil at the time and the woke again a couple hours later and took 2 more. In the morning it seemed fine. I have noticed a very slight change to my lower left eye - it seems lower.
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| 50 | 2021-01-05 | pain in extremity |
Had welt at injection site the size of golf ball with redness spreading from site out about the size...
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Had welt at injection site the size of golf ball with redness spreading from site out about the size of a baseball. Site itched, redness with heat coming out of site for several days. Arm soreness for 5-6 days afterwards. Injection give on 12/22/2020 and today 1/6/2021 there still is soreness at injection site and slight redness of the area.
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| 50 | 2021-01-05 | tingling, numbness |
Employee received the COVID vaccine on 12/21/2020. Employee reports her symptoms started on 12/30/20...
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Employee received the COVID vaccine on 12/21/2020. Employee reports her symptoms started on 12/30/2020. Employee states she cannot turn key in door or use right arm and hand normally. Employee reports parasthesias including slight numbness and tingling. Employee reports pain that is in the back of her shoulder that is rated as 2-3/10. Employee states all of her symptoms have been the same since 12/30 and have not worsened and no new symptoms had started.
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| 50 | 2021-01-05 | tingling |
Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened ...
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Pfizer-BioNTech COVID-19 Vaccine: 1/4/21 Started with dull ache pain to left upper tooth, worsened with chewing and eating on left side on day one. Symptoms became worse during the day with electric like pain radiating to the maxilla, TMJ and temple. Symptoms persisted as episodic aching and electrical radicular pain 1/5 so I saw my dentist in the afternoon with a negative work up on exam and xray. Pain worsened and pattern expanded to include pain under tongue on left side. There are times there is no pain and then the pain will come on without known cause, but anytime with eating or chewing the pain starts and is exacerbated. Also impacted by hot items/drinks. I have tried ibuprofen and tylenol sinus medications without impact on episodic flares of pain.
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| 50 | 2021-01-05 | tingling | Pfizer-BioNTech COVID-19 Vaccine EUA left arm and leg persistent paresthesias for two weeks |
| 50 | 2021-01-05 | tingling |
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w...
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swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
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| 50 | 2021-01-05 | tremor |
Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began...
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Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began after 10 hours - reduced pain after 24 hours, but still present Headache - began after 8 hours - still present Cough - began after 8 hours - still present Sore Throat - began after 8 hours - still present Shaking hands - began next morning - still present
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| 50 | 2021-01-06 | burning sensation, feeling hot |
warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u...
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warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone
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| 50 | 2021-01-06 | depressed level of consciousness |
feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chill...
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feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship. The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-06 | numbness, tingling |
Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive ...
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Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive impaired, dizzy, disoriented
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| 50 | 2021-01-06 | migraine |
MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN A...
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MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN AND SWELLING TO INJECTION SITE BEGAN AT APPROXIMATELY 10:00 PM. TOOK TYLENOL 500MG AT 1:45pm THEN AGAIN AT 10:30 pm, also applied ice to injection site.
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| 50 | 2021-01-06 | pain in extremity, tingling, numbness, feeling hot, flushing |
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf...
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The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
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| 50 | 2021-01-06 | pain in extremity |
Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 he...
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Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 headache still present but improve. Arm is mildly sore - much better
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| 50 | 2021-01-06 | tingling | tinnitus, face tingling, lymph pain, general muscle pain |
| 50 | 2021-01-07 | weakness, tingling |
Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body...
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Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body." She was monitored and placed in a reclining position which did not help her. At 11:30 am client reported feeling weak. EMS was called and client was transported to hospital. She was given IV fluids and monitored and released 2-3 hours after the incident. She has not had any other problems since taking the vaccine.
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| 50 | 2021-01-07 | weakness |
Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf ...
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Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf of his mother). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 31Dec2020 between 09:00 and 10:00 at single dose on left arm for covid-19 immunisation (works in food staff at a hospital). Medical history and concomitant medications were none. Patient experienced: difficulty breathing and weakness on 01Jan2021. Events were ongoing and had gotten a little worse today (05Jan2021). The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.
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| 50 | 2021-01-07 | cold sweat, seizure |
approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness o...
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approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness of breath and blocky red rash on neck and torso. immediately drove to urgent care, was not allowed in for treatment due to did not have phone on med to call for appointment. went home, took 50 mg benadryl and pepcid po. had tachypnea and continued blocky rash on neck and torso with chest tightness. took albuterol inhaler. approx 0200 had rigors/ seizure. with continued prior symptoms. took additional 50 mg benadryl and albuterol inhaler. temp 99.0. in am 1/6 called urgent care to make appointment thought neded steroid. they said to go to ED. was afraid to go to ED in fear would be intubated as had before for allergic reaction. took additonal 50 mg benadryl, pepcid and zyrtec along with a shot of epi pen. within minutes, all symptoms ressolved. will be calling place where I got vaccinated today to report. 1/8/21
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| 50 | 2021-01-07 | cold sweat |
20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/...
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20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/ torso. went to urgent care, wouldnt let me enter becuase didnt have a phone on to call. Went home, took 50 mg benadryl pepcid PO. took albuterol inhaler due to tachypnea. tried to wait it out at home. apporox 0200, rigors/ seizure tachypnea continued with respirations ranging 32-38/min. took 600 mg ibuprofen and albuterol inhaler, additional 50 mg benadryl. continued blocky rash. next day, called urgent care asking for appointment, thought needed steroid, they instructed to go to ED to check for covid. explained to them not covid, but allergic reaction. afraid to go to ED in thinking may need to get intubated. approx 1030 am, had 2 addtional episodes of rigors/ seizure. temp never above 99.0 F. found epi pen in house and used it. no further rigors, no further tachypnea, rash disappeared.
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| 50 | 2021-01-07 | feeling cold |
10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were ...
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10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were burning. I went to bed under 3 blankets and couldn't get warm. 5 hours later, the chills went away, but the pain persisted. 3 hours later, I took tylenol for the pain and felt much better 1 hour later.
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| 50 | 2021-01-07 | flushing, feeling hot |
sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness t...
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sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness that occurred within 3 minutes of injection, no tachycardia, hypertension noted, no wheezing, lungs clear, no SOB, treated with Benadryl and Pepcid with close observation for 30 minutes
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| 50 | 2021-01-07 | flushing |
Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the...
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Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the vaccination, she started to have difficulty breathing and chest tightness. No wheezing. Pt had neck and face flushing without hives. Pt tachycardic at 120 bpm. SOB and tachycardia lasted 1.5 hrs. Pt denies anxiety, dizziness or GI symptoms. Pt monitored and advised to avoid 2nd dose of mRNA vaccine; pt declined to see PCP
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| 50 | 2021-01-07 | pain in extremity, weakness |
headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the bod...
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headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the body, joint pain ( hands, wrist, feet, hips, knees, spine, neck), insomnia, general malaise, fatigue, and lower grade fever. Most symptoms lasted about 7 -10 days. However, it is now day 20 after the initial vaccine and I still have joint pain that has not gone away. esp in hands, wrists, and feet. When I sleep I still wake up with all my joints hurting it gets better as I start moving but the wrist, hands, and feet pain has not gone away. This pain will wake me in the night when I change positions. I called my doctor today to inquire if it is a good idea if I should take the second dose because the first dose made me so dibiliated. Awaiting for a response. I am due to take the second vaccine on 2/9/21.
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| 50 | 2021-01-07 | tingling, numbness, facial pain |
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong...
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sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
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| 50 | 2021-01-07 | tingling, numbness |
decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain s...
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decreased sensation to light touch of right anterior distal thigh with intermittent shocklike pain starting on 12/24/20 which has gradually improved with only rare episodes of numbness as of today 1/8/20. No weakness, back pain or injury.
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| 50 | 2021-01-07 | throat numbness |
Patient experienced swelling of the throat and numbness in the neck within 10-15 minutes of vaccine ...
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Patient experienced swelling of the throat and numbness in the neck within 10-15 minutes of vaccine administration while still under observation. Two oral Benadryl tablets were given (50mg total) and epipen was administered in the left thigh. 911 was immediately called and patient was taken away in ambulance
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| 50 | 2021-01-08 | weakness |
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and...
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01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
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| 50 | 2021-01-08 | flushing | Flushing, kept in Observation area for 30 minutes |
| 50 | 2021-01-08 | migraine |
About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and B...
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About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80. Began to drop after about another 15 minutes. Followed by migraine for the rest of the day. Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes. Injection site hurts to the touch, but otherwise is painful. Throat hurts a little and a little congested, but probably unrelated.
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| 50 | 2021-01-08 | pain in extremity |
Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subseq...
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Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subsequently diagnosed with shingles on 1/7/21
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| 50 | 2021-01-08 | pain in extremity |
Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left a...
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Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left arm and severe headache 12/19/20
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| 50 | 2021-01-08 | tingling, numbness | Tingling and a feeling of numbness to R side of face |
| 50 | 2021-01-08 | tingling |
Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever...
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Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever, fatigue
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| 50 | 2021-01-09 | weakness |
Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness ...
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Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness and weakness. Got home at around 1545hrs and I continued to have diarrhea all night until Saturday -all day. Diarrhea settled at around 1800hrs.
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| 50 | 2021-01-09 | flushing |
Within 15 minutes of vaccine administration, I developed difficult swallowing, scratchy throat and s...
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Within 15 minutes of vaccine administration, I developed difficult swallowing, scratchy throat and severe flushing of face, neck and chest. This lasted about 1.5 hours. Symptoms resolved within 2 hours. Treated with oral Benadryl and Tylenol
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| 50 | 2021-01-09 | pain in extremity | Low grade fever, large hard painful lump in right arm, achy joints |
| 50 | 2021-01-09 | tenderness |
After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the ...
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After first shot notice a lump under my left armpit area. It didn?t quite go away and the after the second dose the lump got bigger and it?s a little tender this time. It?s been two days since the 2nd injection and doesn?t seem to be going down in size.
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| 50 | 2021-01-10 | breast pain |
Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at sit...
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Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at site of injection that progressed to L sided lymph node swelling on day after vaccine and has progressed to Left side lymph node swelling in L side of neck, axilla, Left side of breast, chest wall with pain still present and worsening 4 days after vaccine given (2nd dose)
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| 50 | 2021-01-10 | pain in extremity |
First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but ...
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First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but my armpit was so painful (felt like stabbing sensation). This lasted until around 2:00 pm Saturday. I felt ok except for being tired and armpit still hurting quite a bit. On Sunday, I was very tired and slept during the day and went to bed around 8:30 pm feeling like I had a slight sore throat, tired and mildly nauseous. My armpit still hurt quite a bit. I woke up Monday at 5:30 am and showered and was profusely sweating when I was getting ready for work - my temperature was 100.6 so I took 800 mg of Ibuprofen to help with the temp and the pain in my armpit. I did not go into work. I am still tired and my current temp is 100.1 (12:30pm) and sweaty. I do feel as though the severity of my armpit pain is lessening but it is still bothersome.
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| 50 | 2021-01-11 | weakness |
GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DU...
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GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY MD, XRAY ON LEFT SHOULDER DONE ON 1/6. ON 1/7, STIFFNESS WITH SEVERE PAIN UPON MOVEMENT NOTED ESP IN THE MORNING. ULTRASOUND WAS DONE ON 1/8, NOTED BICEPS TENOSYNOVITIS. ORTHOPEDIC SURGEON SEEN ON 1/11, W DX OF ADHESIVE CAPSULITIS, SUGGESTED FOR PT FOR NOW, AND OFF WORK, AND TO BE FOLLOWED UP ON 2/1 BY SAME ORTHO SURGEON. WILL NOT OFFER CORTISONE SHOT FOR NOW AS IT MAY COMPROMISED OR WEAKEN IMMUNE RESPONSE, IN WHICH MY SECOND COVID SHOT DUE ON THE 15TH OF JANUARY. FIRST APPT FOR PT ON 1/15
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| 50 | 2021-01-11 | burning sensation, numbness, tingling |
Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensif...
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Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensified next day. balance was off, numbness and tingling throughout body. Went to ER. Diagnosed Paresthesia
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| 50 | 2021-01-11 | burning sensation |
day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nod...
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day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nodes. At approximately 30 hours after injection - on face, neck, scalp - burning, blotchy, red rash (item 20 - recovered? yes to rash bcz I took Benadryl. lymph nodes still swollen)
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| 50 | 2021-01-11 | difficulty speaking |
INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PAR...
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INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PARNASAL INFLAMATION AND HOARSLY.
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| 50 | 2021-01-11 | feeling hot |
both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ...
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both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date. No follow up attempts are possible. No further information is expected.
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| 50 | 2021-01-11 | feeling of body temperature change, pain in extremity |
not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she wa...
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not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.
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| 50 | 2021-01-11 | migraine, feeling cold | Chills, body aches, migraine, nausea. Improving |
| 50 | 2021-01-11 | muscle spasms | Fever, headache, nausea, muscle spasms, sensitive to noise and light, loss of appetite, very tired |
| 50 | 2021-01-11 | muscle spasms |
Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; Thi...
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Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; This is a spontaneous report from a contactable healthcare professional, a physician assistant. A 50-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included tachycardia, tension headache, and glucose tolerance impaired. Concomitant medications included rosuvastatin calcium (CRESTOR), gabapentin (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN). On 18Dec2020, the patient experienced hypokalemia, hypomagnesemia, hypocalcemia, tetany, muscle cramps, and hemoglobin dropped little bit. The clinical course was as follows: The patient received the vaccine and about 30 minutes later she started to "feel bad". She went to the urgent care and about an hour after they took her to the emergency room (also reported as hospital). She had a complete blood count, complete metabolic panel, and magnesium level done on the 18th, 21th, 23rd, 26th, 28th, 30th of Dec2020 and then again on 04Jan2021. On 18Dec2020, her initial lab test showed potassium: 2.6, hemoglobin: 10.2, magnesium: 1.2, and calcium: 5.7. The physician assistant reported that a potassium of 2.6 was critically low and a hemoglobin was 10.2 was about normal for the patient. She received oral medications of potassium 20 mEq twice a day and calcium and magnesium supplements once a day. On 04Jan2021, lab data showed: potassium: 4.2, magnesium: 2.1, calcium: 9.5 and hemoglobin: 14.5. Per the reporting physician assistant, the above levels went back to normal but stated she had to be supplemented to get back to that point. The clinical outcomes of the hypokalemia, hypomagnesemia, hypocalcemia, and hemoglobin dropped little bit were recovered on 04Jan2021; while that of the tetany and muscle cramps, were unknown. The physician assistant assessed the events as related to the suspect vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-11 | muscle twitching |
One hour after receiving the COVID Pfizer vaccine, I experienced tightness in my throat. The tightn...
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One hour after receiving the COVID Pfizer vaccine, I experienced tightness in my throat. The tightness lasted about one hour, then I began with all over muscle shaking, which lasted about five hours. I had chills with the shaking, and sat on the sofa with a blanket and heater until the symptoms resided.
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| 50 | 2021-01-11 | pain in extremity, weakness |
Approximately 11 hours after the vaccination my arm became very sore, to the point that it was diffi...
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Approximately 11 hours after the vaccination my arm became very sore, to the point that it was difficult to lift it. I then developed body aches and chills. I did not develop a fever that I know of but the body aches and chills continues throughout the night. During the night a severe headache developed as well as generalized weakness. I was unable to sleep and had to miss work the next day. Because the weakness and body aches continue, I plan to miss a second day of work tomorrow. I treated the symptoms with Tylenol.
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| 50 | 2021-01-11 | pain in extremity, bell's palsy, facial paralysis |
Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 m...
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Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in right deltoid. Pain progressed over the next 5 days to arm and left eye. Dizziness, mouth drooping, and numbness developed. Went to ED and diagnosed with Bell's Palsy. Evaluated in ED for possible causes. Vital signs stable. CVA ruled out. Patient given ketorolac, droperidol, and IV fluids for her headache. Prescribed steroids and acyclovir for Bell's Palsy treatment. Prescriber instructed patient to return to ED immediately if symptoms worsen or additional symptoms develop. Follow up with patient on 1/5/21 with patient reporting some improvement in symptoms. Patient reported having a headache for 2 weeks straight prior to presenting to the ED on 1/3/21. Vaccine was administered on 12/28/21. Unsure if the Bell's Palsy was a result of the vaccine or some other inciting factor.
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| 50 | 2021-01-11 | tingling, flushing, tremor |
30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tig...
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30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tightness and nose tingling, heart felt like it was racing. Blood pressure was 150/80 , Pulse 108, respirations 22
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| 50 | 2021-01-11 | tingling |
Patient reported tightness in her jaw muscles & tingling along her jawline within 10 minutes of rece...
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Patient reported tightness in her jaw muscles & tingling along her jawline within 10 minutes of receiving the COVID vaccine. Fifty mg of liquid diphenhydramine was administered & the patient was monitored for another 45 minutes. She reported her symptoms slowly improved over time. No throat or tongue swelling was reported at any time.
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| 50 | 2021-01-11 | tremor |
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; inject...
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Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
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| 50 | 2021-01-12 | feeling hot |
Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with resi...
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Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with residual left cheek swelling.
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| 50 | 2021-01-12 | tingling, pain in extremity |
Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm sh...
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Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm shoulders pain body aches and fever
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| 50 | 2021-01-13 | feeling hot | Swollen lymph node warmth area fever pain |
| 50 | 2021-01-13 | numbness |
Patient complained of numbness r shoulder blade and up right neck. Denies other symptoms. Reports sa...
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Patient complained of numbness r shoulder blade and up right neck. Denies other symptoms. Reports same symptoms after first dose of Pfizer and lasted ~ 4 days after. Observed x 30 minutes. BP 128/80 HR 71 sat 100%
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| 50 | 2021-01-13 | migraine |
Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontan...
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Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient had the vaccine at her work and like in the night, in the morning, she started experiencing side effects. She was having like chills and muscle pain and she called her doctor and they told her that she had to report the side effects. She felt like real tired and she was having a headache. The patient took some Excedrin for headache, it's like migraine. She took two in the morning at 8:30. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-01-13 | muscle spasms |
"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my ar...
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"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my arms and legs. My arm is red and lumped up but not as bad as it was second day. Also having cold chills as well."
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| 50 | 2021-01-13 | pain in extremity, weakness |
Fatigue/headache/body malaise one hour after 2nd dose of COVID 19 vaccine. Now c/o (L) arm pain rad...
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Fatigue/headache/body malaise one hour after 2nd dose of COVID 19 vaccine. Now c/o (L) arm pain radiating to (L) elbow/(L) leg pain/dizziness/diaphoresis weakness to (L) lower extremity.
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| 50 | 2021-01-13 | pain in extremity |
FATIGUE/HEADACHE/BODY MALAISE ONE HOUR AFTER 2ND DOSE OF COVID 19 VACCINE. NOW C/O L ARM PAIN RADIA...
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FATIGUE/HEADACHE/BODY MALAISE ONE HOUR AFTER 2ND DOSE OF COVID 19 VACCINE. NOW C/O L ARM PAIN RADIATING TO GIRON/R LEG PAIN/DIZZINESS/DIRPHORESIS WEAKNESS TO L LOWER EXTREMITY.
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| 50 | 2021-01-13 | pain in extremity |
It is causing a decrease in mobility and effecting her mobility; soreness in her arm; This is a spon...
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It is causing a decrease in mobility and effecting her mobility; soreness in her arm; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EL1284) via an unspecified route of administration on the left arm on 23Dec2020 17:20 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine and was still experiencing soreness in her arm for more than 2 weeks. She wanted to know if she should get the second dose. She also wanted to know if she does get the second dose can she ask for a different needle size and different injection site. She had soreness in her arm on 24Dec2020 and if it was related to the COVID Vaccine. The soreness in her arm is in the left arm where the site of injection was. She noticed when woke up like am in the morning. She had an X-Ray done yesterday 06Jan2021 and it did not show any type of dislocation or fracture. She stated she knew the soreness in the arm was most commonly seen 48 hours after getting the injection, the COVID shot, she knew this was a normal side effect. However, she was wondering why she is still experiencing this and it's going on 2.5 weeks now. She later clarified when speaking to previous agent they were providing the number to speak to someone more about the side effects and questions. She wanted to know why she was having it more than 2.5 weeks after getting it. She has read literature and she saw there where it can occur, but it indicated it would not be more than 72 hours. She was worried about this. It was causing a decrease in mobility and effecting her mobility. There was no history of all immunizations with the Pfizer Vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to the emergency room or physician office. Outcome of the event soreness in her arm was not recovered, while unknown for the other event.
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| 50 | 2021-01-13 | tremor, cold sweat |
Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdo...
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Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdominal pain.
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| 50 | 2021-01-14 | weakness |
1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tendernes...
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1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tenderness, body/muscle aches. 1/12/2021 @ 2300hrs - Body/muscle aches, chills. 1/13/2021 @ 0300hrs - Body/muscle aches, chills, fever 99.0, general malaise. 1/13/2021 @ 0600hrs - Body/muscle aches, chills, general malaise, no energy. Did not report to work. 1/13/2021 @ 1000hrs - Symptoms continued. Took Advil 600mg PO. Slept from 1030-1230hrs. 1/13/2021 @ 1230hrs - No energy, very tired, rested the entire day. Took Advil 600mg every 4 to 6 hours. 1/13 to 1/15/2021 - Left arm site tenderness with raised, hard area at injection site. Left armpit soft tissue swelling, possibly lymphadenopathy. 1/15/2021 - Reported symptoms to provider, awaiting appointment.
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| 50 | 2021-01-14 | feeling hot, hot flush |
Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to ...
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Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
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| 50 | 2021-01-14 | flushing |
Patient reported feeling throat tight, tongue thick - lightheaded with fluctuating temperature : bp...
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Patient reported feeling throat tight, tongue thick - lightheaded with fluctuating temperature : bp 168-144/100-94 during episode with pulse ox 96%. patient was rosy and flush. Administered 1 epinephrine pen and 50 mg oral diphenhydramine . patient monitored from 3 pm until 530 pm and advised to see primary care provider
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| 50 | 2021-01-14 | pain in extremity, weakness |
feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; wea...
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feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; weak; her middle finger and index finger feel tight; her left shoulder feel really tight but has full sensation; unable to lift her left arm more than 30 degrees; pain in her arm; unable to sleep very well last night; This is a spontaneous report from a contactable nurse (patient) reported that a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 08Jan2021(yesterday morning, Deltoid Left) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical Vaccine was included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Patient received her second dose and within an hour she started feeling extremely tired, had a severe headache. When she woke up she noticed a large palpable knot on her left upper lateral deltoid in Jan2021. She stated that the injection went well and noticed no problems when she received the shot. At this time she was still very weak, her headache was still severe and she has noticed that her middle finger and index finger feel tight and her left shoulder feel really tight but had full sensation. She stated that she was unable to lift her left arm more than 30 degrees. She does not have a primary care physician at this time as she just relocated to her current residence. She stated that she was so uncomfortable due to the pain in her arm she was unable to sleep very well last night. She was going to seek medical attention at a local urgent care to be safe. The outcome of events, fatigue, knot on her left upper lateral deltoid, finger feel tight, shoulder feel really tight, unable to lift her left arm more than 30 degrees, pain in her arm, unable to sleep very well was unknown. The outcome of events of severe headache, weak was not recovered. Information about lot/batch number has been requested.; Reporter's Comments: her symptoms online per the Fact Sheet instructions. Potential
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| 50 | 2021-01-14 | pain in extremity |
Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable co...
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Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 9899), via an unspecified route of administration in right arm, on 21Dec2020 at 19:00, at a single dose, for COVID-19 immunization. The patient's medical history included attention deficit disorder (ADD), gastroesophageal reflux disease (GERD), migraines, allergies to latex and cinnamon (severe), gluten intolerance, and lactose intolerant. The patient's concomitant medications included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), candesartan, galcanezumab GNLM (EMGALITY), glucosamine, magnesium, melatonin, iron, escitalopram oxalate (LEXAPRO), omeprazole, ursodiol, colecalciferol (VIT D3), and buspirone hydrochloride (BUSPAR). The patient previously took acetylsalicylic acid (ASPIRIN), fentanyl, and codeine and experienced allergies to the medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 22Dec2020 at 9 AM, the patient's arm was very sore and had some muscle aches and scratchy throat. These lasted a little over 48 hours (2 days). The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Dec2020.
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| 50 | 2021-01-14 | tingling, facial paralysis, numbness |
HAD WITHIN A MINUTE TINGLING AND NUMBNESS OF THE LEFT SIDE OF THE FACE AND LEFT ARM. MORE PRONOUNCED...
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HAD WITHIN A MINUTE TINGLING AND NUMBNESS OF THE LEFT SIDE OF THE FACE AND LEFT ARM. MORE PRONOUNCED LEFT SIDE OF THE FACE, NUMBNESS LIKE I WAS GIVEN LOCAL TO THE LEFT SIDE OF MY FACE. COULD BARELY FEEL MY FACE ONLY LEFT SIDE. FELT I WAS DROOPING. TEETH WAS TINGLING. MY LEFT ARM GOT BETTER IN 2 HOURS. THERE WAS NO WEAKNESS. HOWEVER MY LEFT SIDE OF THE FACE WAS NUMB AND TINGLING LASTED APPROXIMATELY 2 DAYS. INTENSITY OF THE NUMBNESS GOT BETTER BY THE EVENING OF THE SHOT. I TOOK 325 MG OF ASPIRIN WITHIN 15 MIN OF THE EPISODE . MY PULSE, BP AND OTHER VITALS NORMAL. MAIN WAS MY LEFT SIDE OF THE FACE .
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| 50 | 2021-01-14 | tingling |
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta...
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We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
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| 50 | 2021-01-14 | tingling |
I woke about 3 am and had paresthesia of my fingers on my right hand. Thumb, index, middle and ring ...
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I woke about 3 am and had paresthesia of my fingers on my right hand. Thumb, index, middle and ring fingers. I Thought that I had slept in my hand wrong.; The discomfort at injection site woke me again last night and had the same feeling. It has remained after waking this morning; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 7530) solution for injection, via an unspecified route of administration on right arm on 08Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies to food, medications, or other products. The patient was not pregnant. Patient had the first dose of BNT162B2 on 18Dec2020 (lot number: EK 7530). Concomitant medications included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES), and melatonin at 1.5 mg, daily. The patient reported that on 09Jan2021, she woke about 3 am and had paresthesia of her fingers on her right hand, thumb, index, middle and ring fingers. She thought that she had slept in her hand wrong. The discomfort at injection site woke her again last night (09Jan2021) and had the same feeling. It has remained after waking this morning. No treatment was given. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for Covid-19 since vaccination. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.
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| 50 | 2021-01-15 | hot flush |
I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 1...
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I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 10 hours later-then had severe neck down my entire back pain, with restlessness, chills, and headache-this lasted about 24 hrs. The pain subsided and then I had liquid stooling for about 8 hrs with intermittent hot flashes. I am still having an "odd" feeling in my head, like foggy sensation, vertigo, and the sweating episodes as we speak.
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| 50 | 2021-01-15 | tenderness, pain in extremity |
Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, ...
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Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, malaise
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| 50 | 2021-01-16 | breast pain |
At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102...
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At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102-103 till 1/10/21 and on 1/11/21, temp stayed in the 100?s. I had redness from above the injection site down to my elbow x 4 days. The area was raised 1/2 inch. I had to take Benadryl to help with the reaction. On 1/10/21, my lymph node in my axilla on the same arm where the injection was administered started swelling and had redness and had redness and tenderness that extended to the left breast. Had a severe headache x 4 days with neck stiffness. The swelling in my axilla improved by 1/15/21. The redness and swelling in the arm resolved by 1/15/21. Headache still lingered till 1/16/21. Was out of work x 4 days
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| 50 | 2021-01-17 | weakness |
I got a fever 101 the day after shot , I had chills , my bones hurt the pain was very intense in rel...
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I got a fever 101 the day after shot , I had chills , my bones hurt the pain was very intense in relived by Motrin and Tylenol , intense pain at injection site my underarms hurt very badly / nausea/ intense fatigue all about 20 hours after injection hit me hard like a wall - this went on for 24 hrs then I felt better but felt very weak for 2 more day s- to day is 6 days after injection first day I feel normal again
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| 50 | 2021-01-17 | pain in extremity |
I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a...
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I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a spontaneous report from a contactable nurse (patient). This 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), via an unspecified route of administration, on 06Jan2021 at 5:15 at single dose for COVID-19 immunisation. Vaccine location was left shoulder. The patient was vaccinated at hospital, age at vaccination was 50-years-old. Medical history and concomitant medications were none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE an unknown date. Nurse stated she was just reporting some side effects from COVID Vaccine. She had second one last night at 5:15 and she is a nurse and she worked over night which she would never do that again. So, she has a fever, it maxed of this morning at 101.5 and chills, body ache, and she feels nauseous, and her arm hurts. Nausea was first at about 1:30 in this morning (07Jan2021) and then chills and then fever by about quarter to 6 this morning (07Jan2021), she started to check her temperature. Outcome was not recovered. No treatment was received for the events. She just didn't wanted to mask the fever. She wanted to see how it developed and her highest temperature was 101.5, then it came down a little bit, it's tolerable. About causality, nurse stated Yeah, most definitely.
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| 50 | 2021-01-17 | tingling, burning sensation |
Nausea, Headache, Joint swelling (couldnt make a fist), Pins and Needles on palms of hands, Pins and...
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Nausea, Headache, Joint swelling (couldnt make a fist), Pins and Needles on palms of hands, Pins and Needles bottom of feet,Burning feeling the bottom of feet, body aches, fatigue. No treatment. Event ended 30 hours after vaccine.
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| 50 | 2021-01-17 | tingling |
I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I fe...
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I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly.; little zingy feeling in my left pinky and ring finger; Pain injection site; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included was none. The patient's concomitant medications were not reported. The patient reported: " pain injection site" and "I felt tingling like kind of about 10 minutes after having the vaccine as I was standing there, I felt a little tingly. I had the vaccine in my left arm in my right hand I had a little tingly feeling and I was like well maybe because I am holding my pocket book on that side I shifted over, at work I am getting like just a little zingy feeling in my left pinky and ring finger". The patient outcome of the events was unknown.
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| 50 | 2021-01-18 | weakness, numbness |
Beginning on 12/26 (8 days after dose #1), patient began experiencing severe low back pain, B thigh ...
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Beginning on 12/26 (8 days after dose #1), patient began experiencing severe low back pain, B thigh pain, R knee pain, numbness radiating from her B labia radiating down the medial aspect of her lower extremities to her B halluxes, and possible B shoulder abductor weakness. Pt received dose #2 of the Pfizer vaccine on 6 January 2021 (Lot#EL0142). After dose #2, she noted fatigue and wheezing c/w prior asthma symptoms and took Prednisone 20mg x1. Her pain was much better the next day, but (cont'd)
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| 50 | 2021-01-18 | breast pain |
Pain in arm day of vaccination, 24 hours later felt sick. Had fever, body aches, chills, and dizzin...
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Pain in arm day of vaccination, 24 hours later felt sick. Had fever, body aches, chills, and dizziness. Next day felt ok but very dizzy. Kept feeling waves of dizziness every 20 minutes or so. Felt feverish that night, but just low grade fever. Also pain in the arm is now in my armpit area, down by my left breast.
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| 50 | 2021-01-18 | feeling cold |
10 hours after the 2nd injection I developed severe chills for a couple of hours along with body a...
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10 hours after the 2nd injection I developed severe chills for a couple of hours along with body aches. The body aches lasted 24 hours.
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| 50 | 2021-01-18 | flushing |
Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and fe...
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Received vaccine at 11:30am. At 1:30p didn't feel well, noted that my left hand was swelling and felt tight. The injection site looked OK. I was sweating and face was flushed. I was given Benadryl 50mg PO and lay down for an hour at work. I went home at 2:30p. The following day I went to work but at 12:00noon I was feverish (100.0F), dizzy, SOB, all-over sore muscles and my blood pressure was 200/100 taken twice by nurses at the facility. I was taken to the ER by car and had labs and work up in the ER. They were unable to determine if symptoms were vaccine related or not. I had taken first dose of hypothyroid medication on 1/14/21. They diagnosed hypertension and wrote me a script for Lisinopril 5mg PO daily. I continue to have high BP readings. My left arm at injection site is sore. The edema in my hand resolved the first day after the Benadryl dose.
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| 50 | 2021-01-18 | numbness | Left side face and body numbness |
| 50 | 2021-01-18 | pain in extremity |
Severe arm pain after shot. Woke me out of sleep night after shot. Unable to lift arm horizontal t...
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Severe arm pain after shot. Woke me out of sleep night after shot. Unable to lift arm horizontal to shoulder, knot size of walnut. Diarrhea x 24 hrs, headache, low grade temp, wheezing day 4, shortness of breath noted upon exertion day 3-7. Expiratory wheezing. Much better (able to walk without shortness of breath day 7). Laryngitis day 2-6. Went to ER. Received IVF for low potassium and dehydration due to diarrhea. T max 99.9.
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| 50 | 2021-01-18 | pain in extremity |
low grade fever (99.5), significant left arm pain radiating to neck, ear, hand, and fingers, arthral...
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low grade fever (99.5), significant left arm pain radiating to neck, ear, hand, and fingers, arthralgias, myalgias.
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| 50 | 2021-01-19 | weakness, muscle spasms | Chills fever muscle cramps weakness headache |
| 50 | 2021-01-19 | flushing |
Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. ...
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Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. She was observed for 30 minutes and felt better. Symptoms resolving.
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| 50 | 2021-01-19 | muscle spasms | Swelling, deep muscle ache/spasm at injection site. Tylenol taken and ice pack at site |
| 50 | 2021-01-20 | cold sweat |
hours after vaccine I had an episode of sweating/clammy increase HR 128 lasting for a few minutes. ...
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hours after vaccine I had an episode of sweating/clammy increase HR 128 lasting for a few minutes. The next morning has slight fever 99 but with HA and body aches and continue with increase HR 110-138 at rest. 2-3 days after symptoms continued. On 4thday continue with HA, less intense but HR remain elevated 108-136 at rest and with light activity. HR continues to be elevated 1 week later 100-132 all other symptoms have resolved, no days of work missed
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| 50 | 2021-01-20 | feeling cold |
Chills and fever up to 102.5 reduced with advil. Fever started about 24 hours after vaccine was admi...
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Chills and fever up to 102.5 reduced with advil. Fever started about 24 hours after vaccine was administered. Gone around 48 hours after. Swelling and redness at injection site. No stealing.
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| 50 | 2021-01-20 | feeling cold |
Woke up the morning after vaccination with itching rash on neck, face, chest; chills but no fever; b...
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Woke up the morning after vaccination with itching rash on neck, face, chest; chills but no fever; body aches; rhinorrhea.
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| 50 | 2021-01-20 | migraine |
inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); ...
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inappropriate schedule of vaccine administered (first dose on 18Dec2020, second dose on 07Jan2021); Temp 102; body aches; chills; lymph node in right armpit swelling sz golf ball; vertigo all lasted 2.5 days; migraine pain >10 on pain scale; rash on hands and arms; nausea; blurred vision; Ongoing headache and body aches 5 days now; This is a spontaneous report from a contactable Nurse (patient). A 50-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2020 at 09:00 a.m. intramuscular on right arm at single dose for COVID-19 immunization. Relevant medical history included hypothyroidism, post-traumatic stress disorder, anxiety and allergy to tetracycline. Concomitant medications included escitalopram oxalate (LEXAPRO), celecoxib (CELEBREX), levothyroxine, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and paracetamol (TYLENOL). The patient received first dose of BNT162B2 on 18Dec2020 at 04:00p.m. intramuscular on right arm. On 07Jan2021 at 11:00 a.m. the patient experienced pyrexia with temperature of 102, body aches, chills, lymph node in right armpit swelling sz golf ball (as reported), nausea, migraine pain >10 on pain scale (as reported), rash on hands and arms, blurred vision and headache. On 08Jan2021 the patient underwent Nasal Swab SARS-CoV-2 test (Abbott) which resulted negative. No Treatment received for events. The patient recovered from vertigo on 09Jan2021. At the time of the reporting the patient had not yet recovered from headache and body aches, while was recovering from other reported events. Information about Lot/Batch number has been requested.
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| 50 | 2021-01-20 | pain in extremity |
Persistent Right arm tennis elbow; Increased pain on movement/Pain from back of elbow to top of fore...
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Persistent Right arm tennis elbow; Increased pain on movement/Pain from back of elbow to top of forearm; Increased pain on movement/Pain from back of elbow to top of forearm; This is a spontaneous report from a contactable nurse (patient self). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ELO140), via an unspecified route of administration on 19Dec2020 11:00 at single dose on right arm for COVID-19 immunisation. Medical history included hypothyroidism and known allergies: sulfa drugs and clarithromycin (MACROBID). Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), estradiol (ESTROGEN), testosterone and progesterone (PROGESTON [PROGESTERONE]). The patient experienced persistent right arm tennis elbow. Increased pain on movement. Pain from back of elbow to top of forearm on 21Dec2020 08:00 with outcome of not recovered. No treatment was received for the events. Patient received 2nd dose of bnt162b2 (lot: ELO140) on 09Jan2021 on left arm.
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| 50 | 2021-01-20 | tingling | Moderate tingling and pin prink stabbing sensation in the soles of my feet and burning of my feet |
| 50 | 2021-01-20 | cold extremities, numbness |
When at home unexpectedly developed severe coldness in right hand, especially fingers, followed by n...
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When at home unexpectedly developed severe coldness in right hand, especially fingers, followed by numbness. Since after few minutes and with rubbing it was not going away, proceeded with warming up hand under warm water and continued to rub it. Symptoms resolved 15-20 minutes later
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| 50 | 2021-01-21 | feeling cold |
Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigu...
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Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigue and nausea. About a day later she noted lightheadedness. About 1 days later she noticed soreness at the injection site and sensitivity to cold.
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| 50 | 2021-01-21 | pain in extremity | 3x2, red, hard, swollen, painful, itchy patch in arm |
| 50 | 2021-01-21 | tremor, seizure, numbness, tingling |
Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, nu...
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Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium
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| 50 | 2021-01-22 | weakness | Body aches, headache, fever 101-102.2, weakness, shortness of air, severe chest pain |
| 50 | 2021-01-22 | muscle twitching |
2-3 hrs after injection, L check muscle twitching that lasted until bedtime (3 hrs). Next morning, L...
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2-3 hrs after injection, L check muscle twitching that lasted until bedtime (3 hrs). Next morning, L check was not twitching but felt as though it might. This lasted all day. Within 2 days, there was a nerve sensation that radiated to L eye and L side of mouth. This sensation has persisted but improved now.
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| 50 | 2021-01-22 | pain in extremity |
Within 24 hours of dose, I had low grade fever, headache, and achiness despite being on ibuprofen ar...
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Within 24 hours of dose, I had low grade fever, headache, and achiness despite being on ibuprofen around the clock. Sore arm persisted for 5-6 days as well.
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| 50 | 2021-01-23 | weakness | Nausea fatigue chills body aches low energy |
| 50 | 2021-01-23 | feeling cold |
Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tyleno...
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Nausea, fever, chills, headache, severe muscle and joint aches, fatigue, blurry vision. Took Tylenol and Ibuprofen.
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| 50 | 2021-01-24 | difficulty speaking |
Mild wheezing and hoarse without sore throat on 12/21 Developed cough and wheezing, malaise, low gra...
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Mild wheezing and hoarse without sore throat on 12/21 Developed cough and wheezing, malaise, low grade temp, myalgia, arthralgia on 12/22 Tested positive for Covid on 12/23/20 at a drive through site. No other medical treatment was needed. I suspect I was infected but asymptomatic at the time I was vaccinated. I was told by the Health Department on the telephone to complete this form anyway.
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| 50 | 2021-01-24 | pain in extremity |
Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Sh...
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Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Short of breath and my heart was going faster than normal and short exertion. So I took an antihistamine - Allegra; tums; Tylenol; and took Prevacid. It didn't work. I was worried about my heart and that pressure on my throat. I went to my Dr. appt - she was able to get me in at short notice - and she examined me and did blood work and chest x-ray. Gave prednisone and albuterol . She said my lympyh nodes were swollen on my neck. Symptoms have resolved. And on second dose of vaccine I felt fine. But still have irregular heartbeat but I have a cardio appt coming up. I'm wearing heart monitor - Zeo - I mailed that on the 14 of January.
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| 50 | 2021-01-24 | tingling, feeling cold |
1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient...
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1st 15 minutes, top lips getting warm, tingle legs on legs , coolness after 15 more minutes, patient felt numbness of lips -- > sent to ER
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| 50 | 2021-01-24 | tremor, numbness, tingling |
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes...
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1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
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| 50 | 2021-01-25 | weakness, feeling hot |
fatigue not resolved, muscle and joint pain severe all over body that has lessened but not resolved,...
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fatigue not resolved, muscle and joint pain severe all over body that has lessened but not resolved, intermittent nausea headache, feel feverish but no fever, weakness
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| 50 | 2021-01-25 | feeling of body temperature change |
headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous r...
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headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 06Jan2021 09:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 16Dec2020 (09:00 AM) for Covid-19 immunization. Medical history included hypothyroidism; no known allergies. Concomitant medications included levothyroxine, macrogol 3350 (MIRALAX), docusate sodium (COLACE), and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide (CENTRUM FOR WOMEN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that it was the second dose of her Pfizer COVID vaccine series; 12 hours afterwards she got shaking chills and nausea (06Jan2021) and this continued overnight, no fever. The next morning, she had the worst headache of her life, and nausea and alternating feeling hot and cold, no more shaking chills and no fever. The patient reported that it continued throughout 07Jan2021, and on 07Jan2021 she vomited once. Then 08Jan2021 in the morning, she still had the worst headache of her life, she took Ibuprofen to which the headache became much diminished. But headache continued with less intensity, so she was able to go to work throughout 08Jan2021. She continued with Ibuprofen and added Tylenol. Then at 3 am on 09Jan2021, she woke with the worst headache again so severe and took both Ibuprofen and Tylenol and it got better. By afternoon 09Jan2021, she was back to herself with no more headache and a normal appetite. She did take a sick day on 07Jan2021. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 post vaccination.
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| 50 | 2021-01-25 | pain in extremity |
Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills;...
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Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 50 | 2021-01-25 | pain in extremity |
5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injecti...
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5-10 minutes after shot had a metallic taste in mouth, no adverse reactions. Next 2 days the injection site became red, swollen (knot under skin) and grew in size to a silver dollar. My left arm was sore. Redness and swelling dissipated on 4th day and looked like a bruise. About 6pm on 4th day, I was itchy on my stomach. I didn't think twice as had a neoprene/spandex brace around stomach/back from exercise. When I finally took a shower at 8pm, I noticed my torso was completely red. I immediately took 2 Benadryl. Throughout the evening the rash/hives spread to my shoulders. Took 2 more Benadryl at 1am. By morning rash around torso was almost gone, but some spread slightly to wrists, shoulders, breasts and knees. Took 2 more Benadryl at 8 am. Applied Benadryl cream to few spots on body throughout today. Itching mostly gone but splotches on legs, neck and few on back. Will take more Benadryl about 6pm.
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| 50 | 2021-01-25 | tingling |
Approximately 17 minutes after receiving the vaccine in her left deltoid, patient complained of "tin...
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Approximately 17 minutes after receiving the vaccine in her left deltoid, patient complained of "tingling in arm". After waiting approximately 30 minutes after first report of tingling, patient stated tingling resolved with no other signs/symptoms.
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| 50 | 2021-01-25 | tingling |
About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including lef...
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About 20 minutes after receiving the vaccine I developed tingling of my lips and face, including left eyelid. It improved over several hours. I had no swelling or drooping of my face, or trouble breathing.
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| 50 | 2021-01-26 | weakness, feeling cold, tremor, muscle spasms |
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl...
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involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-26 | weakness |
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea;...
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Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-26 | cold sweat, feeling hot |
1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycard...
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1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycardic with diffuse warmth and claminess. EMS was called after it didn't resolve after 20-30 minutes. Blood sugar 123. BP was elevated to high 160's over high 90s. EMS transported me to the ER. 1 liter of fluids given and BP was back to normal. Head CT scan was done and was normal. Dizziness persisted for about 6 hours and I was very tired for the rest of the day with achiness noted in the evening. I was fine by the next day. 2nd dose received on 1/21/21. I had only slight dizziness after that dose and was able to leave after 30 minutes observation time. Was very tired the weekend following vaccine and have had periods of dizziness/nausea since Sunday1/24/2021. I am still feeling dizzy and nauseated 1/27/21 and was encouraged to report possible side effect to the vaccine.
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| 50 | 2021-01-26 | flushing |
Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - S...
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Flushing, abdominal cramping, and throat fullness and pressure (globus sensation) IV push meds - Solu-Medrol, Benadryl and Famotidine Resolution of symptoms after medication administration. Diagnosis - Allergic reaction to COVID-19 vaccine
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| 50 | 2021-01-26 | numbness |
Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingl...
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Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingling and numbness in my fingers I subsequently chewed three Benadryl tablets; symptoms began to resolve after about 1.5 hrs; fully resolved approximately 48 hours later
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| 50 | 2021-01-26 | migraine |
Migraine, 1/19 after 2nd dose, imitrex, lasted 1hour 1/2 Migraine, 1/26 after 2nd dose imitrex l...
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Migraine, 1/19 after 2nd dose, imitrex, lasted 1hour 1/2 Migraine, 1/26 after 2nd dose imitrex lasted 2hours both relieved with imitrex
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| 50 | 2021-01-26 | pain in extremity, flushing, muscle spasms |
Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surfa...
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Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surface areas. About 10pm developed headache, facial flushing, painful eyes, fever 101.3, rigors, and muscle cramps in feet and legs.
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| 50 | 2021-01-26 | pain in extremity, numbness |
After my first dose in the middle of the night I had an extreme arm pain from my left shoulder down ...
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After my first dose in the middle of the night I had an extreme arm pain from my left shoulder down to my finger tip that caused numbness of my fingers, I could not move my arm due to pain, I was not even able to roll over and sleep on it because the pain was so intense. The severe pain lasted about 2 days and my arm was sore for about a full week after.
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| 50 | 2021-01-26 | pain in extremity |
pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache...
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pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache nausea diarrhea
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| 50 | 2021-01-26 | pain in extremity |
Right upper arm pain when I reach up, reach back, reach around and lift something heavy and with red...
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Right upper arm pain when I reach up, reach back, reach around and lift something heavy and with reduced range of motion and use in right arm. This started about 2-3 days after vaccine administration. I had no difficulty with right arm before vaccine.
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| 50 | 2021-01-26 | tingling |
itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Satur...
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itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Saturday evening 1/23
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| 50 | 2021-01-26 | tremor |
sudden onset of nausea/dizziness, headache, severe chills and shaking, extreme body aches that laste...
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sudden onset of nausea/dizziness, headache, severe chills and shaking, extreme body aches that lasted approximately 10 hours, followed by extreme fatigue that lasted about 10 hours.
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| 50 | 2021-01-27 | numbness, tingling |
About 10 minutes after the injection she notice numbness and tingling in the palm of her hand that s...
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About 10 minutes after the injection she notice numbness and tingling in the palm of her hand that spread to her fingers. It has started to improve.
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| 50 | 2021-01-27 | numbness |
Facial numbness; This is a spontaneous report from a contactable other HCP. A 50-year-old female pat...
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Facial numbness; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) , via an unspecified route of administration in right upper arm on 12Jan2021 16:50 at a single dose for COVID-19 immunization. Vaccination was done in the clinic. There were no relevant medical history and concomitant medications. On 12Jan2021 17:15, the patient experienced facial numbness that started 25 minutes after she got the shot. The outcome of the event was recovered on 12Jan2021. The event was assessed s non-serious and the patient reported that the event was 100% related to the vaccine.
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| 50 | 2021-01-27 | muscle spasms |
14 hours after the shot, I began having chills, a slight headache, muscle and joint pain, muscle cra...
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14 hours after the shot, I began having chills, a slight headache, muscle and joint pain, muscle cramps, and a slight upset stomach. It lasted throughout the night. In the morning (after symptoms between 11pm and 9am) I woke up with only the muscle and joint aches and a slight headache. The chills, muscle cramps and upset stomach were gone.
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| 50 | 2021-01-27 | pain in extremity |
Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine o...
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Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine observation. At 1035 customer called out to provider. Customer reports feeling acute nausea and she states she feels as if she is going to throw up. She appears slightly pale and significantly anxious. Customer is moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports feeling sweaty, with waves of nausea and intermittent ULQ pain that she describes as sharp and bandlike across the diaphragm. She episodically calls out in pain and clutches her left chest below her ribs stating that it feels better when she puts pressure at the site. Customer admits to having significant anxiety and a history of panic attacks. HR 102, 02 99%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 1043. Customer monitored at site. Over the course of the next 15 minutes, she reports feeling better and more relaxed. Customer reports full resolution of symptoms @ 1100. BP 108/82, P 101, O2 100% RA, RR 16. Customer is agreeable to extended monitoring after receiving Benadryl. She has been driven to the vaccination site by a family member and states she will not be alone at home. She is instructed to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer agrees with plan and denies further questions/concerns. Customer released from site at 1115, ambulating independently with steady gait, no obvious s/sx of distress.
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| 50 | 2021-01-27 | tingling, muscle spasms | Joint pain, muscle pain, cramps in legs, tingling in hands and feet |
| 50 | 2021-01-27 | tremor | Tremors, headache, nausea and dizziness |
| 50 | 2021-01-27 | unresponsive to stimuli |
Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache t...
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Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.
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| 50 | 2021-01-28 | weakness | feeling weak, dizzy, light headed and intense headache |
| 50 | 2021-01-28 | face paralysis, bell's palsy | Stabbing pain in left ear, facial and eye weakness, new onset Bell's Palsy |
| 50 | 2021-01-28 | feeling cold |
10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient star...
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10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient started to have hard time breathing and severely cold and BP was rising. 911 was called and patient was transported to hospital where she was admitted.
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| 50 | 2021-01-28 | migraine |
Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 ho...
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Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 hours. The migraine became debilitating on Sunday, January 3, 2021. I had vomiting, nausea and dizziness as well. I was unable to work on Monday, January 4, 2021 because I still had the migraine. I take Ubrelvy (prn) and it did not work. I attempted to return to work Tuesday afternoon as the migraine subsided, but it returned shortly after I made it to work. Our treatment nurse took my blood pressure, it was high. My blood sugar was high. I was dehydrated and the migraine was back. My nurse practitioner treated me with an IV of saline solution, pain relieving injection for the migraine and Zofran for the nausea.
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| 50 | 2021-01-28 | muscle twitching, pain in extremity, muscle spasms |
Leg pain; Back pain; Lips twitching; Achilles tendon pain in her left leg; back pain is almost like ...
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Leg pain; Back pain; Lips twitching; Achilles tendon pain in her left leg; back pain is almost like a spasm; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old female patient received BNT162B2 (lot number: EL1283), via an unspecified route of administration on 13Jan2021 12:04 at single dose for COVID prophylaxis. There were medical history and concomitant medications. It was reported that the patient experienced leg pain, back pain and lips twitching after injection which occurred two days ago on 13Jan2021. Stated that leg pain is like Achilles tendon pain in her left leg and back pain is almost like a spasm. She doesn't know if this is an expected side effect. Second dose is scheduled 09Feb2021. She wants to know if she should proceed with that. The outcome of the event "lips twitching" was unknown wile for the other events was recovering. The reporter assessed the events to be related to the suspect vaccine.
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| 50 | 2021-01-28 | tingling |
pt states that within 10 minutes after vax that she experienced cool tingling sensation down both le...
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pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat. Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot. They checked her blood pressure and it was high at that time 153/? Pt was from out of town so transported to Urgent Care via ambulance. Her blood pressure was 170/? at this time. They did an EKG which was normal. Pt was given Benadryl. Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg. Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong. Pt is waiting for her PCP to do tele visit for a FU.
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| 50 | 2021-01-28 | tremor |
This writer did not administer vaccine. Pt received vaccine at clinic and reported feeling shaky and...
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This writer did not administer vaccine. Pt received vaccine at clinic and reported feeling shaky and nausea . Denies sob chest pain headache feeling dizzy or lightheaded. No respiratory distress
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| 50 | 2021-01-29 | hot flush |
Pt states that immediately after getting the vaccine she started having hot flashes. Pt was assisted...
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Pt states that immediately after getting the vaccine she started having hot flashes. Pt was assisted in walking to the cot. Pt was seated on the cot. Pt's vitals are stable. Pt states she has a history of anxiety. Pt states she started lexapro 2 months ago. Pt continued to have hot flashes for 30 mins. Crew was able to calm the pt. Pt refused transport to hospital.
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| 50 | 2021-01-29 | muscle spasms, tingling, pain in extremity, numbness |
Left leg parasthesias...pain, craming, heaviness and numbness. Improved over next 4 hours but mild ...
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Left leg parasthesias...pain, craming, heaviness and numbness. Improved over next 4 hours but mild tingling and numbness persists.
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| 50 | 2021-01-29 | pain in extremity, discomfort | Headache, Chills, Arm Pain/Discomfort, Fatigue |
| 50 | 2021-01-29 | tingling |
This is a female with a history of breast cancer on tamoxifen, hypertension, asthma who apparently r...
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This is a female with a history of breast cancer on tamoxifen, hypertension, asthma who apparently received her second dose of Covid Pfizer vaccine 10 to 15 minutes prior to presentation who presented in ED with complaints of shortness of breath and tingling sensation over her face and neck. Apparently had rash over the first dose and now presented with shortness of breath. She denies any fever chills. No chest pain. EPINEPHrine (EPIPEN) injection syringe 0.3 mg (0.3 mg intramuscular Given 1/26/21 1547) sodium chloride 0.9 % bolus 1,000 mL (1,000 mL intravenous New Bag 1/26/21 1555) dexAMETHasone (DECADRON) vial 6 mg (6 mg intravenous Given 1/26/21 1548) diphenhydrAMINE (BENADRYL) injection 25 mg (25 mg intravenous Given 1/26/21 1548) famotidine (PEPCID) injection 20 mg (20 mg intravenous Given 1/26/21 1548)
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| 50 | 2021-01-30 | weakness | HEADACHE!!!!!! Fever 101.5, Chills, Muscle pain, Weakness. |
| 50 | 2021-01-30 | cold sweat |
Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband...
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Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband heard a loud thud and found me laying on the floor beside the bed, passed out. He rushed over to me and called my name several times before I became conscious. He estimates it was a span of about 30 seconds. When I awoke, I immediately began to cold sweat and dry heave several times. Then I became cold and was shivering. My husband then transported me to the hospital emergency room. I received a cardiac test, which they said was good. I also received intravenous fluids and medication to treat pain and nausea. They drew labs which they said looked normal and did an X-ray my right shoulder because I struck my head and shoulder on a night stand when I passed out. They released me about an hour later after having me stand and walk to ensure my blood pressure did not drop, causing me to feel faint again. They sent me home with a prescription for Zofran to help with any further nausea, advised me to take ibuprofen for head and shoulder pain and body aches and advised rest. They also said to return if any other incidents occur and to follow up with my family doctor if symptoms persist.
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| 50 | 2021-01-30 | numbness, weakness |
Dec 18, 2020, 1st dose effect was just like flu-like symptoms; I just felt heaviness in my left shou...
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Dec 18, 2020, 1st dose effect was just like flu-like symptoms; I just felt heaviness in my left shoulder and a bit sore; I even proceeded to work after the shot and never thought that the effect of the 2nd dose is severe; Jan 6-8, 2021, (Wed-Fri) @ 11:00am - took covid vaccine 2nd dose, proceeded to work. @4:00pm - sent me home; felt the adversed reactions: left side weakness and numbness from shoulder to foot, fatigue, chills, headache; took naproxen as needed, helped somehow to ease the pain; chills were on and off; Jan. 9, 2021 (Sat ) - continuous monitoring, took Naproxen; No headache; Still present is left side weakness and numbness; new symptoms - sore/pain in left shoulder, swollen in and around left shoulder, underarm, chest and back; lymph node is also swollen and tender; chills in the evening; Jan 10 - continuous monitoring, symptoms still present with sore and pain, , taking naproxen as needed somehow helped when the med kicked in but pain?s back after the effect; Jan 11, took pain med, managed to go to work from 12:00nn continuous until 4:00pm; the pain got worsen, due to pushing and pulling of beds and wheelchairs with patients; I emailed the Covid19 Employee Health, CC'd to my Manager, informed them about my current condition and made PCP appt on Jan 15. Covid19 Employee Health replied in email with instructions to keep the appointment for Jan 15 and take covid test.. then my Manager sent me home. Jan 12, as per advice, took my Covid19 swab test, turned out Negative ; Jan 15, more pain and couldnt hold anything or even raise my left arm; in and around my left shoulder, chest, underarm and back are still swollen and tender. I went to my scheduled PCP appointment, they prescribed me Prednisone and Hydrocodone(PRN) for pain for 5 days and also recommended me to see a Specialist and a special test such as CT or MRI. If the pain doesnt go away, a follow up appointment was also advice. They are also expecting to send them paperworks related to this work injury/illness; Jan 18, continuous monitoring, sore and swelling still exist; emailed me saying that they been notified for my injury/illness report; In the link of the email, it said that they will send me the documents packet to be filled out and my PCP is also expecting for the papers but havent recieved yet; Jan 21, Yesterday was my 5th day of taking prednisone.. As of today, my left shoulder and around chest, underarm and back are still sore and swollen. The prednisone helped during the day but pain still present at night and when in bed. Some nights I hardly sleep even putting some pillows around.. During the day, I am trying to slowly raise my left arm holding it with my right hand and do some stretchings too. Despite all of these efforts, the progress is slow and pain is still exist. I sent an update to my PCP and to my Manager; My PCP sent me a reply saying that she would order for an Imaging but still waiting for the documents packet to be filled out and signed but havent received it yet. Jan 22, took pain med this morning, pain is just #5, but still hardly raise much of my left arm, still sore and swollen around my shoulder; chills and headace no longer present; i just experienced them on and off in my first 4 days after the 2nd dose; slowly raising my left arm with the help of my right hand; doing stretching too Jan 25, 2021. Today, I'm still out from work. my swollen left shoulder is subsiding but 'Im worried about the sore and swelling around it like in my chest, underarm and back. I can now raise my left arm but there is still pain, still weak and no grip. Yesterday, I got my claim number thru Portal and gladly received the hardcopy of the said docs packet on the mail today. I have also a follow-up appointment with my PCP tomorrow, 10:45am and hopefully will get an imaging order.
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| 50 | 2021-01-30 | tremor, pain in extremity |
Extremely sore arm. Had injection at 10:55am on 1/30. 3:00am on 1/31 woke up with body violently sha...
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Extremely sore arm. Had injection at 10:55am on 1/30. 3:00am on 1/31 woke up with body violently shaking like I was cold, but I was not cold. I finally had to lay on my arms to hold them still. It lasted about 15mins.
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| 50 | 2021-01-31 | weakness, feeling cold |
I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very col...
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I became increasingly sick within 24 hours after the shot. I was very tired, felt feverish, very cold, coughing, headache and diarrhea. 36 hours after the shot I began to notice a loss of taste and smell. 48 hours I was very weak and needed to sleep for the next 3 days. Overall loss of appetite, diarrhea and very bad cough continued for at least 1 week.
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| 50 | 2021-01-31 | weakness, feeling hot |
NOT FEELING MY NORMAL SELF, HEARTBURN, HOT IN ABDOMINAL, TEMP99, ANIXETY, DIZZY SPELLS, AWKWARD FEEL...
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NOT FEELING MY NORMAL SELF, HEARTBURN, HOT IN ABDOMINAL, TEMP99, ANIXETY, DIZZY SPELLS, AWKWARD FEELING IN MY HEAD, EXTREAMLY WEAK, THE 1ST DAY NOT SO BAD BUT DAY2-6 MUCH WORSE DAYS 7 &8 GETTING BETTER DAY 9 BACK TO NORMAL SELF.
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| 50 | 2021-01-31 | pain in extremity |
Arm soreness; Aches; Exhaustion; Diarrhea; This is a spontaneous report from a contactable consumer ...
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Arm soreness; Aches; Exhaustion; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 15Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included drug allergy to Quinolones, asthma and thyroid cancer from an unknown date and unknown if ongoing. Concomitant medication included omeprazole, levothyroxine sodium (SYNTHROID), topiramate (TOPAMAX) and sertraline hydrochloride (ZOLOFT). The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021 02:00 PM, the patient experienced arm soreness, aches, exhaustion, diarrhea. No treatment was received for the events. The outcome of the events was recovering. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.
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| 50 | 2021-02-01 | facial paralysis |
Went to ER with left facial paralysis. Diagnosed with Bell's palsy day 19 after initial dose of Pfiz...
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Went to ER with left facial paralysis. Diagnosed with Bell's palsy day 19 after initial dose of Pfizer vaccine (1/5/21 vaccine given). Not sure what the recommendation is as to whether I should still have the second dose. Doctors at the ER were not sure either.
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| 50 | 2021-02-01 | facial paralysis |
Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower...
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Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower left pain under ear, sudden onset; This is a spontaneous report from two contactable consumers. A 50-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, Post-traumatic stress disorder (PTSD), elevated pressure increased (BP), elevated cholesterol, spondylosis with radiculopathy. Known allergies: NSAID's and augmentin. Concomitant medications included hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), hydroxyzine, atorvastatin and ascorbic acid;betacarotene;biotin; calcium; chloride; chromium; copper; folic acid; iodine; iron; magnesium; manganese; molybdenum; nickel; nicotinic acid; pantothenic acid; phosphorus; potassium; pyridoxine hydrochloride; riboflavin; selenium; silicon; thiamine; vanadium; vitamin B12 NOS; vitamin D NOS; vitamin E NOS; vitamin K NOS; xantofyl; zinc (CENTRUM SILVER WOMEN 50+). On 05Jan2021 at 13:00, patient experienced lower left pain under ear, sudden onset. Then, noticed symptoms of a stroke. Left sided face droop. Patient went to ER (emergency room). Patient was diagnosed with Bell's Palsy from Covid-19 injection (1st dose). Patient received treatments for the events included prednisone, acyclovir, ointment to protect eye and eye patch for covering of left eye. Lab test included Nasal Swab: negative on 07Jan2021. Outcome of the events was resolving. Information on Lot/Batch number has been requested.
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| 50 | 2021-02-01 | feeling hot |
metallic taste, hot trachea and esophagus, breathing difficulty, diarrhea, fatigue, extreme headache...
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metallic taste, hot trachea and esophagus, breathing difficulty, diarrhea, fatigue, extreme headache, sensitivity to light
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| 50 | 2021-02-01 | feeling jittery |
Dizziness, light headedness, jitters, tachycardia, high blood pressure; onset from right after injec...
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Dizziness, light headedness, jitters, tachycardia, high blood pressure; onset from right after injection; lasted 2 hours.
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| 50 | 2021-02-01 | flushing, feeling hot |
Immediate flushing of face. Itchy hands and arms. Ears and face red/hot. C/O hives on back. Hyperten...
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Immediate flushing of face. Itchy hands and arms. Ears and face red/hot. C/O hives on back. Hypertensive
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| 50 | 2021-02-01 | flushing, tremor |
Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing...
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Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing, tremors, ina bility to take deep breaths. New diagnosis of Grave's disease and enlarged lymph nodes in chest.
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| 50 | 2021-02-01 | numbness |
[ Pfizer Covid-19 vaccine ] treatment under Emergency Use Authorization(EUA): pt experience numbing ...
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[ Pfizer Covid-19 vaccine ] treatment under Emergency Use Authorization(EUA): pt experience numbing in hand of injection site on day of injection of dose one then experience numbing again three weeks later (before the second dose).
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| 50 | 2021-02-01 | muscle spasms |
R shoulder muscles frozen, unable to rotate R shoulder, to reach or to lift. All ribs and intercosta...
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R shoulder muscles frozen, unable to rotate R shoulder, to reach or to lift. All ribs and intercostals spasming, painful. Rigors and shaking chills without increased temp
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| 50 | 2021-02-01 | pain in extremity |
Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue;...
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Soreness in L arm; soreness in L axilla; Soreness in LU torso; Numbness/tingling in lips and tongue; Metal taste; Numbness/tingling in lips and tongue; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia, chicken allergy. Patient was not pregnant at the time of vaccination. Patient previously took BACTRIM and experienced allergy. There were no other medications received within 2 weeks of vaccination. The patient soreness in L arm, L trap, L axilla, LU torso, numbness/tingling in lips and tongue and metal taste on 29Dec2020 09:00. Outcome of the events was recovered. Treatment was not received for the events. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 05Oct2020 and negative on 08Nov2020. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. The events were considered non-serious.
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| 50 | 2021-02-01 | pain in extremity |
very tired; soreness in the arm; body aches; This is a spontaneous report from a contactable other h...
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very tired; soreness in the arm; body aches; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly on 18Jan2021 13:00, at right arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via a unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient experienced soreness in the arm, body aches, very tired on 19Jan2021 12:00AM. Therapeutic measures were taken as a result of all events includes Tylenol Every 6 Hours. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 50 | 2021-02-02 | tingling |
Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm ...
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Tingling, Numbness Narrative: 5 min after vaccine administered IM to L deltoid she developed L arm and L trunk tingling. Tingling these locations resolved. Developed mild perioral tingling. At 1149 mild numbness tongue and lips. At 1155 resolving perioral tingling and numbness.
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| 50 | 2021-02-03 | feeling hot |
Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/...
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Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/severe nausea. She is also having light headedness. Her vitals are 136/90, P-98, O2- 98 @ 1447. She denies history of vaccine allergic reactions. Her only reaction from 1st injection was a sore arm. Her baseline vitals are 121/?, P-60-70. @1452 vitals are 134/88, P-122, o2-99. No meds have been given. Patient given ice pack for neck and reclined in reclining chair. Dr. consulted. Vitals @ 1510 130/70, P-106, 24 resp. Dr. advised further monitoring for the mean time. TC to patient's manager, that patient is having reaction to vaccine and is being monitored and will be delayed in returning to dept. Manager verbalized understanding and appreciation. (Created on 2/04/2021 and 3:42pm) Vitals @ 1553 147/80, P-98. Patient reported that nausea is still the same but that her throat started feeling funny. 50mg Benadryl IM given in Right Deltoid by RN @1600. Dr. informed. Director and AD also informed of situation. Patient's manager called by RN to give update on patient and to request that someone in dept bring patient's handbag. (Created on 2/04/2021 and 4:21pm) Vitals @ 1620 139/86, P-86, O2-97, Resp- 28. Patient reports that strange feeling in throat is improving. Nausea & light headedness is the same. She said that she had been feeling hot earlier but not anymore. Updated Dr. on patient's status. Asked Dr. if she may be released to go home with her aunt who is picking her up at 5pm if patient is stable and her vitals are stable. Dr. stated that patient may be released with a Benadryl tablet to go. (Created on 2/04/2021 and 4:43pm) Vitals @ 1720 163/96, P-114, O2-100 Called IMT to PFW 4. Patient initially refused to be taken to ER. Noticed that patient was having labored breathing. Vitals @ 1739 162/91, P-124. After IMT team spoke with patient about vitals, patient decided to go to ER. Patient was taken in wheelchair by IMT team@ 1745.
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| 50 | 2021-02-03 | migraine |
Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; hea...
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Swelling of forearm; trouble with movement in right hand; heaviness in same arm; Hives; itching; headache that has turned into migraine.; headache that has turned into migraine.; This is a spontaneous report from a contactable other Healthcare Professional. A 50-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at right arm on 14Jan2021 13:00 at single dose for covid-19 immunization. Medical history included allergies to penicillin and sulfa. Concomitant medication included bupropion, propranolol, topiramate, sertraline, montelukast, alprazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (lot number: EL1284) on 27Dec2020 02:30 PM intramuscularly at right arm for covid-19 immunization. The patient experienced swelling of forearm, trouble with movement in right hand and heaviness in same arm. Hives, itching, headache that had turned into migraine. The symptoms started the day after the injection (15Jan2021). No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
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| 50 | 2021-02-03 | pain in extremity |
arm was sore; arm was sore, muscular; This is a spontaneous report from a contactable consumer (pati...
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arm was sore; arm was sore, muscular; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, COVAX US Support. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose (lot number: EH9899) via an unspecified route of administration (left arm, also reported as "in left shoulder") on 29Dec2020 around 09:30am at single dose; and the second dose (lot number: EL1283) intramuscular (left arm, also reported as "in left shoulder") on 19Jan2021 around 10:30 at single dose for Covid-19 immunization (also reported as "prevent Covid"). There were no medical history and concomitant medications. The patient confirmed that she received first dose on 29Dec2020, and she received the second dose on 19Jan2021. There were no additional vaccines administered on same date of the Pfizer vaccine. The patient reported that she took the second dose of the Covid vaccine on 19Jan2021 and stated that her husband was diagnosed being positive for Covid. The patient asked if she was exposed to Covid if she will still be asymptomatic. The patient further stated that she feels great and has no side effects from the vaccine. She later clarified that her arm was sore on an unspecified date, and it occurred with both doses. She added that it was just muscular and starting to get better. The patient further reported that yesterday her husband was diagnosed with a positive test for Covid. She added that she works with Hospice patients. She confirmed that she is not a hcp. She just needs to know if it is safe for her to start seeing patients if she has zero symptoms, and if she needs a negative Covid test. There was no treatment received for the adverse event. The outcome of events was recovering.
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| 50 | 2021-02-03 | pain in extremity |
Body aches; Chills; Headache; Arm was really, really sore - the whole arm; This is a spontaneous rep...
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Body aches; Chills; Headache; Arm was really, really sore - the whole arm; This is a spontaneous report from a contactable consumer (patient who is a mental health therapist). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 15Jan2021 at 16:00 (4 PM), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. No other vaccines were given the same day or 4 weeks prior. No problem with vaccines in past that she can recall from childhood. The patient received the vaccine last Friday (15Jan2021) and side effects started early evening Saturday (16Jan2021) or late afternoon. The patient had body aches, a few chills, headache, and her arm was really, really sore - the whole arm. At the time of reporting, all are way better. The patient was recovering from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
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| 50 | 2021-02-03 | pain in extremity |
her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where...
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her right hand is slightly swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; Where she got the shot is a little red, warm, and swollen; a little sore; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: 3248), via an unspecified route of administration in the right arm on 18Jan2021 at 08:40 A.M. (at the age of 50 -years-old) as a single dose, dose 2 for COVID-19 vaccination. Medical history was unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), single dose, dose 1 in the left arm on 28Dec2020 and a flu vaccine on 29Aug2020. There were no concomitant medications. On 19Jan2021, the patient's right hand is slightly swollen. It was still mobile. She can move all digits. It was puffy and a little sore and where she got the shot was a little red, warm, and swollen. There were no relevant tests done. The patient had no emergency room or physician office visits. The clinical outcome of right hand is slightly swollen, puffy and a little sore and where she got the shot was a little red, warm, and swollen was not recovered.
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| 50 | 2021-02-04 | burning sensation |
skin on her face feels burnt and sore to touch; skin on her face feels burnt and sore to touch; Bad ...
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skin on her face feels burnt and sore to touch; skin on her face feels burnt and sore to touch; Bad headache; medical history: lupus anticoagulant positive; medical history: lupus anticoagulant positive; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via intramuscular route of administration on 19Jan2021 at 12:00 at a single dose in the arm left for COVID-19 immunization. The patient's medical history included high blood pressure, hypothyroidism, depression, lupus anticoagulant positive, and anemia. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), verapamil, apixaban (ELIQUIS), montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID) , ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC), hydrocodone bitartrate, paracetamol (NORCO). The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and acetylsalicylic acid (ASPIRIN) and experienced allergies. The patient also previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 ) on 29Dec2020 at 08:00 pm, via intramuscular route in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Jan2021 at 19:00, the patient stated that her skin on her face feels burnt and sore to touch without any redness or signs of injury and had a bad headache. The patient did not receive any treatment for the reported events skin on her face feels burnt and sore to touch and bad headache. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient has not recovered from the events.
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| 50 | 2021-02-04 | flushing |
Left arm injection site, itcy and tingling on down both arms, flushed throughout body, 140/80 BP, HR...
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Left arm injection site, itcy and tingling on down both arms, flushed throughout body, 140/80 BP, HR 71 and RR 18. Headache later that night, with chills and fever for 2 days. Took Tylenol.
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| 50 | 2021-02-04 | migraine |
Within 4-5 hours, muscle soreness on shoulder at injection site. Within 12-13 hours, migraine, feve...
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Within 4-5 hours, muscle soreness on shoulder at injection site. Within 12-13 hours, migraine, fever, chills, body aches, nausea, and vomiting. Symptoms lasted 36-38 hours from the time of vaccination
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| 50 | 2021-02-04 | pain in extremity |
Sore arm; headache; This is a spontaneous report from a non-contactable consumer. A 50-year-old fema...
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Sore arm; headache; This is a spontaneous report from a non-contactable consumer. A 50-year-old female patient received received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 20Jan2021 for COVID-19 immunization. Medical history and concomitant drugs were unknown. On 20Jan2021 the patient experienced sore arm and headache. No treatment for the events was received. At the time of reporting the patient was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained
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| 50 | 2021-02-04 | tingling |
ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient...
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ED COURSE / MEDICAL DECISION MAKING / TREATMENT PLAN: ED Course and Medical Decision Making: Patient evaluated. Peripheral IV established labs obtained. I do have concern for adverse reaction secondary to the vaccine as her symptoms started she said shortly before an hour after receiving the vaccine is started with tingling in her tongue throat and her body. She has minimal cardiac risk factors. Given she was tachycardic she cannot be perked out. EKG obtained showed no acute ischemic ST elevation or depression. Initial troponin was not elevated. Patient received 500 mL bolus of normal saline she deceived Benadryl and part of Pepcid. While the Benadryl infusion was going on patient reported feeling lightheaded and her heart rate was noted to increase to the 130s briefly. The medications were stopped, the Benadryl had already finished however the Pepcid was not completed. Her heart rate proved quickly and the lightheadedness resolved. Repeat EKG obtained did show some mild ST depression inferiorly. A repeat troponin obtained at 2 hours remain negative D-dimer was elevated to 91 therefore CTA chest was obtained. This showed no evidence of pulmonary embolism there is small groundglass opacity left upper lobe which is likely related to atelectasis do not feel that this is infectious in etiology patient has not had cough fever or chills. She remained on cardiac monitor here without any further tachycardia and her symptoms had resolved. I do believe patient's presentation is secondary to adverse reaction to the vaccination. She was advised to take Benadryl at home and may also try over-the-counter Pepcid at home for her symptoms. Did not feel that steroids were warranted at this time. She is to follow-up closely with her primary care provider. I did advise if she has new or worsening symptoms she should return to the emergency department and she expressed understanding and agreement with this plan.
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| 50 | 2021-02-05 | weakness |
2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, ...
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2/5/2021 @ 1:00 AM vomited X2, chills, body aches, fever 100.6, HA, fatigue, watery eyes, weakness, sweating, and nausea for 30 hours. Feel weak and tired now.
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| 50 | 2021-02-05 | flushing, feeling hot |
Client complained of feeling hot and flush. BP 128/80, P68-70, BS 67. EMS evaluated. Client given ...
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Client complained of feeling hot and flush. BP 128/80, P68-70, BS 67. EMS evaluated. Client given water and snack and felt better.
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| 50 | 2021-02-05 | numbness and pain in extremities, tingling |
Acute lower back/sacral pain without sciatica-MD diagnosis. Mild tingling neuropathy to thighs and ...
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Acute lower back/sacral pain without sciatica-MD diagnosis. Mild tingling neuropathy to thighs and acute constipation. Began 02/01/21, early am. Advil 400 mg q 6 hours, Salon pas patch and heating pad provided some relief. Mirilax and prunes gave some relief from constipation. MD seen on 02/05/21 and above dx given. Flexeril 5mg given for spasms and Methylprednisolone 4mg tapered dose for inflammation. To follow up with MD after 02/11 if no relief or change in condition.
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| 50 | 2021-02-05 | pain in extremity |
Several symptoms - achy, chills, low grade fever - present 2/5/2021 loose bowels, sore arm - presen...
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Several symptoms - achy, chills, low grade fever - present 2/5/2021 loose bowels, sore arm - present 2/5/2021 and still present 2/6/2021
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| 50 | 2021-02-06 | weakness, tremor, feeling hot |
Feeling "HOT", given crackers & water, began to experience weakness. began SOB. EPE was administered...
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Feeling "HOT", given crackers & water, began to experience weakness. began SOB. EPE was administered 0.3 ml X 1 dose. Began shaking reported feeling better. 911 called to transport to hospital and patient notified that she can't take the 2nd Covid dose, O2 was administered while waiting for EMS. 11:34AM arrived report given.
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| 50 | 2021-02-06 | muscle spasms |
Severe stomach cramping and diarrhea: Began at 4:30 pm 02.03.2021 - 02.07.2021 required hospital ER...
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Severe stomach cramping and diarrhea: Began at 4:30 pm 02.03.2021 - 02.07.2021 required hospital ER visit for iv fluids to treat stomach pain, nausea and dehydration from diarrhea. Sent home with prescription for Dicyclomine 20 mg tablet anti spasm medication. Petechiae on back of both hands, wrists and fingers: Began at 4:15 pm 02.05.2021 required hospital ER visit for multiple blood testing to evaluate platelets, etc. Testing clear and ER Dr. noted condition is associated with vaccination reaction and advised to closely monitor for any change and seek immediate return if continued progression and if so follow-up with hematologist. Foot cramps: Began overnight 02.04.2021, increased fluids and subsided. 99.8 Temperature: Began 02.04.2021 at 9:30 pm - to 11:30 pm and treated with extra strength Tylenol and subsided. Began 02.03.2021 at 10:30 pm -11:30 pm and treated with extra strength Tylenol and subsided. Soreness at injection site: Began 02.04.2021 ongoing treating with extra strength Tylenol.
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| 50 | 2021-02-06 | speech disorder, cold sweat |
Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then col...
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Immediately after 2nd injection, sensitivity to light & color. Hot and sweaty for 24 hours, then cold & clammy, jumbled though and speech. Soreness at injection site. Extreme tiredness. 2-days after injection, swelling of piriformis muscle in hip, extreme pain, bedridden, unable to walk, fever, for going on 36 hours. Taking 800 mg ibuprofen to sleep. Muscle cream, Epson salt baths to reduce pain.
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| 50 | 2021-02-07 | numbness |
Complained of numbness in left arm from injection site to finger tips. Subsided within 30 minutes. ...
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Complained of numbness in left arm from injection site to finger tips. Subsided within 30 minutes. Applied ice to area with improvement. Subsequently patient followed up with her PCP for recurring, transient numbness. Diagnosis: brachial plexus neuropathy of left upper extremity
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| 50 | 2021-02-07 | tingling |
I had an initial feeling of being high. My vision became distorted. My fingers became tingly. My b...
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I had an initial feeling of being high. My vision became distorted. My fingers became tingly. My breathing felt heavy. I felt heavier and heavier. They asked me if I wanted to lay down. I said yes. I was also very dizzy. My blood pressure was 135/83 and pulse was 125. my blood sugar was 102. I drank a bottle of water and laid down for 20 to 30 mins. Then sat in the chairs. I had to wait for the vision disturbance to wear off so I could drive. it also gave me ADD symptoms for 48 hours. Very hyper. Then I had the flu for 5 days. The dizzy wore off on the 6th day. Should I get the 2nd shot?
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| 50 | 2021-02-07 | tremor |
Shakes, severe chills, temp 101.4 extreme fatigue and malaise. Headache, body aches, not smell or ta...
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Shakes, severe chills, temp 101.4 extreme fatigue and malaise. Headache, body aches, not smell or taste. Tylenol, fluids Motrin, rest shower and than heated blanket set to high to try and get warm
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| 50 | 2021-02-08 | discomfort |
I started with chill, fever of 101, head ache, tired, nauseated, achy for two days, the third day se...
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I started with chill, fever of 101, head ache, tired, nauseated, achy for two days, the third day severe stomach cramps from 10:00 AM to 6:00 PM, no appetite during that time, no diarrhea, the next day head ache, tired, heaviness on my head, tired, this lasted for three days. During the fourth day started perceiving a strange smell on and off, it has been 14 days and still have the smell like someone is smoking a cigar rate while in a toilet pooping. I have never smoke and hate the smell of smoke. This last symptom has been driving me insane. This is the only symptom since vaccine is lingering and is bothersome. My next shot will be on Monday the 15 of February, and I am concern, haven't been able to reach the Health Department to report or make questions, called my physician and she is out of the country, reported to the Medical Assistant who answered the phone. I only took motrin and Tylenol during the six days with the first side effects, have done nothing about the smell that is still there.
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| 50 | 2021-02-08 | feeling hot, weakness |
hot, sweaty, sick. could not get out of bed. Weak rest of day. following week-between 10a and 12p, g...
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hot, sweaty, sick. could not get out of bed. Weak rest of day. following week-between 10a and 12p, got really hot, heart beat really fast. 1/24-sitting on couch doing nothing, watching TV, chilling. Heart rate was between 106-110. Saw doctor, next day. All was fine. If happens again-do Holter 2/05, and echocardiogram 2/25. Holter-wear monitor for 2 wks. Current sx? just gets episodes-gets really hot, heart beats really fast, palpitations, chills, then ends. This is not all the time. 2/01/2021 ED-SVT. very intermittent, not concerned. do tests that doctor ordered. She has cont to work thru this.
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| 50 | 2021-02-08 | pain in extremity |
Received vaccine on 12/29/2020 around 11:15am. Approximately 7 hours later, developed left arm pain ...
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Received vaccine on 12/29/2020 around 11:15am. Approximately 7 hours later, developed left arm pain and left neck pain. 12/30 developed a small headache that progressed into a severe headache with nausea and vomiting. Went to ED on 12/30 at 12:04pm and discharged at 15:55. Received 0.9 % sodium chloride 999 mL, ondansetron 4 mg, CBC And Differential (Abnormal), Comprehensive Metabolic Panel (Abnormal), Lipase, acetaminophen 650 mg, SARS-CoV-2 NAT, IP UA w/Microscopic, Reflex Culture (Abnormal). Instructed to take ondansetron-ODT 4 mg disintegrating tablet by mouth every 8 (eight) hours as needed for nausea.
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| 50 | 2021-02-08 | pain in extremity |
Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter p...
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Pain, swelling, formation of large, red, warm, lump, and unable to lift arm. Took over the counter pain relievers, tried cold and warm compresses. Redness, warmth, and lump resolved after 3 weeks. Still will left arm pain. Painful to lift and abduct arm.
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| 50 | 2021-02-09 | pain in extremity | Very very sore arm. And extreme fatigue. |
| 50 | 2021-02-09 | pain in extremity | Chills, arm pain, body aches |
| 50 | 2021-02-10 | facial paralysis |
Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a conta...
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Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-02-10 | feeling cold |
on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued,...
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on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued, joint pain. These symptoms lasted 5 days. skin felt sunburned all over and hurt to touch which lasted 2 days
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| 50 | 2021-02-10 | hypersensitivity of all senses |
I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on ...
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I experienced a hyper-reactive immune response after receving the first dose of COVID-19 vaccine on Friday 12/18/20. On Saturday, 12/19/20, I developed severe pharyngitis, swollen glands in my neck and jaw, blisters and ulcerations on my lips and area surrounding my mouth, intra-oral and buccal lesions, severe headache, photophobia and eye pain, myalgia, skin sensitivity, GI upset consisting of nausea and diarrhea, and lost my sense of taste and smell for 48 hours. I was not febrile. The symptoms were severe on 12/19 and 12/20, with improvement on Monday 12/21. I completed an event form with Pfizer documenting the hyper-reactivity.
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| 50 | 2021-02-10 | pain in extremity |
Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 ho...
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Low grade fever began about 21 hours after shot. Very achy all over about 24 hours after shot. 36 hours after shit the lymph nodes under my left arm began to swell and hurt. Over the course of the next 2-3 days after that, the nodes continued to swell and hurt down my arm past the elbow. A week after the shot it was all resolved
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| 50 | 2021-02-10 | tingling, flushing |
Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat ...
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Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat down immediately headache lump in throat then: tingling fingers , dizziness, swelling hands feet and face, flushed, turn bright & lump in throat bigger within 10 mins to the ER for treatment
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| 50 | 2021-02-14 | feeling cold |
First started feeling very cold, then had shaking chills/ rigors for about 2 hours. Before rigors st...
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First started feeling very cold, then had shaking chills/ rigors for about 2 hours. Before rigors stopped had onset of headache. Had the worst headache I?ve ever had with fatigue and nausea for the next 24 hours. Felt better with symptoms resolved in approximately 36 hours.
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| 50 | 2021-02-14 | flushing |
She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vacc...
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She received her 1st vaccine without any adverse or side effects. Within 30 seconds of her 2nd vaccine she became flushed, within minutes she developed hives starting on her hands and then becoming more generalized, as well as itchy palms. She also was hypertensive. The COVID vaccine clinic administered epinephrine and transfer her to the emergency department where she was given prednisone, Benadryl, and famotidine. ED notes do indicate she had some mild expiratory wheezing but on further discussion with her today this is a consistent finding after being diagnosed with asthma last year (more on this below). She was monitored for over 3 hours and discharged home. Her itching resolved in the ED, hives resolved about 3 hours after discharge and other symptoms resolved around 24 hours post vaccine. She did have labs drawn in the ED: troponin and C4 WNL. CBC showed leukocytosis with lymphocytosis and eosinophilia. No personal history of seasonal, perennial, food, or bee sting allergies; asthma history as below. She did have an episode of bilateral eye swelling in December that was evaluated by her PCP; she was treated with benadryl & prednisone and this took 3 days to resolve. She has no other history of anaphylaxis, hives or angioedema. She was able to show me pictures of this today.
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| 50 | 2021-02-14 | pain in extremity, nerve pain, tremor |
Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain...
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Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches, high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-02-14 | pain in extremity |
14 hours after the shot, experienced sore arm, fever, chills, and headache which subsided within 24 ...
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14 hours after the shot, experienced sore arm, fever, chills, and headache which subsided within 24 hours (except sore arm is still ongoing). Intermittent coughing is ongoing which is a new event.
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| 50 | 2021-02-14 | tingling |
ABOUT TWO DAYS AFTER THE VACCINATION, I NOTICE SMALL ITCHING SPOT ALL OVER MY BODY. TOP LIP WAS THE ...
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ABOUT TWO DAYS AFTER THE VACCINATION, I NOTICE SMALL ITCHING SPOT ALL OVER MY BODY. TOP LIP WAS THE MOST BOTHERSOME. BOTH MY FEET FELT LIKE NEEDLES FOR ABOUT 2HOURS. BUT EVEN TODAY, 2/14/2021, THE ITCHING HAS CONTINUED. DOES NOT ITCH TO THE POINT THAT MAKES ME WANT TO SCRATCH; BUT NOTICEABLE. BOTH ARMS AND LEGS MOSTLY. I HAVE NOT NOTICED A RASH. I HAVE NOT TAKEN ANY MEDICATIONS FOR THIS ITCHING. I AM HOWEVER WORRIED ABOUT TAKING THE 2ND DOSE. AS A MATTER OF FACT, I AM LEANING AGAINST TAKING THE SECOND DOSE.
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| 50 | 2021-02-15 | weakness, cold sweat |
Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red,...
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Night of vaccine (2/13) headache and body ache; Morning after (2/14 am) site injection swollen, red, and hot. body was weak, headache; Night after (2/14 pm) nausea, headache, injection site swollen, hot to the touch, and red. lymph nodes swollen (right armpit); Two mornings after (2/15 am) throwing up (4 times), injection site more swollen, hot, swollen lymph nodes (right armpit), body was clammy; Two evenings after (2/15 pm) injection site swollen, hot, swollen lymph nodes (right armpit), body was clammy; Three mornings after (2/16 am) injection site swelling increased, red, hot, swollen lymph nodes (right armpit), redness line from site to right armpit into a red circle
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| 50 | 2021-02-15 | pain in extremity |
I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. ...
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I had the usual arm soreness. Foot pain started on 22nd and worse on 23rd. Left foot hurt the most. This foot was the one that hurt a little before vaccine. It was in the center of my foot where the arch is but inside the foot - an achy pain. It would shoot through my foot with pain if I stepped a certain a way. I was limping a bit. I tried to stay off my feet as much as I could. It continued through Christmas holidays. December 28 -(my PCP) - she thought it was tendonitis - could see a red circle and swelling where most of the pain was. Dec 28 - x-ray of foot was done. There was no fractures Meloxicam - anti-inflammatory 15 mg daily starting 12/28/2020. Pain continued - trouble walking and started having hip pain and left leg pain maybe from compensating. I saw Dr. on January 7th. He said it was posterior tibialis tendonitis. He gave me a foot brace to wear - around ankle and foot. It helped but I was still having pain. I was still taking Meloxicam every day. A chiropractor and a physical therapist -they gave me foot exercises and leg exercises and that has been helpful - I see them once a week still. Dr check-up on February 9 and he ordered an MRI and I had that done on February 11th. Report says Tendinopathy and not tendonitis. I got the second dose on January 8th.
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| 50 | 2021-02-15 | pain in extremity |
On the 10th, I started to feel achy that morning. It seemed like it had a focal point in my right hi...
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On the 10th, I started to feel achy that morning. It seemed like it had a focal point in my right hip and thigh that was a deep shooting pain. It continued to be there. I have been taking Tylenol - 1000 mg once a day and sometimes I skip it because I don't want to hurt my liver - so daily as needed. It seems like my foot pain got worse during the time after the second dose and the week after. At this time it has plateaued - not getting worse - as long as I walk on the side of my foot, I'm okay. Can't walk on it in a regular way. My right hip and thigh is a continuous ache unless I take Tylenol and sometimes that wakes me up. If I lose sleep I get a migraine. I see the chiropractor weekly and the physical therapist weekly.
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| 50 | 2021-02-16 | flushing, feeling hot | flushing and feeling hot. No resp sx. |
| 50 | 2021-02-16 | flushing, speech disorder | Flush face chest, swollen checks , lips, tongue, had issues talking |
| 50 | 2021-02-16 | pain in extremity | Soreness in arm, extreme body aches, headache, low-grade fever, fatigue, Swelling in left armpit |
| 50 | 2021-02-16 | pain in extremity |
After the first shot I just had a sore arm and nauseous for 4 days. After the second shot I had a s...
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After the first shot I just had a sore arm and nauseous for 4 days. After the second shot I had a sore arm (significantly more than after the 1st), had a massive headache for about 24 hours, but woke up this morning (2nd day after the shot) with swollen nymph nodes under my left arm along with pain and tenderness. It hurts to lift my arm or have anything putting any form of pressure on it.
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| 50 | 2021-02-17 | weakness, cold sweat, feeling cold, feeling of body temperature change |
6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax: headache/ 48 hours post ...
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6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax: headache/ 48 hours post vax: remaining symptoms headache; 24 hours post vax: as above plus extreme fatigue/ 48 hours post vax: extreme fatigue; 24 hours post vax: chills/inability to feel warm; 24 hours post vax: inability to feel warm; 28 hours post vax: hot and cold flashes/ 48 hours post vax: remaining symptoms hot and cold flashes; 28 hours post vax: as the above plus nausea; 32 hours post vax: as above plus vomiting/ 38 hours post vax: vomiting ended; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 48 hours post vax: general physical weakness and malaise; 48 hours post vax: general physical weakness and malaise; This is a spontaneous report from a contactable other Health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261), via an unspecified route of administration on 28Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. Age at vaccination was 50-years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0142) administered on 07Jan2021 (at the age of 50 years), at single dose in left arm. Medical history included anxiety, depression, obesity. The patient has allergies to certain unspecified antibiotics. Concomitant medications included citalopram, linum usitatissimum seed oil (FLAX SEED OIL), daily multivitamin 50+. It was reported that 6 hrs post vax on 29Jan2021 the patient experienced injection site pain, headache, 24 hours post vax: as above plus extreme fatigue, chills/inability to feel warm, 28 hours post vax: as the above plus nausea, hot and cold flashes, 32 hours post vax: as above plus vomiting, 38 hours post vax: vomiting ended, otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body, 48 hours post vax: remaining symptoms headache, injection site pain, hot and cold flashes, ex-treme fatigue, general physical weakness and malaise. The events were reported as non serious. No treatment was received for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
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| 50 | 2021-02-18 | feeling hot |
chills started about 8 hrs after 2nd dose injection; waking up with body aches, headache and continu...
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chills started about 8 hrs after 2nd dose injection; waking up with body aches, headache and continued chills - going from chilled to warm. No fever yet.
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| 50 | 2021-02-18 | numbness, facial pain, facial paralysis, bell's palsy |
On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling rig...
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On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling right. There was a pressure in my head, along with sinus and ear pain and a fuzzy feeling in my face. By Monday, Feb, 1, 2021, the pain was worse now with a fatigued feeling after sleeping 20 of the last 24 hours. I went to my Dr on 2/1/2021 and recognized a slide on the left side of my face. From my forehead not wrinkling up the same as right side, left eye wasn't closing as tight and the left cheek and side of mouth were sliding. He said it was Bells Palsy. He prescribed 10 days of prednisone and an antivirus medicine to be taken 3 times a day. That week I slept a lot and wasn't able to sit up much due to the head pain and the lightening bolt feeling in my face. By the 2nd week I was able to sit up more, but still very tired/fatigued. I was off work for 2 weeks, returning to work on 2/14/2021. There is still a slight slide on the left side in the eye and cheek.
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| 50 | 2021-02-21 | pain in extremity, night sweats, feeling of body temperature change |
dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, ni...
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dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, night sweats, severe fatigue, sinus congestion, runny nose, post nasal drip, sore arm
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| 50 | 2021-02-21 | pain in extremity |
sore arm; other vaccine same date vaccine date: 01Feb2021; This is a spontaneous report from a conta...
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sore arm; other vaccine same date vaccine date: 01Feb2021; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 01Feb2021 15:15 (lot number: EL3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history includes ulcerative colitis, shellfish allergy, sulfa allergies unknown if ongoing from an unknown date. The patients historical drug included benzthiazide (REGULON) which caused allergies. Patient received the first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 14:15 in the left arm for COVID-19 immunization. Concomitant medications included tofacitinib citrate (XELJANZ) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D). The patient was administered with other vaccine on same day i.e. 01Feb2021. However, it was also reported that the patient did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm on 02Feb2021 05:00 AM. The patient did not received treatment. The consumer assessed the events as non-serious. The outcome of the sore arm was recovered in Feb2021. No follow-up attempts are possible. No further information is expected.
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| 50 | 2021-02-21 | tingling, flushing |
Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling do...
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Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling down right side. Also had mild muscle aches and a headache. Had a similar reaction on her first dose. Oxygen: 97% on room air, BP109/57 and HR 54. Pt declined Benadryl and was taken to ED for further evaluation,
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| 50 | 2021-02-22 | feeling hot |
C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg ta...
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C/O feeling warm all over and developed a red lacy rash on trunk and extremities. Benadryl 25 mg tablet PO was given. BP taken.
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| 50 | 2021-02-22 | numbness |
The next day after receiving the vaccine, at 9:15 am her hand became numb and she was unable to cont...
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The next day after receiving the vaccine, at 9:15 am her hand became numb and she was unable to control or move it. She could not grip the steering wheel or hold anything. She shook her hand and it returned to normal. At 10:15 itjhappened again. It happened a few more time while at work. She also had a few epidsodes in which her jaw became slack and off to the side and she had to close her mouth with her hand, because she could not control her jaw. The episodes lasted about 10 seconds and then they would disappear. She reported her symptoms to the us at about 12:30 PM, 2/23/2021.
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| 50 | 2021-02-22 | muscle spasms |
Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in gl...
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Swelling at injection site leaving round circle that itches. Swelling under arm and tenderness in glands under arm. Muscle spasms in arms and chest. Slight nausea.
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| 50 | 2021-02-22 | night sweats, weakness |
Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms...
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Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms included cough, rhinorrhea, sore throat, sinus congestion, severe headache, weakness, body aches, N/V/D, fever, chills, night sweats, abdominal pain. Was quarantined for 10 days post symptom onset.
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| 50 | 2021-02-22 | tingling, flushing |
Arm burning from the inside out from injection site right after injection; headache; tingling hand a...
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Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-23 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable healthcare professional. A 50-year-old...
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Bell's Palsy; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on 21Jan2021 (at the age of 50 years old) at a single dose for covid-19 immunization. Medical history included hypertension, gastrooesophageal reflux disease (GERD), obesity, and allergies: sulfa. Concomitant medications included hctz, escitalopram oxalate (LEXAPRO), losartan, metoprolol and omeprazole (PROTONIX [OMEPRAZOLE]). The patient is not pregnant. The patient had no other vaccine in four weeks and was not tested for covid post vaccination. On 09Feb2021, the patient experienced Bell's palsy. Therapeutic measures were taken as a result of the event Bell's palsy included prednisone and valacyclovir. Outcome of the event was not recovered.
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| 50 | 2021-02-23 | pain in extremity |
Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from ...
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Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 18Dec2020 at 09:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included asthma, chronic back pain (surgery and scoliosis), migraines, systemic reaction to allergy injection, and COVID-19 in Jun2020 (prior vaccination). The patient's concomitant medications included pregabalin (LYRICA), butalbital, ascorbic acid (VITAMINS C), biotin, boron/ calcium/ Cimicifuga racemosa extract/ folic acid/ Glycine max extract/ Magnolia officinalis/ nicotinic acid/ pyridoxine hydrochloride/ riboflavin/ selenium/ thiamine/ tocopherol/ vitamin B12 NOS (ESTROVEN), Linum usitatissimum seed oil (FLAXSEED OIL), paracetamol (TYLENOL ARTHRITIS), and an unspecified stool softener and D (unspecified). The patient previously took amoxicillin and cinnamon oil and experienced allergies to both. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 18Dec2020 at 08:00 PM, the patient experienced throbbing arm pain for 2 days, fever, chills, body aches, headache, and fatigue for 2 days - some of the same symptoms she had when she had COVID-19 back in Jun2020. The events were considered non-serious. Treatment was received for the adverse events including ibuprofen, paracetamol (TYLENOL), and famotidine/ ibuprofen (DUEXIS). Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from "Throbbing arm pain" and "Fatigue" on 20Dec2020, and from the remaining events on an unspecified date.
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| 50 | 2021-02-23 | pain in extremity |
back pain; bilateral leg pain; This is a spontaneous report from a contactable other health professi...
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back pain; bilateral leg pain; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 123302), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ergocalciferol (VIT D) and an unspecified vaccine (lot number: P 100242861) taken for an unspecified indication on 01Dec2020. The patient previously took the first dose of BNT162B2 (lot number: EL0140), at 50-years of age via intramuscular route, on 30Dec2020 at 03:30 pm on the left arm for COVID-19 immunization and four days after the injection, patient had severe low back pain, difficulty walking, standing, sitting. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, the patient experienced back pain along with bilateral leg pain. The patient did not receive any treatment for the reported events. The patient underwent lab test which included nasal swab test which showed negative result on 21Jan2021. The outcome of the events was recovering. The patient was not pregnant at the time of vaccination.
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| 50 | 2021-02-24 | feeling hot |
I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face f...
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I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face felt very hot and was flushed and the right side of my tongue felt thick for a day or more. Yesterday was one week ago from my vaccine and my tongue intermittently still feels thick. My tongue feels like it does when novocaine starts to wears off from the dentist. My right arm also felt sore and puffy; however, there was no skin reaction. The next day or so the right side of my neck was sore. As to be expected, my arm was also sore.
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| 50 | 2021-02-24 | pain in extremity |
Painful joints - ankles, knees, hips, shoulder, elbows, wrists, and fingers Fatigue Painful swelling...
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Painful joints - ankles, knees, hips, shoulder, elbows, wrists, and fingers Fatigue Painful swelling of lower legs and ankles
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| 50 | 2021-02-24 | tenderness |
Severe back pain, unbearable to sit or lean back, painful to the touch. Took Advil 24 hours after ha...
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Severe back pain, unbearable to sit or lean back, painful to the touch. Took Advil 24 hours after having the vaccine.
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| 50 | 2021-02-24 | tenderness |
On one week follow-up visit to both urgent care and the emergency room, my primary care doctor notic...
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On one week follow-up visit to both urgent care and the emergency room, my primary care doctor noticed that my symptoms occurred less than 48 hours from my vaccine. I received the vaccine approximately 3:00 pm on Saturday February 13. At 11 am on Monday February 15 started feeling pain and tenderness on lower left side which was intermittent and worsend by nightfall. The next day on Tuesday February 16 I went to the urgent care and then they sent me to the ER in which epiploic appendigitis was determined to be the cause. Sent home to a course of ibuprofen and rest because the condition self-corrects.
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| 50 | 2021-02-25 | migraine | Shaking chills, Fever, Muscle aches and pain, joint pain, migraine |
| 50 | 2021-02-25 | pain in extremity |
Received first covid vaccine 1/17/21 to the right deltoid (Pfizer, lot #EL3248). On 1/27/21 seen by ...
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Received first covid vaccine 1/17/21 to the right deltoid (Pfizer, lot #EL3248). On 1/27/21 seen by an APNP for right arm pain and decreased mobility. Presented to EHS on 1/29/21 with pain and concern that vaccine was give posterior to the deltoid. Pt did not take pictures or get seen around the time of her vaccine. So, 12 days later, unable to verify exact placement of the vaccine back on 1/17/21. Per the APNP's report on 1/27/21, the pt developed sharp shooting pain into the right trap/scapular area and radiation to lower arm. The pain started within a few seconds after the covid-19 vaccine was given. Feels soreness and tension in the shoulder/scapular area which has not resolved since vaccine. Pt advised continue supportive cares, trial diclofenac gel, use oral NSAIDs cautiously, apply heat. Follow up with EMG (scheduled for 4/14/21). Pt was also given a prescription for cyclobenzaprine. Per documented telephone encounters, as of 2/26/21 pt continues to have significant pain. Note: Pt received her second covid-19 vaccine on 2/13/21 in her left deltoid and there has been no mention of issues with pain in the left arm (Pfizer, lot #EN5318)
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| 50 | 2021-02-25 | tingling |
subjective 50 yo female presenting for 2nd covid vaccine with h/o anxiety a/w tingling in left hand ...
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subjective 50 yo female presenting for 2nd covid vaccine with h/o anxiety a/w tingling in left hand 15 min after first covid vaccination which resolved during a 30 min observations period . Again, approximately 15min after the 2nd covid vaccination c/o tingling without weakness in the palm of left hand a/w anxiousness Pt denies swelling in hand, no rash, no flushing, no swelling sensation in face or neck, no globus no sob no wheezing no chest pain no palpitation no gi sx no headache no altered mentation or brain fog Objective Pulse 63 bp=154/103 rr 12 temp afeb Heent wnl Neck wnl Chest clr p&a Cor rrr Neuro grossly intact Skin clr Assessment/plan Anxiety with psychosomatic features and elevated bp due to hyperadnergic state from anxiety. Pt reassured being observed by physician and pt reclined in a quiet room. Repeat vital signs were p 64 bp 150/89 and p 62 bp 120/85 repectively d . pt discharged home with resolution of left hand paresthesia and normalized vital signs
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| 50 | 2021-02-26 | burning sensation, numbness, muscle spasms |
Sciatic nerve pain, burning, numbness, muscle cramping - started 2/20/21 in lower left back, travele...
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Sciatic nerve pain, burning, numbness, muscle cramping - started 2/20/21 in lower left back, traveled across left buttocks on 2/22/21, continued to left outer thigh on 2/23/21, continued to left lower leg and foot on 2/24/21. Loss of ability to walk properly due to left leg/foot pain and numbness which resulted in loss of contorl of left leg and foot on 2/24/2021. No prior history of injury or problems of this nature.
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| 50 | 2021-02-26 | migraine, pain in extremity |
2/24/21 Injection Site arm soreness (8 hours) 2/25/21 - Right arm pain, nausea, body aches (12 hou...
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2/24/21 Injection Site arm soreness (8 hours) 2/25/21 - Right arm pain, nausea, body aches (12 hours) stomach pain (6 hours) Migraine-like headache (8 hours) 2/26/21 Tired 8 hours
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| 50 | 2021-02-28 | feeling cold, tingling |
her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high bloo...
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her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.
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| 50 | 2021-02-28 | pain in extremity |
1st - arm pain and heaviness from shot - 1 day after shot - took Tylenol 2nd - mild itching on face ...
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1st - arm pain and heaviness from shot - 1 day after shot - took Tylenol 2nd - mild itching on face and head - 3 -4 days after shot - did not recognize it as a reaction - no treatment given 3rd - difficulty breathing, asthma attack, full body covered with hives - 5 days after shot - took Benadryl for 24 hours - went to urgent care the next morning and was given steroid medication to take each day for a week, directed to continued to take Benadryl until steroids stop the hives 4th - second respiratory reaction with coughing and difficulty breathing - took an extra Benadryl.
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| 50 | 2021-02-28 | tremor, flushing |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: All...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
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| 50 | 2021-03-01 | numbness |
Roughly 25 minutes after receiving the vaccine, I experienced numbness in my face (both sides). It ...
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Roughly 25 minutes after receiving the vaccine, I experienced numbness in my face (both sides). It lasted approx. 1.5 - 2 hours. No treatment was sought as there were no issues with breathing. The feeling returned to normal on its own.
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| 50 | 2021-03-01 | migraine, pain in extremity, numbness |
dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purp...
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dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
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| 50 | 2021-03-01 | pain in extremity |
fever and severe body aches and chills , body aches pfizer - no problems / first vaccine no problem-...
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fever and severe body aches and chills , body aches pfizer - no problems / first vaccine no problem- sore arm only
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| 50 | 2021-03-01 | tremor |
Increased heart rate to 110 bpm within 15 minutes of vaccine, lasting for 40 minutes, headache with...
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Increased heart rate to 110 bpm within 15 minutes of vaccine, lasting for 40 minutes, headache within 15 minutes of vaccine that lasted the whole day , dizziness and shakiness with in 15 minutes that lasted about 30 minutes.
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| 50 | 2021-03-02 | pain in extremity, tenderness |
Arm soreness. This morning my armpit is very tender, sore and swollen. Very swollen in gland area. S...
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Arm soreness. This morning my armpit is very tender, sore and swollen. Very swollen in gland area. Soreness down my arm.
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| 50 | 2021-03-02 | tingling, pain in extremity |
headache on right side of head; back went out from right side and cannot bend over; right leg hurts;...
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headache on right side of head; back went out from right side and cannot bend over; right leg hurts; right foot tingles; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (lot number: EK4176, administration time: 02:00 PM on left arm). The patient previously took levofloxacin (LEVAQUIN) and cefalexin (KEFLEX) and experienced allergies to medications. On 30Jan2021 10:00 PM, the patient experienced headache on right side of head, back went out from right side and cannot bend over, right leg hurts and right foot tingles. No fever. No treatment was received for the adverse events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
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| 50 | 2021-03-03 | hot flush |
nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided...
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nausea, hot flashes, aches, blood pressure drops and spikes, low oxygen, dizziness symptoms subsided with antihistamine lasted 2 hours
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| 50 | 2021-03-04 | weakness |
While in observation @ 4:25p, a pt stated she felt weak, and that her defibrillator went off. She ha...
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While in observation @ 4:25p, a pt stated she felt weak, and that her defibrillator went off. She has a hx of heart issues and that her defibrillator goes off several times a year when her HR goes above 118 for a certain sustained amount of time. EMT's evaluated the pt, pt was placed on a monitor by emts, refused oxygen, didn't agreed to go to the ER at first but agreed after speaking with EMT's. Brought to ER, husband who was in the car, was notified by police detail.
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| 50 | 2021-03-04 | pain in extremity | Left forearm pain |
| 50 | 2021-03-05 | feeling cold |
12 hours after injection fever, chills, ague, extreme fatigue lasting 12 hours. 15 hours later loss ...
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12 hours after injection fever, chills, ague, extreme fatigue lasting 12 hours. 15 hours later loss of taste & smell lasted for 6 hours. Ague & extreme tiredness lasted 48 hours
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| 50 | 2021-03-05 | night sweats |
Three hours post vaccine, onset of moderate headache, moderate body aches, moderate fatigue. Twelve ...
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Three hours post vaccine, onset of moderate headache, moderate body aches, moderate fatigue. Twelve hours post vaccine, onset of severe headache/body aches/fatigue/chills/night sweats. Treatment: 1000 mg acetaminophen every 6 hrs
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| 50 | 2021-03-05 | speech disorder |
On Sunday following vaccine my husband noticed that I had a lisp when I spoke and my tongue wanted t...
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On Sunday following vaccine my husband noticed that I had a lisp when I spoke and my tongue wanted to protrude out of my mouth sporadically. As the week has progressed, I now have trouble speaking without jumbling my words - have to stop and speak slowly to make sense
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| 50 | 2021-03-05 | tenderness |
Appx 24 hours after the injection, the site of injection started itching very badly and a bright red...
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Appx 24 hours after the injection, the site of injection started itching very badly and a bright red solid spot appeared and a lump that was sore to touch. Redness was just smaller than a quarter at first. That was about 5:10pm 3/5 and then appx 8-9 hours later, while sleeping, I developed a severe cough and my nose was completely stopped up. Eyes were itching with drainage too. My husband got up and gave me a Benadryl and that calmed everything down so I could sleep again. This morning, my eyes were pretty red and still had some drainage. My cough is there but very faint and less frequent. My arm hasn?t stopped itching and the red spot is slightly larger at appx 1.5 inches tall and 1 inch wide. Still with a lump and soreness. I expected the lump and soreness.
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| 50 | 2021-03-07 | flushing | tongue tingling, throat and mouth feels swollen, flushing. Evaluated by EMS-Cleared |
| 50 | 2021-03-07 | flushing |
10 minutes after COVID vaccine was administered, pt reported facial flushing to pharmacy staff. Per ...
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10 minutes after COVID vaccine was administered, pt reported facial flushing to pharmacy staff. Per pt, her heart is pounding. RPh checked the blood pressure of the patient, blood pressure reading was 168/60, HR was 77. RPh spoke to another RPh in the store, RPh reported that BP was high for patient and per RPh if we administer EpiPen that can increase the patient's blood pressure even more. RPh gave the patient Benadryl 50 mg. RPh spoke to patient and patient's husband, he recommended to visit the nearest urgent care.
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| 50 | 2021-03-07 | muscle spasms | Body aches, joints pains, back pain, muscle cramps and headache |
| 50 | 2021-03-07 | pain in extremity, migraine |
Arm hurt immediately , few hours later severe sweats, fever ,severe migraine like headache , complet...
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Arm hurt immediately , few hours later severe sweats, fever ,severe migraine like headache , complete body ache lasted 2 days
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| 50 | 2021-03-07 | pain in extremity |
Sore Arm, about 1 hour after shot, lasting 3 days Tiredness, fatigue. Tiredness same day, lasting 5...
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Sore Arm, about 1 hour after shot, lasting 3 days Tiredness, fatigue. Tiredness same day, lasting 5 days. Fatigue 24 hours after-36 hours after (slept for 11 hours, day after shot) Headache 6 days
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| 50 | 2021-03-07 | pain in extremity |
Swollen lymph nodes in neck and armpit and this morning started having severe pain in my left thumb/...
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Swollen lymph nodes in neck and armpit and this morning started having severe pain in my left thumb/wrist
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| 50 | 2021-03-07 | pain in extremity |
"Pfizer-BioNTech COVID-19 Vaccine EUA" Around 5pm on March 7th, noticed my arm at site of vaccinatio...
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"Pfizer-BioNTech COVID-19 Vaccine EUA" Around 5pm on March 7th, noticed my arm at site of vaccination was feeling more tender, hot, swollen, and red. In the night, I couldn't lay on that side. Stayed the same throughout March 8th, until 7pm, became increasingly sore. My entire arm is aching. The redness and swelling has also increased. I also have a headache started this evening.
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| 50 | 2021-03-07 | pain in extremity |
Fever of 99.8 went up to 100 then holding steady at 99.3. Fever began around 1:20 PM and is still oc...
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Fever of 99.8 went up to 100 then holding steady at 99.3. Fever began around 1:20 PM and is still occuring at 8:30 PM on March 8, 2021. Also have a headache (like a sinus headache) and neck pain on the left side of the back of my neck. Typical arm pain/soreness from what others have described and feeling a little sluggish.
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| 50 | 2021-03-07 | tingling |
tingly sensation in my chin area; This is a spontaneous report from a contactable consumer (patient)...
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tingly sensation in my chin area; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 15Jan2021 15:30 on left arm at single dose for covid-19 immunization. The facility type vaccine was hospital. Patient was not pregnant. Medical history included type 1 diabetes mellitus from an unknown date, Raynaud's from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included insulin glargine (LANTUS), insulin lispro (HUMALOG), lansoprazole. The patient experienced tingly sensation in chin area in Jan2021 with outcome of unknown.
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| 50 | 2021-03-08 | pain in extremity, burning sensation |
Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inabil...
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Left arm pain at site of injection, throbbing down the arm, burning sensation and heaviness. Inability to raise arm and entire arm swollen. In addition to this on the first day of the adverse event flu like symptoms which lasted two days. Arm pain continues as at day four since adverse event started
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| 50 | 2021-03-08 | pain in extremity, tremor, feeling hot |
Minimal issues after 1st vaccine. After 2nd vaccine, about 8 hours later my arm hurt so bad I could ...
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Minimal issues after 1st vaccine. After 2nd vaccine, about 8 hours later my arm hurt so bad I could not sleep (2:30am) and taking Tylenol only cut the pain 50%. As time progressed that day about 12hours after injection I started to get the chills, achiness even after Tylenol which didn't do much. By 16 hours after injection I got hot/damp, shaky, nausea but once able to cool down nausea resolved. By 18 hours thru 28 hours I had difficulty walking due to achiness and extreme fatigue. Chills going on most of the time throughout and some looser stools. The next day 40h post injection I felt better-no chills. At 48h I was tired- no achiness, some looser stools. Day 3- I had some blood blowing my nose, resolved by day 4.
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| 50 | 2021-03-09 | weakness, muscle spasms |
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection s...
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joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
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| 50 | 2021-03-09 | weakness |
Fever, chills, severe muscle aches, severe headache, dizziness, weakness, loss of appetite 12 hours...
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Fever, chills, severe muscle aches, severe headache, dizziness, weakness, loss of appetite 12 hours post vaccine Chest pain/heaviness which led to some shortness of breath 32 hours post vaccine following temperature returning to normal Treated severe headache with Tylenol without relief
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| 50 | 2021-03-09 | weakness |
Caller is having a fever, nausea, and feels weak and wants to know if this is normal and what to do....
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Caller is having a fever, nausea, and feels weak and wants to know if this is normal and what to do. She has taken Motrin to reduce her fever A. 400. Advised caller injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever can occur .Swollen lymph nodes and nausea have also been reported. Please seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash. TR
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| 50 | 2021-03-09 | feeling hot |
Patient reported to nurse that she was starting to develop hives. Upon inspection patient was seen t...
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Patient reported to nurse that she was starting to develop hives. Upon inspection patient was seen to have red blotchy hives on her neck and chest. She reported that it felt hot but not itchy.
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| 50 | 2021-03-09 | numbness, muscle twitching |
Facial twitches and numbness (mild, on and off) on side vaccine was given. Warm feeling in throat an...
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Facial twitches and numbness (mild, on and off) on side vaccine was given. Warm feeling in throat and metal taste in mouth (both of these have gone). Twitches and mild numbness still happening.
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| 50 | 2021-03-09 | migraine |
First 3 days migraine ,fever, extreme pain all over. Could barely move injection arm. Still sore al...
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First 3 days migraine ,fever, extreme pain all over. Could barely move injection arm. Still sore all over currently.
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| 50 | 2021-03-09 | tenderness |
This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient (n...
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This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 05Feb2021 08:30 at the age of 50-years-old at single dose for COVID-19 immunization. Medical history included obesity, inflammatory lung disease. No known allergies. The patient's concomitant medications were not reported. The historical vaccine included BNT162B2 on 15Jan2021 at the age of 50-years-old for COVID-19 immunization. The patient experienced 6 out of 10 pain, tenderness and mass of some sort behind left collarbone pain radiating toward shoulder and neck, injection site minimally sore on 05Feb2021 20:00. Pain resolves with ibuprofen, no treatment received for the other events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.
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| 50 | 2021-03-10 | tenderness |
I have had major swelling above my collarbone between my shoulder and neck on the left side, the sam...
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I have had major swelling above my collarbone between my shoulder and neck on the left side, the same side as I received my shot. It is tender to the touch. After four days, I can feel harder masses inside.
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| 50 | 2021-03-11 | weakness |
On day of shot, I was fine, more tired than usual by bed time. Next morning I was extremely weak an...
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On day of shot, I was fine, more tired than usual by bed time. Next morning I was extremely weak and fatigued not able to get out of bed for two hours. I went downstairs to get water, blacked out and completely fainted. I got out of bed around 10:25 or so, went downstairs very slowly, saw clock when I was able to get up around 10:47. I don't believe I was passed out for long. Woke up on kitchen floor, arm bruised. Thankfully head was not injured, apparently fell with arm supporting head (assumption since no head injury). Advised by nurse to come to dr. office, they tested blood pressure, top number was 82 (did the tilt test for orthostatic hypotension). EKG was normal and other blood tests were normal. Was diagnosed with dehydration and low BP. I habitually drink water and even if I did potentially skip a day, I should not faint.
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| 50 | 2021-03-11 | flushing |
Chest tightness and flashing with anxiety feeling immediately after the shot. Vital signs were stab...
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Chest tightness and flashing with anxiety feeling immediately after the shot. Vital signs were stable HR 86, Sat 98% RA, BP 107/75. Physical exam were unremarkable and she did not look in any acute distress she just felt anxious. Lungs clear to auscultation bilaterally. She was observed in the car for 30 minutes and was discharged home in stable condition. Denies any symptoms before discharge.
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| 50 | 2021-03-11 | tingling |
Increase heart rate 135, tingling hands and legs, complaint of swollen throat BP 158/85 called for a...
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Increase heart rate 135, tingling hands and legs, complaint of swollen throat BP 158/85 called for ambulance heart rate 93 heart rate 117 EMS arrived taken to hospital
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| 50 | 2021-03-12 | burning sensation, cold sweat |
Abdominal pain, vomiting, diarrhea, burning sensation in back and arms, clammy, chills, weak legs fr...
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Abdominal pain, vomiting, diarrhea, burning sensation in back and arms, clammy, chills, weak legs from about 4AM until 5:30 AM and then went to sleep. Woke up at 8:30AM and felt better
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| 50 | 2021-03-13 | pain in extremity |
I had severe flu like symptoms: headache and body aches, on and off fever. The injection site where ...
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I had severe flu like symptoms: headache and body aches, on and off fever. The injection site where my steroid shot was extremely sore, joints sore, nausea, acid reflux, constant urination and bowel movement, extreme dizziness and light-headedness.
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| 50 | 2021-03-13 | tingling |
tingling lips, one to two hours, subsiding to slight only on left side intermittently tingling left ...
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tingling lips, one to two hours, subsiding to slight only on left side intermittently tingling left side of tongue, one to two hours slighter tingling next to left eye, intermittent for days very strong metallic taste in mouth, subsided to slight metallic taste after a few hours
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| 50 | 2021-03-13 | tremor | Violent shaking, chills, mild fever, about an hour |
| 50 | 2021-03-14 | weakness |
The next day after receiving vaccine I had weakness and fatigue. The second day after receiving vacc...
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The next day after receiving vaccine I had weakness and fatigue. The second day after receiving vaccine I could not move in the morning. I went to the ER both days. I was admitted to hospital at the second ER visit. I received 3 days of high dose IV steroids. Improvement of symptoms.
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| 50 | 2021-03-14 | feeling hot |
Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to...
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Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to sinus headache); after approximately 15 minutes, I experienced a ringing in my ears. I told the attending person, but she said it was probably due to being anxious about getting the shot. I left after being in the waiting area for 30 minutes and began driving home. My face felt very warm, so I opened the car window. I touched the side of my face and felt hives. My tongue felt thick, but I did not feel hives going down my throat. My torso started to itch and I had hives there as well. There was no raised area at the injection site. I became very itchy on my head, neck, and arms. When I arrived home, I took a dose of benadryl. Four hours later, I took a dose of zyrtec. My hives subsided and my tongue returned to normal, but I was still itchy. The next morning, I took a dose of claritin and called my doctor. In the afternoon, I took benadryl. In the evening, I took zyrtec. I continued this for 2 more days. The day after my vaccine, a node between my thumb and forefinger on my left hand was swollen and painful to the touch. My hand was swollen and my finger joints ached. I went to the doctor for an examination. The swelling and pain in my hand continued to worsen during the day and overnight. I kept ice packs on my hand and it felt better after 3 days.
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| 50 | 2021-03-14 | flushing, tingling, pain in extremity |
I was told by my doctor after talking with his office on the phone to report my reaction and that he...
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I was told by my doctor after talking with his office on the phone to report my reaction and that he is recommending that I NOT HAVE THE SECOND DOSE of this vaccine. On Tuesday March 9th I had my first dose of the Pfizer vaccine at our drive up site with the health department. I did not have any tylenol or claritin that morning and only took Tylenol that night. Starting the NIGHT of the 10th I started taking my usual Child's dose of Claritin for seasonal allergies. I took Claritin the nights of the 10th, 11th and 12th (thank goodness apparently). The only issue I had the 9th and 10th was REALLY SORE ARM. One the morn ing of Saturday the 13th I woke up and my neck was itching. Then my decollete area. Then my face and head and shoulders and the back of my arms. I felt like I was flushing after a steroid shot with the pin prickly itching and very very very slight pink color to my skin. Eventually by the evening the itch moved to my bra line. I called my local pharmacy (since the urgent care center was closed) and was told to take benedryl or claritin and keep an eye on it. The ADULT dose of Claritin really helped to calm the majority of the itching. I itched a little yesterday and still itch in spots today but the Claritin is helping as is topical Cortaid. The nurse said the claritin I had in my system probably prevented me from turning red. I have been told by two doctors that I should NOT take the second dose. ALL OF THE CONVERSATION WITH MY DOCTOR WAS DONE OVER THE PHONE.
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| 50 | 2021-03-14 | pain in extremity, hot flush |
Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes...
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Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes; low grade fever; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection and lot number: EL9265) via an unspecified route of administration on 03Feb2021 07:00 to Left arm at single dose for COVID-19 immunization. Patient medical history included Eosinophilia and colitis. Concomitant medications included Escitalopram, alprazolam and ibuprofen. Past drug included Wellbutrin and experienced allergy and first dose of BNT162B2 for COVID-19 immunization. On 03Feb2021 22:00 patient experienced Very large swollen lymph nodes in left armpit, neck, arm pain, headache, hot flashes, low grade fever still continues at 1 week after last dose. Seriousness was reported as non-serious. Patient did not receive any treatment for events. Outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
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| 50 | 2021-03-14 | pain in extremity, muscle spasms |
Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. ...
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Fine for 10+ hours. That evening, L arm really ached, really painful to lift above shoulder height. Noticeably sore at injection spot. Joints started aching, tired, noticeably sore up through neck on L side. Was driving at night- distance vision was blurry (could have been dry eyes, not sure related to vaccine). Slept 14 hours. Woke with muscles still achy, not quite as much as day before. Neck still sore. Injection site only sore to touch. Still very tired, could have slept more. Woke up today, feel pretty normal. A bit tired.
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| 50 | 2021-03-14 | tingling |
more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a ...
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more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on left arm, on 06Feb2021 15:30 (at the age of 50-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included type 1 diabetes and Raynaud's, patient had no known allergies. No COVID prior vaccination. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), and lansoprazole, all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration, on left arm, on 15Jan2021 15:30 (at the age of 50-year-old), at single dose, for COVID-19 immunization, and after receiving the first dose the patient experienced tingly sensation in her chin area. After receiving the second dose on 08Feb2021 13:00 (reported as "day three") patient experienced more intense tingling sensation around the chin area and extreme dizziness. Patient took diphenhydramine hydrochloride (BENADRYL) and meclozine hydrochloride (BONINE) as a result. On 09Feb2021 (reported as "day 4") patient still experienced the tingly sensation around chin and lower mouth area. Patient felt almost like a sensation of when, for example: your arm fell asleep. It was constant. No COVID tested post vaccination. The outcome of the events was not recovered.
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| 50 | 2021-03-15 | pain in extremity, discomfort |
day of: queasiness, tightness at site of injection 1 day after: heaviness/weighed down, headache, qu...
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day of: queasiness, tightness at site of injection 1 day after: heaviness/weighed down, headache, queasiness, sore arm 2 days after: muscle aches, loss of appetite. night time: arm hurts 3 days after: loss of appetite, arm has raised rash about 3"x4" near the site of injection -hurts like a bruise, itchy, warm/hot 4 days after: rash symptoms same as above 5 days after: rash is beginning to dissipate, still itchy at times
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| 50 | 2021-03-15 | pain in extremity |
101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening inte...
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101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening intense headache unable to sit due to back pain could not sleep due to pain left underarm is VERY swollen
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| 50 | 2021-03-15 | pain in extremity |
Achiness, fever, lethargy, chills, sleepiness within four hours of vaccine dose. Continued symptoms ...
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Achiness, fever, lethargy, chills, sleepiness within four hours of vaccine dose. Continued symptoms into following day. Symptoms subsided by 10:00 PM the day following the dose. Extreme soreness in arm even though it was moved and massaged to relieve the stiffness and soreness.
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| 50 | 2021-03-15 | tingling |
pt. experiencing tingling to the L. leg and warmth throughout the body. pt. advised to wait an addi...
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pt. experiencing tingling to the L. leg and warmth throughout the body. pt. advised to wait an additional 15 mins.
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| 50 | 2021-03-16 | discomfort, muscle twitching |
Patient was sitting in chair post-vaccine and initially complained of feeling lightheaded, nauseated...
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Patient was sitting in chair post-vaccine and initially complained of feeling lightheaded, nauseated and that her limbs were heavy. She was ambulated with assistance x2 to the exam table by the CNPs. She was laid in the supine position, feet elevated and given a cool cloth for her head. VS 150/96, HR 82 and regular, pulse ox 93% on room air. She was monitored for approximately 10-15 minutes, and the patient then stated that she was having involuntary twitching and her limb heaviness was worse. Strength 3/5 to BUE and BLE at that time. She stated a medical history of anxiety/depression and tardive dyskinesia, NKA, no previous history of vaccine reactions. She states she had eaten breakfast that day but did not have lunch. Her blood glucose was 111. 911 was called to escort the patient to the ER for further evaluation. Vitals remained stable during the observation period, repeat BP 138/76, HR 80 and regular, pulse ox ranged from 89-93% on room air, she did state some heaviness with breathing. Respirations appeared even and non-labored. She remained oriented x4 but was drowsy. She was not able to sit up or move herself to the medic cart upon arrival. Her husband was notified and she was transported to the hospital.
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| 50 | 2021-03-16 | feeling hot |
Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she lo...
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Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she looked in the mirror and was red/blotchy all over. She took 25mg benadryl as she was driving home and took another 25mg benadryl 20-30 min later when she arrived home. She continued to feel hot and itchy so took benadryl for the next 48 hours before those symptoms resolved. On day 4 after vaccine (2/29/01) pt began to notice redness in her right eye. The eye became more "bloodshot" as the day progressed and started feeling painful and "pressure" sensation. She went to see ophthalmologist urgently who diagnosed it as acute scleritis. She is currently on NSAIDs and topical steroid. She notes that the eye is very photosensitive and has significant "pressure" sensation. She is still experiencing these symptoms almost 3 weeks later.
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| 50 | 2021-03-16 | pain in extremity | joint pains, right toe, left foot, bilateral knees, right elbow |
| 50 | 2021-03-16 | tingling |
Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination,...
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Severe dizziness 1 hour after immunization, cleared after 1/2 hour. Starting day after vaccination, awoke with dizziness, nausea, chills. Diarrhea later in day. Starting 3 days after vaccine, painful and swollen and hard supraclavicular, Left axilla, cervical lymph nodes. Dizziness and nausea persist. Fatigue requiring 12 hours sleep. Paresthesias (tingling, "pins and needles"), both lower extremities, from toe to knee, unremitting, worst on day 2 after vaccination.
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| 50 | 2021-03-17 | inability to speak |
Patient had COVID-19 vaccine and approximately 20 minutes later could not seem to talk. She was not...
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Patient had COVID-19 vaccine and approximately 20 minutes later could not seem to talk. She was not reactive by speech while on site at facility and blood pressure was 170/110. She was not given an epi-pen but was sent to hospital by transport.
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| 50 | 2021-03-17 | flushing |
Patient waited the 15 minutes post vaccine and felt fine. After 40 minutes patient returned to the p...
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Patient waited the 15 minutes post vaccine and felt fine. After 40 minutes patient returned to the pharmacy light headed, flushed, and claimed mouth, lips and tongue were tingling. No signs of facial swelling. Nurse practitioner attached to the pharmacy examined the patient before sending her home in her husband's care.
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| 50 | 2021-03-17 | pain in extremity, discomfort |
Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Ac...
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Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Achiness in my legs. Ringing in both ears. Took 800 mg ibuprofen 3.12.2021 @ 12:30am. All symptoms resolved by 2:00pm on 3.12.2021 with the exception of Ringing in my ears. that is ongoing.
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| 50 | 2021-03-17 | speech disorder, inability to speak |
I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted ...
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I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted to be sure to send this along to you as well as, to the adverse effect website. It?s almost as if I?ve had a stroke. Initially (after the shot), I was a little lightheaded but as the rest of the day wore on, (say around 6 hours later), I started to get foggy in my brain - like I had to remember to even breathe - and tightness in my chest like asthma. There was a high pitch scream in my ears and I was more or less, kind of out of it. My hands and feet were sweating profusely. My tongue kind of reacted, too and got a little burned, like when I eat pineapple. It was then that I noticed difficulty swallowing. My sister (a medical professional) suggested Benadryl for the mouth and tongue sensation and she kept an eye on me the rest of the night. She also warned that I should not get a second shot (I totally agree). Being a trooper, I thought all of the weird stuff would blow over in a day or two, so I decided to power on and not report my issues. Today is day 6 post vaccine and I can now see a pattern to the symptoms or episodes which are still present, on and off: 1. The ringing in my ears will intensify, and then I stare off into space, my words get garbled (I have to really concentrate on being present), my tongue gets very dry and then the swallowing issue returns (it?s like slow motion swallowing, so I bite my tongue to stay in the moment). 2. The tightness in my chest intensifies and my breathing gets shallow. I must focus and breath through it despite discomfort. Note, since the shot, I keep a Benydryl and my inhaler with me, although I haven?t used Benadryl since day 3. I used my inhaler yesterday, day 5 because of discomfort and that seemed to help, but using it triggered an ear ringing/screaming episode that came and went the rest of the day. 3. I also have nasal constriction throughout the day. The nasal passage just inflames and then relaxes. I also have phantom smells and my sense of taste got a little off on day 1, but recovered. ________________ March 18, 2021 Update Saturday, 3/13 went to the ER because the cognitive issues had advanced. I found myself staring off into space, losing my train of thought, and unable to speak. When I did speak I stammered or stuttered. They wanted to make sure I did not have a stroke or that I was not in the middle of one, so they did some tests. They also recommended that I go ahead and take the prednisone. After my ER visit the cognitive issues continued, but began to be not-so-frequent by Sunday afternoon. I felt like I was on the road to recovery and so delayed again, taking the prednisone. On Tuesday (3/16), I had what I would call an asthma attack. I was having very strong bronchial spasms that would not abate. I used my rescue inhaler to try to mitigate the symptoms, but that did not work. At the same time, the cognitive issues sort of returned and the big loud ringing and whooshing in my ears was really really noticeable. I am having a protracted allergic reaction to the vaccine. I am not normally allergic to things, but I have noticed new allergies since this all began. Certain food items seem to bother me now and push me into the lung seizing, raw tongue, neurological, ear ringing event.
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| 50 | 2021-03-18 | facial pain, involuntary muscle movements, pain in extremity |
Got vaccine around 10:00 a.m. About 30 minutes after shot, I suddenly felt very exhausted, but it pa...
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Got vaccine around 10:00 a.m. About 30 minutes after shot, I suddenly felt very exhausted, but it passed within another 30 minutes. A few hours later, pain in upper arm got pretty intense. Then around midnight, the pain in my upper arm had grown so severe that it was spreading into my shoulder and neck. By 2:00 a.m., I woke up in sever pain in my face, not able to open my mouth because my jaw hurt so much. I went back to sleepI was not able to open my mouth until I repeatedly coaxed it open, around 8:00 a.m. By 10:00 a.m., my eyes itched like crazy and were red. My jaw getting stuck shut and my eyes itching insanely are why I'm completing this form.
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| 50 | 2021-03-18 | feeling cold |
6 am awoke fatigued, by12 pm started to have slight fever. By 1:30 fever of 100.3 continued to drink...
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6 am awoke fatigued, by12 pm started to have slight fever. By 1:30 fever of 100.3 continued to drink water at least 40 oz by 12pm. Layed down at 1:00 pm took 250mg of Tylenol. Still felt fatigued, fever may have been higher i did not retake. Slight headache, chills, fever, slight congestion. I felt super cold. Slept for a couple of hours, Isolated my self in my bed room. By 6 pm I awoke to eat dinner in my room. I could taste my food but dont remember smelling it. Fever was coming down but I still felt fatigued. At arpund 10 pm ate a little cutie tangerine noticed that it smlled like pine. Slept until 8am Sunday awoke rested no fever slightly fatigued. No other symptoms. Rested all day.
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| 50 | 2021-03-18 | feeling hot |
About 6 hours after being vaccinated, right hand got hot and was itching between the fingers. Laste...
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About 6 hours after being vaccinated, right hand got hot and was itching between the fingers. Lasted about 10 minutes.
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| 50 | 2021-03-18 | feeling hot |
Pfizer-BioNTech Covid-19 Vaccine EUA. Increased heart rate, severe headache, vomiting (due to naus...
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Pfizer-BioNTech Covid-19 Vaccine EUA. Increased heart rate, severe headache, vomiting (due to nausea from headache). Warm but did not take temperature.
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| 50 | 2021-03-18 | feeling jittery |
extreme hyperness and jittery. Felt wired. Symptoms calmed down after about 7 hours, but still jitt...
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extreme hyperness and jittery. Felt wired. Symptoms calmed down after about 7 hours, but still jittery the next morning.
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| 50 | 2021-03-18 | hot flush, discomfort |
Dose 1 was given at 9 am on Friday morning Feb 26, 2021. I was fine until mid afternoon the next da...
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Dose 1 was given at 9 am on Friday morning Feb 26, 2021. I was fine until mid afternoon the next day when I started experiencing a bad headache. The headache was severe from Saturday Feb 27, 2021 evening until Monday morning February 28, 2021. After that I was fatigued and very tired until Wednesday, March 3, 2021. Dose 2 was given this morning, March 19, 2021 at about 9:30 am. On the drive home at 10 am, I started feeling the heaviness again.. as if a large heavy blanket is draped over my shoulders. This feeling comes in waves and I often experience hot flashes with the heavy feeling. No headache yet (fingers crossed!)
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| 50 | 2021-03-18 | muscle twitching | muscle twitch in arm lasting for several minutes |
| 50 | 2021-03-18 | pain in extremity |
Intermittent painful electrical impulse in left hip radiating down into left leg. Started mildly, i...
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Intermittent painful electrical impulse in left hip radiating down into left leg. Started mildly, increased in intensity with each episode, approximately 12 episodes in total. This began about 5 hours after receiving the vaccine and continued for about 36 hours. As of today, March 19, the adverse reaction has disappeared. I had Covid 19 in November 2020, but I did not experience this reaction. In addition to the adverse reaction after receiving the vaccine, I also experienced severe fatigue, a mild headache, chills, inability to control body temperature but no fever, inability to eat, incredible thirst, which have all disappeared.
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| 50 | 2021-03-18 | pain in extremity |
a welt the size of a ping pong ball developed below the injection site; entire arm in pain with vein...
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a welt the size of a ping pong ball developed below the injection site; entire arm in pain with veins swelling; entire arm in pain with veins swelling; This is a spontaneous report from a contactable nurse, the patient. A 50-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 15:00 (at the age of 50 years-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient has no allergies to medication, food or other products. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2, via an unspecified route of administration, administered in the left arm on 22Jan2021 at 16:00 (at the age of 50 years old) for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 00:00 (reported as 12:00 AM), two days after the second dose (as reported), the patient experienced entire arm in pain with veins swelling, and on 14Feb2021 (exact time unknown), day 3 after the second dose, a welt the size of a ping pong ball developed below the injection site. The patient reported the events as non-serious. Therapeutic measures were taken as a result of entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site included unspecified home pain medications and creams. The outcome of the events entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site was recovering. It was also reported that since the vaccination the patient has not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
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| 50 | 2021-03-18 | tenderness | Muscle pain, severe. Large muscle groups, legs and arms only. Also tender to touch. |
| 50 | 2021-03-19 | tingling, weakness |
Doctor and EMT on site and provided care. Vasovegal syncope. Symptoms presented within 5 minutes of...
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Doctor and EMT on site and provided care. Vasovegal syncope. Symptoms presented within 5 minutes of vaccine given. Tingling started in Left arm tingling own to fingers and traveled to right arm and down through both legs. Rapid heart rate and disorientation prior to fainting. Sternum rub given to revive. Patient vomited. Able to drive home after 30-45 minutes. Continues to feel week and dizzy. Currently 24 hours after incident. Pain in arm preventing me from normal daily activities.
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| 50 | 2021-03-19 | tremor, muscle twitching |
Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme t...
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Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme trembling, chills and twitching, blistering of the skin on the forearm of the same injection arm, delirium and hallucinations, wet cough with blood in sputum. Patient called pharmacy on Saturday 3/20/21 03:45pm to advise of reaction, RPh advised patient to go to a physician ASAP for evaluation of symptoms.
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| 50 | 2021-03-20 | weakness, pain in extremity |
Started at 1 am. from 1st vaccination. Sever headache , vomiting, chills, body aches, fever from 101...
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Started at 1 am. from 1st vaccination. Sever headache , vomiting, chills, body aches, fever from 101 to 102.7, nausea, few times I thought I was going to pass out, weakness., arm extremely sore As of 3/21/21 still weak, have a headache (not as intense) fever runs 99 to 101, arm still sore with a knot and is hot
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| 50 | 2021-03-20 | weakness |
Chills, body aches, head congestion, headache, low grade fever (100.5) at its highest. Started at ab...
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Chills, body aches, head congestion, headache, low grade fever (100.5) at its highest. Started at about 7 am on 3/20 and lasted to 7 :30 a.m. the next day. Still feel a little tired and weak with very mild headache.
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| 50 | 2021-03-21 | weakness |
Sudden onset of weakness and extreme light headedness. Avoided fainting by putting head between legs...
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Sudden onset of weakness and extreme light headedness. Avoided fainting by putting head between legs. Became very weak. Had to leave the appointment I was at and go home. Became very fatigued and temperature went up to 99.5. All symptoms came out of nowhere. There was no feeling bad or strange before onset.
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| 50 | 2021-03-21 | weakness |
Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contac...
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Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6199), via an unspecified route of administration on 05Mar2021 15:15 in right arm as single dose for covid-19 immunisation. The patient medical history was not reported. Known allergies was no. The patient had no other vaccine in four weeks. Concomitant medications included fluticasone propionate (FLONASE); vitamin d; cyanocobalamin (VITAMIN B12). On 05Mar2021 16:00, the patient experienced weakness after vaccination, sore throat last night and today, choking when sleeping, she kept waking up from it. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Outcome of events were not recovered.
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| 50 | 2021-03-21 | migraine, pain in extremity |
Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccin...
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Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccination. Presented to ED on 3/7/21 with back pain, no COVID symptoms reported and was discharged home. Presented to ED on 3/10/21 with generalized body aches, nausea, vomiting, and headache for 2 days. Noted mild cough and sinus congestion and was admitted to hospital for 5 days until 3/14/21. Returned to ED on 3/15/21 with worsening shortness of breath and was admitted to hospital for another 5 days until 3/19/21.
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| 50 | 2021-03-21 | pain in extremity |
My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that...
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My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that?s weird. I just happened to have the same person injecting both times. Never reported or had me speak with anyone at that time. He said I could get it in the left, but I denied due to I didn?t want the pain in both arms. When he gave me the 2nd shot I felt it so much more than the first shot that I blurted out that hurts and a felt a twinge in my arm, as if it hit something other than the muscle. My arm 2 mos later is not let up the pain. I can only raise it so high. I cannot sleep on either side w/o pain. Same days are worse than others. The pain is right at the injection site. This is the only thing I have had done to my arm so I know it has something to do with the vaccine. I alternate ice and heat along with ibuprofen and it does not touch the pain/aches. It is a constant ache in my arm. I did contact my employee health at work and she advised me to fill out report on this website and in the Hospital safety report.
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| 50 | 2021-03-21 | tingling, tremor, numbness |
Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and need...
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Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
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| 50 | 2021-03-22 | cold sweat |
4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, ...
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4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, felt very "clammy", and had general ague upon any type of exertion such as walking a very short distance using my rolling walker device. This happened 3 times in approximately 2 hours on the day of vaccination. The next day (03/05/21) my blood pressure and heart rate were very elevated (BP 174/111, Heart Rate 168); I went to the emergency room where they were unable to lower my heart rate but sent me home anyway. 03/7/21 I went to ER, where I was diagnosed with atrial flutter and admitted. The atrial flutter was corrected via cardioversion and I was released 3/9/21; I was prescribed Multaq 400mg, 2X/day and take it faithfully.
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| 50 | 2021-03-22 | slurring |
Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After...
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Patient felt fatigued, tongue felt heavy. When bringing patient to UC felt heart beating fast. After bringing patient to UC patient felt itching of tongue, feeling like throat is swelling, shortness of breath, dizziness, slurred speech, loss of consciousness, and chest heaviness.
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| 50 | 2021-03-22 | flushing | Facial flushing, trouble swallowing, metallic taste, lip tingling |
| 50 | 2021-03-22 | nerve pain |
On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morn...
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On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morning (18th), I had a small Shingles lesion along with those symptoms. . I went to the doctor's office and saw the NP, who diagnosed me with an ear infection--right Otis externa. On Wed (19th) my right eye was swollen and my scalp, right forehead and eye were covered in shingles. On the 20th, I was diagnosed with having Ocular Shingles. I was put on steroids and sent to an emergent appointment with ophthalmologist because they were concerned that I would lose my sight. He put me on Acyclovir 800mg, 5 times a day and increased my steroids to: 40mg a day for 2 days, 30mg for 3 days and 20mg for 3 days and 10mg for 4 days. Fortunately the branch that goes into my cornea was not affected. I was in bed the entire time. I still had lesions when I went back to see him, which is why he kept me off work until Feb 1st. I continued to have neuralgia (nerve pain) and then I started itching. I went back to quick care and put on Atarax. I took that every 4 hours for about a week. Then I tapered it down to about twice a day. It eventually got better, but I do itch sometimes. Looking back, I did have a little right ear pain after the 1st dose of the vaccine.
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| 50 | 2021-03-22 | pain in extremity |
Symptoms day of and next day: sore arm only Day 3, 6am- 12 noon: Nausea, vomiting, fever, severe h...
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Symptoms day of and next day: sore arm only Day 3, 6am- 12 noon: Nausea, vomiting, fever, severe headache, body aches, excessively tired.
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| 50 | 2021-03-22 | pain in extremity |
Severe left arm pain, ice pack applied. Five minutes later dizziness occured, BP 79/50. BP raised to...
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Severe left arm pain, ice pack applied. Five minutes later dizziness occured, BP 79/50. BP raised to 116/79 over next three minutes with giving juice.
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| 50 | 2021-03-22 | tenderness |
left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day ha...
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left ring finder tender on Monday 03/22/21, Woke up Tuesday, 03/23/21 finger swollen, as the day has gone on it has gotten redder Called and spoke with a Teladoc doctor, said to take ibuprofen and ice, watch for 24/48 hours if gets redder or hot go and have it checked out for possible infection
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| 50 | 2021-03-22 | tremor |
Approximately 10 minutes after patient received vaccine, she became shaky and lightheaded. BP 125/80...
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Approximately 10 minutes after patient received vaccine, she became shaky and lightheaded. BP 125/80, pulse 100, pulse ox 95%. Respirations unlabored at 18/min. Patient was talkative and oriented. She did request further evaluation at the ER. She requested transport to the ER and EMS was called. Patient ambulated to the squad per medic.
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| 50 | 2021-03-23 | feeling jittery, tremor, feeling hot |
Vaccine given IM about 9:30am to right deltoid muscle. Patient monitored for 15 minutes, felt okay ...
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Vaccine given IM about 9:30am to right deltoid muscle. Patient monitored for 15 minutes, felt okay and left monitoring area. Patient returned after about 20 minutes from vaccine (a little after 9:50am) complaining of itching of throat, shortness of breathe, and feeling very hot and "off" Due to SOB and itching in throat administered 1 dose of Epinephrine autoinjector 0.3mg shortly upon her return, called EMS. EMS arrived and evaluated patient, patient refused transport to hospital since she was feeling better except for jitters/shaking from epinephrine. We monitored patient for additional 20-30 minutes. Patient walked around store, felt fine and drove home. Called patient, verified still feeling mostly better with some slight itchy throat. Patient will continue to monitor.
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| 50 | 2021-03-23 | flushing, feeling hot |
diagnosed acute right eye scleritis; Rash on face, neck, chest, arms, hands; flushed in the face; it...
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diagnosed acute right eye scleritis; Rash on face, neck, chest, arms, hands; flushed in the face; itchy all over the body; hot all over within 45 minutes of the shot administration; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 25Feb2021 13:00 (Lot Number: EL9266, at age of 50-year-old) at single dose for covid-19 immunization. The COVID-19 vaccine was administered at facility of workplace clinic. Medical history included hashimotos thyroiditis, allergies to sulfa, penicillin, latex. The patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication with in 2 weeks of vaccination included thyroid (THYROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 13:45, the patient experienced rash on face, neck, chest, arms, hands, flushed in the face, itchy all over the body, hot all over within 45 minutes of the shot administration. Diphenhydramine hydrochloride (BENADRYL) was required for 36 hours to mitigate the reaction. Then on 01Mar2021, right eye developed increased pressure, pain, inflamed blood vessels, severe photosensitivity. At emergent eye doctor appointment, the patient was diagnosed acute right eye scleritis. Treatment for the events included diphenhydramine hydrochloride, steroid eye drop, antiinflammation meds. The events were non-serious per reporter. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.
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| 50 | 2021-03-23 | pain in extremity |
Very sore arm, muscle aches, fatigue, slight off and on headache, dry eyes, slight nausea, tickle in...
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Very sore arm, muscle aches, fatigue, slight off and on headache, dry eyes, slight nausea, tickle in throat with light coughing.
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| 50 | 2021-03-23 | pain in extremity |
Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pai...
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Got it at 330 stayed for 30 min. By 7 that evening had a horrible headache, very tired, left haw pain, and a welt on my tongue. Blood sugar high in 300s The next day tongue was a bit better other symptoms the same and heart felt fluttery, and my left breast and center between felt like bruises and small lumps. Headache finally gone by Tuesday and sugars in high 200s but the rest is about the same. Less tired though
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| 50 | 2021-03-23 | pain in extremity | Swelling in left axilla, pain in lower arm. |
| 50 | 2021-03-23 | tingling | Tingles in hand, aches. Assessed RMA . no transport |
| 50 | 2021-03-24 | feeling cold, tingling, burning sensation |
11am - jaw felt odd, tingling on left side 1pm - rt side of lower back of head felt like ice, tingli...
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11am - jaw felt odd, tingling on left side 1pm - rt side of lower back of head felt like ice, tingling on rt side of head over next few hours ( I wouldn't call this a headache) 4pm- roof of mouth burning 10pm - went to sleep but only one side of head felt like fire/ice along with mouth 7am - upper body and head feels like on fire/ice Never had a fever
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| 50 | 2021-03-24 | feeling cold |
evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen...
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evening around 4p.m. after the vaccine Adverse effect- lethargy, sleepy 03/23/21 felt cold, swollen lip and face, lethargy, sleepy Ever have a reaction to a previous vaccine? If yes, what? no- usually gets 3 vaccines each month for allergies she didnt take the third dose this month because she was getting the COVID vaccine, area of injection usually gets swollen when she gets these vaccines and it goes away within a few hours Recommendations: please contact your PCP for recommendations since he has your medical records available, see what he recommends for you to take whether it be your prescribed allergy medication or any OTC items. If you are currently experiencing any Shortness of breath please visit your nearest Emergency Department, otherwise inform your PCP that you are experiencing swelling on your lips and that you experienced a swollen face that subsided. Consult with him on whether you should or shouldn't get the second dose vaccine, one of the contraindications for the vaccine is anaphylaxis so its better to take precaution.
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| 50 | 2021-03-24 | feeling jittery, weakness |
Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot ...
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Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot at 8:48am, symptoms began at 12:30pm while on a bike ride. I finished the ride but was too weak to do anything the rest of the day. That night I couldn?t stop shaking and lay in bed wide awake until about 2am. I felt dizzy like I was spinning when I closed my eyes. I slept off and on until 6:30am. Today I?m feeling slightly better but still can?t sleep. I am drinking an excessive amount of water and herbal tea.
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| 50 | 2021-03-24 | muscle spasms |
Starting either the night of the vaccine or the next I had a horrible time sleeping. Up and down, ba...
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Starting either the night of the vaccine or the next I had a horrible time sleeping. Up and down, back and forth. Then I developed terrible pain in my neck all over. I tried OTC meds that did not alleviate the pain in addition to heating pad, stretching, neck constriction with neck brace. This lasted about a week with the pain mostly in the two front muscles in the neck. I had a day or two of respite but the pain came back as what feels like muscle spasms in my upper left and right shoulder/neck area. Difficulty turning head. Headache.
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| 50 | 2021-03-24 | numbness and pain in extremities, pain in extremity |
Very tired; A little upset stomach; Neuropathy returned in my hands, feet and lower legs; Neuropathy...
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Very tired; A little upset stomach; Neuropathy returned in my hands, feet and lower legs; Neuropathy returned in my hands, feet and lower legs; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (BNT162B2, Lot number: EN6199; Expiration date was not reported) on the left arm on 04Mar2021 (16:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the public health clinic. Medical history included rectal cancer from 2018 to an unspecified date; chemo from 2019 to an unspecified date; and neuropathy that was left from the chemotherapy. The patient had unspecified concomitant medications. The patient previously took aspirin (acetylsalicylic acid), and had drug allergy. The patient was not pregnant at the time of vaccination. On 04Mar2021 (17:30), the patient's neuropathy had returned in the hands, feet and lower legs; and had sore arm. On 05Mar2021 (10:30), the patient was very tired, and had a little upset stomach. The patient did not receive treatment for the events. The outcome of the events, 'neuropathy had returned in the hands, feet and lower legs', 'sore arm', 'very tired' and 'little upset stomach', was recovering. The patient has not had COVID-19 prior to vaccination; and was not tested for COVID-19 post-vaccination.
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| 50 | 2021-03-24 | pain in extremity |
The next evening after the day of the vaccine I experienced dizziness, I felt like I was going to fa...
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The next evening after the day of the vaccine I experienced dizziness, I felt like I was going to fall over but never did, it was pretty unnerving and scary, my doctor suggested me to take Extra strength Tylenol and that did not help with anything. I also tried Claritin as well it did not help either. The dizziness lasted 4-5 weeks. I also had a sore arm.
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| 50 | 2021-03-24 | pain in extremity |
After two days of fever and headache , I had some painful lumps on left underarm toward my left bre...
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After two days of fever and headache , I had some painful lumps on left underarm toward my left breast for three days. They disappeared for a couple of days and back again from yesterday. Its kind of burning in lumps with mild pain left side, arm, neck and back shoulder.
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| 50 | 2021-03-24 | pain in extremity | the evening of the injection, patient noted arm pain radiating from shoulder to hand. |
| 50 | 2021-03-24 | tingling |
Pt developed left sided facial tingling shortly after receiving her vaccination. She noted some very...
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Pt developed left sided facial tingling shortly after receiving her vaccination. She noted some very mild difficulty swallowing.. Her symptoms resolved after several minutes. She denied any other associated symptoms. No objective mouth/throat swelling appreciated. HR 46 which pt states is normal for her, BP 110/80, SP02 99%. EMS services were offered but pt declined and drove home.
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| 50 | 2021-03-24 | seizure |
While I was asleep my partner saw me having what looked like a seizure on Tuesday 03/23/2021 @11:30p...
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While I was asleep my partner saw me having what looked like a seizure on Tuesday 03/23/2021 @11:30pm. I was sleeping on my stomach, my partner describes it like a fish flopping.
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| 50 | 2021-03-25 | weakness, hot flush, pain in extremity |
I began with some throat closing and pain in arm. It progressed to body aches, feeling winded and fa...
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I began with some throat closing and pain in arm. It progressed to body aches, feeling winded and fatigue, weak, sneezing, congestion, dripping nose, hot flashes and joint pain. I went to bed and had insomnia the whole night. Had rapid heartbeat and trouble breathing. I called doc next day and they recommended o go to hospital.
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| 50 | 2021-03-25 | numbness |
Patient received her 1st Pfizer vaccine on 3/21/21 around 2:30. She states she started to feel numbn...
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Patient received her 1st Pfizer vaccine on 3/21/21 around 2:30. She states she started to feel numbness over her face and some slight difficulty swallowing within minutes after receiving her vaccine. She sat in the observation area for 15 minutes but never reported her symptoms to the staff. She also states that she started to feel anxious as well and wasn't sure if it contributed to her symptoms. She said she felt like she just needed to get some fresh air. When she got home she took Zyrtec 10mg and had relief of her throat symptoms and some improvement of the numbness over her face. She did not have complete numbness until 3/25/21. She notified her physician of this event and he advised her to return to the clinic and report it.
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| 50 | 2021-03-25 | muscle spasms |
Confusion, dizziness, loss of coordination, excruciating body pain, nauseous,diarrhea, headache, vo...
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Confusion, dizziness, loss of coordination, excruciating body pain, nauseous,diarrhea, headache, vomiting Within 48 hours of both vaccines menstrual cycle began with severe cramping , heavy bleeding and 2 weeks early
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| 50 | 2021-03-25 | muscle spasms |
muscle spasms in neck and back , self treated after calling doctor. was told to take 200mg of benadr...
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muscle spasms in neck and back , self treated after calling doctor. was told to take 200mg of benadryl and 80mg of pepcid, and 800mg of ibuprofen.
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| 50 | 2021-03-25 | tingling |
Client c/o tingling sensation to the right hand and arm. Client seen and assessed by EMt and V.S. a...
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Client c/o tingling sensation to the right hand and arm. Client seen and assessed by EMt and V.S. are BP 153/93, HR 81, O2 97. Within 15 minutes of observation client verbalized that she started to feel a decrease in sensation. Client then cleared to go home by EMT. Client advised to seek medical attention if symptoms worsen.
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| 50 | 2021-03-25 | throat numbness, hot flush |
Patient received COVID vaccine at 1048 a.m. Initially reported "throat numbness to medical assistant...
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Patient received COVID vaccine at 1048 a.m. Initially reported "throat numbness to medical assistant after 15 minutes of observation. At 1126 patient reports "hot flashes and knot to throat. Epinephrine 0.3 mg administered to left thigh. EMS called and patient transferred to hospital ER per patient request.
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| 50 | 2021-03-26 | numbness |
Pt developed numbness in R arm, radiating to hand progressing to L arm, face and tongue. Medical con...
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Pt developed numbness in R arm, radiating to hand progressing to L arm, face and tongue. Medical consultation recommended transport BP 104/80, HR 60, SpO2 100%, RR 12 EMT arrived 10:45am, pt transported.
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| 50 | 2021-03-26 | tremor |
Patient stated that approximately 5 minutes after receiving Pfizer COVID-19 vaccine (1st dose), she ...
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Patient stated that approximately 5 minutes after receiving Pfizer COVID-19 vaccine (1st dose), she began to feel nauseous and notified RN gave patient a bottled water. RN assessed patient and notified EMS on scene. During assessment, patient admitted allergies to bee stings (was previously prescribed an Epi-Pen, but has "not had one in a while"). Patient also admitted having recent allergic reaction to seafood 2 months ago that caused lightheadedness and nausea; patient was seen at Hospital for this reaction. Patient also stated an allergy to aspirin that causes "flu-like symptoms." During this assessment, patient appeared to be alert and oriented x 3 with no signs of respiratory distress. During assessment, patient developed red patches on the posterior and bilateral neck, along with red hives (approximately 1/2 inch in size). Patient complained of feeling lightheaded and nauseous. Hands were trembling. Patients vitals were within normal limits, although blood pressure was slightly elevated.
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| 50 | 2021-03-27 | weakness | Chills weakness muscle pain muscle weakness body aches. sweating |
| 50 | 2021-03-27 | pain in extremity |
Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my bod...
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Pain in left arm and running down into my fingers and joints - two weeks Pain on left side of my body 1-2 days All of my body ached 1-2 days Headache for a day or two (not extreme) Scratchy throat off and on for a few days Nauseous/ nothing sounded good to eat 3-5 days Upset stomach and rolling stomach with borderline diarrhea about 3 days Itchy all over (no rash at all) for a solid two weeks and now just occasionally Left hand and joints swelled slightly 2 weeks+ Tightness in chest 2 days and periodically for 2 days more
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| 50 | 2021-03-27 | pain in extremity |
For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell....
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For the first 24-48 hrs I was fatigued, had a very sore arm and experiences a metallic taste, smell. After two days I got a canker sore. 7 days later my resting heart rate is 158-163. prior to the shot my resting heart rate was 168.
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| 50 | 2021-03-28 | feeling cold |
On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swo...
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On Mar 26 I was achy and frigid. On Mar 27 I have poke up to a red rash on chest, face and neck, swollen lymph nodes in throat, sore throat, and very large swollen lymph node in left arm pit. This lasted thru Sunday Mar 28. On Mar 29 I woke up to severe, frequent watery diarrhea and stomach gurgling along with burping and general gastro discomfort.
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| 50 | 2021-03-28 | pain in extremity, hot flush, tingling |
shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in...
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shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm; got extreme pain all the way down to the tips of my fingers; slight tingling in the fingertips; could not move my arm; nausea; dizziness; bone pain in arms and legs; exhaustion; My arm still hurts; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 50-years-old, administered in Arm Right on 05Mar2021 11:00 (Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included allergies to walnuts. The patient was not pregnant. The patient's concomitant medication included High blood pressure medication. The patient previously took Niacin and experienced allergies. The patient reported, "shooting up high blood pressure after Pfizer vaccine almost immediately after getting the vaccine in my right arm, less than five minutes. I felt a flush go down my left arm, starting at the top of my shoulder down to my hand and got extreme pain all the way down to the tips of my fingers with slight tingling in the fingertips. I could not move my arm, blood pressure shot up to 200 then it was 192/121 and so on I was monitored at the hospital for a couple of hours with no change or help. I went home and monitored for 29 hours it stayed elevated in the upper hundreds, spiking lowering down a few to 174/124 and spiking back up I got the vaccine on Friday at 11:00 AM my blood pressure did not break until Saturday around 3:00 p.m. I got other side effects, nausea, dizziness, bone pain in arms and legs, exhaustion but the blood pressure scared me the most. My arm still hurts to this day 12Mar2021. I was evaluated but not given anything to bring it down." The adverse events started on 05Mar2021 11:00 AM. The events resulted in Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization). No treatment for adverse events were received. The patient underwent lab tests and procedures which included blood pressure measurement: high, up to 200 then it was 192/121 on 05Mar2021 spiking lowering down a few to 174/124 on Mar2021. The patient recovered with lasting effects. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
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| 50 | 2021-03-29 | hot flush, feeling hot |
client reported being hot b/p 120/84 SP02 100% pulse 68 Has hot flashes, monitored then walked to th...
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client reported being hot b/p 120/84 SP02 100% pulse 68 Has hot flashes, monitored then walked to the door with staff and husband. Reported feeling fine except still warm. Steady gate.
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| 50 | 2021-03-29 | tingling, numbness |
Received shot at 4:15pm got in car after waiting 20 minutes at site.my. left arm was starting to get...
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Received shot at 4:15pm got in car after waiting 20 minutes at site.my. left arm was starting to get numb and tingly as i drove home at home my face felt numb and tingly. Called 23 hour nurse told me to call 911 my left leg was numb and tingly and weak my left side of my brain was numb and tingly.
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| 50 | 2021-03-30 | weakness |
I could barely move; a lot of weakness; fell at home twice; This is a spontaneous report from a cont...
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I could barely move; a lot of weakness; fell at home twice; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the first dose of bnt162b2 (Batch/Lot Number: EM9809), via an unspecified route of administration, administered in the right arm on 10Mar2021 12:15 as a single dose for covid-19 immunization. The patient's medical history included multiple sclerosis known allergies (not specified) from an unknown date and unknown if ongoing. On 11Mar2021, the day after the vaccine patient had a lot of weakness and fell at home twice. No injury from falls. They were more guided drops to ground. Patient was seen in the emergency room (ER). The next morning 12Mar2021, patient could barely move from weakness. She went back to ER and was admitted for high dose IV steroids. Work up while in hospital lead the doctors to conclude it was from the vaccine. It was reported that the patient was hospitalized for 3 days. The patient was recovering from the events at the time of the report. The patient has not had Covid-19 prior to vaccination and was not tested for Covid-10 post vaccination.
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| 50 | 2021-04-01 | tremor | dizziness , Fainting, loss of consciousness , shaking ,chills, may be seizure |
| 50 | 2021-04-02 | feeling cold |
had a little heart palpitation; achy; like a muted flu; runny nose; nose felt like it was burning on...
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had a little heart palpitation; achy; like a muted flu; runny nose; nose felt like it was burning on the inside; Sneezing; chills; feeling feverish; Elbow or right arm muscle was contracting or moving on its own; Heart fluttering; always cold; This is a spontaneous report from a contactable consumer (patient) via the medical information team and a Pfizer-sponsored program, COVAX US Support. This consumer reported similar events for two patients. This is the first of two reports. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 10Mar2021 11:30 (lot number: EN6204, expiration date: Jun2021) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included lupus from 2012 and ongoing; blood clot disorder from 2017 and ongoing, heart attack from 2010 and ongoing: heart attack/heart condition; stroke in 1992 and ongoing; Sjogren's syndrome from 2012 and ongoing; ongoing allergies to all sulfas, penicillins, latex (no manufacturer lot or expiration date); allergic to dye they put in CAT scans; obese from 2014; gastric bypass from 2014 and pulmonary embolism: rare and grew in her lungs in 2017 and was on apixaban (ELIQUIS) for that now. Concomitant medications included apixaban for pulmonary embolism and blood clotting disorder. The patient had no prior vaccinations within 4 weeks. The patient received a rubella shot and came down with German measles. Family medical history included a large family history of thoracic aortic dissections associated with vascular Ehlers-Danlos syndrome (EDS). The patient experienced heart fluttering on 10Mar2021 at 11:30; elbow or right arm muscle was contracting or moving on its own on 11Mar2021 at 15:00; chills and feeling feverish on 12Mar2021 at 22:30; nose felt like it was burning on the inside and sneezing, on 16Mar2021 at 10:00; achy in 19Mar2021; runny nose, like a muted flu, always cold and had a little heart palpitation in Mar2021. The patient received her first dose on 10Mar2021 and 2 days after she started having chills and feeling feverish. The patient had fever twice. A day before (18Mar2021) she had a slight fever, runny nose and chills. On 19Mar2021, she had chills, achy and felt like she has a fever, but she doesn't have a fever. It was like a muted flu; it was not horrible but can be debilitating at times because she can't function and was always cold. She constantly has chills, then her nose feels like it is burning on inside and she sneezed a few times. She added that 3 days before getting the vaccine (07Mar2021) she was not feeling well and had a rapid COVID test done and it was negative. The day of the actual day of vaccine the patient was okay. The patient has lupus and a blood clotting disorder for which she takes apixaban. She continued that she has not been out of the house since Mar2020. When she got the shot she had a little heart palpitation. She does not know why she was feeling this way after all these days. She wanted to know how long this would last and should she get tested for COVID. There was a lady that was sick when she got vaccinated and they allowed her in. The heart fluttering felt like it was in esophagus at first. It felt like it was going down her throat. It lasted only a couple of hours. She heard that from other people (her sister). No ER or physician's office required. The patient wanted to know how long the side effects were going to continue. The patient wanted to postpone her second dose until after Easter and her birthday, she did not want to be sick during that time. She has re-scheduled her second dose for 05Apr2021. Her son was getting married 27Jun2021 and she saw a study that immunity was still high at 62 days. The patient wanted to know if she would still have immunity or high antibodies on 27Jun2021 or would it still be effective. The outcome of achy, runny nose, like a muted flu, always cold and had a little heart palpitation was unknown. The patient has not recovered from chills and feeling feverish. The patient was recovering from the remaining events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021312325 Same reporter, same drug and similar event, different patient.
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| 50 | 2021-04-07 | bell's palsy, numbness |
She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My fac...
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She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown. Information about lot number has been requested.
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| 50 | 2021-04-12 | bell's palsy |
Bell's palsy; This is a spontaneous report from a non-contactable consumer (Patient). A 50-year-old ...
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Bell's palsy; This is a spontaneous report from a non-contactable consumer (Patient). A 50-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: ER8727, expiry date: unknown), via an unspecified route of administration in right arm on 24Mar2021 at 09:00, (at the age of 50-year-old) as a single dose, for COVID-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication was none. The patient previously took codeine and experienced allergies (known allergies_ codeine). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced bell's palsy on 26Mar2021, at 07:00. The patient visited physician office and emergency room. The patient received steroids as treatment to the event. The outcome of the event was recovering No follow up attempts are possible. No further information is expected.
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| 50 | 2021-04-13 | face paralysis, slurring |
The patient is a 50 year old female with no medical problems who developed sudden severe headache on...
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The patient is a 50 year old female with no medical problems who developed sudden severe headache on 3/24 accompanied by nausea and vomiting. She presented to urgent care on 3/25 and was considered to be dehydrated and given IV fluids. On 3/27 she developed left hand weakness. On 3/29 she revisited urgent care with residual symptoms plus hand weakness and was sent to hospital where she was admitted and MRV demonstrated Cerebral Venous Sinus Thrombosis of the sagittal sinus, right transverse sinus, and right sigmoid sinus. The left transverse sinus may also be occluded or congenitally absent. There was no evidence of hemorrhage or stroke. The patient was admitted and started on heparin then transitioned to Eliquis and discharged. On 4/3, she had worsening of symptoms consisting of dysarthria, left facial, and worse left arm and hand weakness. She was readmitted to hospital then transferred to hospital for further management.
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| 50 | 2021-04-14 | migraine |
blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, sho...
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blackout or passed out, dizziness, unable to walk, bitter taste in the mouth, dry heaving, rash, shortness of breath, extreme blood pressure immediately upon injection for 1 hour. Continued reactions 48 hours, extreme fatigue, blood pressure, dizziness, metal and bitter taste in the mouth, migraine, stomach upset, red polka dots on hands, itchiness underarms, cough, sore throat, and fever
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| 50 | 2021-04-15 | bell's palsy, facial paralysis |
28 hours after 2nd Pfizer vaccine administered: First symptom was inability to suck from a straw. ...
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28 hours after 2nd Pfizer vaccine administered: First symptom was inability to suck from a straw. Lips could not be closed together on left side of mouth. Second symptom noticed was left eye not blinking or closing all the way compared to right eye. Third symptom was drooping smile on left side of face. We did not connect the timing of vaccine to this event until the following morning. It was Saturday morning and the symptoms still existing. We observed and monitored through the weekend and called the Doctor's office on Monday. The Doctor asked us to go to Emergency Room right away for possible stroke.
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| 50 | 2021-04-16 | migraine, seizure |
Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoi...
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Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoing since time of second dose administration
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| 50 | 2021-04-17 | speech disorder, bell's palsy |
right sided facial paralysisBell's Palsy; dizzy; headache; feeling extreme fatigue; couldn't speak; ...
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right sided facial paralysisBell's Palsy; dizzy; headache; feeling extreme fatigue; couldn't speak; This is a spontaneous report from a contactable consumer (patient). The 50-years-old female patient (age at vaccination was 50 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney donor. The patient was healthy with no medical issues. Concomitant medication(s) was not reported. The patient experienced right sided facial paralysisbell's palsy, dizzy, headache, feeling extreme fatigue on an unspecified date. Reported as: Within 8 hours of receiving the dose, she said "the room got dizzy" and she developed a headache and Bell's Palsy. She states she had right sided facial paralysis, couldn't speak, and exhibited other stroke like symptoms. Was admitted to the hospital, given Plavix, and a headache "cocktail" to treat her symptoms. She underwent an MRI, CT, and echocardiogram to rule out a stroke. She is still hospitalized and states her symptoms started to resolve today, 02Apr2021, at around 8 AM. She also reports feeling extreme fatigue after receiving the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 50 | 2021-04-18 | numbness |
DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pai...
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DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 13:30 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included breast cancer, hypothyroidism, diabetes. The patient did not have covid prior vaccination and no covid tested post vaccination. No known allergies. The patient was not pregnant. Concomitant medications in two weeks included metformin; atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID), vit d, multivitamin. No other vaccine in four weeks. Back pain started on 20Mar2021, chest and back pain on 24Mar2021 and chest pain continued until she went to the ER on 27Mar2021. When PE in right lung was found on CT scan on 23Mar2021 12:00 PM. The patient was hospitalized on 27Mar2021 and heparin was started and continued until 29Mar2021 when she was released. The DVT in right leg was found on 28Mar2021 with ultrasound after she mentioned numbness in both legs on 23Mar2021 12:00 PM. She started apixaban (ELIQUIS) on 29Mar2021 before leaving the hospital and still taking it now. She went to follow up appointment with hematologist that suggested that she remained on apixaban and return in 10 weeks for another checkup. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3. Treatment received for events included heparin and apixaban. The outcome of events was recovering. The patient received second dose of BNT162B2 in arm left on 09Apr2021 12:30 (Lot Number: EK8727).
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| 50 | 2021-04-18 | pain in extremity |
Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and sl...
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Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and slight shortness of breath and shared this information with her PCP at her regularly scheduled visit on 03/01/2021. PCP refilled inhaler at that time. Her shortness of breath progressively worsened, and she was seen by another provider as a walk-in at the office of her PCP on 03/13/2021. At that time, she was prescribed prednisone for 5 days, noting some improvement after a few days. She received her 2nd Pfizer COVID vaccine on 03/19/2021. The patient woke up on the morning of 03/20/21 with a swollen and painful leg and by 03/22/21 called PCP and was seen in the office. PCP ordered D-Dimer and LE ultrasound. Per the patient, the D-dimer was abnormal and the LE U/S showed a blood clot. PCP sent the patient to the ER, where a chest CT was ordered and showed a pulmonary emobolus. She was admitted overnight and started on Eliquis, and discharged the next day after seeing a hematologist.
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| 50 | 2021-04-20 | weakness, hot flush |
hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus...
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hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2, COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 13:45 (Batch/Lot Number: EN6204) as single dose for covid-19 immunization. Patient was not received any other vaccine in four weeks, Vitamin B12 received in two weeks. Concomitant medication included cyanocobalamin (VITAMIN B12). Patient was not pregnant. The patient experienced difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus, hot flashes, could not focus on 31Mar2021 13:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included allergies to shellfish (though allergy test says otherwise, wool, poison ivy, jewelry not identified why, heart rate fast on 31Mar2021. There was no covid prior vaccination, no covid tested post vaccination. Therapeutic measures were taken as a result of hot flashes, difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus. The events outcome were resolved with sequel. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. No follow-up attempts are needed. No further information is expected.
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| 50 | 2021-04-20 | numbness, sensory loss, weakness, tingling |
she had the prickly feeling like when her nerves were regenerating; feeling draining from my right a...
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she had the prickly feeling like when her nerves were regenerating; feeling draining from my right arm from the site of the shot downward to my finger tips/ I lost more and more feeling; numbness in my peripheral nerves/have not fully regained the feeling in my palm and fingers; trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue; could not get my arm to move and steer the car properly; weakness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number : ER2613) via an unspecified route of administration, administered on the right arm on 21Mar2021 10:30 at a single dose for COVID-19 immunization. Medical history included GBS (when I was 20 years old), Type 2 diabetes mellitus and high blood pressure related to type 2. Concomitant medications included rosuvastatin and metoprolol succinate. The patient previously took paracetamol (TYLENOL) and experienced allergies (anything with Tylenol). In less than 5 hours after the vaccine (21Mar2021 03:30 PM), patient started to feel the feeling draining from her right arm from the site of the shot downward to her finger tips. As each hour passed, she lost more and more feeling. She had complete numbness in her peripheral nerves for over 48 hours and have not fully regained the feeling in her palm and fingers. She had trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue and nearly caused an accident yesterday b/c she could not get her arm to move and steer the car properly. It has considerable weakness as well. The feeling between her right and left arm were distinctly different and it's really frightening. She was scared she won't get the feeling back in her right arm fully. From my elbow down was still a significant issue. Last 01Apr2021 she did have one incident where she had the prickly feeling like when her nerves were regenerating. The events resulted to a doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Outcome of the events was not recovered.
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| 50 | 2021-04-20 | tingling |
Shingles. January 26th - Received first Pfizer vacccine at hospital February 8th - infusion of R...
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Shingles. January 26th - Received first Pfizer vacccine at hospital February 8th - infusion of Remicade 500 mg February 13th - skin started to get pins and needles and very painful February 15th - Received second Pfizer vaccine at hospital February 17th - Patches started appearing, extremely painful, went to dermatologist and was diagnosed with Shingles. February 18th - blisters started appearing on right side of face . Cheekbones, nose, under eye, cheek, upper lip
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| 50 | 2021-04-21 | migraine, tremor |
*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for h...
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*4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day. Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good on 4/7 but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
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| 50 | 2021-04-24 | numbness |
hearing is also coming and going periodically in both ears; I also felt like I was going to pass out...
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hearing is also coming and going periodically in both ears; I also felt like I was going to pass out about 5 minutes after the shot; Tinnitus in both ears started within about a half hour; I also have some facial numbness/tightness; I also have some facial numbness/tightness; intermittent ear pain; My joints in my feet and the bottom of my feet hurt.; ear fullness; very sensitive to sound; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 10:15 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. Medical history included Lyme disease from an unknown date. The patient has no known allergies. The patient is not pregnant. Concomitant medications included colecalciferol (VITAMIN D); probiotics; fish oil all taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 at 10:30 AM, the patient reported of tinnitus in both ears started within about a half hour of receiving first dose. The patient also felt like she was going to pass out about 5 minutes after the shot. The patient also has some facial numbness/tightness that started the same day as her shot (after the shot). The tinnitus, intermittent ear pain, ear fullness was reported as still continuing. The patient reported that her hearing is also coming and going periodically in both ears. The patient was also very sensitive to sound now. The patient's joints in her feet and the bottom of her feet hurt. Therapeutic measures were taken as a result of the events. Treatment of antihistamine and nasal spray was recommended. The patient do not have covid prior to vaccination and was not tested for covid post vaccination. The patient has not recovered from the events.
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| 50 | 2021-04-30 | migraine, pain in extremity, burning sensation |
A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased i...
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A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.
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| 50 | 2021-05-03 | weakness | Fever day 1 101.5; Fever day 2 99.5; chills, weakness, fatigue |
| 50 | 2021-05-03 | tingling, burning sensation |
heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across...
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heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across back/tingling down right leg; burning sensation in her shoulder blade; muscle pain; muscle tightening; aching to left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FR8732, on 05Apr2021 at single dose in left arm for COVID-19 immunisation. Medical history included blood clot in lung from 26Mar2021 (according to the chest X-ray she did not still have it but she had not been to her pulmonologist yet), complete hysterectomy in Jan2021, liver condition, high cholesterol and blood clot. Concomitant medications included apixaban (ELIQUIS) for blood clot, ursodiol for liver condition, and pravastatin for high cholesterol. The patient had the first dose on 05Apr2021. She began feeling muscle pain and a burning sensation in her shoulder blade the Thursday after receiving the vaccine (08Apr2021) and into Friday (09Apr2021). She had muscle tightening and aching in her left shoulder on 08Apr2021. By Monday mid morning (12Apr2021) she had tingling all down her left arm, across her back, down her right arm and into both legs. She began having tingling in her arms and legs bilaterally since last Monday (12Apr2021), however it was more prominent in her left extremities rather than the right. She wanted to know if this was a side effect of vaccine. She got the shot in her left arm. She went to the hospital and they admitted her. She had tests in the ER. She had MRIs, CTs and a battery of blood tests. They could only tell her what it was not and not what it was. It was not cancer, stroke, heart attack, aneurysm or a brain tumor. She was released and did not know what caused it. Again from the above that on Thursday (08Apr2021) her left shoulder muscle started aching and on Monday a week later she experienced tingling. She thought she was having a heart attack and was hospitalized for 4 days. She asked the doctor if this was a side effect and she was told to call the place where the vaccine was administered. She called the nurse and she could not give answers and recommended that she call Pfizer. Several conditions were ruled out but she was not given a reason for her symptoms. Her HCP has not been helpful. She stated she had a complete hysterectomy in January but doesn't think that would have any effect. She had a CT on 12Apr2021, a MRI of her head and neck on 12Apr2021, a MRI with contrast on 14Apr2021 of her upper neck, a MRI of her lower back on 15Apr2021 and a bone scan on 15Apr2021. Stated that they all came back normal no abnormalities. The outcome of muscle tightening was resolving. The outcome of heart attack was unknown. The outcome of other events was not resolved.
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| 50 | 2021-05-03 | tremor, numbness, feeling hot, burning sensation |
fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation do...
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fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.
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| 50 | 2021-05-04 | night sweats, pain in extremity |
Left arm soreness, fatigue, headache all began same day. Migraine, joint stiffness (elbows, hips, an...
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Left arm soreness, fatigue, headache all began same day. Migraine, joint stiffness (elbows, hips, ankles), nose bleed, left armpit pain, fever, chills, night sweats began next day (5.4.21) and continued to 5.5.21. Adverse effects ongoing.
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| 50 | 2021-05-10 | weakness, seizure, tremor |
Shakes that feel like a seizure; Shakes that feel like a seizure; Choking; Side effects are minimal ...
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Shakes that feel like a seizure; Shakes that feel like a seizure; Choking; Side effects are minimal unless she got sun on her; sunlight made her sick; Nauseous; Light headed; Weak; Sweaty but chills; Sweaty but chills; Brain fog got really bad; This is a spontaneous report from a contactable consumer(patient). The 50-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 22Apr2021 16:00 (Lot Number: ER8736) as first dose, single for covid-19 immunization. Medical history included Polycystic ovarian syndrome(PCOS), Neuropathy, disabled, asthma, allergies, beat kidney cancer, autoimmune deficiency, anemic, gastric bypass. Concomitant medications included hydrocodone 10-325, escitalopram oxalate (LEXAPRO) 20mg, omeprazole 20mg. The patient had known allergies: tramadol, melamine, gabapentin. The patient stated sunlight made her sick. Side effects are minimal unless she got sun on her. Even through window. She got nauseous, shakes that feel like a seizure, light headed, weak, choking, sweaty but chills. Brain fog got really bad. She had brain fog from it but to the point she forgot she was headed to the bathroom after sunlight touched her. She had been able to handle indirect sunlight until today. Now she can't have any sunlight touch her without a reaction. Direct or Indirect. Nothing helped. Just sundown. Once the sun went down, the side effects calmed down. Events occurred on 26Apr2021 14:30 with outcome of recovering. There was no treatment received. Since the vaccination, the patient had not been tested for COVID-19.Case was assessed as non-serious by reporter.
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| 50 | 2021-05-12 | muscle twitching, pain in extremity |
twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically espe...
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twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; twitches in her legs and then pain after; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; Face periodically twitches; eye twitches periodically especially after sneezing or coughing; stinging in her legs and it went up to her waist and felt like a band around her waist; stinging in her legs and it went up to her waist and felt like a band around her waist; Unexpected weight loss; no appetite; Unexpected weight loss; no appetite; This is a spontaneous report received a contactable nurse, the patient. A 50-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EW0158 and expiry information not provided) as a single dose via unspecified route in the right arm on 08Apr2021 at 19:30 (at 50-years-old) for COVID-19 immunisation. Relevant medical history included COVID with insomnia (Nov2020). There were no concomitant medications or past drug history reported. The patient reported as soon as she got the shot, she did not feel sick or nauseated, maybe she had no appetite, but she has lost ten pounds three weeks. States before the vaccine she was 138 pounds. The patient reported that on 18Apr2021, reported as eight to ten days later she developed stinging in her legs and it went up to her waist and felt like a band around her waist. The patient reported that on 20Apr2021 she experienced twitches in her legs and then pain after, her face periodically twitches; eye twitches periodically especially after sneezing or coughing. The patient reported that she had COVID back in Nov2020 and she had some problems after and then recovered. States she just got the Pfizer COVID vaccine three weeks ago and she did really well with the first one; however eight to ten days later, she noticed stinging in her legs and it went up to her waist and felt like a band around her waist. Then she started having twitches in her legs, and then pain, states the twitches have remained, she cannot see them, but she can feel them. Caller states her face periodically twitches as well. Her eye will twitch periodically when she sneezes or coughs. The patient, a retired nurse, assessed the events as medically significant, because she needs to know if it is something more serious. The patient denied any visits to the emergency room or to any doctor's office for the events reported. The patient reported that she called a few neurologists to see if she could have gotten in but they are so booked up that she could not get an appointment until August. The patient stated that the neurology place said they are seeing some very strange things, so the patient believes she is not the only one. The reporter stated that maybe because she had COVID, she does not know if it is because of that, but maybe the first one acting is acting like the second dose for her. The patient inquired if it was okay to get the second dose. The outcome of the event stinging in her legs and it went up to her waist and felt like a band around her waist was recovered on 20Apr2021. The outcome of the event weight loss; no appetite, twitches in her legs and then pain after, and Face periodically twitches; eye twitches periodically especially after sneezing or coughing was not recovered.; Sender's Comments: Based on a compatible temporal association a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2020-12-31 | tingling, numbness |
About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and fe...
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About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and feeling tingling and maybe swollen, also, all of my regular pains in my body, ie. various mouth pains and said pains, certain things that act up in my body, were intensified and more bothersome, and I had a headache that wouldn't go away. I felt "off" that night and the next day. Probably like I was mildly sick and fatigued with body feeling sore all over and headachey. About 36 hours after getting the initial dose, I was feeling regular again.
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| 51 | 2020-12-31 | tenderness |
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ...
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*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
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| 51 | 2021-01-03 | numbness | Ear pain pulling sensation, down my neck numbness jaw locking on same side of injection |
| 51 | 2021-01-03 | pain in extremity |
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt ...
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20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.
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| 51 | 2021-01-04 | flushing |
chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). ...
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chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in the left arm on 24Dec2020 11:30 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lysine hydrochloride, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (ONE A DAY MULTI VITAMIN & MINERALS). The patient did not receive other vaccine in four weeks. The patient previously took ephedrine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The patient experienced chest flushing and racing heart rate on 24Dec2020 11:45. Outcome of the events was recovered in Dec2020; no treatment was needed for the events. The events was assessed as non-serious.
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| 51 | 2021-01-04 | numbness, tingling, feeling hot |
Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she t...
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Within 10 minutes of vaccine administration, patient reported that her arm began feeling warm, she then had numbness and tingling in her face and reported her throat felt warm.
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| 51 | 2021-01-04 | numbness, tingling |
Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clav...
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Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved. 3 days later noted left clavicular probable lymph node which is large and painful. Possible neck lymphadenopathy as well.; Experienced numbness and tingling in left arm on day 1 which resolved; Experienced numbness and tingling in left arm on day 1 which resolved.; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 AM at left arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and known allergies to amoxicillin. The patient was not pregnant at the time of vaccination. The patient experienced numbness and tingling in left arm on day 1 (23Dec2020) which resolved in Dec2020. 3 days later noted left clavicular probable lymph node which is large and painful on 25Dec2020 07:00 PM. Possible neck lymphadenopathy as well. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events numbness and tingling in left arm was recovered in Dec2020. The outcome of the other events was not recovered. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about lot/batch number has been requested.
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| 51 | 2021-01-04 | numbness |
Numbness and tingling in arm and especially in fingers and hand of the vaccinated arm. Numbness for ...
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Numbness and tingling in arm and especially in fingers and hand of the vaccinated arm. Numbness for over 4 hours and continues at this time, but lessening. Numbness also felt on tip of nose- lasted an hour on tip of nose and then dissipated. No treatments provided only watched for anything worsening.
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| 51 | 2021-01-04 | migraine |
Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contact...
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Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via intramuscular route of administration in the left arm on 18Dec2020 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included fibromyalgia and history of migraines. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Dec2020 at 13:00 the patient experienced migraines for several days, nausea on day three. The patient did not receive any treatment for the events. The clinical outcome of the migraines for several days, nausea on day three was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-04 | pain in extremity |
felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning ...
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felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine. On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability. On 21Dec2020, the patient had itchiness in her head. The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability. The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020. The outcome of the events was not recovered. The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, stroke was not diagnosed. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-04 | tingling, numbness |
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), to...
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swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-04 | tingling, numbness |
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/...
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lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
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| 51 | 2021-01-04 | cold extremities, tingling |
tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands...
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tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands and feet are cold/She felt cold; This is a spontaneous report from a contactable nurse (patient). A 51 years old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Dec2020 10:00 at single dose in the arm left for covid-19 immunisation. Medical history included change in taste, altered taste. Concomitant medications were none. Caller reported she was having side effects with the COVID vaccine she received yesterday (28Dec2020) morning at 10am. The patient experienced paresthesia, tingling in hands and feet and they are cold, said she "felt cold" and has soreness in the injection site on 28Dec2020 17:00. Caller confirmed the above details. Her hands got really cold and tingling to them and she was wondering what this is and went to her other half and asked him to take a look. It passed and lasted about 10-15 minutes and just thought it was unusual. Did a 5:00pm check-in and she was doing okay and everything was fine so she didn't mention it. At 7:00pm she got tired and laid down and started feeling the tingling in the fingers and her hands. Upon waking this morning when her feet met the ground it was intensified, the tingling, and she went to walk it out it got better, but she is still having the tingling in both fingers/hands and feet. Stated unsure of seriousness criteria for the tingling in hands and feet and coldness. Wondered if it is something she needs to worry about that is why she called. Is it something that could go away or worse like with Guillain-barre syndrome. It's not disabling, but it is concerning. Unable to provide the NDC or expiry for COVID vaccine given. Stated she can't understand the writing on the card provided for her with product details. Does see on card Pfizer, X40113 and stated the lot number looks to be either "ES1685 or EJ1685 or E51685". Unable to provide the dose/strength. Received this vaccine at her workplace. Mentioned in past she had flu vaccine with the additive of mercury and experienced changes in taste, altered taste. It was reported to her primary care provider. This was between 6-8 years ago, unable to provide name of vaccine, NDC, Lot, or expiry. Since then she only receives single dose vials instead of multidose vials. They were looking for a list of side effects and wanted to know if she should seek care for her symptoms, it's unusual. Wanted to know if the side effects she is having is something Pfizer has been seeing and will it go away and when. Previous transfer agent sent her to safety. It is difficult to navigate the website. Outcome of event fatigue was unknown, while outcome of other events was not recovered. Causal relationship between vaccine and events "paresthesia, tingling in hands and feet" "hands and feet are cold" "soreness in injection site" were related by agency and Primary Source Reporter. Information about Lot/Batch number has been requested.
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| 51 | 2021-01-05 | burning sensation |
Palpatations and systemic burning sensation. Lasted approx. 2 minutes then goes away; 2 episodes wit...
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Palpatations and systemic burning sensation. Lasted approx. 2 minutes then goes away; 2 episodes within 5 minutes of each other.
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| 51 | 2021-01-05 | cold sweat |
caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vacc...
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caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vaccine was scheduled on 06Jan2021; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Nausea; Headache; Body aches; fatigue; Cold sweat; This is a spontaneous report from a contactable other health professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as either EK5730, ER5730, or EX5730), via an unspecified route of administration on 18Dec2020 16:00 at single dose at left deltoid for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously had shingles shot in Sep2020, previous shingles shot either three months or six months prior to the one in Sep2020 (2020), both for immunization, and severe myalgia and fever that lasted for two days after the second shingles shot (adverse events followed prior vaccinations). It was reported that did a callback as caller couldn't hear properly. Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020. Want to know if it's safe for her to get the second dose. The patient received Pfizer COVID-19 Vaccine on 18Dec2020 at 16:00. Patient had a couple days worth of symptoms. Now patient had COVID. Patient believed most likely got COVID from her son who was home from college. She was in between dosages of COVID-19 Vaccine. Looked like from research her quarantine would be done on 05Jan2021 and her second dose of COVID-19 Vaccine was scheduled on 06Jan2021. Everything she had read stated if her symptoms were gone to go ahead and get the second COVID-19 Vaccine. Patient wanted to know if Pfizer was doing any studies regarding people who test positive for COVID after receiving the COVID-19 Vaccine. Not sure if Pfizer would be interested in doing antibody studies. Declined obtained COVID-19 Vaccine through work Clarified caller's days worth of symptoms as: Headache the same evening as vaccination. Body Aches: began overnight on 18Dec2020. Fatigue that lasted all week, began overnight on 18Dec2020. Cold sweats: Lasted two days and began overnight on 18Dec2020. Nausea: began on 21Dec2020, not sure if it was related to COVID-19 Vaccine or not. The reporter considered the events weren't serious, but felt like she was having an immunological response. Diagnosed with COVID Seriousness: As of now, not serious. Is having a recurrence of all of those same symptoms as the COVID-19 Vaccine and then some. Lot number provided from patient card. Stated she was unable read it accurately. would take picture in case Pfizer wanted it. Stated lot number was either EK5730, ER5730, or EX5730. A sample of the product was not available to be returned. Vaccination facility type was Hospital, not administered at military site. No additional vaccines administered on same date of Pfizer suspect. No adverse events required a visit to. No prior vaccinations received within 4 weeks. The outcome of the event "Cold sweat" was recovered on 20Dec2020. The outcome of the other events was unknown. The reported considered the events Headache, Body aches, fatigue, Cold sweat, Nausea were related to the suspect drugs. Information on the lot/batch number has been requested.; Sender's Comments: The reported COVID test positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
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| 51 | 2021-01-05 | flushing |
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse Al...
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Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021  Date: 1/6/2021  Subjective Patient is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.  She denied any history of previous adverse reactions to vaccines.  She was given the Pfizer vaccination in the left deltoid muscle.  During her 15 minute waiting period after the injection, the patient began to experience dizziness, flushing and HA. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling.  This provider was notified of patient reaction and she was then assessed in the emergency bay area.  Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.  Hx: pt has history of breast CA and is on oral chemotherapy.   ALLERGY REVIEW OF SYSTEMS: All other systems negative    Objective  Vitals Vitals:  01/06/21 1415 01/06/21 1427 01/06/21 1443 BP: (!) 168/89 (!) 154/94 (!) 154/84 Pulse: 87 85 72 SpO2: 99% 98% 99%  Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.    Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.  Pt was given Food and water and started to feel better. For her headache she was given Tylenol 1000 mg orally. Pt left clinic at 2:45 pm.    Electronically Signed 1/6/2021 2:44 PM  Â
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| 51 | 2021-01-05 | numbness, speech disorder |
Patient complained of episodes of numbness on left side of face along with difficulty speaking lasti...
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Patient complained of episodes of numbness on left side of face along with difficulty speaking lasting up to 5 minutes. She has had 4 episodes since vaccination, last one was 1 week ago
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| 51 | 2021-01-05 | pain in extremity, tingling, weakness |
felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling ...
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felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.
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| 51 | 2021-01-05 | tingling |
15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but ...
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15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given
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| 51 | 2021-01-06 | flushing |
Dizziness Narrative: Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration ...
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Dizziness Narrative: Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration began to feel lightheaded, sweaty and flushed. Pt states this is not uncommon for her, has history of this after shots and occurs spontaneously throughout the day. Pt's face was flushed but did not develop any tongue or lip swelling, denied sob or respiratory difficulty. On exam op clear, no swelling to lips, tongue, no stridor, lungs cta bil, no wheezing, cor rrr s1s2 no m/g/r, abd soft nontender, ext no c/c/e, left upper ext injection site without redness or swelling. Vital signs were T 97.5, bp 154/97 p 95, o2 sat 97%, bp 146/80, p98, 100% 148/05 p 102 99%, 163/92 p83 o2 99%. Pt was observed for the next approx. 15-20 mins, given water and improved. Walked around the clinic with the pt who felt comfortable to be discharged. She was instructed to monitor her symptoms, follow up with her primary md regarding pretreatment prior to second vaccine and to go straight to the ED if her symptoms progress or worsen. Pt understood and agreed with instructions. Pt works in the facility and will be around medical personnel until 8pm.
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| 51 | 2021-01-06 | migraine, muscle spasms |
Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That nig...
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Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That night woke up with muscle spasms all over her body and took her temp which was 101. The muscle spasms stopped at 0300 on 12/31. After that she developed a migraine. Headache last 22 hours and then just went away. She was tired the following day 1/1. All symptoms resolved on 1/2. She received the first vaccine in the ED and is scheduled to receive the second one in the ED as well. She has h/o anaphylaxis to food and bugs.
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| 51 | 2021-01-06 | muscle twitching |
36 hours after receiving the vaccine I was awakened at 4:00 AM 12/20/20 by muscle fasciculations- mo...
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36 hours after receiving the vaccine I was awakened at 4:00 AM 12/20/20 by muscle fasciculations- mostly in my legs. It was very bothersome and caused difficulty sleeping for a few days. The second week after the vaccine it seemed to get better. I?m due for my second dose tomorrow and the fasciculations are back as of a few days ago, around 1/4/21. I?m wondering if I should get the second dose.
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| 51 | 2021-01-07 | weakness, muscle twitching |
Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches ...
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Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches and weakness that evening, took tylenol with relief. 1/8/21 patient woke up in the middle of the night with fever, blister on the inside of her lip, and her right cheek twitching. 1/8/21 patient went to PCP to be checked out. Discovered redness and bruising at the injection site. Patient has had relief with tylenol and zyrtec.
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| 51 | 2021-01-07 | pain in extremity |
Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache,...
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Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.
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| 51 | 2021-01-07 | pain in extremity |
I started few hours later started feeling thought it was stress. The next morning around 9am high mo...
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I started few hours later started feeling thought it was stress. The next morning around 9am high moderate pain left leg jaw, chest hurt, sudden panic attack and I had to calm down for minutes. I informed my coworker I was having a reaction and then it stopped. Then I scheduled an appt with my PCP had lab work, EKG results was normal. On 12/24 still exp high mild left jaw pain, heart racing and chest pain .I was scheduled stress test on 12/30 was normal.
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| 51 | 2021-01-08 | burning sensation | lip swelling, facial hives/erythema, burning |
| 51 | 2021-01-08 | flushing |
After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. ...
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After 20 minutes my heart started to race and pound in my chest, I was flushed and had a dry mouth. I sat and monitored what was happening and then notified the staff that it was not improving. I was directed to go to the ER for further evaluation and went. They monitored me and it resolved after about 3 hours and went home. No other issues occurred.
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| 51 | 2021-01-08 | tingling |
Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "differ...
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Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "different" and spotty non-confluent erythema and pruritis over affected arm, upper chest, posterior neck. She reported feeling faint and began to have mild hyperventilation. Vital signs remained stable and WNL, lungs were clear with good air movement and there was no mucosal involvement. Pt was treated with PO bendryl. Over the course of 45 minutes her rash faded and her sense of pruritis also lessened. She was able to return to work with no further symptoms
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| 51 | 2021-01-09 | facial pain |
Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left b...
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Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left back of shoulder, neck, face pain , moderate severe headache. SOB.
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| 51 | 2021-01-09 | numbness, tingling |
Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to h...
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Pt felt tingling and numbness in left jaw and ear area. A few minutes later, she felt it spread to her nose and other ear/jaw area. Then she experienced tongue heaviness and tingling. She was transported to the ED for further evaluation.
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| 51 | 2021-01-09 | migraine |
Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm...
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Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm that received vaccine
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| 51 | 2021-01-09 | pain in extremity |
Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move ...
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Received vaccine on 1/5/2021 and is complaining of swollen and stiff left arm and inability to move the left arm. States pain is 10 on a 10-point pain scale . Has been on Advil and Tylenol with no relief
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| 51 | 2021-01-09 | tingling, burning sensation, pain in extremity |
2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tin...
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2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
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| 51 | 2021-01-09 | tingling, migraine, numbness |
1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and...
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1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and tingling in the arm the vaccine was administered in
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| 51 | 2021-01-09 | tingling, pain in extremity, burning sensation |
1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever ...
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1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever and chills temp at that time 100 degrees , : fever 100 to 101 degrees on day 1 , 2 , 3 , 100 degrees on day 4 , day 5 , myalgia , body aches and headaches daily week 1 and fatigue week 2 was bed bound for 2 days and then could not work for 3 days after that 2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
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| 51 | 2021-01-10 | feeling hot |
0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920...
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0900 - Vaccine given 0910 - felling warm all over, fast HR, itchy arm at injection site (x5min) 0920 - symptoms improving
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| 51 | 2021-01-10 | pain in extremity |
Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Ac...
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Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Achy all over Left arm down to fingers and up the arm and across the chest to swollen arm under arm pit is in pain
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| 51 | 2021-01-10 | pain in extremity |
Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience seve...
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Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience severe headache and nausea. They also developed chills, body ache, and arm pain at night. On a follow up call on 1/11/2021, they reported that their symptoms resolved on 1/8/2021.
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| 51 | 2021-01-11 | discomfort |
erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round ar...
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erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine. She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information on the lot/batch number has been requested.
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| 51 | 2021-01-11 | feeling hot | Warm feeling in chest Better after waiting and drinking water |
| 51 | 2021-01-11 | hot flush |
Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; Thi...
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Hot flash, lasted whole day; Itching all over whole body/Itching in hands and feet all the time; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Vaccine location was arm. None medical history. The patient's concomitant medications were not reported. Patient stated she had the COVID vaccine on Dec18th, her first one and she was fine, no issues and she would say the following Wednesday (23Dec2020), she started getting like a hot flash, it lasted whole day and then her feet started itching. And now, she have got itching all over her whole body and especially in her hands and her feet all the time. She went to her family doctor. She have not had this issue before and she don't have any known allergies. And she went to family doctor and he prescribed some antihistamines and of course they are still bothering patient. Besides itching, she was not having any other complication. Patient went to family doctor last week and he put her on a prescription of antihistamine trying to help. It is not helping, Benadryl helped her. When probed for the name of the product, patient stated she think the name of it is Lyrica. The events were persisting. She had better times but then it was other times when it is worse. When asked the causality, the patient stated she think so. She has never had a reaction like this and it has been going on everyday ever since. The only thing that worries is she was due to get her second one on the 8th which is this Friday and she have heard people rumors saying that when get second vaccine, whatever symptoms she was having are even worse. Patient don't know is it true. And of course everyone is saying like, normally they say - any reactions you get like the first 24-48 hours but her didn't happen until almost halfway till first week.
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| 51 | 2021-01-11 | numbness |
"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro ...
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"EOHD Note 12/29 EE states she recieved the COVID19 vaccine (first dose) 12/28 at 7 pm at the Metro EOHD location. She stayed 15 minutes for observation and was feeling fine, however 30 minutes after vaccine administration started feeling her left upper lip was swollen and tip of her tongue felt thick. When she looked in the mirror her lip and tongue appeared normal, but she had the sensation they were swollen. She then took 50 mg of PO Benadryl and about 4 hours later felt swelling had resolved. Today, feels normal. Pt denies hx of allergies but her mother has a hx of anaphylaxis with IV contrast. EE denies throat tightness, SOB, wheezing. Numbness on left leg. Advised EE to go to ER if she experiences throat tightness and itchyness, SOB, or wheezing. Advised pt that she should consult her PCP to decide whether or not the benefits of recieving the second dose of the vaccine outweigh the risks and if she should pre-medicate with benadryl for the second dose if she choses to recieve it. "
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| 51 | 2021-01-11 | numbness |
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry...
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anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | migraine |
Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; S...
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Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Vaccination site cellulitis, shortness of breath, stridor and migraine, due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | pain in extremity, breast pain |
10 hours later after received vaccine developed Left arm pain . During the night wake up due to seve...
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10 hours later after received vaccine developed Left arm pain . During the night wake up due to severe left axillary pain irradiated to left scapula, left breast, also has adenopathy, bone ache and fatigue. Taken acetaminophen
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| 51 | 2021-01-11 | pain in extremity, feeling hot |
Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness ...
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Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
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| 51 | 2021-01-11 | pain in extremity |
body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contacta...
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body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contactable nurse (patient) from a Pfizer-sponsored program. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 28Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included possible exposure to COVID-19 patient on 22Dec2020 to 23Dec2020 (patient's patient tested positive on 24Dec2020 and saw the patient on 22Dec2020 and 23Dec2020). The patient's concomitant medications were not reported. The patient experienced fatigue on 28Dec2020, very mild sore arm on 29Dec2020, and body aches (just legs ache) on 02Jan2020. The clinical course was reported as: The patient felt fatigue on the day of vaccination and very mild sore arm the next day. The patient experienced body ache (just legs) on 02Jan2021, but it was less on 03Jan2021. The clinical outcome of fatigue and very mild sore arm was unknown and of body aches (just legs ache) was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
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| 51 | 2021-01-11 | pain in extremity |
COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/...
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COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; arm pain; she felt like crap the night; chills; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date Mar2021), intramuscular on left arm, on 18Dec2020 at 0.3 mL, a single dose for vaccination. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she tested positive with Covid. She received the Pfizer Covid vaccine on 18Dec2020. She was exposed to the virus through close personal contact right around this same time-frame and did develop the virus herself. She wanted to know if there were any recommendations regarding her needing to get the second dose in series. She stated that her husband, who was not vaccinated, had the virus and developed more serious symptoms than she did. She is concerned about worsening side effects with the second dose and stated that she felt like crap the night after her first dose with chills and arm pain. The patient tested positive for COVID-19 on 26Dec2020. Specific test name was unknown, but she knows it was not a rapid test. She is scheduled to get the second dose of the Pfizer COVID-19 Vaccine on 08Jan2021. She called to ask if she should or should not get the second dose relative to the COVID-19 diagnosis. She has not been able to find the information she is asking about. The outcome of the event of Covid-19 was recovering while other events was unknown. The Covid-19 was assessed as unrelated to the suspect drug.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment. COVID-19 antigen test positive.
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| 51 | 2021-01-11 | pain in extremity |
Vaccine 2 only: severe arm pain began 2 hours after shot. Within 8 hours I had severe pain all over...
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Vaccine 2 only: severe arm pain began 2 hours after shot. Within 8 hours I had severe pain all over my body and fever 103F. Still have severe headache 36 hours late and fever 100F.
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| 51 | 2021-01-12 | burning sensation |
Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 d...
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Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 days. Treated with steroid injection and Benadryl. Treatment started January 4, 2021.
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| 51 | 2021-01-12 | discomfort, flushing |
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ...
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Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
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| 51 | 2021-01-12 | feeling jittery |
Jitters and increased anxiety and feeling of being overwhelmed. Prescribed Prozac 10 mg daily at th...
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Jitters and increased anxiety and feeling of being overwhelmed. Prescribed Prozac 10 mg daily at this office visit.
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| 51 | 2021-01-12 | flushing |
gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a co...
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gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a contactable other HCP(patient). A 51 years old female patient received first dose BNT162B2(lot number EL0140), via an unspecified route of administration on 29Dec2020 08:00 at the 51 years old at Arm Left at single dose for COVID-19 immunization. The patient medical history was none. The concomitant medications were none. The patient had her first dose on 29Dec2020, she had no fever or chills and she got it at 8AM, and she woke up on 30Dec2020, and for the last 9 days when she wakes up, she was gut wrenchingly nauseated. It lasted like up to sometimes until noon, she still had a little nausea now, and it is almost noon there, and this comes along with being so nauseated. She was having a pretty moderate stomach ache on 30Dec2020, especially after eating, then she was really felt flushed and dizzy on 30Dec2020, but she thought because the nausea was so bad. She had a headache on 30Dec2020 and lasted for 5 days. She was not sick prior to the COVID vaccine. The outcome of the event Headache was recovered on 04Jan2021, the other events was not recovered.
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| 51 | 2021-01-12 | flushing |
Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt f...
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Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt flushed in her hands and face. She felt a little short of breath. She started to get fluid-filled blisters on bilateral palms. This is a milder form of the reaction pt has to flu vaccines (she was advised by PCP not to receive flu vaccines because of the blistering). Pt took diphenhyramine 25 mg PO x 1 and the fluid-filled blisters resolved within a few hours. 12/28 around 0330, pt awoke and felt like her right carotid was "pulsating." Pt drank water, did not go back to sleep. "Pulsating" resoved within an hour. No other symptoms develped. In the morning, pt called employee health RN who instructed her to contact PCP and report the reaction. Pt called PCP who advised pt not to get second dose of vaccine due to her reaction to COVID and the flu vaccines.
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| 51 | 2021-01-12 | flushing |
dizziness; flushing; HA (Headache); This is a spontaneous report from a non-contactable healthcare p...
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dizziness; flushing; HA (Headache); This is a spontaneous report from a non-contactable healthcare professional. A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, then the second dose (lot number: EK9231, expiry date not reported) via intramuscular route of administration the left deltoid muscle on 06Jan202, both at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience dizziness, flushing and HA (headache). She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, and lightheadedness. No therapy/ treatment was given. Events were non-serious. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-01-12 | pain in extremity |
Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain...
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Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain.
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| 51 | 2021-01-12 | pain in extremity |
Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies;...
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Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies; Body was not feeling well, she felt like she was getting the flu; Body was not feeling well, she felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E10142), via an unspecified route of administration on left upper arm at 10:40 AM on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hip replacement from Aug2020 (Right hip replaced in Aug2020, she was a runner and this is due to wear and tear), allergies, family history included diabetes and high blood pressure. Concomitant medication included cetirizine hydrochloride (ZYRTEC). Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. The patient previously received flu vaccine for immunization. The patient was having symptoms, nothing life threatening but she wanted to report them. Weight: 150lb-152lb. She was in healthcare but not a healthcare provider, she work in a outpatient clinic. Her first shot was on 05Jan2021. That day she experienced nausea and was light headed in the evening on 05Jan2021. She thought it was her allergies. She was really tired and went to bed really early that night. She got chills last night on 06Jan2021 and her body was not feeling well, she felt like she was getting the flu. Her joints were sore and her head started to hurt. The nausea, light headedness and tired feeling got worse last and she went to bed even earlier that night. She took her temperature this morning, she didn't take it last night as she knew she would get some symptoms from the shot, and she had no fever. Sometimes got light symptoms from the flu vaccine that she got every year, she had no product name, NDC, Lot, or Expiry for that product. When she woke up her head was still killing her but felt sickly. She went to work, she just thought she would power through it but she felt like she could go home and go right to sleep. The day of the shot she took a One a Day Women for 50 and over and a Zyrtec. Yesterday morning she took the Zyrtec but not the vitamin and she didn't take either this morning due to her stomach. She was told she should take Tylenol so maybe she would take that today. It was also noted that her left upper arm was sore where she got the shot on 05Jan2021, it had gotten better today. The outcome of events feeling unwell and flu-like illness was unknown. The outcome of event pain in arm was recovering, the outcome of rest events was not recovered.
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| 51 | 2021-01-12 | pain in extremity |
No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, min...
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No reaction immediately after receiving vaccine. Next day, 1/10/2021, noted left axillary pain, minimal pain at left deltoid injection site. Used Tylenol for ineffective relief of discomfort. Next day, 1/11/21, noted swelling and pain along left collarbone area on chest/neck area. Called to speak with Dr. Told that I had left supraclavicular lymph node swelling causing discomfort, and still had swelling of left axillary lymph node causing discomfort. Also noted minimal left groin lymph node enlargement with no pain. Told to monitor symptoms and continue to use Tylenol or Advil as needed. Recommended that I call back if symptoms worsen, change or have additional symptoms.
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| 51 | 2021-01-12 | pain in extremity |
The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I ...
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The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I began to get fatigued chills overall body aches but was afebrile. I also had nasal congestion and sneezing for 4 hrs. that resolved. At 12 noon I felt progressively worse and had to leave work. I got home and my temp was 100.2 and took more Ibuprofen at 1 PM. At 2PM the body aches and chills were pretty severe- my temp rose to 103.2. I took more Ibuprofen and alternated with TYLENOL and it returned to normal at 10 PM. I notified my Drs office and had a telemedicine visit with Dr at 4PM who thought it was a normal immune response but suggested getting a COVID Test in the meantime before returning to work. I woke up this morning afebrile with no issues notified employee health got a referral and had my COVID test completed at 09:30am. The urgent care MD strongly urged me to report to VAERS, not just CDC as I had yesterday. My COVID tests are still pending.
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| 51 | 2021-01-12 | tingling |
Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to ...
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Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to right toe, right jaw lock, and headache on right side 4/10 pain.
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| 51 | 2021-01-12 | tingling |
Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ea...
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Site: Itching at Injection Site-Mild, Systemic: pt had tingling on left side of face from lips to ear and arm felt funny
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| 51 | 2021-01-12 | tremor, pain in extremity | Left arm pain, armpit pain, body aches, shaking chills, nausea, extreme tiredness |
| 51 | 2021-01-13 | feeling cold, weakness |
Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and f...
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Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and flu like symptoms. Next day the symptoms progressively got worse to include chills, body aches and joint pain and headaches, sluggish and no energy. Had to leave work early due to feeling tired, no energy and went home slept rest of day throughout night, unable to eat. Symptoms stayed the same throughout a Friday Jan 8th still with chills, aches, joint pain and headaches, nausea started to subside finally ate some soup and drank liquids , again was sluggish no energy still and went to bed early. Saturday January 9ththe headaches subsided and I started to feel better... Saturday January 9ththe headaches subsided and I started to feel better, but still did not feel like myself, all over less aches and pains but still not feeling well, still tired and Sunday the same but was able to have an appetite. Monday went into work still not 100% but was able to function. Started feeling like myself by wednesday 1/13.
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| 51 | 2021-01-13 | feeling hot, flushing | Felt hot and flushed |
| 51 | 2021-01-13 | hot flush, tingling, numbness |
Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no se...
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Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no sensation of hot/cold.
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| 51 | 2021-01-13 | pain in extremity, discomfort |
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath...
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received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
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| 51 | 2021-01-13 | pain in extremity, tenderness |
Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , g...
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Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , given morphine, Valium,zofran, dexamethasone and norco and discharge home. No relief with med. lower feet noted trace of swelling, jaw pain and epigastric discomfort. Leg pain subside after 3 days but with muscular pain esp the upper arms. Extreme fatigue and mild tenderness on the back of head. It?s been 3 weeks now and I have the fatigue, epigastric discomfort, loss 10 lbs of wt. muscle easily get sore.
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| 51 | 2021-01-13 | pain in extremity |
Brief (less than 2 minutes) itching in throat. Sore left arm for 2 days. On day 2, inability to lif...
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Brief (less than 2 minutes) itching in throat. Sore left arm for 2 days. On day 2, inability to lift arm for about 1 hour, improved after ibuprofen. Significant fatigue for 2 days. By day 3, all symptoms resolved.
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| 51 | 2021-01-13 | speech disorder, numbness, tingling |
Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30a...
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Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision. I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand. I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
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| 51 | 2021-01-14 | weakness |
Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, ...
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Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, body aches, skin sensitivity, headache, chest tightness and burning on inspiration, runny nose, unproductive cough, just felt horrible with all of this for two days fever ran between 99.7 and 100.6. Symptoms began to resolve and no fever by day three. Every day after continued to improve but joint pain, weakness with a general malaise through Thursday. It is now the following Friday and I am still experiencing fatigue and just a general feeling of not being quite 100%.
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| 51 | 2021-01-14 | weakness |
2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen...
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2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen as a rock, hot to touch and sore. 1/15/21 injection site redness, swollen as a rock, hot to touch and sore; skin temp taken 100.0 at injection site, localized in area, not feeling well, weakness, neck stiffness, headaches Midrin taken for intense headache. Pt has been resting all week, off work returned today no fever. 1st dose: no ae to report
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| 51 | 2021-01-14 | breast pain |
On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a r...
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On the 1/11/2021 I noted a discoloration to the outer left axilla area- resembling bruising, and a round, flat rash like area. I have swelling to my left axilla, with 3 points of pain with palpation within it. I also have tenderness in my left breast closest to my axilla.
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| 51 | 2021-01-14 | feeling hot | body itching, eye itching and irritation, body warm, chest tightness, bradycardia |
| 51 | 2021-01-14 | feeling hot | body itching, eye itching and irritation, body warmth, chest tightness, bradycardia |
| 51 | 2021-01-14 | numbness |
Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syn...
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Approximately 30 minutes after injection I developed a sunburn type reaction (similar to red man syndrome), it lasted 5 hours and dissipated after. Also developed right ear pain and jaw pain, which is still present. At the same time my right side of my face was numb which lasted a couple days.
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| 51 | 2021-01-14 | seizure |
Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic re...
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Rash, swollen tongue and 2 seizures. Admitted to hospital with diagnosis of seizure and allergic reaction.,
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| 51 | 2021-01-15 | night sweats |
1st day- Body aches, headache, mild fever 100.1, night sweating when sleep 2nd - Body aches, headac...
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1st day- Body aches, headache, mild fever 100.1, night sweating when sleep 2nd - Body aches, headache, mild fever 99.9 3rd day - body aches only
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| 51 | 2021-01-17 | burning sensation |
Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue ti...
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Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue tingling. Started having symptoms a couple of hours after 2 dose of vaccine. Feels like nerves are burning in these areas. Intense headache 24 hrs after shot. Took Tylenol 500 mg with no relief. Took naproxen 550 mg Tuesday night around 10 pm. Resolved headache but not burning sensation around mucus membranes. Got progressively worse. Saw MD on Friday who did pelvic exam. Confirmed vaginitis. Prescribed Medrol dosepak, refresh vaginal lubricant and topical desitin. Currently on day 4 on Medrol dospak with some relief. Burning sensation now comes and goes and is not constant. Again, the burning sensation feels like the nerves in the areas of mucus membranes are inflamed.
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| 51 | 2021-01-17 | migraine |
BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe ...
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BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe nausea (but could be from headache).; Possible migraine; Mild photophobia; Mild photophobia; This is a spontaneous report from a contactable Physician who reported for herself. A 51-year-old female patient received her second single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EL3249) at left arm at 17:30 06Jan2021 for Covid-19 immunization in a hospital. She had her first injection at 07:15 PM 18Dec2020 and experienced mild photophobia within 5-10 min. The patient had a medical histroy of allergic rhinitis and was allergic to cashews. Concomitant medications included fexofenadine, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to her first COVID vaccine. Within 5-10 minutes of 2nd injection, the patient had mild photophobia (also after 1st injection but patient did not recognize the symptom at that time). About 20 hours after 2nd injection, the patient developed severe sharp headache behind left eye, severe nausea (but could be from headache/ possible migraine). The patient stated that she had no prior history of migraines or frequent headaches. Three days after 2nd dose, the patient's lingering intermittent mild left-sided headache persisted. The patient self-administered OTC oral analgesics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events headache, nausea, migraine, photophobia at the time of last observation was resolving. The patient considered that the events were non-serious.
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| 51 | 2021-01-17 | pain in extremity, hot flush |
Arm started hurting within hours of shot and was mainly gone in 2 days. The next morning I was so le...
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Arm started hurting within hours of shot and was mainly gone in 2 days. The next morning I was so lethargic and exhausted I could barely get out of bed. Late afternoon I started feeling better. Also had headaches, hot/cold flashes , was very achy and a lot of sinus pressure. By Monday morning minimal arm pain still lingered
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| 51 | 2021-01-17 | pain in extremity |
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati...
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Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
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| 51 | 2021-01-18 | burning sensation, pain in extremity |
Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; ...
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Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; kidneys were hurting; body aches; tested positive; tested positive; The arm wasn't swollen it was just burning.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. At first, she thought she was having a reaction, but then she started feeling sick so she got tested. She was positive so she wasn't having a reaction. She was scared from the pain of COVID. She experienced sickness. Her stomach was still weirded out. She did experience arm pain from the vaccine. Her doctor told her it was fine that it needed to air out. She left the bandage on too long. She didn't have a prescribing doctor. She received the vaccine on the 29Dec2020. She tested positive 02Jan2020. The arm wasn't swollen it was just burning. She was sick to her stomach when she got the stomach. The sick to the stomach lasted maybe two days, but then she got COVID. The burning was around the arm. It wasn't that bad. It lasted for a day. It started the day she got the shot (on the 29Dec2020). On 07Jan2021, she went to the hospital because her kidneys were hurting. The doctor said her kidneys were good. They did labs which were good. She was still going through body aches. She was told she was currently in the worst part of the virus. She still had a sour stomach going on from the virus as well. The outcome of the body aches and sour stomach was not recovered, for other events was unknown.
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| 51 | 2021-01-18 | difficulty speaking |
Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit i...
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Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit itchy? and her ?nose was closing up?. Vitals taken at 3:48- 129/75 BP, 98 HR, 98% O2. Continuing complaint of ?itching?. 1 mL of Benadryl (Lot #080010, Exp 08/22) given at 3:52. Vitals taken again at 3:54- 150/84 BP, 92 HR, 97% O2. Patient sipped water and speaking with responding nurses at 3:55. At 4:00, reported ?throat itching? and had hoarseness, coughing, and congestion. 4:01, 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:06 patient reported her tongue was less ?itchy? and decreased congestion. 4:14 vitals were 123/72 BP, 106 HR, 98% O2 & patient reported no improvement of symptoms. 4:15, Dr. was called at which time recommended to call EMS. 4:16, RN called EMS. 4:18 patient reports ?someone is pushing on my throat?. 4:20 a 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:22 vitals were 126/81 BP, 107 HR, 96% O2. 4:26 EMS arrived at clinic and left via stretcher. EMS provided with medications given to patient.
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| 51 | 2021-01-18 | facial paralysis |
9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 we...
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9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.
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| 51 | 2021-01-18 | migraine |
Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sne...
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Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Information of lot/batch number has been requested.
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| 51 | 2021-01-18 | pain in extremity |
Bleeding at left arm injection site; Flu like symptoms; feeling unwell; fatigue; mild headache; inje...
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Bleeding at left arm injection site; Flu like symptoms; feeling unwell; fatigue; mild headache; injection site pain; injection site pain, increased soreness in 24 hrs; This is a spontaneous report from a contactable nurse. A 51-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular into the left arm on 17Dec2020 at 02:45 PM at single dose for COVID-19 immunization. Medical history included Childhood asthma, NIDDM and known allergies to Latex. Concomitant drugs included Metformin, Glyburide, Lisinopril, Jardiance, Januvia, Atorvastatin, Proventil, Advair, Tylenol, MVI, D3, Diosmin, Niacin, Flonase, Vit C. On 17Dec2020 after first dose administered, at 03:00 PM, the patient experienced injection site pain, increased soreness in 24 hrs, bleeding at left arm injection site; flu like symptoms at the 12th hour of vaccination despite of tylenol and ibuprofen alternate medication. Generalized feeling unwell, fatigue, mild headache. At the time of reporting, the patient was recovered.
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| 51 | 2021-01-18 | pain in extremity |
At the time of the vaccine administration the vaccine was burning going in from the injection site u...
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At the time of the vaccine administration the vaccine was burning going in from the injection site up to my shoulder. I think the shot was given to high. The pain in the arm was bad for the first 3 days. The pain in the shoulder, almost right on the bone, is still present.
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| 51 | 2021-01-18 | tingling | Tingling of Lips and face |
| 51 | 2021-01-18 | unresponsive to stimuli |
COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff wi...
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COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff will continue to observe adverse reaction. Will continue to monitor. Patient at start of shift awake in the bed. Pt at 3am was on the commode leaned to the side. Patient body still warm to touch no pulse. Called for assistance Asap. Cpr started promptly. Cpr given patient on floor 911 arrived at the scene at 3:10am Cpr rotated Between Nursing and EMT on Scene. Cpr was given to patient for over 45 minutes. Patient was pronounced at the scene at 3:50am. Call placed to Pt family by supervisor on shift. MD to be notified. AT 3:00am, I was notified by the nurse that resident is unresponsive. Upon entering room, resident was sitting on the commode unresponsive with absent respiration and pulse. Resident lowered down on the floor with 4 person assist. CPR initiated, AED pads placed on chest with no shock indicated. 911 called and EMT and paramedics arrived around 3:10am. ACLS performed until code stopped and pronounced death at 3:48am. I called and notified family member of his demise and awaiting for family to call us back for funeral arrangements.
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| 51 | 2021-01-19 | electric shock sensation |
Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , D...
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Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , Disiness, feels like electrical currents in head and ears. These symptoms have been all 7 days.
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| 51 | 2021-01-20 | feeling cold |
12 hours later: 2 am -fever, chills, lethargy, bone pain persistent for 48 hours, Took one Tylenol ...
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12 hours later: 2 am -fever, chills, lethargy, bone pain persistent for 48 hours, Took one Tylenol For one week after the shot: rhinorrhea, sore throat, no fever.
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| 51 | 2021-01-20 | feeling cold | body aches vomiting diarrhea temp 101 chills flat, red, splotchy rash |
| 51 | 2021-01-20 | nerve pain |
Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) bod...
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Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; Low grade fever (99.9) body aches, nerve pain chills, headache, ear pain; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number El3248), via an unspecified route of administration in the left arm on 09Jan2021 06:30 at single dose for COVID-19 immunisation at hospital. Medical history included asthma, seasonal allergy, milk allergy, eucalyptus allergy. Concomitant medication included montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL), ciclosporin (RESTASIS, eye drop). The patient previously took tetanus vaccine and experienced drug hypersensitivity. The patient experienced low grade fever (99.9 F) body aches, nerve pain chills, headache, ear pain on 10Jan2021 08:00 with outcome of recovered. The patient took diphenhydramine hydrochloride (BENADRYL) 25mg every 6 hours and it relieved all symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
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| 51 | 2021-01-20 | pain in extremity | Body aches, chills, fever, headache, sweats, dizzy, arm soreness, tender at injection site |
| 51 | 2021-01-20 | pain in extremity |
feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattre...
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feeling malaise; general soreness/Body and joints with extreme pain everywhere it touched the mattress; no real taste; chest pressure/tightness/ general pressure in the chest; SOB/ SOB with movement; Body and joints with extreme pain everywhere it touched the mattress; a screw in left foot, it felt like it was on fire at some point during the night; My left leg ached up into my hip; fever 99.9; HA; eye pain; intermittent nausea; This is a spontaneous report from a contactable nurse (patient). This 51-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) on 07Jan2021 at 11:15, in right arm, for COVID-19 immunisation. Medical history included asthma, allergies to latex, banana, kiwi and acetylsalicylic acid (ASPIRIN). The patient received the first dose of BNT162B2 vaccine on 17Dec2020 at 19:45, lot number EJ1685, in right arm. The patient had no COVID prior vaccination. No other vaccine was given in 4 weeks. COVID was not tested post vaccination. Concomitant medications included thyroid (ARMOUR THYROID) and escitalopram. On 07Jan2021 at 12:30 the patient began experiencing SOB; assumed it was asthma, 2 puffs of albuterol were taken. At 13:30 she had still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 14:15 reported to the vaccination clinic and told them of symptoms, SOB with movement and general pressure in the chest. 2 paracetamol (TYLENOL) were taken. She had to check into the ER for observation. Oxygen saturation was checked for 2 hours. No change in symptoms, no worsening. She then left work in the ER and went home. At approximately 18:00 she ate dinner, no real taste, but needed to eat. At 18:30 she showered, at 20:00 she went to bed just feeling malaise, continued pressure in the chest and general soreness. 2 Tylenol. Body and joints with extreme pain everywhere it touched the mattress. She had a screw in her left foot, it felt like it was on fire at some point during the night. Her left leg ached up into her hip, she had fever 99.9, continued to 10Jan2021 with malaise, HA, eye pain, intermittent nausea. The events had not yet resolved at the time of report.
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| 51 | 2021-01-21 | weakness |
Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at...
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Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at the injection site it swollen and red happened in the middle of the night. For the next 2 days I had extreme fatigue and after that I was fine (by Sunday). I did not have any energy but no chills or nothing. I took Tylenol and it helped me. I was able to return to work on Monday and as the day passed I started feeling like myself. I also developed a lump on my neck on 01/18/2021 on the left side (on my collarbone) and my PCP prescribed Doxycycline 2 tablets a day. I also developed a lump on my right side when I took the first dose and took a ZPack and that lump is still here on my neck.
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| 51 | 2021-01-21 | discomfort, hot flush |
An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tyl...
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An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tylenol as soon as I got home due to symptoms getting worse. That night I went to bed at 10pm and didn?t wake up till 7:45am (I was dead tired, I didn?t even hear my alarm). Jan/19/21. Soon as I got up, I experienced headache, vertigo, and this time with mild body aches/heavy feeling and mental fog (Tylenol helped relieved symptoms). Towards the afternoon, I also felt mild burning sensation in my eyes and somehow I felt hot flashes around my face only. Been taking my temperature with normal results. Jan/20/21 Still experiencing off/on headaches and light headedness, otherwise feels okay. All symptoms gone by end of the day.
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| 51 | 2021-01-21 | difficulty speaking |
I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-work...
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I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-worker told me my voice was strange, was hoarse. I was feeling fine. The next day I lost my sense of smell. Talked to my PCP and he told me to get tested for COVID, to my surprise I was positive. That was on the 28 or 29 of December. I also developed a lump on my neck on the right side and my PCP prescribed a Z Pack. I finished it but it never went away. I developed another lump on my left side when I took the second dose and I am taking Doxycicline for it.
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| 51 | 2021-01-21 | feeling hot, tremor |
Feeling of warmth on head and face at 9:00pm on 1/19/21 Woke with fever (99.6F), shaking chills, he...
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Feeling of warmth on head and face at 9:00pm on 1/19/21 Woke with fever (99.6F), shaking chills, headache at 4:00am on 1/20/21 Fever (100.6) joint pain, muscle pain at 9:00am Fever 101.0 at 1:00pm with intense headache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise. Fever 101.0 at4:00pm. Accompanied by symptoms listed above.Took 1,000mg Tylenol. Fever 101.0 at10pm. Accompanied by symptoms listed above. Took 1,000mg Tylenol. Insomnia. 1/21/21: Fever 99.0 degrees 4am. 1,000mg Tylenol. Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/21/21: Fever resolved at 6pm. Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/22/21: Body aches, headache, fatigue, malaise, fatigue, dizziness, nausea
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| 51 | 2021-01-21 | feeling hot |
Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly it...
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Pfizer-BioNTech COVID-19 Vaccine EUA 25 minutes after my 2nd dose I feel warm , my lips slightly itch, pinpoint itch at my scalp and different parts of my body, fine rash in my bilateral forearm near my wrist, immediately I took Zyrtec, my rash started to fade but every now and then I fell fine itch in different parts of my body more than 2 hours now.
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| 51 | 2021-01-21 | flushing, tremor | Throbbing pain R. Clavicle, shaking hands, Flushing, increased B/P |
| 51 | 2021-01-21 | flushing | sporadic flushing of the face and neck Increased flushing of the face and neck with wine/champagne |
| 51 | 2021-01-21 | muscle twitching |
Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/1...
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Swollen on injection site (about 2inches circumference) blood pressure and hear rate elevated (153/103 pulse99) -patient refused to call 911 and asking staff to drive to hospital at 9:45am. hospital and nurse in charge at the facility, has contacted each other. At 11:46am nurse has inforemed me that hospital provided IVBenadryl/Fluid IV/Epipen, her heart still raised up, and has twitching, patient has left hospital and back to facility at 12:20pm
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| 51 | 2021-01-21 | pain in extremity, migraine |
HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVE...
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HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVER THE FIRST 24 HRS AND THEN STARTED TO DISSIPATE AFTER ABOUT 36 HRS AND WERE COMPLETELY GONE IN 48 HRS. TOOK ADVIL. SLEEP.
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| 51 | 2021-01-21 | tingling, flushing | Tingles, Flush, Blood Pressure initial reading 172/79 at 3:09pm |
| 51 | 2021-01-22 | weakness | Chills, muscle aches and weakness, headache, tachycardia |
| 51 | 2021-01-22 | burning sensation |
20 Jan 2021 face and arms reddening and burning about half hour after injection. 21 Jan 2021 fatigu...
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20 Jan 2021 face and arms reddening and burning about half hour after injection. 21 Jan 2021 fatigue, body aches, dizziness throughout day, went to bed very early no appetite, nauseous 22 Jan 2021 fatigue, body aches, dizziness. Temp 99.3 higher than normal. No appetite 23 Jan 2021 condition improved. No symptoms.
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| 51 | 2021-01-22 | feeling cold |
EXTREME COLDNESS started around 8am the day after the shot. Also all over body aches. 1/23/2021 wo...
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EXTREME COLDNESS started around 8am the day after the shot. Also all over body aches. 1/23/2021 woke up with patchy red torso rash
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| 51 | 2021-01-22 | feeling hot |
Received vaccine at 8:45am. Face felt hot and developed hives at 11:15am. Took Benadryl 25mg at 1pm....
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Received vaccine at 8:45am. Face felt hot and developed hives at 11:15am. Took Benadryl 25mg at 1pm. Continued to work. Two Pepcid and ice at 2:30pm. Had little improvement. Took Claritin at 4:30pm then Benadryl 50mg. Symptoms resolved that am - no further issues.
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| 51 | 2021-01-24 | bell's palsy | Received covid vaccine on December 30th. Developed Bells Palsy. |
| 51 | 2021-01-24 | feeling hot, hot flush |
Patient developed hot flashes (body and face getting warm) 60 minutes after receiving vaccination. P...
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Patient developed hot flashes (body and face getting warm) 60 minutes after receiving vaccination. Patient claimed she was feeling very hot no sign of itching or respiratory depression. Had patient under observation for 30 minutes while she cooled down with ice and water. Patient was also given 2 doses of Benadryl 25mg. Patient cooled down and went back to work after feeling better. However, we checked on patient again after a few hours to make sure she was ok. She was getting another episode of hot flash about 3:30 hours after first episode. Patient was given 1 more dose of Bendaryl. Checked patient BP systolic was slightly elevated (140s/70s)and HR was 101. Patient called husband to pick her up to go to PCP for monitoring. Patient claimed she only had a sore arm during her first COVID vaccine.
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| 51 | 2021-01-24 | numbness, tingling |
n/t arm and leg immediately after vaccine- numb /ting arm on follow up call next day. Pt felt immu...
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n/t arm and leg immediately after vaccine- numb /ting arm on follow up call next day. Pt felt immunization was administered too high on arm/shoulder. 1/25 pt is to get dose #2 this week and concerned re: still some numbness but also some ringing in the ear. Tells staff has had some ringing in the ear previous to vaccine mostly at night- this has now intensified to where she is also hearing it during the day. She has d/w her PCP- she is very unsure if she should get vaccine #2 or not.
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| 51 | 2021-01-24 | numbness |
Within 10 minutes of 2 dose of COVID 19 vaccination, Patient experiences RIGHT side facial numbness....
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Within 10 minutes of 2 dose of COVID 19 vaccination, Patient experiences RIGHT side facial numbness. Monitored patient vitals and facial symptoms until mostly resolved. With facial numbness, patient could still laugh, smile, wink, talk, breath. Vitals 30min post vaccination= 135/78 bp, 105 pulse, Temp 98.2F, O2 100%, 18 RR. 2hrs post vaccination= 138/90 bp, 96 pulse, Temp 97.3F, O2 100%, 18RR Right side facial numbness is resolving downward past eye. 2hr 20min post vaccination= 140/82 bp, 92 pulse, temp 98.2F, O2 100%, 18 RR Patient feels better and will notify Facility if facial numbness does not resolve.
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| 51 | 2021-01-24 | muscle spasms |
I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chi...
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I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chills. At 2am, I woke with more chills and a splitting headache. I took Tylenol which decreased the symptoms. All day on Sunday, I had a horrible headache, a fever of 101F, body aches (muscles and joints), cramping, nausea, terrible fatigue. I took Tylenol every 4 hours which did help some. Today, I feel fatigued, fever is gone, I feel nauseated.
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| 51 | 2021-01-24 | pain in extremity |
I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7...
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I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7 pm started exp chills, fever 101.9, the highest it got over next 2 days 100.5. The pain in my legs cause me to not be able to walk and severe headache. Due to the pain in my legs exp bruises in both legs of calf muscles. I felt as if I had Covid therefore I went to the doctor 4 days.
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| 51 | 2021-01-24 | tingling |
Dizziness/ SOB about 30 minutes after injection, utilized inhaler, relaxed in bed. SOB and dizzines...
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Dizziness/ SOB about 30 minutes after injection, utilized inhaler, relaxed in bed. SOB and dizziness resolved GI symptoms started about 2 hours after injection - took protonix and maalox resolved by evening , Tingling in legs/feet in evening -Premedicated with Extra strength Tylenol and Benadryl for both doses of vaccine.
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| 51 | 2021-01-25 | weakness, pain in extremity |
With dose #1, some HA, arm pain (in particular arm pit pain). With this dose #2, uncontrollable rigo...
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With dose #1, some HA, arm pain (in particular arm pit pain). With this dose #2, uncontrollable rigors at about 12 hours post-dose for at least 1-2 hours, Tm to 103.3F, HA, myalgias, right leg pain, weakness and again, significant, severe arm pit pain on same side as injection site. At 34 hours, much improved (almost 100%), but arm pit pain did not dissipate until about day 5.
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| 51 | 2021-01-25 | feeling hot |
about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. ...
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about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. I also had a headache. I was taken back to medic area and was assessed. My oxygen was good but my pulse and BP were high. I layed down and after 10 minutes felt better and my pulse recovered. Shortly later I was told I could go home. I sat up and felt briefly dizzy then my heart started racing again (pulse 137). I layed back down and EMS was called. By the time they arrived my pulse had slowed to normal but I still had a headache. This was about 45 min after vaccine. They performed an EKG and monitored my vitals as I sat up and then stood up. I did not have any incidents of my heart racing but my BP was 157/98 so I was told they could take me to EC for monitoring or to my doctor. I chose to go to my doctors. I arrived at my doctor an hour later and still had elevated BP and headache . He chose to monitor me. I had another incident where my heart started to race so he gave me liquid Benadryl and let me rest. I think I had one more milder incident of my heart racing but it was not as strong. After about 3 hours I went home and was told to monitor for Anaphylaxis. I went home and slept 3 hours and woke up feeling fine. I was fatigued for next 3 days but not issues with heart. About day 5 I was working and had a couple of incidents where I felt my heart pick up a little bit and I couldn't catch my breath. After that I feel like I was fine and don't remember any more incidents.
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| 51 | 2021-01-25 | numbness, facial pain |
Patient developed unilateral facial numbness 2 days after the vaccine. The numbness subsided and was...
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Patient developed unilateral facial numbness 2 days after the vaccine. The numbness subsided and was replaced with pain. No weakness or drooping. No eye involvement. Patient's pain was located on the right side of the jaw below the eye. Patient was treated with prednisone on the same schedule of dosage as used for Bell's Palsy. Patient saw immediate improvement from the prednisone and is no longer having the pain. She never developed any other complications.
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| 51 | 2021-01-25 | numbness, feeling hot |
warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and t...
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warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour. Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes. I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal. I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons. I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart. I am on day 6 now and I have joint pain and headache.
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| 51 | 2021-01-25 | migraine |
Triggered a migraine within a day. Within 3 days, muscle weakness and fatigue. On day 11, muscles i...
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Triggered a migraine within a day. Within 3 days, muscle weakness and fatigue. On day 11, muscles in jaw tight - unable to open or close my jaw. Difficult to eat.
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| 51 | 2021-01-25 | migraine |
Same day, triggered migraine that lasted 3 days; By Day 3, muscle weakness and fatigue; Day 11, coul...
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Same day, triggered migraine that lasted 3 days; By Day 3, muscle weakness and fatigue; Day 11, couldn't open my jaw or close it. Went to ER 1/25/21. Seeing PCP on 1/27/21
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| 51 | 2021-01-25 | tingling, numbness, sensory loss |
numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on...
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numbness for 10 days and is ongoing/numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/numb all over her spine; loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine/loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; paresthesia; having trouble with dexterity; This is a spontaneous report from a contactable physician (neurologist) via a Pfizer-sponsored program. A 51-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration in left arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took thimerosal and experienced allergy. The physician reported that the patient received the first dose of the vaccine and has been experiencing numbness for 10 day from an unspecified date. This patient received the injection in the left arm and she started experiencing numbness and loss of sensation in the 4th and 5th digit, then on her arm, her shoulder and the spine, she's still experiencing ongoing numbness the numbness in her 4th and 5th digit. The patient experienced loss of sensation in the left 4th and 5th finger that then went to her shoulder and back; and felt numb all over her spine, all on unspecified dates. The patient was having trouble with dexterity. The physician ordered an MRI for the patient but does not have the results back yet. The physician asked if it is safe for the patient to get the second dose. The second dose will be on 15Jan2021. The outcome of the event numbness was not recovered, and the outcome of the remaining events was unknown. Information on the lot/ batch number has been requested.
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| 51 | 2021-01-26 | weakness, flushing |
metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went t...
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metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily. There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 51 | 2021-01-26 | numbness and pain in extremities |
Pt received Pfizer vaccine 2nd dose on 1/11/2021. On 1/12/2021, pt had severe lower back seen her P...
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Pt received Pfizer vaccine 2nd dose on 1/11/2021. On 1/12/2021, pt had severe lower back seen her PCP and lower back pain progressed on 1/18/2021. Employee went to ER and was discharge. She continued to have back pain and went ER on 1/24/2021, she was admitted and doctor related her symptoms/neuropathy to the COVID vaccine, per employee. On 1/24/2021, admitted to Hospital for treatment included CT scan, MRI scan, medication such as morphine, dulaudid, Norco and gabapentin. Current using a walker for stability.
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| 51 | 2021-01-27 | weakness, migraine |
Started with an ocular migraine( I have had these in the past but not for a couple of years) on Thur...
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Started with an ocular migraine( I have had these in the past but not for a couple of years) on Thursday the 21st 2 days after vaccination, On Friday, still had dull headache. Woke up Saturday with a slight fever. It progresssed until Sunday and I became very weak, horrible headache, extreme dizziness. This is still going on. The fever left yesterday. But am still weak and having severe dizziness and fullness in my head. I have had labrinthitis in the past but haven't had any major issues for 6 years when I had the flu. Went to doctor yesterday. Flu was negative. She thought maybe another an upper respiratory virus which I question because I only go to work with a small group and come home and no one at my work has been sick. I also always start out with a sore throat when I have some sort of URI and I never had this. I do not have any congestion to speak of. I am a rule follower and always wear my mask and to be honest wear gloves if I have to touch anything. but I do not go anywhere except for work. I was exposed to covid the day after vaccination but have tested negative 2 times. I had the RT-PCT test. I am just trying to take it one day at a time
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| 51 | 2021-01-27 | hot flush, tingling, numbness |
slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuf...
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slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
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| 51 | 2021-01-27 | muscle twitching |
rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; musc...
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rash on chest and upper back; sore throat; muscle twitching around left eye; Fatigue; headache; muscle aches; swelling on left side of body including facial, arm pit, and arm down toward elbow, upper back under shoulder blade; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), intramuscular on 12Jan2021, at 13:00 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN). On 12Jan2021, at 15:00, the patient experienced fatigue, headache, muscle aches, swelling on left side of body including facial, arm pit, and arm down toward elbow, and upper back under shoulder blade, rash on chest and upper back, sore throat, and muscle twitching around left eye. The patient had no treatment for the events. The patient had no other vaccine in 4 weeks; and patient was not Covid tested post vaccination. Outcome of the events was not recovered.
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| 51 | 2021-01-27 | pain in extremity |
About 3 hours after the 1st dose of the vaccine, I was dizzy and lightheaded. This continued for 24...
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About 3 hours after the 1st dose of the vaccine, I was dizzy and lightheaded. This continued for 24 hours. I then had a fever of 101.5 for about 30 hours. My arm is extremely sore. I now have a splitting headache.
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| 51 | 2021-01-28 | inability to speak |
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble...
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cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
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| 51 | 2021-01-28 | weakness |
headache; Diarrhea; dizziness/severe dizziness; weakness/very weak; muscles and joints are aching an...
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headache; Diarrhea; dizziness/severe dizziness; weakness/very weak; muscles and joints are aching and painful; muscles and joints are aching and painful; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EL1284, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose on left arm for Covid-19 immunization. Medical history included pre-diabetes 3-4 years ago. The patient's concomitant medications were not reported. Certified Nursing Assistant said that she has been experience some side effects from the Pfizer-BioNTech Covid-19 Vaccine which she took two days ago, 13Jan2021. She said she was having side effects include headache on an unspecified date. Furthermore, she experienced diarrhea, dizziness/severe dizziness, weakness/very weak and muscles and joints are aching and painful on 14Jan2021. The outcome of all events was not recovered except for headache that was unknown. She wanted to know what she should take and what she should do about these symptoms.
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| 51 | 2021-01-28 | feeling hot |
Patient reported tongue numbness and throat itching sensation within three minutes of vaccine admi...
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Patient reported tongue numbness and throat itching sensation within three minutes of vaccine administration. BP 131/87, HR 80, O2 97%. Patient then developed macular rash on bilateral arms and described sensation of generalized warmth about 15 minutes after vaccine administration. presented to vaccine clinic for consult, patient was then transferred to ER via stretcher.
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| 51 | 2021-01-28 | numbness |
Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her a...
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Her arm killed her and was painful for two days, she could barely move her arm; Her arm killed her and was painful for two days, she could barely move her arm; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; She also experienced numbness in her face, jaw, cheeks, mouth that lasted for about 3 hours; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK5730), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing asthma for approximately 25 years ago. There were no concomitant medications. After she took the first dose, on an unknown date, her arm killed her and was painful for two days, she could barely move her arm. She also had numbness in her mouth, face, jaws, and cheeks that lasted about 3 hours. The outcome of the events was unknown.
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| 51 | 2021-01-28 | pain in extremity, migraine |
Started approx 1/17/21 with migraine type headache, then by 1/19/21 had arm soreness, muscle weaknes...
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Started approx 1/17/21 with migraine type headache, then by 1/19/21 had arm soreness, muscle weakness, joint pain and headache. All symptoms improved 1/25/21 except lingering headache which is still current.
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| 51 | 2021-01-28 | pain in extremity |
Started with body aches about 14 hours after injection progress to severe joint and bone aches espec...
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Started with body aches about 14 hours after injection progress to severe joint and bone aches especially in hands and feet . Stabbing random headaches , fever 101, chills, sweating these symptoms lasted about 24 hours . Then about about 36 hours I woke up in the morning with swollen lymph nodes under left arm very painful. All other symptoms have gone but swollen lymph nodes are persisting current time since dose is about 48hrs.
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| 51 | 2021-01-28 | tingling, pain in extremity, feeling cold |
Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain;...
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Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD). Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
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| 51 | 2021-01-28 | tingling |
Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over...
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Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) intramuscularly at right arm on 14Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. The patient's concomitant medications were not reported. The patient experienced elevated heart rate at 7pm on evening of vaccine (administered at noon), tingling sensation all over. Laid down and issue resolved within 2 hours. No treatment received. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on 14Jan2021.
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| 51 | 2021-01-29 | flushing, feeling hot |
Patient began to feel hot, vital signs were assessed and patient was found to be tachycardic and flu...
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Patient began to feel hot, vital signs were assessed and patient was found to be tachycardic and flushed. Given history of other allergic reactions and rapid onset of symptoms, patient was sent to the ED for additional f/u.
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| 51 | 2021-01-30 | weakness, flushing |
1st dose - tachycardia, onset within a few minutes of injection, HR over 100 for about 5 minutes. ...
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1st dose - tachycardia, onset within a few minutes of injection, HR over 100 for about 5 minutes. 2nd dose - tachycardia, onset within a few minutes of injection accompanied by nausea. Had to lie down. Felt fine after a few minutes of lying down. Flushed face. RN thought I was dehydrated, so drank a bottle of water. Had eaten breakfast that day as well as two cups of coffee and some water. Blood pressure elevated lying down and significantly dropped upon standing. After 30 minutes, orthostatic hypotension was gone. About 4 hours later while at home and having already had another meal and lots of water, developed. Orthostatic hypotension again - I simply could not stand for more than 30 seconds without feeling extremely weak and about to pass out. This went away quickly. Then, around 730 at night I stood up to walk across the room and had to collapse into a chair, as I was about to pass out. Again, orthostatic hypotension. No sxs the day following injection.
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| 51 | 2021-01-30 | pain in extremity |
The day after I got my vaccine, I started to have pain in my right arm (opposite arm of vaccine). I...
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The day after I got my vaccine, I started to have pain in my right arm (opposite arm of vaccine). It kept getting more intense every day, and I developed a rash on my right arm, right shoulder, and right side of my chest. It started to scab over in parts. I saw my nurse practitioner on 1/19/21 who said it was most likely shingles, and prescribed anti viral and nerve pain meds.
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| 51 | 2021-01-31 | flushing |
1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt f...
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1250: presents with heart racing, HR: 144, BP: 142/90, Upper lip numbness, throat tightening, felt flush, complained of dryness to throat, drank a glass of water and tolerated Rapid response called; transferred to Ed
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| 51 | 2021-01-31 | muscle spasms, migraine |
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; ...
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malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 51 | 2021-01-31 | pain in extremity | Arm a little sore . That's about it so far. |
| 51 | 2021-01-31 | pain in extremity |
About 3 hours after the 1st dose of the vaccine, I was dizzy and lightheaded. This continued for 24 ...
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About 3 hours after the 1st dose of the vaccine, I was dizzy and lightheaded. This continued for 24 hours. I then had a fever of 101.5 for about 30 hours. My arm is extremely sore. I now have a splitting headache.
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| 51 | 2021-02-02 | facial paralysis, numbness |
On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my n...
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On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my neck, jaw, and ear. On Saturday, 1/30, I woke up, and the right side of my face was numb, and my right eye would not blink. I went to ER. When they took my vitals, I had high blood pressure and fever. They did a CT scan of my head and admitted me. I was diagnosed with Bell's Palsy. I was discharged on Sunday, 1/31, with medications: Valacyclovir 1 gram three times a day and Prednisone 20 mg three times a day. I was instructed to followup with a neurologist, immunologist, ophthalmologist, and my primary care physician.
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| 51 | 2021-02-02 | numbness |
States she has had arm and hand numbness in L hand since 1st vaccine. States it started within 15 m...
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States she has had arm and hand numbness in L hand since 1st vaccine. States it started within 15 minutes of last injection. Denies any other symptoms.
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| 51 | 2021-02-02 | pain in extremity |
Woke up 1/7/21 at 4:00 am with a temp of 102.0, Nausea, body aches, chills, arm pain, joint pain, ex...
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Woke up 1/7/21 at 4:00 am with a temp of 102.0, Nausea, body aches, chills, arm pain, joint pain, extreme thirst and fatigue. Tylenol taken temp continued to be 102 and increased to 102.4. All symptoms lasted until until 1/8/21 5am woke up sweating temp down to 99.8, arm pain, fatigue. 1/9/21 all symptoms resolved.
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| 51 | 2021-02-02 | unresponsive to stimuli, pain in extremity |
**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze de...
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**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal
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| 51 | 2021-02-03 | feeling of body temperature change, discomfort, pain in extremity |
chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm...
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chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
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| 51 | 2021-02-03 | numbness |
She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her f...
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She got her first vaccine o 12/30/20 and by 1/5 started noticing some swelling and numbness in her face, it has slowly gotten worse and now has a drooping eye, worsening facial numbness and droop.
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| 51 | 2021-02-03 | pain in extremity, discomfort |
This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hell...
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This employee sent me an email on 12/23/20. "Subject: Re: Attention Covid Vaccine Volunteers Hello, I had received my vaccine earlier today and just awoken to chest pains. I do not think it wise to be there for my shift in the next 8 hrs. I will stay and observe for additional symptoms. I was on vacay and had out-of-office notice set for my email. I discovered this email yesterday while catching up on emails. I immediately called her. She described the details of the events; stated she has not sought medical care; all symptoms resolved spontaneously but still has some intermittent, mild SOB> She sent me this email describing the reaction: Here explanation of the reaction: Thank you for the follow up. Below is a list of symptoms I experienced after I received my initial dose of the Pfizer vaccine. I am scheduled to receive my 2nd dose next week on the 13th of January. following up: I received my shot at 8:15 am, within approximately 45 min I felt a very slight heaviness to my breathing something similar to allergy season breathing, and a slight headache on my rt temple. This was nothing that stopped me or slowed me down that day. At ~ 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At ~ 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I noticed much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopeful that all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night." I advised she contact her PCP to determine if follow up is indicated given persistent, intermittent cough and SOB.
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| 51 | 2021-02-03 | pain in extremity |
her arm was sore and hurting; This is a spontaneous report from a contactable consumer reporting for...
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her arm was sore and hurting; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284 /expiration date: not provided), via intramuscular route of administration, on 29Dec2020 10:15 AM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was none. Concomitant medication was not provided. On an unknown date, the patient experienced her arm was sore and hurting. The outcome of the event her arm was sore and hurting was unknown.
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| 51 | 2021-02-04 | weakness |
FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, C...
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FEVER, SWEATS/CHILLS, FATIGUE, FLUTTERING, PALPITATIONS, HEADACHES, WEAKNESS, SHORTNESS OF BREATH, COUGH, LOWER ABDOMINAL PAIN, MUSCLE PAIN, CHEST PAIN. PAIN AND SWELLING AT INJECTION SITE.
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| 51 | 2021-02-04 | weakness |
Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle o...
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Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle of the night, had increased SOB and chest weakness. Describes as felling "Not well." Drank water. Felt better. Went back to sleep. 2/4: Patient c/o nasal congestion, slight blurred vision, increased SOB/chest weakness, had body aches, slight swelling in neck lymph node (hx of swelling due to abscess). Felt better as day progressed but in afternoon @ 3:30 p.m. while at store with family, had to leave to sit in car due to fatigue and reoccurring SOB. Minor SOB episode throughout the day. Slept well at night. Took Ibuprofen 400 mg PO x1 which improved body ache.
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| 51 | 2021-02-04 | numbness | Numbness in face, dizziness, tiredness, pain in muscle at injection site, joint pain |
| 51 | 2021-02-04 | muscle spasms |
Pt had 2nd vaccine, went home and started having "cramping" in all of her muscles. It became bad en...
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Pt had 2nd vaccine, went home and started having "cramping" in all of her muscles. It became bad enough that she was taken to local ED where she then started coughing up blood, required intubation and about 6 hrs later, died.
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| 51 | 2021-02-04 | pain in extremity |
02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to inj...
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02/02/2021 at 11:30am breathing uneasy; I took Benadryl at home and slept for 10 hours. Pain to injection site upon waking; I took Tylenol 8 hrs and drank 20 oz water. 02/03/2021 at 130am running nose and nausea started. At 9am I took some alka seltzer cold tabs. At 5pm I realized pain to right arm was worsening after full inspection I recognize swollen axillary lymph nodes; entire arm pit is swollen. I applied moist heat compress throughout the night and took more Tylenol. I hydrated with water and just layed around resting my body. 02/04/20 swelling continues with some decreased visible; pain to right arm pit continues and nausea continues.
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| 51 | 2021-02-04 | tremor | Uncontrollable body shakes and I am very, very cold with no fever. |
| 51 | 2021-02-05 | weakness |
Extremely achy, tired ,rundown, headache. I took Tylenol, used a heating pad ,rested ,drank plenty o...
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Extremely achy, tired ,rundown, headache. I took Tylenol, used a heating pad ,rested ,drank plenty of fluids, was fine by the next day
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| 51 | 2021-02-06 | tremor |
Within 5 hours of the second vaccination (3pm) fever set in @100.5..throughout the nite the fever co...
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Within 5 hours of the second vaccination (3pm) fever set in @100.5..throughout the nite the fever continued to rise. At the onset of fever, 650mg of acetaminophen was taken. Went to bed and awoke around 4am with severe chilling/shaking and high fever of 105, took 400mg ibuprofen. Awoke 6am, shaking and chills again, fever down to 103.6. Fever did not break completely until 48 hours after vaccine dose.
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| 51 | 2021-02-07 | weakness, pain in extremity | Swelling and very painful arm. The size of a grapefruit. Fever, headache, weakness and body aches |
| 51 | 2021-02-07 | feeling hot |
felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine ra...
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felt warm; lower lip was slightly itchy; pinpoint itch mostly in her scalp left ear; cluster fine rash in her bilateral forearm near the wrist; on and off pinpoint itch in different parts of her body; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; medical history of Chronic Hep B, borderline DM, HTN, high cholesterol; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via intramuscular route of administration on 22Jan2021 at 08:15 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included Chronic Hep B, borderline DM, HTN, high cholesterol. Concomitant medications included losartan, amlodipine, atorvastatin, metformin, fish oil, and docusate sodium (COLACE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730) on 04Jan2021 at 08:30 am (age: 51 years), intramuscular, in the left arm for COVID-19 immunization; flu vaccine in 2010 and experienced allergies; and Penicillin G and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 22Jan2021 at 08:35, the patient felt warm. At the same time, her lower lip was slightly itchy. She also had pinpoint itch mostly in her scalp left ear and cluster fine rash in her bilateral forearm near the wrist, and four hours on and off pinpoint itch in different parts of her body. The patient was given Zyrtec as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-02-07 | flushing |
Headache; flush; diaphoretic; stiff neck; This is a spontaneous report from a contactable pharmacist...
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Headache; flush; diaphoretic; stiff neck; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: cl3249) intramuscularly at left arm on 22Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included hypothyroid, asthma, seasonal allergies and known allergies: bee stings. The patient was not pregnant. No other vaccine in four weeks. Other medications in two weeks included levothyroxine. The patient experienced adverse events included headache, flush, diaphoretic, stiff neck; with start date on 22Jan2021 at 12:00 PM. Treatment ibuprofen received for events. The outcome of events was resolving. No covid prior vaccination and no covid tested post vaccination.
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| 51 | 2021-02-07 | pain in extremity |
Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to ...
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Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to the touch. I iced both locations and ultimately took 2 200mg Advil tablets. Arm is still tender the second day. The toe felt fine all day then at 5:30pm it started to feel like it was swelling again. I immediately took 2 200mg of Advil.
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| 51 | 2021-02-07 | tingling |
Tingling in the hands; This is a spontaneous report from a contactable other healthcare professional...
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Tingling in the hands; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ED1283), intramuscularly on 15Jan2021 in the Right arm at single dose for COVID-19 immunization in hospital. Medical history included Celiac Disease, Dystonia, Hypothyroid, GERD (Gastrooesophageal reflux disease), Anemia, Ovarian cancer, Migraines, gastroparesis and known allergies with Penicillin. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took and had known allergies with prochlorperazine maleate (COMPAZINE), nicergoline, metoclopramide, dihydroergotamine, doxycycline, prochlorperazine, sulfamethoxazole and trimethoprim (SULFAMETHOXAZOLE-TRIMETHOPRIM). The patient experienced tingling in the hands on 18Jan2021. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 51 | 2021-02-08 | numbness, facial paralysis, one side paralysis |
1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to ...
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1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to L face L arm and left leg. Presentation consistent with acute ischemic stroke. Risks and benefits discussed with the patient, who agreed to proceed with tPA. MRI brain 1/12: "Acute infarct right MCA territory predominantly involving the right parietal/insular lobes. No acute hemorrhage or midline shift." Started on aspirin 325 mg daily and rosuvastatin dose increased to 40 mg daily 24 hours post tPA. Patient reported a history of a-flutter many years ago for which she was on a beta-blocker, but the diagnosis remains unconfirmed. Tele reviewed during stay, no arrhythmias. ECHO, normal EF, NO PFO. Discharged to rehab on 1/15.
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| 51 | 2021-02-08 | migraine |
yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 10...
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yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.
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| 51 | 2021-02-08 | pain in extremity |
Pain to left underside of arm, travels from armpit down left wrist, centralizes in elbow, difficulty...
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Pain to left underside of arm, travels from armpit down left wrist, centralizes in elbow, difficulty moving left arm above head, feels like pulling sensation. Pt. tried warm compresses, showers, exercises, motrin all started on Sunday 2/7/21 with some relief. Pt. states that she has been taking one dose of motrin ever since with some relief. Pt. denies numbness and tingling in fingers.
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| 51 | 2021-02-09 | muscle spasms |
Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under ...
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Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under arms; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular in the left arm on 22Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to IV dye. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the left arm on 31Dec2020 09:30 at the age of 51 years old for COVID-19 immunization and codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 22Jan2021 10:00, the patient experienced nausea, vomiting, body aches, chills, constipation, cramping, swollen lymph nodes in neck and under arms. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
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| 51 | 2021-02-09 | pain in extremity | General fatigue Red, sore arm |
| 51 | 2021-02-09 | tingling |
Received 2nd vaccine on 2/5/21 and on 2/6/21 started having a headache. Experienced tingling and pin...
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Received 2nd vaccine on 2/5/21 and on 2/6/21 started having a headache. Experienced tingling and pinprick sensation over her entire body. Went to ER on 2/8/21.
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| 51 | 2021-02-09 | tenderness |
Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base ...
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Swelling in the area at the base of the neck on the left shoulder; swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area); Soreness/tenderness in the area near the collarbone; Soreness/tenderness in the area near the collarbone; Pain in the left armpit; Swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELI283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 18Jan2021 12:15 at single dose for covid-19 immunisation. Medical history included high blood pressure and seasonal allergies. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan potassium, naproxen sodium (ALEVE) and unspecified OTC allergy medications. There were no other vaccines received within 4 weeks prior to COVID vaccination. The patient experienced pain in the left armpit and swollen lymph node on 23Jan2021 11:30. On 24Jan2021 17:00, patient experienced swelling in the area at the base of the neck on the left shoulder, (there was a small lump in that area) and soreness/tenderness in the area near the collarbone. Patient had not recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 51 | 2021-02-10 | discomfort | Facial pressure, anxiety/adrenaline surge |
| 51 | 2021-02-10 | pain in extremity, flushing, burning sensation |
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch...
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2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-02-10 | pain in extremity |
Arm pain, Fever 102, body aches, chills, back pain, nausea/vomiting which began 3 hours following in...
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Arm pain, Fever 102, body aches, chills, back pain, nausea/vomiting which began 3 hours following injection with both injections.
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| 51 | 2021-02-10 | pain in extremity |
LT Arm Pain and swelling of arm and Lt hand , treated with hot and cold packs and pain relievers, s...
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LT Arm Pain and swelling of arm and Lt hand , treated with hot and cold packs and pain relievers, still have pain and swelling 5 weeks after shot
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| 51 | 2021-02-14 | weakness |
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t...
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Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
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| 51 | 2021-02-14 | flushing |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Other- Anxiety/Panic-Medium
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| 51 | 2021-02-14 | tingling |
Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left a...
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Patient is a 51 year old female c/o possible reaction to covid vaccine. C/o tingling of lips, left arm, hands and feet. Hives and itching. Received 1st dose of covid vaccine at 1635 today. Developed sxs 2-3 minutes after. Was given bendryl 25 mg po at 1643. Was brought by nurse. Hx of chronic urticaria, takes claritin daily with control. Hx of allergic reaction to bactrim. Has epi pen with her. Nurse brought note from Doctor, to order tryptase lab
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| 51 | 2021-02-15 | feeling cold, pain in extremity |
At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three ti...
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At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three times it's size. I couldn't move my arm for 24 hours. Arm pain was gone after 24 hours. Two days after - I was freezing cold, on the couch. Following day, I called my doctor. He told me to rest. I had a high fever and I had body aches. I was really cold. I felt like I had the flu for about a week - missed a couple days of work.
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| 51 | 2021-02-16 | weakness | Dizziness and weakness |
| 51 | 2021-02-16 | numbness |
Throat began to feel like it was closing/difficulty swallowing, numbing on left side of tongue and j...
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Throat began to feel like it was closing/difficulty swallowing, numbing on left side of tongue and jaw and left side of nose. Bad headache. At 5:53pm still feeling numbness on tongue and roof of mouth, but otherwise symptoms of subsided. Called doctor, Took 2 Benedryl (25 mg capsules).
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| 51 | 2021-02-16 | pain in extremity, tenderness |
General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of ...
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General soreness at the injection site for 48 hours. 4 days later left arm (injection) swelling of armpit lymph node. And later entire arm. Very painful, tender, sore and with restricted movement. Home medical visit Sat and Monday with Doctor. Ice/heat, liquids, Ibuprofen compression sleeve and elevation
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| 51 | 2021-02-17 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patien...
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Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 51 | 2021-02-17 | facial paralysis |
Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a cont...
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Bell's Palsy/right side of my face is completely paralyzed; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 21Jan2021 17:45 at single dose (left arm) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products and patient was not pregnant. On 23Jan2021, the patient experienced Bell's Palsy about 48 hours after receiving the vaccine. The right side of her face was completely paralyzed. The patient was treated with prednisone and valacyclovir. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.
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| 51 | 2021-02-17 | cold extremities |
Cold hands and feet; Chills; Back of the head aches; Stinging in injection arm; This is a spontaneou...
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Cold hands and feet; Chills; Back of the head aches; Stinging in injection arm; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9265, expiry date: unknown), via an unspecified route of administration in the left arm, on 28Jan2021, at single dose, for covid-19 immunization, at an urgent care center. Medical history included known allergies to seafood. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included metformin, and hydrochlorothiazide, telmisartan. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced cold hands and feet, chills, back of the head aches and stinging in injection arm on 28Jan2021. No treatment was given for the events. The patient was recovering from the events. The events were assessed as non-serious.
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| 51 | 2021-02-18 | night sweats |
After first injection, did not feel good starting about 12 hours after the injection for about 24 ho...
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After first injection, did not feel good starting about 12 hours after the injection for about 24 hours of minor chills, aches, pains and headache. After second injection, did not feel good starting about 12 hours after injection for about 24 hours with full flu like symptoms, nausea, diarrhea, heavy chills, persistent headache, strong body aches, night sweats. After 24 hours, persistent neck, shoulder and arm aches and pain on the right side (same side as injection).
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| 51 | 2021-02-19 | difficulty speaking |
Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treate...
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Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treated with OTC Benedryl, Pepcid, and Zyrtec. Had a decrease in itching and mild improvement in the rash. At about 26 hours post-vaccination itching and severe hives developed a sought treatment in the emergency department for severe hives, severe itching, throat swelling, and hoarseness in voice. Was treated with solu-medrol, Pepcid, and Benedryl. Sent home with steroids and Benedryl. Then on 2/20/2021 began to develop throat swelling and voice hoarseness again. Sought the emergency room again for the same treatment list above.
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| 51 | 2021-02-19 | nerve pain, migraine |
Initially nerve pain from left neck to left fingers lasting 12 hours. Woke up with a migraine. Have ...
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Initially nerve pain from left neck to left fingers lasting 12 hours. Woke up with a migraine. Have had nearly daily headaches or migraines ever since. Previous to vaccination I would get one or two migraines per month. I also had joint pain in joints previously affected by Lyme disease 9 years ago that hadnt bothered me since being treated. That lasted about 6 weeks and has now finally subsided.
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| 51 | 2021-02-21 | weakness, one side paralysis |
Lightheaded, dizziness. Weakness on the side of the injection. No energy and shortness of breath wit...
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Lightheaded, dizziness. Weakness on the side of the injection. No energy and shortness of breath with activity ongoing. Patient normally very active and has not chronic conditions
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| 51 | 2021-02-21 | weakness |
Flu-like. Headache, sweats/chills, fever (100.1), tired, body aches - for 2 days Body aches/tired ...
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Flu-like. Headache, sweats/chills, fever (100.1), tired, body aches - for 2 days Body aches/tired - continuing for 1 week Tired/low energy - for 2 weeks.
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| 51 | 2021-02-21 | discomfort |
Mild discomfort; This is a spontaneous report from a contactable consumer, the patient. A 51-years-o...
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Mild discomfort; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL-1283) , via an unspecified route of administration in the left arm (at 51 years of age) on 22-JAN-2021 at 13:00 as a single dose for Covid-19 Vaccination. Medical history included hypertension and Hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, losartan potassium (HYZAAR). The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 22Jan2021 at 14:30, the patient experienced mild discomfort. No treatment was given for the event. The clinical outcome of the event mild discomfort was unknown.
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| 51 | 2021-02-21 | flushing | The day after felt very fluish. Very fatigued and had swollen lymph node above right collar bone. |
| 51 | 2021-02-21 | migraine, pain in extremity, numbness |
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th...
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Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
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| 51 | 2021-02-21 | tingling |
Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO wi...
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Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO with water, monitored closely for 1 hr. Instructed per Dr. not to have the second dose administered and to discuss with her physician. Symptoms subsided and pt sent home.
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| 51 | 2021-02-22 | flushing, feeling hot |
Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensatio...
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Left arm 1st dose given at 12:39 pm. 15 mins post vaccination, patient began having a warms sensation on her left shoulder blade followed by itching in her extremities. She was brought to observation and reported urticaria all over, flushing of the face, and hives in her upper and lower extremities. Vitals taken and were stable. Benadryl 50mg was administered 15 mins post vaccination and immediately patient reported decreasing symptoms of warmth sensation, itching, and hives. Patient reports she has recently developed hives with cortisone injections. Patient examined 20 mins post vaccination: S1,S2, CTA, hives noted on bilateral UE and LE. Hives resolved 25 mins post vaccination. Patient monitored for over 45mins and reported her symptoms were mild. She declined transportation to the ER. She left in stable condition with her husband.
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| 51 | 2021-02-23 | feeling hot | Splitting headaches, extreme fatigue, nausea, feeling hot without fevers, joint and muscle aches. |
| 51 | 2021-02-23 | tingling, pain in extremity |
Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy ...
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Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy body, tingling sensitive scalp, stiff neck. Two days after vaccine: rash and swollen lymph nodes behind and in front of ear, in a line down neck, and at collarbone. Rash on one side of body only, in a band from the back of neck, across ear, down side of jaw and neck to collarbone. Slight pain and sensitivity in entire arm where I received the vaccine, which is the same side of body as rash. Three days after vaccine: rash continues, some blisters erupt. Four days after vaccine: rash is worse, tingling and burning, painful welts;visited clinic and diagnosed with shingles and prescribed topical medications.
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| 51 | 2021-02-23 | tingling |
Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting are...
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Pt received dose #1 of Pfizer vaccine at 12:48 PM. After about 10-12 min wait period in waiting area, c/o feeling "whoozy", a metallic taste in mouth and tingling of mouth. A short time later, reports that symptoms are worsening. Walked with stand by assist of two to cot. BP elevated, other VSS. C/o feeling "whoozy", middle tongue feeling swollen, metallic taste in mouth, mouth feeling numb/tingling. Symptoms progressed to rest of body feeling "tingling". Denies dizziness. Symptoms progressing. Denies SOB, itchy throat or throat swelling sensation. Denies any itching of skin. No hives or rash noted. Due to worsening of symptoms, a First Responder was called at 2:01 PM for transport, monitoring and treatment in ED.
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| 51 | 2021-02-24 | weakness |
1 hour past 2nd shot, I felt fatigue, dizziness, brain fog and mild nausea. Possibly 12 hours past ...
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1 hour past 2nd shot, I felt fatigue, dizziness, brain fog and mild nausea. Possibly 12 hours past the shot, I awoke with a massive headache, achy joints & muscles from head to toe, chills, sweating, congestion, sore throat, increased dizziness and weakness. This was similar, but not as severe, as the onset of Covid-19 symptoms I experienced on January 5, 2021. 30 hours past the 2nd shot, I am still experiencing aches, pains, dizziness, fatigue, and a headache I cannot alleviate with Ibuprofen.
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| 51 | 2021-02-24 | hot flush |
First Fever, body aches, joint pain. Second Fever, head ache, body aches, joint pain, hot flashes an...
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First Fever, body aches, joint pain. Second Fever, head ache, body aches, joint pain, hot flashes and has missed work for 3 weeks.
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| 51 | 2021-02-25 | numbness |
had great amount of weakness to left leg that began evening of receiving vaccine dose. i also felt w...
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had great amount of weakness to left leg that began evening of receiving vaccine dose. i also felt weak, but left leg was extremely weak and just could not get much feeling in my leg.. also left foot numbness as well. headache increased over course of the evening and into the next morning. i alternated tylenol and advil to try and help with the headache beginning evening of receiving dose. by next morning i decided to take vicodin to help get the headache under control. i then began with vomiting late am on 2/06. had chills, headache continued, and headahce persisted. i also had very large amount of nausea that lasted until mid to late morning of 2/07. vomiting saturday am, afternoon, and evening. unable to keep any food or liquid down at all. swallowed 3 sips of gingerale saturday pm, and vomited within 5 minutes of it. feeling to my leg gradually returned to normal on saturday (vaccine was friday). i'm doing report mostly because of the left leg symptoms and vomiting. not sure if this should be reported, so i am just reporting it.
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| 51 | 2021-02-25 | pain in extremity |
Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea...
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Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea; Slight headache; Right arm injection muscular pain radiating to elbow; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscular at right arm on 25Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included HTN, cholesterol, known allergies: sulfa. Historical vaccine included the first dose of BNT162B2 (lot number=EJ1686) on 04Jan2021 13:00 via intramuscular at left arm for COVID-19 immunization. Concomitant medication included amlodipine, rosuvastatin calcium (CRESTOR), clonazepam. On 26Jan2021 12:00, patient had body aches, joint pains, chills, right arm injection muscular pain radiating to elbow, slight nausea, slight headache with outcome of unknown. No treatment was received. The patient underwent lab tests included COVID-19 virus test (nasal swab): negative on 10Jan2021. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination.
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| 51 | 2021-02-25 | tingling, numbness |
About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient w...
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About 15 min after administration, patient started c/o numbness/tingling in chin and lips. Patient was given oral diphenhydramine 50mg and notified EMS. When EMS arrived about 15 min later, patient initially declined to go to ER for eval. About another 15 min later, patient returned to clinic as face and chin were starting to swell slightly. Re-notifed EMS and the returned and picked up the patient. Patient left in awake condition, no respiratory distress.
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| 51 | 2021-02-26 | feeling cold, tremor |
About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I st...
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About 10 min after the in jection I started to feel nausea with a metal taste in my mouth. Then I stared to get a headache and tremors in my hands and arms. After another 5 min I was getting mussel tightness in my face and throte. I started to get dizzy and feel very cold.
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| 51 | 2021-02-26 | flushing |
20 minutes status post vaccination while sitting in the observation area the patient indicated to th...
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20 minutes status post vaccination while sitting in the observation area the patient indicated to the RN nurse observer that she "felt her face was flushed". Pt was seen and evaluated by NP, a redness was observed on patients bilateral cheeks and forehead. Pt was negative for chest pain, SOB, Facial Swelling, or N/V. There was no rash noted vital signs were taken, Patient was treated with 50mg of oral diphenhydramine, EMS was activated, pt was able to ambulate out of the vaccination center under the care of EMS and was transfered to the Hospital for further evaluation.
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| 51 | 2021-02-27 | feeling hot, flushing |
Headache -fatigue felt hot and flushed Body ache Chills Lasted 24 hours- came on evening after sh...
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Headache -fatigue felt hot and flushed Body ache Chills Lasted 24 hours- came on evening after shot
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| 51 | 2021-02-27 | tremor |
Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after...
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Elevated blood sugar levels beginning 6 hours after injection; Diarrhea multiple times 5 hours after injection; Fever of up to 102.5 starting 12 hrs after injection; Chills and shaking starting 12 hrs after injection; Very swollen and tender lymph node above clavicle noticed approximately 42 hours after injection; Muscle and joint pain
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| 51 | 2021-02-28 | facial pain |
3 days of body pain; muscle aches all over body and face; muscle aches all over body and face; other...
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3 days of body pain; muscle aches all over body and face; muscle aches all over body and face; other vaccine same date; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 22Jan2021 at 09:00 (at the age of 51-years-old) as a single dose in the left arm for COVID-19. The patient had no medical history. She was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not take any concomitant medications. The patient received another unspecified vaccine on 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously took penicillin from an unspecified date for an unspecified indication and experienced allergy. On 23Jan2021 at 06:00, the patient experienced 3 days of body pain and muscle aches all over body and face. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of 3 days of body pain and muscle aches all over body and face was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.
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| 51 | 2021-02-28 | facial pain |
~approximately 30 min after vaccination received a funny feeling in my head not quite like a headach...
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~approximately 30 min after vaccination received a funny feeling in my head not quite like a headache and pain around my nose and between my eyes which lasted about 5 minutes followed by ear popping which ceased after about 5 minutes followed by ear pain for about 15 minutes
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| 51 | 2021-02-28 | muscle spasms |
Within 15 minutes of shot, itching and muscle pain. Within 45 minutes of shot muscle cramping in ex...
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Within 15 minutes of shot, itching and muscle pain. Within 45 minutes of shot muscle cramping in extremities. Had taken 2 benadryl to ward off allergic reaction. That evening these symptoms continued and fatigue as well as low mood occurred. Next morning, right flank over the kidney pain-all day. Muscle pain- all day. Fatigued. Sunday, severe vertigo that lasted for several hours. Remitted for 5 hours and then returned. Dr. and Neurologist contacted.
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| 51 | 2021-02-28 | pain in extremity, feeling cold |
Side effects included chills for nearly 15 hours, extremely sore back, especially lower back, inject...
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Side effects included chills for nearly 15 hours, extremely sore back, especially lower back, injection site soreness of muscle area and back of legs were very sore. It was uncomfortable to walk. Could not get warm until I went to bed and wore fleece and used a down comforter and a fleece blanket. Laid on a heating pad to help ease the back pain. When I got up the following morning, all side effects were gone and nothing hurt. Also, I had Covid at the end of November, beginning of December 2020. I will not be getting the second vaccination - do not trust what is "not known". The side effects were worse than my experience with Covid.
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| 51 | 2021-02-28 | pain in extremity |
Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm, ...
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Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm, low grade fever and earache right side only.
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| 51 | 2021-02-28 | pain in extremity |
Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Numb...
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Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Number 2, Date of start of drug 21Jan2021/ Dose Number 1, Date of start of drug 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 51-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on the left arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: unknown) in the left arm on 29Dec2020 at 15:00 (3:00PM) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 04:00, the patient experienced stomach cramps and arm soreness for two days. On the same day, the patient experienced severe vertigo with nausea and was unable to get up or walk. The following day, 24Jan2021, vertigo was slightly less. On the fifth day, the patient was still having some dizziness and nausea. No treatment was administered for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events stomach cramps and arm soreness resolved in 25Jan2021, and the events nausea, unable to get up or walk and dizziness had not resolved, while the event severe vertigo was resolving.
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| 51 | 2021-02-28 | pain in extremity |
Vaccination given in the joint of Left shoulder (Top of shoulder). Not Deltoid Muscle as recorded....
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Vaccination given in the joint of Left shoulder (Top of shoulder). Not Deltoid Muscle as recorded. Although I did not see the location of the vaccination given at that time, the location of the bandage indicated site of vaccination given. Pain in Left arm was excruciating for 3 days. Ice packs and Tylenol was taken but did not help. Pain continues since vaccination was given. Spoke to nurses and physicians since the incident occurred, and all sources has stated that vaccination should not have been given in the joint but in the muscle. I am reporting this so nurse can be corrected so that she does not cause unnecessary pain and trauma to other people.
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| 51 | 2021-03-01 | feeling hot | treatment - benadryl, hydration, rest, monitoring vitals at home |
| 51 | 2021-03-01 | hot flush, feeling cold |
Fever chills fatigue and ongoing hot flashes and cold spells where I cannot get warm. Temperature sw...
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Fever chills fatigue and ongoing hot flashes and cold spells where I cannot get warm. Temperature swings are terrible for over 3 weeks since the second vaccine
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| 51 | 2021-03-02 | burning sensation |
After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. Howev...
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After the first dose for the Pfizer, I experienced a metal like taste in mouth, shortly after. However, that went away within an hour. I had the typical low side effects of localized injection soreness, swelling, redness, warmth feeling and it was red around the injection site. The following two days after vaccination (2/22/21) I experienced the expected low side effects. On the third day after vaccination, I was feeling well again. However, yesterday 3/2/21, I noticed the area where I received the Covid vaccine was red again, with itching, warmth feeling, redness, and a bit of burning sensation. This is only apparent on the injection site. I contacted the CDC today, 3/3/21 and they directed me to you to report this and also to contact my healthcare provider, which I have. The CDC was not able to tell me if it was considered normal to have the localized injection site side effects resurface again a week after receiving the 1st dose vaccine. Therefore, I was advised by the CDC to report it. It is also unclear to me if the reason for the localized injection site side-effects being more prominent because of where the injection was administered. There is a question about it having been administered closer to subcutaneously by the nurse than intramuscular, but I do not know.
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| 51 | 2021-03-02 | discomfort |
Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever c...
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Nausea vomiting diarrhea severe headache unable to eat so far for 3 Days cannot lift my head fever chills. Severe internal ear pain and headache but it's not touched by Tylenol or Ibuprofen
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| 51 | 2021-03-02 | hot flush, feeling cold |
low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore ...
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low grade fever 101 highest; hot/cold flashes; hot/cold flashes; exhausted; overall body achy; sore arm at/around injection site; This is a spontaneous report from a contactable consumer. A 51-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN 5318), via an unspecified route of administration at Left arm on 16Feb2021 08:45 at single dose for covid-19 immunisation. The patient medical history was not reported. Allergies to medications, food, or other products: none. Prior to vaccination, was the patient was not diagnosed with COVID-19. Concomitant medication included naproxen sodium (ALEVE) and multi vitamins. The patient previously received first dose of bnt162b2 on 26Jan2021 for covid-19 immunisation. The patient experienced low grade fever 101 highest, hot/cold flashes, exhausted, overall body achy, sore arm at/around injection site on 16Feb2021 12:30. No treatment received for the events. Outcome of events was recovering.
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| 51 | 2021-03-02 | migraine |
In the early evening after my second Covid vaccine I began to have moderate body aches, fatigue, inj...
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In the early evening after my second Covid vaccine I began to have moderate body aches, fatigue, injection site swelling and headaches. Some of my headaches developed into migraines. The body aches lasted about 14 hours but the headaches persisted for almost two weeks before resolving.
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| 51 | 2021-03-02 | pain in extremity |
Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a ...
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Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264, expiration date was not reported), via an unspecified route of administration on the left arm on 30Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Sulfa allergy, penicillin allergy, COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol. The patient experienced fever over 100, headache, chills, joint soreness and arm soreness on 31Jan2021 at 04:00 am. No treatment was given in response to the events. Outcome of the events was unknown.
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| 51 | 2021-03-02 | pain in extremity |
I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administratio...
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I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; left arm soreness onset evening of vaccine for about 1.5 days; This is a spontaneous report from a contactable nurse (also the patient). A 51-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration at the left arm on 07Jan2021 14:40 (also reported as 02:45 PM) at SINGLE DOSE for Covid-19 immunization. The patient was vaccinated at a Hospital. The patient is not pregnant at the time of the report. Medical history included Environmental allergies: some trees and grass (also reported as Known allergies: No). The patient had no COVID prior to vaccination. Th patient was not COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication included (reported as Other medications in two weeks) bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VITAMIN D NOS) and MVM (exact meaning unspecified). It was reported that: "Administration time on my paperwork was documented incorrectly; I received 07Jan2021 dose at 2:40pm and not the 1:40pm time that is documented. I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration (reported as 5:30 PM), lasting about 2 hours and resolved; left arm soreness onset evening of vaccine for about 1.5 days." The patient was not treated for the events. The outcome of the events was recovered.
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| 51 | 2021-03-02 | pain in extremity |
Left arm soreness; This is a spontaneous report from a contactable nurse (reporting for herself). A ...
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Left arm soreness; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for covid-19 immunization. The patient's medical history included Environmental allergies: some trees and grass. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), colecalciferol (VITAMIN D [COLECALCIFEROL]), all for unspecified indication. The previously took her first dose of bnt162b2 on 07Jan2021 (lot number: EL3248) on her left arm for covid-19 immunization. On 28Jan2021 at 17:30, the patient experienced Left arm soreness beginning a few hours after vaccine administration and lasting about another 24 hours. The outcome of the event was recovered on an unspecified date. The seriousness of the event was reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
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| 51 | 2021-03-02 | pain in extremity |
just a sore arm starting approx 6 hours after injection; This is a spontaneous report from a contact...
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just a sore arm starting approx 6 hours after injection; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3249; expiration date: unknown) at vaccination age of 51-year-old intramuscular in the right arm on 15Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included high blood pressure, and allergies to penicillin and sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included unspecified medication. The patient received her most recent COVID-19 in a public health clinic/veterans administration facility. The patient reported that she did no adverse events, she was just a sore arm starting approximately 6 hours after injection (15Jan2021) and lasting about 24 hours (16Jan2021). The event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on 16Jan2021. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
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| 51 | 2021-03-03 | numbness, weakness | Feeling of weakness, numbness around fingers and mouth, nausea. |
| 51 | 2021-03-03 | migraine | See previous answers. |
| 51 | 2021-03-03 | migraine | Migraine, vomiting, intense injection arm pain ( unable to lift arm), joint pain, diarrhea |
| 51 | 2021-03-03 | migraine |
Would consider myself someone extremely healthy without any disease. My symptoms included intermitte...
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Would consider myself someone extremely healthy without any disease. My symptoms included intermittent migraines with rainbow halo around lights for two weeks, myalgia that I have never experienced. Vaginal breakthrough bleeding with period ( have IUD placement x2 years and haven't had bleeding since). In addition I experienced the normal fever, malaise and fatigue for the first three days following but wanted to report the extended symptoms that continued. Feel great now and am thankful, but thought it would be useful for research purpose.
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| 51 | 2021-03-03 | nerve pain, numbness, pain in extremity |
Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular siz...
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Numbness in fingers and hands, arms, legs, and feet. Right leg swollen. Knee 3 times the regular size. Throbbing in feet and swollen, stiffness can't hardly bend right knee. Made my neuropathy worse. Head aches more, blurry vision, light sensitive, body aches, backache, coughing.
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| 51 | 2021-03-03 | pain in extremity | lower back pain, fatigue, flu-like symptoms, arm pain |
| 51 | 2021-03-04 | pain in extremity | Sore arm, temp 99.9, headache, fatigue, dizzy, HTN, sweats, chest pain |
| 51 | 2021-03-04 | seizure | Loss of failing left side stroke like symptoms with seizures |
| 51 | 2021-03-04 | tremor |
Patient received vaccine, reports that she had "chills, shakey, trembling, difficulty thinking, brea...
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Patient received vaccine, reports that she had "chills, shakey, trembling, difficulty thinking, breathing fast"
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| 51 | 2021-03-05 | bell's palsy |
On March 4 the patient noticed the L side of her face sagging and thought it might be a stroke. She ...
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On March 4 the patient noticed the L side of her face sagging and thought it might be a stroke. She went to Urgent Care and was diagnosed with Bell's Palsy. She is currently being treated with Prednisone 60mg/day and Valcyclovir 1gr tid. She returned to the Vaccine POD with parents to inquire about the next vaccine. She has a neurologist whom she will see and discuss the issue
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| 51 | 2021-03-05 | cold sweat, feeling hot |
Patient slowly lost consciousness and dropped out of her chair to the floor. She appeared clammy and...
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Patient slowly lost consciousness and dropped out of her chair to the floor. She appeared clammy and was not responsive for about a minute. After that time, the patient came back to consciousness and was able to articulate her symptoms, She felt warm for a few minutes and was brought an ice pack to cool down.
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| 51 | 2021-03-06 | flushing |
Once I sat down about 4 minutes after the shot my heart started racing very rapidly. I became very ...
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Once I sat down about 4 minutes after the shot my heart started racing very rapidly. I became very light headed and my face was flushed. It took about 10 minutes of trying to force myself from panicking ( I do not get panic attacks). There were too many other people in the waiting room so I didn't feel like I could discretely tell the nurse about my reaction. I felt light headed the rest of the day. About 5 days later, I was sitting in the chair at my salon and it happened again. Racing heart rate and all the same cardiac symptoms as before. I do not have high blood pressure or any cardiac illness. I also had a heaviness, congested feeling in my chest for about 2 weeks. I had another issue with very rapid heart rate for most of the day over the last two days.
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| 51 | 2021-03-06 | tingling |
tingling on hands/feet/arms/legs for the past 7 days(everyday, all days) after 4th day from the ino...
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tingling on hands/feet/arms/legs for the past 7 days(everyday, all days) after 4th day from the inoculated date
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| 51 | 2021-03-07 | feeling cold, night sweats |
dizzy; nauseous; sweating and sweated all night; fever of 99; achy; feeling cold/freezing; chills; T...
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dizzy; nauseous; sweating and sweated all night; fever of 99; achy; feeling cold/freezing; chills; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 51-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration on the left arm, on 03Feb2021 15:00, at single dose, for covid-19 immunization. Medical history included high blood pressure and, diagnosed with COVID-19. The patient has unspecified concomitant medications. The vaccine was received at the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 04Feb2021 around 12NN, the patient started feeling cold and chills. By 17:00 on 04Feb2021, she had fever of 99 and was freezing and achy. Around 20:00 on 04Feb2021, she started sweating and sweated all night. She felt better on 05Feb2021 around 14:00. On 06Feb2021 she got up, and then was dizzy and nauseous. At the time of the report, the patient was recovering from all the adverse events with no treatment received. The patient has not been tested for COVID-19 since the vaccination.
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| 51 | 2021-03-07 | tingling, numbness |
I stayed 30 min after injection because I receive allergy shots. (Grass, pollen, dust, mold) approxi...
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I stayed 30 min after injection because I receive allergy shots. (Grass, pollen, dust, mold) approximately 10-15 min after leaving I experienced numbness/tingling on the right side of my face. It lasted approximately 1 hr I would say.
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| 51 | 2021-03-07 | tremor | Very sudden on set extremely bad headache and shaking. |
| 51 | 2021-03-08 | difficulty speaking |
Approximately 5 hours after the second shot (EN6205) on March 5, 2021, I experienced full body aches...
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Approximately 5 hours after the second shot (EN6205) on March 5, 2021, I experienced full body aches, slight tingling on the tongue, and eventual loss of voice over the subsequent two days. The on duty nurse who had administered the shot, strongly suggest that I drink lots of water and take Tylenol. March 6 and 7, my voice was to a whisper; however, the body aches and tingling of the tongue had subsided. I was extremely exhausted and unable to speak above a whisper on March 8, but did not experience any of the aforementioned side affects. Today, March 9, my voice is back above a whisper, with intermittent hoarseness. I will continue regiments of rest, Tylenol, hot tea with crushed ginger. It is important to note that my breathing had not been affected since having taken the 2nd shot on March 5, 2021.
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| 51 | 2021-03-08 | feeling hot |
Patient felt hot once sat down at bleachers, became sweaty and queasy. 15 minutes passed. Patient fe...
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Patient felt hot once sat down at bleachers, became sweaty and queasy. 15 minutes passed. Patient felt better then stood up and became hot and queasy again.
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| 51 | 2021-03-08 | feeling jittery |
The patient reports nausea and vomiting with a jittery feeling. Patients B/P was 132/73, HR was 83,...
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The patient reports nausea and vomiting with a jittery feeling. Patients B/P was 132/73, HR was 83, RR WAS 18. Patient denies any difficulty breathing. The patient is awake and alert with no apparent distress.
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| 51 | 2021-03-08 | flushing | flushing, lip numbness/tingling, lightheaded, HA. Evaluated by EMS-Cleared |
| 51 | 2021-03-08 | numbness |
Nausea, oral tingling, dizziness, leg/oral numbness. Evaluated by EMS-Transported to Emergency room/...
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Nausea, oral tingling, dizziness, leg/oral numbness. Evaluated by EMS-Transported to Emergency room/department or urgent care.
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| 51 | 2021-03-08 | muscle spasms, weakness |
first night had strange vivid dreams, extremely fatigued/sleepy, muscle aces all over, joint pains a...
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first night had strange vivid dreams, extremely fatigued/sleepy, muscle aces all over, joint pains all over (arthritis is only in a few joints), runny nose, sore throat. 2nd day felt better but still very sleepy, fatigued, muscle cramping. 3rd day still extremely sleepy, muscle soreness, joint pain. 4th day fatigue, weakness, nausea.
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| 51 | 2021-03-09 | cold sweat, tremor, pain in extremity, feeling of body temperature change |
Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with...
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Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with being tired then led to extreme exhaustion and lethargy and loss of taste (salty and sweet), but had an appetite and drank a LOT of water, taking Tylenol around 6 pm; slept restless and in pain with fever and feeling both burning up and freezing cold with clammy chills. Couldn't settle. Approximately 3:30 am, had diarrhea until I had nothing in my system and developed uncontrollable shaking. Finally got some sleep after a hot bath. The next day, no appetite, drank little water and kombucha to settle my stomach, exhausted, feverish, napped off and on all day, right arm began hurting tremendously and right side including jaw and tongue felt swollen, took Tylenol in the morning and BC Powder pm before bed. Slept moderately well. Monday, napped off and on but started feeling better with only moderate exhaustion around 6 pm, but right arm was in pain. Tuesday, moderate exhaustion, had to nap for 2 hours mid-day, right side of body including tongue was swollen, arm in pain and entire upper arm muscle felt knotted. Went for a massage and worked out knot quite painfully. Today, moderate to mild exhaustion, upper right arm a bit sore, semi- decent appetite.
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| 51 | 2021-03-09 | numbness, tingling | Left side facial numbness ,tingling and discomfort also feeling woozy |
| 51 | 2021-03-09 | numbness |
Itching began on 3/6, followed by pustules extending from left shoulder to elbow. Pustules started s...
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Itching began on 3/6, followed by pustules extending from left shoulder to elbow. Pustules started small and are now much larger. Right sided facial numbness.
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| 51 | 2021-03-09 | pain in extremity, numbness |
left arm soreness - like inside, like the bones are dying or festering - very hard to describe (at l...
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left arm soreness - like inside, like the bones are dying or festering - very hard to describe (at least 21 days as it's never changed nor gone away since starting the day of the injection); whole body joint pain for at least 3 full days (couldn't walk at normal pace or grip chopsticks etc), fatigue for maybe 6/7 days (in bed 10-14 hours barely able to move, but awake and alert so not sleepy per se), muscle numbness in left arm for 2 days.
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| 51 | 2021-03-09 | pain in extremity |
1st day just sore arm. 2nd day just felt off, 3rd day mild headache chills, 4th day sever headache, ...
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1st day just sore arm. 2nd day just felt off, 3rd day mild headache chills, 4th day sever headache, vomitting, nausea, stiff neck and shoulders.
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| 51 | 2021-03-09 | pain in extremity |
One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I ...
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One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I got in bed at 10pm, all of my muscles began hurting really badly, and I was awake most of the night, feeling sick with nausea, dry mouth, and pain all over. The next day I felt really wrecked, way worse than my usual Fibromyalgia/Anxiety symptoms. My body really hurt all over and I was really fatigued. I felt general malaise all day long and my left arm hurt a lot. That second night I slept better and the next day I was better except my left arm was still sore that day also.
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| 51 | 2021-03-10 | breast pain |
"I had to go to the doctor office due to sensitivity, soreness in the right armpit and tenderness in...
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"I had to go to the doctor office due to sensitivity, soreness in the right armpit and tenderness in both breasts after receiving the first shot. This occurred approximately 3 days after the first inoculation and continued for 10+ days with the breast tenderness continuing to be an issue. The second shot was extreme fatigue for 2 days, and the continuing breast soreness."
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| 51 | 2021-03-10 | breast pain | Fatigue and breast soreness |
| 51 | 2021-03-10 | flushing |
Pt was given Pfizer COVID-19 vaccine #1 at approx. 0830. Shortly after pt experienced flushing, shor...
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Pt was given Pfizer COVID-19 vaccine #1 at approx. 0830. Shortly after pt experienced flushing, shortness of breath, and chest tightness. Pt was given benadryl and EpiPen at approx. 0930. Pt was referred to Hospital ER where she is presently being monitored.
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| 51 | 2021-03-10 | numbness |
At 1615 Patient reported symptoms after coivd19 vaccine Pfizer 2nd dose. With left arm rash, warm to...
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At 1615 Patient reported symptoms after coivd19 vaccine Pfizer 2nd dose. With left arm rash, warm to touch and numbness. Same symptoms were reported by patient after receiving the first dose coivd19 vaccine Pfizer. Adverse reactions were reported to Dr. and RN. for further medical intervention As per Dr. orders, Benadryl 25 mg IM.
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| 51 | 2021-03-11 | bell's palsy |
Bell's palsy of right face - slight symptoms occurring 2 days after vaccination and worsened until n...
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Bell's palsy of right face - slight symptoms occurring 2 days after vaccination and worsened until noticed and taken to local ED 5 days after vaccination.
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| 51 | 2021-03-11 | tingling |
Patient came in for first COVID vaccine. Given at 0942 on left deltoid. At 0957, patient complaint o...
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Patient came in for first COVID vaccine. Given at 0942 on left deltoid. At 0957, patient complaint of having a headache and tingling to her body. Headache pain at 4/10. Denied any dizziness. Was awake, alert and oriented.
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| 51 | 2021-03-12 | feeling cold |
At 8pm 3/11/21 I was very tired and cold. (different than chills from a fever). Did not feel feveris...
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At 8pm 3/11/21 I was very tired and cold. (different than chills from a fever). Did not feel feverish. At 4am 3/12/21 I woke up with severe muscular pain in my entire body and severe head pain. I took 2 Advil and went back to sleep. Woke up at 8:00am 3/12/21 with severe back ache and headache. Took 3 Advil and pain subsided over the next 3 hours. Did not have to redose Advil.
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| 51 | 2021-03-12 | flushing |
Patient received vaccine and1 minute after patient had a warm flushing sensation that she described ...
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Patient received vaccine and1 minute after patient had a warm flushing sensation that she described as being similar to getting contrast. She stated that the back of her throat was warm and the tip of her tongue as well, she was remvoed from the cell and brought to the observation area, her blood pressure was 173/87, heart rate 109, pulse ox 98 in the L arm. She was observed and follow up at 0906 was 174/96, pulse 99 and pulse ox 100. She was observed for another minutes and at 0920 in the R arm her blood pressure was 152/ 85 and heart rate 101. She stated that the warm feeling was resolving and that her tongue still felt a little warm. She did have reddened arms as well in her bilateral arms, no other skin changes noted.
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| 51 | 2021-03-12 | flushing | Elevated HR, Flushing. Evaluated by EMS-Cleared |
| 51 | 2021-03-13 | pain in extremity, inability to speak |
Im not sure if this is an adverse effect - But here are the sxs I felt - after my shot - when i was ...
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Im not sure if this is an adverse effect - But here are the sxs I felt - after my shot - when i was sitting in the waiting area for the mandatory waiting period of 15 or so minutes - I felt a slight pain in my left arm, a slight pain in my left chest area, and a slight pain in my left back area. I came home and felt a brain fog. I was forgetful, and very slow, I could feel a part of me being acutely aware that I was struggling to process information that I processed before normally. I was very irritable more so than I have experienced before, and that lasted approximately days till March 17th. The brain fog dissipated slowly over 24 hrs, Blood Pressure on March 11th ( fourth day) was 143/80 - 69 beats per minute at 6:15 pm and 155/88 - 75 BPM at 8:14 pm. Blood pressure reading on March 12th 155/105 - 71 bpm at 5:31 pm. and 142/98 - 80 BPM at noon . The pain in the chest and arm area existed, for a few more days and is intermittent in the last few days. Today 3/13/21 i felt it when i was bending to push and pushing potted plants around. But that was the only time. Today's BP reading was 139/85 - 88 BPM at 6:15 pm. I am concerned if I should take the second dose or not. If this is normal and Im ok to take the second dose please email me either way. I just want to ensure that this is not an adverse cardiological side effect and wanted to check in . Thankyou
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| 51 | 2021-03-14 | flushing, tremor |
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T...
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Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
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| 51 | 2021-03-14 | migraine, burning sensation |
Extreme Headache, Rash on lower portion of both arms, felt like my skin was on fire from the inside ...
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Extreme Headache, Rash on lower portion of both arms, felt like my skin was on fire from the inside out on my face, neck and arms, extreme fatigue, chills. Lasted for a week. Longer Effects, extreme fatigue and brain fogginess ( it's now March 15th, I am still having these effects)
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| 51 | 2021-03-14 | muscle spasms |
Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 ...
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Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 hrs, leg cramps began maybe a couple of days later and still continue over a month later, high fever lasting 3 days
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| 51 | 2021-03-14 | pain in extremity | Fatigue, headache, and soreness in the arm, back, and leg shortly after administration of vaccine |
| 51 | 2021-03-14 | pain in extremity |
swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This...
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swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This is a spontaneous report from a contactable consumer reported for herself that a 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 51-years via an unspecified route of administration in left arm on 24Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure; fibromyalgia; kidney stones. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included paracetamol (TYLENOL ARTHRITIS); enalapril; amlodipine; hydrochl (as reported). The patient historically received first single dose of BNT162B2 at the age of 51-years via an unspecified route of administration in left arm on 03Feb2021 03:00 PM for COVID-19 immunization. On 26Feb2021 06:00 AM, the patient experienced swollen lymph node under left arm causing pain. It was unknown if treatment was received for the adverse events. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 51 | 2021-03-14 | pain in extremity | After the first 24 hrs, arm was sore for 48 hours, score of a 7 |
| 51 | 2021-03-14 | tingling |
10-hours after vaccination, I experienced an inability to swallow, tingling sensation in face; lips...
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10-hours after vaccination, I experienced an inability to swallow, tingling sensation in face; lips began to feel swollen, chills. Took a Zyrtec and symptoms went away within an hour.
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| 51 | 2021-03-15 | weakness |
Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5...
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Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5 -10 minutes resolved . Weakness within 20 minutes and dizziness later that night into next day . Itchy injection site at night .
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| 51 | 2021-03-15 | burning sensation |
3 Hours after vaccination, I experienced swelling around my Left ear and Left Lower Jaw with a burni...
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3 Hours after vaccination, I experienced swelling around my Left ear and Left Lower Jaw with a burning sensation. The burning stopped with the fir dose of Benadryl 25mg (which I took every 8 hours for 3 additional doses) The swelling eventually decreased after 3-4 days.
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| 51 | 2021-03-15 | hot flush |
After vaccine on 2/25/2021 had standard chills, aching lasting 2 days. 2 days after vaccination st...
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After vaccine on 2/25/2021 had standard chills, aching lasting 2 days. 2 days after vaccination started to develop pimples to chin (painful) and hot flashes which were intense but have since decreased in severity.
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| 51 | 2021-03-15 | pain in extremity |
At the time of my vaccine, the nurse asked me if I experienced any pain at the site and happened to ...
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At the time of my vaccine, the nurse asked me if I experienced any pain at the site and happened to mention that the needle being used did not retract from my arm. I did not experience any pain in that moment. Later in the evening, I begun to experience muscle pain at the site of the vaccination but believed it was due to the shot. It has now been about a week and a half and pain is now in my shoulder and has traveled down my arm.
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| 51 | 2021-03-15 | tingling, numbness |
about 45 min after shot, face began tingling and then felt numb. numbness continued for about 24 hou...
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about 45 min after shot, face began tingling and then felt numb. numbness continued for about 24 hoursn
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| 51 | 2021-03-15 | tingling, numbness | Face became numb and tingling. It lasted about an hour then went away on it's own |
| 51 | 2021-03-15 | tingling |
Patient complained of chest pain radiating to her L shoulder starting at 1620. Patient moved to den...
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Patient complained of chest pain radiating to her L shoulder starting at 1620. Patient moved to dental chair, Dr called and vitals taken at 16:30 was O2 92%, BP 142/91. 16:38 pt complains of slightly improved CP and but tingling in both arms and hands, O2 remains 92-98%. EMS called at 16:40. Aspirin 325mg chewed given 16:50. Pt declined ambulance ride to ER but agrees to go to ER with daughter immediately for further assessment.
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| 51 | 2021-03-15 | tingling |
Patient complains of Lt. hand tingling after the vaccination. it was resolved after 20mins. pt. le...
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Patient complains of Lt. hand tingling after the vaccination. it was resolved after 20mins. pt. left and went home.
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| 51 | 2021-03-16 | feeling hot |
After injection, immediately felt warm squeezy feeling and pain going up to my neck and going to my ...
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After injection, immediately felt warm squeezy feeling and pain going up to my neck and going to my head and giving me a headache. It eased up. About an hour later, I was getting itchy - arms; legs. Big welts on arms and legs and one my back. I took Benadryl hoping it would go away - took it for three days. It wasn't going away. I would scratch and every time I would scratch then hives would spread throughout the whole area that I scratched. Called my Dr's office - he told me to take Benadryl. By Saturday, I went to clinic. Was given steroid pills and prescription for Claritin or Zyrtec. No testing. The meds helped with the smaller hives but my welts still remained and by rubbing the welts I would still get hives around it and they get re-inflamed and they swell up - even it it's my clothes that rub against it. Still have dry patches but they are a little raised but as much as before. I was told to put some cortisone cream on them to help them go away. I was advised not to get second shot.
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| 51 | 2021-03-16 | flushing |
Pt in COVID-19 observation area complained of loosing strength to arms and legs and flushed color. ...
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Pt in COVID-19 observation area complained of loosing strength to arms and legs and flushed color. Warm and dry to touch. B/P @ 182/62 HR-121 Alert and oriented. Code Assist called. Pt was given Benadryl 25mg IM by Code Assist Team. Pt was taken to Adult W.I. Clinic to Continue of care.
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| 51 | 2021-03-16 | migraine, weakness |
Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6...
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Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6:30pm I began to feel extremely wired and like my body would jump through my skin. I tried to relax and started feeling sick at the stomach. I went to bed early. 3/12/21 at 6:15am I was awakened with heart racing extremely fast and migraine starting at base of back of head. I could not get my heart to slow down. My husband called 911. Paramedics came and my blood pressure was 163/116 and heart rate 85. 10 minutes later it was 157/84 and heart rate 64. (The day before vaccination my cardiologist recorded my blood pressure at 110/52 and it has always run low. ) I had no energy nor appetite and slept most of the day 3/12/21 through 3/12/14. Still feeling extremely fatigue and ears ringing and can hear heart beating in ears.
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| 51 | 2021-03-16 | migraine |
1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /mi...
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1/8-1/10/2021: prolong fever 102 1/8: vomiting 1/11-1/13: temp 101 to 99.9 1/8-1/16: headaches /migraines w/ double vision 1/11-1/16: thrush ,open fever blisters lips and mouth,+ swollen mouth, lips, tongue Treated at home w/ Tylenol q4,fluids, benadryal ,salt water mouth rinse. ice pack. Subsided 1/16/2021 . healthy prior to second vaccination
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| 51 | 2021-03-16 | migraine |
The following is the timeline of progression: First 48 hours: Immediately following the vaccine I fe...
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The following is the timeline of progression: First 48 hours: Immediately following the vaccine I felt I would vomit. That lasted 2 hours. The remainder of the 48 hours I had a growing headache that turned into a migraine level. Cognitively my husband would say I was out of it, not able to focus. The area around my eyes – my eyelids and below eyelids bright red – like I had put a bright red blush on them. Three to four days later: Saturday night my symptoms started to progress over a span of a few hours very drastically. I had symptoms of Diarrhea– crazy impact in my gut. Sunday I still had migraine level pain in a headache. I felt increased symptoms of nausea and diarrhea increased. Sunday I still had migraine level pain in a headache. I felt increased symptoms of nausea and diarrhea increased. By Sunday afternoon I had full blown symptoms of stomach flu. I had chills, extreme nausea that became debilitating. We do not have a thermometer that works, as a result I do not know if I had a fever. By Sunday night I was vomiting and symptoms progressed to tightness of chest, shortness of breath, vomiting, diarrhea, chills. My gut was literally moving in sharp pain, sounds, and cramping. It was severe diarrhea. I was achy and tired, but could not fall asleep due to nausea and vomiting. I was unable to stand up without the fear of passing out. I tried to manage the nausea with medicine that I have at home. It assisted but did not ultimate make an impact. By 4:30 a.m. I was scared by the lack of breath and asked my husband to call 911. The paramedic stated that I had an increased heart rate, but good blood pressure. I went to the hospital and received fluids, two different additional doses of nausea medicine, oxygen and a gut muscle relaxer. After 30 to 40 minutes I showed improvement and was able to go home. Still had pink color tone in skin around my eyes. On that Monday (2/8/2021), I was unable to go to work and called in for Covid PTO. I slept most of the day. Five days later: Still have a headache that can be managed with Tylenol. I still have diarrhea. I no longer have nausea, the pink color around my eyes seems to be gone.The nurse team and ambulance team all stated that the second shot was awful. Three folks stated they were in fetal position for two days. I was not able to ask what that meant due to my extreme nausea and trying to not dry heave. Note: I did not have any symptoms from the first vaccine – just a dull headache.
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| 51 | 2021-03-17 | weakness, pain in extremity |
headache @1:30pm pain left arm @ 8pm body aches9:20pm nausea10pm an urgency to move bowels 10:30pm...
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headache @1:30pm pain left arm @ 8pm body aches9:20pm nausea10pm an urgency to move bowels 10:30pm ( relieved after bowel movement @7am) chills10:30pm sweating10:30p loss of strength/ lack of energy/ weak 11pm muscle aches 11pm slight confusion 1:30am joint (wrists and ankle) 7am all previous symptoms exists into next day 3/18 except the confusion motion appears to relieve the body aches
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| 51 | 2021-03-17 | numbness |
when I first got it I remembered I felt off and a little dizzy so I laid down and my BP was high ab...
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when I first got it I remembered I felt off and a little dizzy so I laid down and my BP was high about 15 mins after, my right side of face and arm went numb, that went away but that night I had body aches headache fever chills and fatigued which was out of the ordinary for me. About two weeks later I tested positive for Covid. I'm still dealing with covid related symptoms but I don't think that was from the vaccine
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| 51 | 2021-03-17 | tingling |
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: , MD at 3/18/2021 7:58...
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Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: , MD at 3/18/2021 7:58 AM Expand AllCollapse All COVID VACCINE CLINIC 66612 3/17/2021 Patient: Date: 3/17/2021 Subjective is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience dizziness and nausea and tingling down left arm where she got her shot. . She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency . Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing, vomiting (nausea), muscle aches (left arm), dizziness and headaches CONT negative Eyes negative Respiratory negative Skin negative Previous Reactions: Nausea with first Covid shot Objective Vitals Vitals: 03/17/21 0140 03/17/21 1332 03/17/21 1407 BP: 134/82 (!) 144/87 135/74 Pulse: 93 89 SpO2: 97% Physical Exam Constitutional: Appearance: Normal appearance. She is well-developed. HENT: Head: Normocephalic. Jaw: There is normal jaw occlusion. Right Ear: Hearing normal. Left Ear: Hearing normal. Nose: Nose normal. Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. No angioedema. Pharynx: Oropharynx is clear. Eyes: General: Gaze aligned appropriately. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: Cervical back: Full passive range of motion without pain. Neurological: Mental Status: She is alert. Psychiatric: Behavior: Behavior is cooperative. Assessment/Plan Treatment included: water and pepcid, zofran and Ibuprofen Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Released to go home with sister. No driving tonight. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) 2:30 pm Electronically Signed 3/17/2021 2:30 PM
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| 51 | 2021-03-18 | pain in extremity | Persistent muscle and joint aches: wrist, shoulder, hands and elbows. |
| 51 | 2021-03-18 | tingling, feeling hot, burning sensation, flushing, pain in extremity, numbness |
Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flu...
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Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flushed; her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm; upper part of her left arm started turning pink, and then red; burning feeling in her left hand fingers; her left hand got numb and tingly; her left hand got numb and tingly; her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers; the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey"; blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021; she looked like she had hives; rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist; there is a flush color around the vaccine injection site, but not on the vaccine injection site; Injection site pain/injection site is sore; left shoulder is warm to the touch around her COVID-19 Vaccine injection site; she looked completely wiped out, and pale; looked completely wiped out/Tiredness; Short of breath; her pulse was 101; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 21Feb2021), via an unspecified route of administration in the left arm, on 17Feb2021 15:40, as single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from 2012 to (diagnosed with Type 2 Diabetes Mellitus almost 9 years ago), neuropathy in her feet/nerves and reported that she only turns pink if she gets overheated. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. Historical vaccines included influenza vaccine (reported as flu vaccine) which she gets every year and pneumococcal vaccine (reported as pneumonia vaccine) which she gets every 5 years. The patient reported that she received her first Pfizer COVID-19 vaccine on 17Feb2021 and had an allergic reaction. She said she was at a podiatry appointment, and her podiatrist told her the pharmacy had an extra COVID-19 Vaccine available. She said the pharmacy staff came to her podiatrist's office to administer her COVID-19 Vaccine. She said about 5 minutes after she received the COVID-19 Vaccine injection, on 17Feb2021 15:45, her left arm started feeling flushed, her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck. She said 20 minutes later, she walked from her podiatrist's office to a nurse's station to be monitored further. She said while she was at the nurse's station, a doctor came by twice to evaluate. She clarified the upper part of her left arm started turning pink, and then red. She said her podiatrist asked her if that was a normal reaction for her. She said she told her podiatrist she only turns pink if she gets overheated. She said her left hand got numb and tingly. She said the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey". She said her podiatrist and his nurse felt both her arms, and said her left arm was much warmer than her right arm. While she was at the nurse's station being monitored, she felt short of breath. She said she wasn't sure if she was short of breath because of her nerves. She said her oxygen level was checked and it was at 99%. She said her pulse was 101, her blood pressure was 118/76, and her blood glucose finger stick test was 128. She said she was told by the staff monitoring her, she should expect her blood glucose number to skyrocket because there is a steroid in the COVID-19 Vaccine shot. She said the staff also mentioned she can expect blood glucose spikes as the COVID-19 Vaccine's steroid goes through her system. Her fingers in her left hand became itchy while she was at the nurse's station being monitored. It was a deep down itch in her left hand fingers. She said she asked for an ice pack to put on her left hand because she uses ice packs for neuropathy in her feet, and she felt an ice pack would help with the itch and burning feeling in her left hand fingers. The doctor came to look at her again and wanted to give her IV Benadryl. Then the doctor decided against the IV Benadryl because she would be too sleepy to drive home but the doctor did eventually give her an intramuscular injection of Benadryl 25mg (clarified as Diphenhydramine 25mg in a syringe) in her upper right arm. Within 5 minutes the itching in her left hand fingers calmed down, and the redness in her left arm calmed down to a pink color. She said 20 minutes later her left arm was still pink and warm. She said she was told by the doctor if her reaction moved out of the localized area of her left arm, to go to the Emergency Room, and to use an icepack, again, on her left hand. When she arrived home, her husband said she looked like she had hives and a rash going down her left arm. Her left arm was not itchy though. She clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist. She reported that while she was at her podiatrist's office her left arm was a solid pink. She then mentioned that when she goes out in the sun and gets overheated, she turns pink. She said from her left shoulder to left elbow was warm to the touch. She said by the COVID-19 Vaccine injection site there is a flush color around the vaccine injection site, but not on the vaccine injection site. She said the COVID-19 Vaccine injection site is sore and her left shoulder is warm to the touch around her COVID-19 Vaccine injection site. She reported there were no blotchy, red marks on her left arm on 18Feb2021. She said her left arm is a pretty normal on 18Feb2021. The nurse who monitored her after the COVID-19 Vaccine shot said she needed to report her allergic reaction. She was told she needs to let the COVID-19 Vaccine staff know of her reaction before she gets her second COVID-19 Vaccine injection, so she can be monitored closely. She took no other treatment after she returned home from receiving her COVID-19 Vaccine. She reported she had a headache on 18Feb2021, clarifying her whole head hurts, and the headache has been persisting all day. She said she experienced tiredness, as well. She said the tiredness started on 17Feb2021 and can be partially attributed to the Diphenhydramine 25mg injection she was given. Her husband told her she looked completely wiped out, and pale when she got home after getting her COVID-19 Vaccine on 17Feb2021. She said she remembers being tired when she got home because her eyes were squinty. She reported feeling more tired on 18Feb2021 and her whole left arm and left hand are sore. She clarified her blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021. The patient recovered from the events "her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers" on 17Feb2021; from "upper part of her left arm started turning pink, and then red" and "rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist" on 18Feb2021; from "her left hand got numb and tingly", "the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were twingey", short of breath, "burning feeling in her left hand fingers" and "she looked completely wiped out, and pale" in Feb2021; was recovering from "left arm started feeling flushed"; has not recovered from "her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm", "blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021", "there is a flush color around the vaccine injection site, but not on the vaccine injection site", "Injection site pain/injection site is sore", "left shoulder is warm to the touch around her COVID-19 Vaccine injection site", "looked completely wiped out/Tiredness", "Headache" and "her whole left arm and left hand are sore". The outcome of the events allergic reaction, "her pulse was 101", "she looked like she had hives" was unknown.
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| 51 | 2021-03-18 | tremor, numbness |
Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly eleva...
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Numbness of the lips hands and feet. Swelling of the hands purple red rash a long arms. Highly elevated blood pressure. Tunnel vision. Shaking. 30 minutes after receiving second vaccine for Covid.
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| 51 | 2021-03-19 | facial paralysis | Patient reported facial paralysis starting 4 days after COVID dose |
| 51 | 2021-03-19 | feeling hot, pain in extremity |
Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm...
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Thursday night arm became sore, red, swollen and itchy. Took Benadryl. Next morning, not better. Arm was hot, swollen, red, itchy and bruising occurred. All was on left arm at injection site.
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| 51 | 2021-03-19 | flushing, tremor, tingling, weakness, feeling hot, pain in extremity |
Within 15 min. Headache, eyes hurt (pressure) nose became stuffy, felt like I had a sudden sinus inf...
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Within 15 min. Headache, eyes hurt (pressure) nose became stuffy, felt like I had a sudden sinus infection. I became shaky and tingly. My arm was sore and felt heavy. My face became dark red and was hot to the touch. All symptoms still continue now (27 hours later) however my face is not as dark red, just pink. About 10 hours after the vaccine my muscles in my neck and shoulders began to ache. I was very fatigued. My entire body felt week and movement become a chore. Worst symptoms: Through the night I began to experience acid reflux. I have only experienced this a couple of times in my life and very mild. This was severe to the point that I couldn't sleep, my throat burned from the acid. Even drinking water was very painful and it would come back up. I located some Tums and ate 4. This was also a challenge as I couldn't hardly swallow due to the pain. After about 35 min. I began burping which help a little with the ability to keep some water down. Today I feel exhausted, my eyes still hurt, still have the headache and sinus pressure, and continue to have the acid reflux but not as severe as the night and early morning. I haven't tried to eat yet today.
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| 51 | 2021-03-19 | muscle spasms, pain in extremity |
Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since ...
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Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since day 1; brain fog since day 3; PMS like symptoms (cramps, achy feet) only on day 3; itchiness around injection site since day 1; redness and inflammation around injection site (moderate redness, size of adult woman's thumb from day 1 to day 3; increased about 25% in size on day 4 and had returned to previous size with a less red color). Has taken Tylenol when pain was present, removed headache pain on days 1-3 but not on day 4. Used cold compress on day 3 to reduce swelling but did not affect redness/swelling. Has not slept on injection site arm.
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| 51 | 2021-03-19 | tingling |
PATIENT WAS BEING MONITORED POST COVID VACCINE. INFORMED STAFF THAT HER ARM FELT A LITTLE TINGLING, ...
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PATIENT WAS BEING MONITORED POST COVID VACCINE. INFORMED STAFF THAT HER ARM FELT A LITTLE TINGLING, AND SOME HEAVINESS. PATIENT HAD NO PROBLEMS WITH MOVEMENT OR PAIN, NO OTHER COMPLICATIONS JUST TINGLING AND SOME HEAVINESS. CLINICAL SPECIALIST WAS INFORMED, AND PATIENT WAS FURTHER MONITORED. UPON FURTHER MONITORING PATIENT DID NOT GET WORSE, NO FURTHER SYMPTOMS AT THAT TIME. PATIENT WAS INFORMED TO FOLLOW UP WITH PHYSICIAN IF ANY CHANGES OCCURED POST MONITORING.
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| 51 | 2021-03-20 | feeling cold, cold sweat, unresponsive to stimuli |
The day after the vaccine, pt experienced typical side effects of fatigue and fever that was control...
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The day after the vaccine, pt experienced typical side effects of fatigue and fever that was controlled by Tylenol. The fatigue was extreme and has continued to present day. Also, she has inability to focus and concentrate. She is nauseated daily intermittently. The main complication was in post vaccination day 5, she felt worse than before. Vertigo, nausea, extreme fatigue and inability to perform ADLs and spent most of the day in bed. Approximately 1 am the next morning she woke me, cold, clammy and pale collapsing on the side of the bed with a feeling of impending doom after having diarrhea saying ?something is really wrong.? She went back to the toilet, but had a syncopal episode from standing where she fell straight and flat on her back with no attempt to break her fall. She hit her head on the marble floor and shoe molding. She was unresponsive for 10-20 seconds with no palpable pulse or visible respiratory effort before becoming arousable. She was groggy, but oriented to person and place. She was amnestic for the event. She had an approximately 6 inch full thickness laceration to her posterior scalp that required staples. I took her BP- 85/56, pulse 50, respirations were normal. Ambulance called. Mild hypotension that responded to fluid bolus. CT of head was negative and other than non-specific leukocytosis, labs were normal (CBC, CMP, TFTs, Mg and PO4).
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| 51 | 2021-03-21 | weakness |
3:15 pm Injection, c/o dizziness afterwards and feeling weak. Advised by Paramedics to wait in obse...
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3:15 pm Injection, c/o dizziness afterwards and feeling weak. Advised by Paramedics to wait in observation a bit longer. Skin w/d, no diff breathing. 3:55 pm stated "feeling better". Advised if dizziness returns pull over safety and dial 911.
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| 51 | 2021-03-21 | bell's palsy | Bell?s Palsy treated with prednisone steroid and Valacyclovir anti-viral prescription |
| 51 | 2021-03-21 | burning sensation |
Burning sensation started in my left chest area through to the back of the left shoulder blade. Then...
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Burning sensation started in my left chest area through to the back of the left shoulder blade. Then a light of tightness and hard to breath in the middle of my chest near my throat. then a later that day into the next day burning sensation in the very middle of my chest.
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| 51 | 2021-03-21 | flushing |
Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ ap...
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Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ approx 11:00am. She was escorted to triage area where she begin to c/o increased itching and tongue swelling. Epi pen and Benadryl was administered. Patient then begin to c/o difficulty swallowing and breathing. She remained alert and oriented to self, time, place and situation. She was taken to Regional per EMT's.
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| 51 | 2021-03-21 | pain in extremity | Arm pain from shoulder to elbow |
| 51 | 2021-03-22 | weakness |
Within 45 mins started sweating, feeling a bit weak, got home still feeling weakness and tiredness, ...
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Within 45 mins started sweating, feeling a bit weak, got home still feeling weakness and tiredness, headache and muscle aches to injection site and leg, still have muscle aches today. Yesterday AM awoke and stomach still bothering me - when asked she has upper abdominal pain - the equivalent to a bad stomach ache ie something didn't agree with it, worst the first day and yesterday pretty bothersome. Two weeks before vaccine started breaking out in hives, small red bumps that were red and irritated and appeared on upper back, below cleavage and on on face, thought reaction to something she ate or something she may have touched even tho she wears gloves when she leaves her home, she took Benadryl for 3 days and improved. Yesterday started itching again, sister looked at back and bumps are two fold to back and buttock, traces today on face. When asked, not bites, looks like reaction to something. Caller states she doubts related as started two weeks ago, plans to see physician today, typically would get some form of steroid, how would that affect her as it lowers the immune system. Advised ok to receive the steroid if needed for other medical condition. Patient states she moved to this last year, where she typically experiences seasonal allergies and takes meds for same this time of year. Caller also states she had some left over steroid cream that she has used.
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| 51 | 2021-03-22 | numbness |
EXTREME PAIN THE LEFT SHOULDER SOMETIME RADIATING DOWN THE ARM . CANT LIFT ARM UP PAST BREAST OR R...
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EXTREME PAIN THE LEFT SHOULDER SOMETIME RADIATING DOWN THE ARM . CANT LIFT ARM UP PAST BREAST OR REACH IN THE BACK. SOMETIMES ARM GOES NUMB FEELING . IT ALSO CAUSED A PSORIATIC FLARE UP ON DAY 5 AFTER THE SHOT .
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| 51 | 2021-03-22 | tingling |
Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, clo...
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Difficulty breathing, severe tingling in hands and feet, spike in heart rate and blood pressure, closing throat, itching and hives, heart palpitations and taste of vaccine after injection and nausea.
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| 51 | 2021-03-22 | paralysis | Paralysis to bilateral hands for 2-3minutes |
| 51 | 2021-03-23 | weakness |
I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger ...
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I got my shot around 12:20pm. After about 10-15 minutes, my tongue felt strange (like it was larger or heavier) and my mouth was dry. I thought maybe I was just thirsty. Shortly after that, I felt a pressure toward the bottom of my neck, like someone was pushing their thumb on my lower neck. Then, I felt pressure going down my chest. I told the monitor, and she brought the nurses over. The nurses took me to a different location for monitoring. I took some benadryl at about 12:45 pm. At 12:55pm, my throat began to close up, and when I breathed in, it was like a tiny straw was in my throat. The nurses gave me an epinephrine shot and called the ambulance. This event happened on 3/20/2021. On 3/21, I was physically and emotionally drained. I still had a slight pressure going down my chest. On 3/22, I went to work and developed a headache and was nauseous and my stomach was cramping by 10am. I went to the allergist at 3pm. She told me to take non-PEG liquid benadryl and Pepcid AC. On 3/24/2021, I still feel like I have some tightness in my chest (very minimal but still present) and a headache and am continuing to take liquid Benadryl.
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| 51 | 2021-03-23 | feeling hot |
pt reported slightly light headed ,felt like her neck was warm and left gland swollen, about 1/2 hou...
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pt reported slightly light headed ,felt like her neck was warm and left gland swollen, about 1/2 hour after vaccine, denied any difficulty swallowing, sob or chest pain(reported she had vaccine at other pharmacy and was fine after waiting 15 min.
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| 51 | 2021-03-23 | pain in extremity |
horrific arm pain from shoulder to elbow that last for approximately 48 hours; chills; respiratory a...
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horrific arm pain from shoulder to elbow that last for approximately 48 hours; chills; respiratory allergic reaction - stuffy head, nose running for 4 days; constant sneezing for 36 hours
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| 51 | 2021-03-23 | tingling, pain in extremity, numbness, burning sensation |
When receiving the vaccine I felt a pain run down my arm, within minutes my left hand went numb. ...
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When receiving the vaccine I felt a pain run down my arm, within minutes my left hand went numb. Weeks later my hand still feels like I have carpal tunnel and my outer hand, ring finger and little finger get tingly, burning painful sensation.
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| 51 | 2021-03-23 | tingling |
Metallic taste after shot. Pins/Needles on left side of face - continually near eye, every few hours...
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Metallic taste after shot. Pins/Needles on left side of face - continually near eye, every few hours rest of face.
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| 51 | 2021-03-23 | tingling | Paresthesia of left arm and leg, foggy brain, muscle weakness, headache, |
| 51 | 2021-03-24 | weakness |
low grade fever 101, for 3 days. Felt like I had been hit by a truck. Muscle aches and pains. Headac...
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low grade fever 101, for 3 days. Felt like I had been hit by a truck. Muscle aches and pains. Headache, sleepy, no energy. Out of work for 3 days was miserable. I'm on day 10 after the first shot of the vaccine and still feel foggy headed, low energy and tired.
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| 51 | 2021-03-24 | flushing, feeling hot |
Approximately 5 minutes post injection, patient reported feeling flush, overheated, and promptly vom...
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Approximately 5 minutes post injection, patient reported feeling flush, overheated, and promptly vomited. Patient was observed for s/sx of anaphylaxis. Patient was given 25mg diphenhydramine, temperature checked (temp had elevated ~2 degrees from time of injection), pulse and breathing function. Pt was visibly flushed in the face. Patient was given a cool rag as well. Patient was A&Ox3. Pt did not report any immediate issues of breathing issues, cardiac abnormalities, etc. Injection site was unremarkable. Pt reported feeling a bit better after the medication. About 7 minutes later, patient began to complain of scratchy throat and minor difficulty breathing. Patient does have a history of atopic reactions and has noted this sensation in the past when experiencing allergic reactions. Observed patient tongue and mild signs of angioedema were noted. Patient given second dose of diphenhydramine and water. Epipen was on site. Patient was observed and monitored for 25 minutes further. After approx. 5 more minutes, patient reported feeling better and looked visibly less flushed and the swelling of the tongue had diminished. Approx 5-10 min later patient was walking around, talking normally, and showed no signs of distress or reaction.
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| 51 | 2021-03-24 | numbness | Numbness right upper extremity at vaccination site. VS WNL, patient is nervous |
| 51 | 2021-03-24 | pain in extremity | Low fever, aches, headache, R arm soreness |
| 51 | 2021-03-24 | pain in extremity | 101.5 fever, nausea, dizziness, fatigue , headache, muscle aches, sore arm |
| 51 | 2021-03-24 | tingling |
Client complained of tingling on left arm after receiving 1st dose Pfizer Covid vaccine (lot# ER8732...
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Client complained of tingling on left arm after receiving 1st dose Pfizer Covid vaccine (lot# ER8732, exp 3/28/21). Client was sitting in post vaccine waiting area 30 mins when she alerted EMT of tingling of arm. EMT performed first assessment. Vitals 1445: blood pressure 128/92, pulse 81, oxygen 99. PHN joined EMT shortly after. Client stated tingling on left arm that began 5 minutes after receiving vaccine; did not alert EMT until later. Per client no shortness of breath, chest pain, numbness, palpitations, headache, or blurry vision. Client stated this was a new onset that she did not have prior to receiving vaccine. No history of reaction to vaccines in the past. Current medication include daily vitamin and nasal spray. Allergy to antibiotic, but unsure of name. PHN assessed bilateral strength, facial droop, and arm weakness. Per client feeling fine besides the tingling sensation. PHN asked client to stay additional 15 mins for observation. Vitals 1452: blood pressure 132/92, pulse 78, oxygen 100. Alert and oriented. Tingling sensation the same, no changes. Per client history of anxiety and also had caffeine this morning, which she usually does not take. Last vitals at 1515: blood pressure 128/90, pulse 80, oxygen 100. Per client no change in tingling sensation. Was not radiating or worsening. Client advised to follow up with provider prior to receiving second dose. Client instructed to seek medical care if symptom did not improve or worsened. ER precautions given. Client left facility with steady gait at 1517.
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| 51 | 2021-03-25 | electric shock sensation |
tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from sh...
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tongue numbness/tingling, rapid heart rate, electrical or nerve zap down both arms beginning from shoulders down to fingertips that happened simultaneously (one occurence), slight swelling and tingling sensation of lips.
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| 51 | 2021-03-25 | feeling hot |
As soon as shot was given warm sensation throughout body and metal taste in mouth. Felt dizzy for a ...
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As soon as shot was given warm sensation throughout body and metal taste in mouth. Felt dizzy for a minute as well
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| 51 | 2021-03-25 | throat numbness |
I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back ...
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I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back of my throat felt numb and had a significant headache. I could not sit up straight due to dizziness. By 11:30 it was hard to talk, my throat felt thick, tight, and like it was getting small. It was difficult to swallow. I was too dizzy to stand up. I would tip over when I stood up. The hospital was called and advised my family to closely observe my symptoms. At 11:20 the pharmacist gave me liquid Benadryl. At 11:30 I took hydroxyzine, prescribed after an adverse reaction to my first covid vaccine and Tylenol. At 12:30 my throat felt less enflamed but sore and scratchy. At this time my whole head was itchy and the headache was not reduced. I had a difficult time walking due to the dizziness.
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| 51 | 2021-03-26 | numbness |
developed chest pain with numbness radiating down left arm. Paramedics called, patient refused trans...
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developed chest pain with numbness radiating down left arm. Paramedics called, patient refused transportation to ED for evaluation. Patient instructed to seek care if symptoms continue or get worse. Patient verbalized understanding of all information.
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| 51 | 2021-03-26 | tingling | Tingling sensation in right foot that gradually progressed to my right leg and arm. |
| 51 | 2021-03-27 | seizure |
Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: Patient sitting on ...
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Site: Pain at Injection Site-Mild, Systemic: Seizure-Medium, Additional Details: Patient sitting on chair post vaccine (waiting area) she reported (after seizure and fall) that she was feeling dizzy. She doesn't remember after that and was awake on the floor. Customer reported witnessing a seizure for 4-7 seconds BEFORE the fall. She has an abrasion on her left temple post fall. EMS called and patient refused to go to the ED. She said she would go with her friend.
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| 51 | 2021-03-27 | tremor |
Patient following vaccine developed right hand tremor following getting vaccine in her left arm. Pa...
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Patient following vaccine developed right hand tremor following getting vaccine in her left arm. Patient was removed from cell and brought to the medical observation area. Her BP was 128/82, P 62 RR 16 @ 3:25 she was alert and oriented times 3 ,at 3:38 her blood pressure was 141/94 and at 3:45 was 148/91 HR 68 at , O2 sat 100%. Her tremors began in her right hand and then went to her trunk and legs. She began to hyperventilate, patient was warm to the touch and an ice pack was provided to her She was not able to have a mask in place and she was hyperventilating, we asked her to focus and take deep breaths she was responsive to that and stated that helped to calm her down. Her husband was brought to her side, her vital signs continued to be obtained. at 3:50 her bP was 156/99, HR 104, pulse ox 99, at 3:55 BP was 150/102 HR 106. EMS was called as patient continued with tremors and her blood pressure continued to be elevated . EMS arrived , her final blood pressure was 156/99, HR 90 and pulse ox was 99%. EMS transported patient out of the center via stretcher. Patients husband planned to follow her to the hospital
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| 51 | 2021-03-28 | weakness, muscle spasms |
Over night, "calf muscles were contracting really tight over and over. Every time the muscle would ...
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Over night, "calf muscles were contracting really tight over and over. Every time the muscle would stop, it would start again over and over. I also woke up feeling weak and a headache"
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| 51 | 2021-03-28 | weakness, pain in extremity |
Effects Lasted approx. 15 hours Sore Left Arm - (Expected), Tiredness, Headache, Muscle Pain, Chills...
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Effects Lasted approx. 15 hours Sore Left Arm - (Expected), Tiredness, Headache, Muscle Pain, Chills, Sweats, Joint Pain, Nausea, Throat felt swollen, Shallow Breathing, Swelling in Face (Left side of face for 48 hours), Weakness
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| 51 | 2021-03-28 | feeling hot |
11 hours after receiving the vaccine chills started, and a fever of 99.5. Over the next 18 to 20 ho...
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11 hours after receiving the vaccine chills started, and a fever of 99.5. Over the next 18 to 20 hours temp rose to 102. Chills were uncontrollable until I began taking tylenol to bring down tge fever. Then I began to get very hot...sweating. alternated chills and sweats during that 18 to 20 hour period. Fever finally broke but ended with a slight headache. Also during the same time period of the fever I experienced diarrhea. Woke up less than 48 hours post vaccine feeling better, but extremely tired.
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| 51 | 2021-03-28 | pain in extremity |
Symptoms started approx. 11 hrs. post injection- sore arm, fever, body aches. Max temp. 104.2 and f...
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Symptoms started approx. 11 hrs. post injection- sore arm, fever, body aches. Max temp. 104.2 and fever was constant/ did not go to baseline until Sunday 3/28/21 around 6pm. I have been sweating on and off since fever broke. Body aches were severe, Moderate HA with onset of fever and body aches. Arm pain from injection remained mild to moderate with no swelling or redness. GI symptoms- diarrhea, pain and nausea started 24 hours after vaccine and mild symptoms remain today 3/29/21. Fatigue present. I had a severe COVID illness back on 12/09/20 with Monoclonal Antibodies on 12/11/20 and I did not feel as bad as I did with this vaccine. With the vaccine my fever never broke for almost 48 hours. With Bilateral COVID pneumonia I only spike temps mostly at night and broke with Tylenol and Motrin.
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| 51 | 2021-03-28 | tingling |
Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter devel...
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Chills, fever x2 days. From shot #1. Chills, Fever x2 days, 2nd day swelling size of a quarter developed. 3rd day R arm swelling, hot to touch, sheering pain size half of a grapefruit. Tingling in right hand. Sought medical help.
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| 51 | 2021-03-30 | numbness |
Numbness in hands and feet Intermittent; This is a spontaneous report from a contactable other healt...
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Numbness in hands and feet Intermittent; This is a spontaneous report from a contactable other health care professional reported for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown) via unspecified route of administration in left arm on 19Feb2021 12:30 AM at age of 51 years old at single dose for COVID-19 Immunization. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies reported. Other medications the patient received within 2 weeks of vaccination included Natasia (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previous received the first dose of BNT162B2 in left arm on 22Jan2021 12:30 AM at age of 51 years old for Covid-19 Immunization. Patient experienced numbness in hands and feet intermittent on 22Feb2021. Since the vaccination, the patient had not been tested for COVID-19. The report was reported as non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was not received treatment for the adverse event. Outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 51 | 2021-03-31 | pain in extremity, involuntary muscle movements, bell's palsy |
hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and g...
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hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot; Left side of mouth muscle not holding water while brushing teeth; Cannot close left eye/eye wasn't moving; Left eye burning during shower; sick; cannot move that part of your mouth; Sore Arm over Weekend; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Mar2021 08:15 (Lot Number: EN6204) at single dose for covid-19 immunization. Medical history was none. Concomitant medication included diphenhydramine hydrochloride (BENADRYL Tablet). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200) on 19Feb2021 and experienced felt really tired, and received flu shot. The patient experienced bell's palsy on 18Mar2021, sore arm over weekend on an unspecified date in 2021, Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot on 18Mar2021, left side of mouth muscle not holding water while brushing teeth on 18Mar2021, cannot close left eye/eye wasn't moving on 18Mar2021, left eye burning during shower on 18Mar2021, sick in 2021, cannot move that part of your mouth in 2021, hard of hearing on an unspecified date. She felt great over the weekend other than a sore arm. Morning on 18Mar2021 when she woke up her left eye felt weird. When brushing her teeth she noticed the left side of her mouth muscle was not holding water to spit out. Looked in the mirror and noticed when she smiled her left eye wasn't moving. Went to the emergency room and the doctor told her she has Bell's Palsy. Explained that was why she cannot close her left eye. Was given two medications to take; one a steroid and one a antiviral. Left eye has been feeling weird, like when you look away from your cell phone and one eye hasn't dilated or adjusted to the darkness yet. Stated she took a sick day from work today. Mentioned again her left eye burning in the shower and that she has to sleep with an eye patch. She was hard of hearing. Stated she had hearing aids and can currently hear call handler fine. Had a CAT scan and everything at the emergency room this morning. Her grandmother and aunt died from a stroke and she was concerned that she had one. She cannot close her left eye completely. Stated was a weird feeling like when went to the dentist and get the Novocain shot and cannot move that part of your mouth. The doctor told her he thought it will last for 2 weeks. Stated that it could've started overnight but she was uncertain as she was sleeping and didn't notice it until this morning. Mentioned her husband was at the hospital all day yesterday for procedures. After receiving her second dose of the vaccine she thought she didn't feel to bad at all, not tired like with the first one; until she woke up with this today. Stated no for medications but mentions that on 11Mar2021 she had bad allergies and was like a water faucet. She took Children's Benadryl 12.5mg 2 tablets and some eye drops. Stated that it helped. Thought she was allergic to something in the building. Stated was given Prednisone, as she was reading the label she notices she was supposed to take two a day and had only taken 1 this morning. Prednisone is prescribed as 20mg 2 tablets by mouth every day for 7 days. Spelt out name of antiviral medication as IC Valacyclov. Prescribed as 500mg 2 tablets by mouth three times a day. Also has eye drops to keep eye moist. Has eye patch for bedtime. Was instructed to manually close left eye and cover with eye patch at night. Mentioned that she had a flu shot in October no issues voiced. Nephew with Covid, Niece that had Covid. Stated she was not around them. There was no physician office visit reported. The patient underwent lab tests and procedures which included blood sugar: normal, blood pressure: normal, CAT scan: normal on 18Mar2021. There was treatment and emergency room visit except event hard of hearing. The outcome of the events was unknown.
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| 51 | 2021-04-02 | pain in extremity |
headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits ...
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headache; arm started aching; The lymph nodes in her arm are still swollen; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits; itching on both of her feet; red circle where she got the injection. It was the size of a dime and only there on 28Jan2021; arm that she got the vaccine in got very large; Swelling in the upper breast area/swelling in her upper chest; Swelling and pain in the neck/Neck pain; Swelling and pain in the neck/Neck pain; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 15:00 as single dose for covid-19 immunization.Medical history included menopause or has been through menopause, Flu shot, hormonal issues, she started with a bizarre virus, whole lymph node response; It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting, she had a little infection and inflammatory markers come back positive. Concomitant medication included probiotics, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient previously took flu for influenza immunisation and experienced peripheral swelling, tetanus vaccine for immunisation, amoxicillin, and experienced drug hypersensitivity, flagyl [metronidazole] and experienced drug hypersensitivity. The patient reported adverse events associated with her first Pfizer COVID vaccine shot. She experienced swelling in the upper breast area, swelling and pain in the neck, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared. She thought on whether to get the second shot of the vaccine considering these side effects since her doctor did not know why this was happening according to her. She thought she would report some side effects after one shot of the Pfizer COVID19 Vaccine. It was strange. She did not read the symptoms until seven days out. Then she saw some have reported a lot less. After the shot, that night she had swelling in her upper chest. She thought it was lymph nodes in the breast and chest area on the side she got the shot. The next day her arm that she got the vaccine in got very large. Then, she does not know if it was related, two days later she had itching on both of her feet. It was the tops of her feet and only for a couple of days. She is not counting that. Day five after the shot has been the main problem. Her armpits started itching like crazy. It was severe itching and swelling in her armpits. The itching lasted for three to four days. The lymph nodes in her arm are still swollen. It was five days after the shot. It was both armpits. The night of the shot she had a lot of neck pain and she thought it was probably the lymph nodes in the back of her neck. That has lasted and was slowly diminishing. The patient was not planning on getting it. There was an agency that for assisted living for people that need help. They were giving it and had extra doses. This guy in charge at the assisted living house offered it to caller and caller's husband because her and her husband run a behavior health counseling. He offered it to them as healthcare professionals. He was given a batch for the residential agency but had extras. She was going through menopause or has been through menopause. She has hot flashes and has hormonal issues. The first week of December she started with a bizarre virus. She got tested for COVID and it was negative. It was not a rapid test it was a sendoff. Through that illness she had a whole lymph node response which was super unusual. The doctor said it was really strange. It was lymph nodes in her neck, arm pits, and groin. Every two days she would have lymph nodes reacting. She had recovered from that and was back to normal. Four days before she got the shot all of that had resolved. Prior to getting the vaccine she had been tested for Lymphoma and it was negative, and she had a little infection, and her white blood count was normal. She had inflammatory markers come back positive prior to getting the vaccine. She went to the doctor on 27Jan2021 and asked if she should get the shot. The doctor said to do it because if she got COVID it would be worse. She was going to have a follow up with doctor for the ongoing stuff and he might do more test. Never in the course of any of that did she have itching armpits or swelling that lasted all this time. She never had chest swelling. The shot in the arm and it moved across her chest. It was reported that, back in the 90's, in 1993 or 1994, flu shots caused her arm to swell really large and stayed swollen for three months. That was the last three flu shots she got in the 90's. Then the doctor said not to get them. No one said why. She doesn't have allergy to eggs or anything that she knows to cause that. She has gotten all other vaccines and tetanus within the last 10 years. Her arm would kind of react but not like that. It went away in a reasonable amount of time. She didn't get a fever. The patient does not have NDC, lot and expiry for flu shots, other vaccines or tetanus to provide. When her kids were younger, they all had to be vaccinated for rabies. She did not have any reaction at all with those vaccines. She has allergies to antibiotics. She does not have lot numbers, NDC, or expiry for the antibiotics she was allergic to. She was allergic to Amoxicillin, Flagyl, Doxycycline, and Sulfa drugs. She has allergies to adhesive and contrast dye. No food allergies. She has allergies to dog and other environmental allergies. She does not take any medications for any of that. She has never had any anaphylactic shock of any kind. It has always been hives. The patient experienced swelling in the upper breast area/swelling in her upper chest, swelling and pain in the neck/neck pain, swelling and pain in the neck/neck pain, swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/it is both armpits, arm that she got the vaccine in got very large, itching on both of her feet, red circle where she got the injection. It was the size of a dime and only there on 28jan2021, headache, arm started aching and the lymph nodes in her arm are still swollen. Outcome of the events Swelling in the upper breast area/swelling in her upper chest and arm that she got the vaccine in got very large was recovering, outcome of the events Swelling and pain in the neck/Neck pain, Swelling in the armpits (for about 7 days) that got very itchy for 3-4 days but has since disappeared/severe itching and swelling in her arm pits/lymph nodes in her arm are still swollen/It is both armpits, itching on both of her feet and red circle where she got the injection. It was the size of a dime and only there on 28Jan2021 was recovered and outcome unknown for other events. Information on the lot/batch number has been requested.
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| 51 | 2021-04-12 | speech disorder, numbness, tingling |
Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general ...
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Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general malaise; fatigue; difficulty concentrating; Day 2: General malaise, fatigue; difficulty concentrating; headache; lower back pain Day 3: Fatigue; runny nose, sneezing, cough, aches all over the body; headache; a red, itchy blotch on the right index finger; lower and upper back pain Day 4: Same as above, but vision problems right before bedtime; Day 5: Severe headache, lightheadedness, difficulty talking, numb left side of thCT e face, left hand, left arm, left food. Went to ER and still in the hospital in observation (Day 6)
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| 51 | 2021-04-13 | unresponsive to stimuli |
Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional D...
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Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: 6 days after dose patient had a syncopal attack and severe palpitations. Daughter called ambulance after finding mother had fainted.
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| 51 | 2021-04-15 | pain in extremity, facial paralysis, numbness, facial pain, weakness |
Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccin...
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Pfizer dose #1 EJ1686 1/1/2021 12:30 pm Onset of symptoms 2 pm 1/1/2021, around 1.5 hrs post vaccine: severe headache, stiff neck ache, dizziness, nausea, chills, extreme fatigue, feverish but below 100.4, severe muscle aches, loss of taste and smell. Loose bowels at times, slept all the rest of the day and night, drank lots of fluids and electrolytes (low sugar). Felt more weak and dizzy the next day, and when walking felt veering right more, more issues with extended activity. e next dose on 1/22 onwards, and has never gone away fully. R arm pain and raised, tender area at vaccine site contiued to hurt for weeks, even into the next dose on 1/22 onwards, and has never gone away fully. 1/3.2021 woke up 5:30 am sudden onset shortness of breath, deep lung pain in the center of the chest. I felt like my R lung blocked, and started to cough up large amounts of clear mucus, and vomiting mucus due to airway feeling blocked. I did a 4 albuterol puffs to try to open my airway, but I was not wheezing, and did not have any respiratory symptoms or illness at the time before this started. I had been having continued less lung capacity for many months prior due to having been very sick in March 2020 onwards, including loss of sense of smell and taste, shortness of breath, deep lung pain, fever, No wheezing, not sick. Pfizer dose #2 EL9261 1/22/2021 3:50 pm after work. Onset of symptoms by 5:30 pm with headache, dizziness, nausea, extreme fatigue, increased R arm pain at the vaccine site, but it was still hurting at the site from the 1/1/21 shot too, before this dose. Drank fluids and went to bed. Loss of smell and taste returned 1/23/21. Had continued bad headache from 1/22 onwards, with nausea and feeling more dizzy at times, and on 1/26/21 I was at work with increased headache, dizziness and nausea, and went home early from my shift (I am an RN) due to symptoms. Went to bed early, due to continued nausea and headache and dizziness at times. 1/27 continued bad headache, then in the afternoon around 3 pm, GI felt bloated, bad nausea, and then felt shortness of breath around 4 pm and faster heart rate in the upper 80?s lasting for minutes, despite laying down in bed, so I too used my oximeter (I Have photos) and the sats were staying at 88% continuously, and had shortness of breath and return of deep internal mid lung pain, and this lasted for over 10 min. I used a canister of Boost oxygen for 5-6 puffs to try to recover, and the sats raised to 90%. No wheezing. Not sick. I had a bad headache and nausea, and was not feeling good and went to bed. On 1/28/21 I woke up at 5:30 with severe vertigo and dizziness, nausea and a bad headache and could not walk due to the vertigo, and vomited when I was trying to have my head up. I had to crawl to the bathroom on my hands and knees. I called out sick for work due to this and contacted my DR. I was started meclizine 25 mg 3 times a day for vertigo, and was taking Zofran to help. 1/31/21 noted my Re upper eyelid was doing a lot of spastic twitching at times, that would stop and start, but did not think about it much. The vertigo was unrelenting and then I started to have Right arm and hand weakness noted on 2/3/21 and was still very dizzy, nauseated and had a constant headache since I got dose #2 of the COVID vaccine on 1/22. I was using a walking stick for the dizziness to be stable, and also felt weaker on the R side, and drifting to the right when walking .On 2/4/21 I had my first MRI (no contrast, unfortunately) and noticed I could not fully shut my Right eye in the MRI, and by 2/5/21 my face was drooping. I still had the constant headache, nausea and dizziness, and increased R hand, arm and R leg weakness and R hip weakness. I could not lift my R leg up to walk well, cannot grip well with the R hand, and uncoordinated, and cannot walk straight, and am unstable when trying to walk heel to toe, or even stand still with my eyes shut, and have had some double vision with the R eye. I was started on Prednisone and on Klonopin for the vertigo on 2/9 after seeing my neurologist. I took Prednisone for 5 days, from 2/9-2/13 and did not have improvement with the R facial droop or R side weakness and the headaches have persisted, along with some dizziness and nausea. on2/14-15 I had increased shortness of breath and R lung felt like it was not inflating much, and got an xray, and went onto Zithromax for 5 days, which did help my lungs to improve, and I was able to breathe better, and got my Right lung capacity back. I stopped the Klonopin after a week (2/9-2/16), to manage through the symptoms without it, and have been doing physical therapy and. Vestibular therapy. I had another MRI, with contrast on 2/25, after an in-person neurology appointment, and was having some improvement with the vertigo, so I started back to a desk job, not my RN job on 3/4/21, but I was still having the constant headache, nausea, and some dizziness, R face droop, R hand weakness, R leg weakness and walk with a walking stick, and have increased issues with exertion, but have been walking and doing therapies to get stronger.3 I started to have increased R facial droop. EMG done on 3/23 of my R arm. Worse headache, nausea, dizziness at the desk, and fatigue, but R side weakness issues increased, so I started back onto Prednisone on 3/28/21 with 50mg day for 3 days, then 40mg for 3 days, 30mg for 3 days then 230mg for 2 days, but had increasingly bad headache,nausea and increasing R facial droop, and much worse R hand weakness, R arm weakness and pain, and R hip pain and weakness, worse walking, cannot lift my R leg or foot as high as the L, again, and am struggling to walk, and get worse with exertion with R side walking and weakness. I also had shooting pains in my R jaw start on 4/6-7, along with R jaw and face pain and increased numbness, more face droop shooting pains in my R hip, and arm and body pain and a worse headache making it hard to even sleep, and some increased issues with my R eye that I need to have checked. The prednisone last dose was on 4/7, and stopped due to the symptoms I was having, after a video visit with the neurologist. Increased R leg weakness, R weak hip vs left, R foot drag/drop, with increased issues to maintain walking with progressive walking, still using walking stick to try to walk, but now for stability and to keep from drifting, R facial droop increasing and now some R eye blurring 4/9 onwards, that is new.
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| 51 | 2021-04-20 | bell's palsy, pain in extremity |
Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; c...
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Bell Palsy; pain in arm; pain in neck; headache worsen from center of head to neck; dizzy; nausea; chills; tongue swollen; no taste; This is a spontaneous report from a contactable consumer (patient). A 51-year-old (also reported as 52-year-old) female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 51-years-old, administered in Arm Left on 10Mar2021 10:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included asthma and high blood pressure. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient experienced "Bell palsy", pain in arm, pain in neck, headache worsen from center of head to neck, dizzy, nausea, chills, tongue swollen, no taste; all on 19Mar2021 22:30. Description was as follows: "pain in arm, neck, headache, dizzy, nausea, chills and then days later other symptoms, headache worsen from center of head to neck, neck hurting, tongue swollen, no taste, and then woke up with Bell Palsy and was taken to the emergency room". Therapeutic measures were taken as a result of Bell palsy. The outcome of the events was recovering. The events were considered as serious (Disability or permanent damage/ Disabling/Incapacitating). The adverse events resulted in any Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. More information has been requested.
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| 51 | 2021-04-20 | feeling cold, pain in extremity, weakness |
All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pa...
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All my muscles and whole body is hurting; All my muscles and whole body is hurting; Chills; Joint pain; I had some wired nausea, I can even hardly eat; I had some wired nausea, I can even hardly eat; My heart rate is kind of low but it's been 125 for last 2 days; I have a rash; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; I feel dizzy and weak; cannot stand up and walk; My lymph nodes are very swollen; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have ray nods also that's circulation disorder; I feel like I have been freezing cold ever since I got the second shot; I got half fever; I have been passed out; I had mine my fever gone up to 104.9 and down to 103; my arm is swollen, hard and hurts terribly; my arm is swollen, hard and hurts terribly; whole arm get deep red; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in the left arm on 01Apr2021 (Batch/Lot Number: EN6199) (at the age of 51 years old) at a single dose for covid-19 immunisation. Medical history included lupus and high blood pressure both from an unknown date. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam (KLONOPIN) and topiramate (TOPAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 12Mar2021 (lot number: EN6198) (at the age of 51 years old) and reported that she was really not feeling well. On 01Apr2021, the patient got the second dose of covid vaccination and reported that she had a pretty serious side effect since the first one. The patient then reported her fever gone up to 104.9 and down to 103 and reported that she was worried about herself, not only the fever; her arm is swollen, hard and hurts terribly; patient reported that all her muscles and whole body is hurting and the chills, the joint pain of course the fever and further reported that had some wired nausea, she can even hardly eat. The patient then stated that within a few hours after her shot, she started having mild problems: swelling of her arm, her whole arm get deep red and throughout pain in her arm. The patient had a video call with her primary care doctor, the doctor said it's just normal, don't worry about it, the doctor didn't let the patient give all her symptoms (as reported). The patient further stated she have that pain and something is not right in her body and that she have been taking Tylenol. The patient also reported that her heart rate is kind of low but it's been 125 for last 2 days (as reported), patient reported that she has a rash, feel dizzy and weak, cannot stand up and walk, the patient have attended to go for her family house for the Easter and she was there for 15 minutes. Keep in mind Covid normally they all were vaccinated and it's been a very special time, but within 15 minutes the patient have been passed out and had been taking home and further reported that her lymph nodes are very swollen and her head is killing her. The patient have an electric blanket in her arm because she have chills so bad, her joints are hurting and she have ray nods (as reported) also that's circulation disorder and she feel like she have been freezing cold ever since she got the second shot. The outcome of the events was unknown.
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| 51 | 2021-04-22 | muscle spasms |
Painful body and joint cramps aches fingers arms hands legs feet toes neck hips shoulders. Mild he...
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Painful body and joint cramps aches fingers arms hands legs feet toes neck hips shoulders. Mild headache. Stomach nausea. Very tired
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| 51 | 2021-04-24 | tingling, numbness, bell's palsy |
Bell's Palsy; something felt weird; asthma; facial numbness and tingling; facial numbness and tingli...
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Bell's Palsy; something felt weird; asthma; facial numbness and tingling; facial numbness and tingling; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration administered in arm left on 05Apr2021 (Batch/Lot Number: ER8727) at age of 51 years old as single dose for covid-19 immunisation. There was no medical history. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No events following prior vaccinations. There were no concomitant medications. The patient had her 1st dose of Pfizer Covid-19 vaccine on Monday morning (05Apr2021). The patient experienced facial numbness and tingling on 05Apr2021. After the injection she sat and waited for 15 minutes. When she got in the car, she felt her face tingling. It had been a couple days of having the sensation in her face. She called her physician and it was labeled as Bell's Palsy. Her physician suggested she phone and report her experience. She had her appointment at 11:30. She was back in her car around 13:00. She noticed as she was driving, that something felt weird. She didn't know if it was numbness or tingling. She added it was not painful and she was not distorted. She thought it's numb. Her physician advised she take Motrin. Her physician shared an article about a trial that some people may experience this after, it included 4-5 people. Her symptoms shifted. First in her cheeks, then over the course of yesterday and today, she feels it's on the side of her face. The forehead had gone away, but it's on the right side of her face. She added the symptoms were improving and clarified they were persisting. She had asthma and wanted to minimize the severity of Covid if she would ever get it. She had loved ones around and added that you never know. She wanted to protect herself. She wanted to get out and see her family and friends. Some of them have already been fully vaccinated. She was concerned when it started. It wasn't affecting her breathing, but she called her physician and asked if she needed to come in. Her physician suggested to just monitor it. The events did not require visit to emergency room or physician office. The outcome of events facial numbness and tingling was not recovered. The outcome of other events was unknown.
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| 51 | 2021-04-28 | pain in extremity, bell's palsy |
Bell Palsy; sever leg pain; This is a spontaneous report from a contactable nurse (patient). A 51-ye...
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Bell Palsy; sever leg pain; This is a spontaneous report from a contactable nurse (patient). A 51-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm on 12Jan2021 (Batch/Lot Number: EL3246) as a single dose for COVID-19 immunization. Medical history was reported as none. The patient had no known allergies and no other medical history. The patient had no Covid prior vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 5730) in the right arm on 22Dec2020 at 11:00AM for COVID-19 immunization. The patient had no other medications in two weeks and no other vaccines in four weeks. The patient experienced Bell Palsy and sever leg pain on 28Mar2021. The patient was hospitalized for the events for 1 day. The patient was tested post vaccination. The patient underwent lab tests and procedures on 31Mar2021 which included Nasal Swab: negative. Treatment for the events included steroids and antiviral as well as antibiotics. The events had not resolved.
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| 51 | 2021-04-30 | pain in extremity |
Significant gerd immediately following administrationsing; left arm and shoulder pain; left arm and ...
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Significant gerd immediately following administrationsing; left arm and shoulder pain; left arm and shoulder pain; This is a spontaneous report from a contactable consumer, the patient. A 51-Year-old (non-pregnant) female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 27Feb2021 14:30 (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient medical history included colitis ulcerative, fibromyalgia, premenstrual dysphoric disorder all from an unknown date and unknown if ongoing. Known allergies includes food allergy (lobster), contrast media allergy (contrast dye). Allergies to medications includes, drug hypersensitivity with ZIPACK, BACTRIM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications were not reported. No COVID prior vaccination. Prior to vaccination, the patient has not been tested for COVID-19. On 27Feb2021 14:45 (at 02:45 PM) the patient experienced Significant GERD immediately following administration and left arm and shoulder pain within a couple of hours. The GERD was surprising not the arm and shoulder pain. The patient did not receive treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID. Seriousness of the event was reported as non-serious. The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.
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| 51 | 2021-05-04 | bell's palsy |
Bell's palsy; This is a spontaneous report from a contactable consumer (the patient). This 51-year-o...
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Bell's palsy; This is a spontaneous report from a contactable consumer (the patient). This 51-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm, upper arm, on 06Apr2021 14:00 (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient denied being sick at the time of vaccination. The patient's medical history was not reported. No relevant family medical history was reported. There were no concomitant medications. On the night of 08Apr2021, the patient was having intense pain down her neck and behind her left ear, and it has been waking her up at night. On 09Apr2021, she went to Urgent Care and they misdiagnosed her with a possible oncoming ear infection. On Saturday morning (10Apr2021), she woke up and could not move the left side of her face so she went to the ER (emergency room) and they diagnosed her with Bell's Palsy. On 10Apr2021 at the ER, blood test for Lyme disease was negative. The ER gave the patient a steroid and antiviral pill and told her to follow up with her primary doctor in 8 days. The patient went to her physician's office on 19Apr2021 to follow-up with her Bell's Palsy. The patient stated that intense pain (down her neck and behind her left ear) was apparently a symptom of the Bell's Palsy. The only improvement with the Bell's Palsy was that she can sip out of straw a little easier but lips are still to the side. The clinical outcome of the event Bell's Palsy was resolving. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
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| 51 | 2021-05-04 | migraine |
Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swa...
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Apnea episodes, felt like she couldn't breathe; rash, small tiny pimple a rash; she could barely swallow; Ears were itching, scratching her arms; Ears were itching, scratching her arms; really, really sick; Sore throat; throat and gland started swelling really big; throat and gland started swelling really big, glands were swollen; complaining about stomach; I noticed that my ear started swollen so bad; it is like an allergic reaction; Severe Flu-like symptoms, COVID-like symptoms; Migraine from back of her head, headaches; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 13Apr2021 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Lyme disease. Concomitant medication was none. On 14Apr2021, the patient experienced severe flu-like and COVID-like symptoms which included body aches which was very strong, and feeling feverish, she was complaining about stomach, her throat and gland started swelling really big, her ear started to swell so bad, it is like an allergic reaction. On 15Apr2021, the patient experienced sore throat, and she got really, really sick. On 16Apr2021, the patient experienced glands were swollen, she could barely swallow, ears were itching, and she was scratching her arms. On 18Apr2021, the patient experienced I had rash, small tiny pimple a rash. On 19Apr2021, the patient experienced apnea episodes, felt like she couldn't breathe. On an unspecified date in Apr2021, the patient experienced, migraine from back of her head, headaches. On 16Apr2021, the patient went to urgent care, and she was tested for COVID, strep, influenza and they did a urine test, because she was also reporting stomach aches and pulmonary test. All the test results were negative. Cultures, to the previous tests were performed and everything was negative. The events required and emergency room visit and the emergency room doctor, didn't think it was an allergic reaction to the vaccine, because it took so long, to happen. The patient was treated for the events in the emergency room, with steroids, Benadryl and an intravenous infusion. The patient said that she was fine now. The outcome of the events was recovered on an unspecified date in Apr2021. Information on the lot/batch number has been requested.
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| 51 | 2021-05-06 | weakness |
tiredness; A little bit of chills; A sense of not feeling well/She just does not feel good/her body ...
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tiredness; A little bit of chills; A sense of not feeling well/She just does not feel good/her body not feeling okay; Her neck and head felt so heavy. Her neck and head felt so heavy that she could not hold it up; She felt like her body was so sick, she had no strength; she has pain in her back, neck and spinal cord; Body pain/body aches; Neck pain/neck felt so heavy; She felt like her body was so sick/Her body felt really really sick; Severe back pain/pain in her back; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) at right arm on 18Mar2021 09:00 AM at single dose for COVID-19 immunization (She believes in vaccines. She thinks its better to be vaccinated than to not be vaccinated). Medical history included COVID-19 from 01Feb2021 and three heart ablations. Concomitant medications were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to AE was None. She is calling about the Pfizer covid vaccine. She received her first dose of the covid vaccine on 18Mar2021. She got body aches (Mar2021) after. On 02Apr2021, she had to go to the emergency room. She had severe neck and body pain. She went to the emergency room because she could not take it anymore. Her body felt really really sick. Now she has pain in her back, neck and spinal cord (Mar2021). She has a weird feeling in her body. She just does not feel good. At the emergency room, they did blood tests on her. She did not have covid or the flu. Her hemoglobin came back normal, and so did all of the other things. She has this tiredness (Apr2021), pain in her back and a sense of not feeling well. She is calling to see what Pfizer suggests. She is asking if she can take anything, if so what can she take. She is asking how long will this last. She is asking if this is related to the vaccine. After first dose, Body aches began about five days after receiving the covid vaccine. She had body aches, a sense of not feeling well, and a little bit of chills. A little bit of chills began about five days after receiving the covid vaccine and resolved completely now. Clarifies that on 18Mar2021, she received the first dose of the covid vaccine. On that same day (18Mar2021), is whenever she had chills and a sense of her body not feeling okay. 48 hours after that, she had no more chills. Two or three days after, she started having back and neck pain. Her neck and head felt so heavy. Her neck and head felt so heavy that she could not hold it up. She was in pure desperation. She had to go to the emergency room. She never goes to the emergency room, unless she absolutely has too. She felt like her body was so sick, she had no strength. Then she received her second dose on 08Apr2021 (Lot number: ER8732). It has been 12 or 13 days since and her body aches have continued. She still feels like she is very sick. She just wants to lay down, but she can not because she has to work. She does not feel like herself. She feels like something is off in her body. Pain in her back, neck and spinal cord began two to three days after receiving the first dose of the covid vaccine. Body aches was reported as worsened. Pain in her back, neck and spinal cord was reported as worsened. No Investigation Assessment. She was not admitted to the hospital. Physician Office was No. outcome of Body pain, neck pian, Severe back pain, she has pain in her back, neck and spinal cord and She felt like her body was so sick was not recovered, outcome of chills is recovered in Mar2021, outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 51 | 2021-05-10 | pain in extremity |
Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches...
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Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; bitter taste; This is a spontaneous report from a contactable consumer(patient). The 51-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Apr2021 14:30 (Batch/Lot number was not reported) as second dose, single for covid-19 immunization. Medical history included hashimoto. Concomitant medication included collagen, peptide powder, multi vitamins. She previously received sulfur based antibiotics. Historical vaccine included first dose of BNT162B2 on 03Apr2021 09:30 AM for COVID-19 immunization and experienced bitter taste in back of throat for half day on date of administration. After second dose, the patient experienced same bitter taste for 24 hours from time of administration. Pulse continued body aches especially in legs making her almost immobile, all on 26Apr2021 06:00 with outcome of recovering. Treatment included alternated taking ibuprofen(ADVIL) and paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID 19, Since the vaccination, the patient had not been tested for COVID 19. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466738 Same patient/drug, similar AEs, different dose
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| 51 | 2021-05-11 | pain in extremity |
extreme soreness in the area of uterus; sore arm; has fibroid tumors and on Saturday night, she expe...
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extreme soreness in the area of uterus; sore arm; has fibroid tumors and on Saturday night, she experienced very severe cramping from them; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 23Apr2021 at 11:30 AM (at the age of 51 years old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included chronic pain, fibromyalgia, ongoing fibroid tumors, and penicillin allergy. Concomitant medications included pregabalin (LYRICA); diazepam; ibuprofen; morphine; and multivitamins. The patient received the shot on Friday on 23Apr2021. The patient experienced sore arm on Saturday (24Apr2021), which is expected. The patient also has pre-existing fibroid tumors, and on Saturday night (24Apr2021), she experienced very severe cramping from them. On Sunday (25Apr2021) and Monday morning now (26Apr2021), the patient is experiencing extreme soreness in the area of uterus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the events. Information on the lot/batch number has been requested.
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| 52 | 2020-12-31 | discomfort | Tinnitus, worse in left ear. Heavy feeling all over. Headache, Tylenol 500mg q6h. |
| 52 | 2020-12-31 | flushing, speech disorder |
Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my thr...
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Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER. The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea and feeling very unwell.
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| 52 | 2020-12-31 | numbness, discomfort |
10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ...
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10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ANXIETY. SMILE SYMETRICAL PROTRUDING TOUNG CENTERED. @10:45AM B/P 153/93 @10:58 AM B/P 146/89 @11:15AM EMERGENCY SERVICES WERE OFFERED SEVERAL TIMES BY RPH ( PATIENT REFUSED) . PCP WAS NOTIFIED BY FNP - B C . MEDICAL DIRECTOR DR SPOKE TO PATIENT OVER THE PHONE DIRECTLY. NO PARLYSIS WAS DETERMINED. PATIENT COULD FEEL A PINCH IN THE AFFECTED AREA. PATIENT STATED THE REACTION ABATED BEFORE THE END OF THE CLINIC @12:30PM
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| 52 | 2021-01-03 | difficulty speaking |
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to b...
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Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate. Patient answered "no" to questionnaire about allergic reactions prior to vaccination. 11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine. Patient brought to ICU for monitoring. Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558 with macular papular rash on leg, chest and back with itching on eyelids and face. No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
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| 52 | 2021-01-03 | facial paralysis |
52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial dr...
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52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial droop as left lower lip numbess on 31 Dec 2020, which has become more pronounced over the past 2 days. She states she spoke to the nurse hotline right before speaking to me who told her to go to the ED (she was on her way). Denies any extremity weakness, numbness, HA or dizziness. No pain to face or ear. Speech clear on the phone. No recent illness or history of Bell's palsy. NKDA or any prior adverse reactions to immunizations.
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| 52 | 2021-01-03 | pain in extremity, muscle spasms | Arm pain, extreme fatigue, muscle spasm (charley horse) in left inner thigh, shin and foot. |
| 52 | 2021-01-03 | pain in extremity | Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face) |
| 52 | 2021-01-03 | pain in extremity |
Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The...
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Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The morning of the 26th (day 3 after vaccine) , I woke up and felt great.. I took my normal 4- 5 mile run. I felt a little dizzy , & hungry when I ran (not my normal) , got home had diarrhea 1 x , then for next two days very faint GI discomfort and I had fever for two days , temp range 99-100
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| 52 | 2021-01-04 | weakness |
Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see prov...
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Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see provider and CXR and EKG normal. States low-grade fever lasted couple of days.
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| 52 | 2021-01-04 | cold sweat, feeling hot |
1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received...
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1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received COVID POC test and was negative. Left to go home and had loose stool then chills, body aches, hot spells, and extremely tired. Could not stay awake and was in brain fog. Slept all day, all night and all day on 1/5/21. No appetite, stuffy nose, headache, chills and hot spells, no fever, Again unable to stay awake.
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| 52 | 2021-01-04 | cold sweat |
Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and c...
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Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and clammy. Felt like heart racing. Dizzy. Radial pulse 88 and regular. BP 116/72. Patient declined going to the Emergency Department and was observed for approximately another 30 min, Chest discomfort subsided. Her husband ( an MD) came in and took her to his office for further observation.
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| 52 | 2021-01-04 | facial paralysis |
Droopy left cheek.; This is a spontaneous report from a contactable nurse. A 52-year-old female pati...
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Droopy left cheek.; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), intramuscularly in the left arm, on 17Dec2020 at 14:30 (at the age of 52-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no other medications within two weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took sulfamethoxazole, trimethoprim (SEPTRA) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced droopy left cheek on 21Dec2020. No therapeutic measures were taken as a result of the event. The clinical outcome of droopy left cheek was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of droopy left cheek might not be excluded considering the plausible temporal relationship. The patient had previous allergy reaction to antibiotic (sulfamethoxazole, trimethoprim) use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-04 | flushing, feeling hot |
Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toe...
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Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
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| 52 | 2021-01-04 | numbness |
About a half hour after receiving the vaccine I started feeling a numbness under my right eye that p...
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About a half hour after receiving the vaccine I started feeling a numbness under my right eye that progressed slowly progressed to around my right eye, cheek, ear and upper right side of my teeth. I was able to move my muscles (no crooked smile) and close my eyes completely. Today I still have this strange feeling but it's very subtle. This hasn't worsened at all since yesterday but hasn't gone away either.
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| 52 | 2021-01-04 | pain in extremity | Nausea, lightheadedness, headache, fatigue, sore/swollen arm |
| 52 | 2021-01-04 | tingling, numbness |
intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and...
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intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and tingling L arm. Sometimes radiating to my hand.; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient, not pregnant, received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer BIONTECH Covid-19 vaccine, lot EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 11:15, single dose (dose 1) for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and had drug allergy. Approximately 4days after injection (25Dec2020), the patient started having intermittent numbness and tingling in left arm that sometimes radiating to her hand. She reported that she still have these symptoms as of today. No treatment was given. The outcome of the events was not recovered.
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| 52 | 2021-01-05 | weakness |
Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER ...
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Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.
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| 52 | 2021-01-05 | cold sweat |
Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in ...
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Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in supine position Observation maintained until vitals returned to normal
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| 52 | 2021-01-05 | numbness, tingling, tremor |
Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated p...
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Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.
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| 52 | 2021-01-05 | night sweats |
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, n...
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Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
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| 52 | 2021-01-05 | pain in extremity |
Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (p...
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Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) via an unspecified route of administration on 30Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol and asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC), hctz (HCTZ), metoprolol succinate (TOPROL XL), omeprazole (OMEPRAZOLE) and pravastatin (PRAVASTATIN). The patient previously took diphenhydramine (BENADRYL) and experienced drug allergy. The patient experienced headache and sore arm on 30Dec2020 13:00. Outcome of events was recovering.
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| 52 | 2021-01-05 | pain in extremity |
the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; t...
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the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; top of her stomach had a bad burning sensation; Vomiting; she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing; sore throat with a mild cough, like she needed to be clearing her throat; sore throat with a mild cough, like she needed to be clearing her throat; got a chill; food was not tasting right; arm was sore; could not raise her arm; her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on 21Dec2020 on left upper arm at a single dose for COVID-19 prevention. Current medical history included a lung disease called asthma and allergies, diagnosed in her late 20's; Diabetes Type 2, diagnosed about 10 years ago and High Blood pressure, diagnosed when she was in her 30's. Caller also wanted to include that she did have COVID before, she had COVID in Jul2020. Current concomitant medications included salbutamol (ALBUTEROL) at 2 Puffs via inhalation, twice daily for asthma; Unspecified Blood Pressure Medication One pill, once daily by mouth in the morning; Unspecified Nasal Spray 1 spray in each nare, once daily via nasal inhalation; montelukast sodium (SINGULAIR) at 1 pill via oral, once a day for allergies; metformin at 1 pill, daily, by mouth for Diabetes Type 2. The patient stated that her place of employment did not give her the card that has the lot number on it, they said they would give it to her with her second injection. The patient did not know the dose received, just that it was the first in the series. The patient had no other vaccines on the same day as the COVID vaccine. The patient reported that her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds. The patient received the vaccine on 21Dec2020, and as soon as she got the shot, her arm was sore like a flu shot. When she got the shot, she could not raise her arm past her shoulder without pain, but now she can raise her arm again. On Thursday, 24Dec2020, patient got a chill, and later that same night, food was not tasting right. On 25Dec2020, the chill continued, and she had a little bit of a sore throat with a mild cough, like she needed to be clearing her throat. On 26Dec2020 morning, the patient experienced vomiting when she woke up, and the top of her stomach had a bad burning sensation, and she had diarrhea. The patient stated that while she was vomiting, she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing. But the patient stated that she vomited, had diarrhea, and the burning sensation, the whole day on Saturday. The patient stated that on 27Dec2020, it calmed down, and she did not vomit at all. The patient stated that she felt like she needed to vomit, but she did not. The patient states that on Sunday, she still had the chills a little, and the top part of her stomach was still burning. The patient took some Pepto-Bismol and that helped calm down the caller's stomach. The patient stated that she could feel the Pepto-Bismol cooling her stomach off, like it had been hot, and patient stated that the top of her stomach felt swollen and gassy. The patient stated that later Sunday night, things calmed down, but she still has the burning sensation and she did not feel like she needed to vomit anymore. This morning, patient reported that she still has some burning sensation, but now, it is coming and going like labor pains. The patient stated that she did go to the bathroom once this morning and had diarrhea that was like liquid-y water. The patient stated that during all this over the last few days, each and every time that she tried to eat, she couldn't eat much because her stomach would burn more with eating. But yesterday, the patient had some fried fish and stated that the fried fish did not burn as much as the rest of the food she tried eating. The outcome of the events vomiting and the top of her stomach felt swollen and gassy was recovered on 27Dec2020, arm was sore and could not raise her arm was recovered on 26Dec2020, chills, top of her stomach had a bad burning sensation was recovering, Diarrhea/had diarrhea that was like liquid-y water was not recovered and other events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vomiting and Foreign body aspiration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-05 | tingling |
Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on star...
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Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on starting 12/24/20. Fatigue and chills 12/28/20. Occasional right back tingling resolved 12/31/20.
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| 52 | 2021-01-06 | weakness |
Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest...
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Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest and fluids, acetaminophen started at 0400 am on 1/6 symptoms started to resolve by 2000 (8pm) on 1/6
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| 52 | 2021-01-06 | numbness | Diarrhea numbness of face/tongue Narrative: |
| 52 | 2021-01-06 | numbness |
Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was t...
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Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was tingling and felt numb. I continued to close up my desk to leave work for the day thinking it would just go away in few minutes. When I got to my vehicle I took two Benadryl capsules and drank a bottle of water and waited nearby the hospital emergency department parking area for 30 - 40 minutes. The numbness had eased and I drove home. Tuesday and today (Wednesday) I have felt very tired and fatigued.
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| 52 | 2021-01-06 | pain in extremity |
12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. H...
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12/22 vaccination. Felt fine. Arm sore 12 hours 12/26 - sudden sharp pain in chest, palpitations. HR irregular. waiting 15 min. Went to the ER. Frequent PVCs; occasionally over the years. Discharged home. Not sure if related to vaccine as under a lot of stress.
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| 52 | 2021-01-07 | weakness, feeling hot |
SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO...
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SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO TO WORK DUE TO SYMPTOMS
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| 52 | 2021-01-07 | weakness, pain in extremity, feeling hot, cold sweat |
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Ski...
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Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
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| 52 | 2021-01-07 | weakness | LEFT AXILLARY PAIN AND EDEMA, GENERALIZED WEAKNESS AND MUSCLE PAIN WAS UNABLE TO GET OUT OF BED |
| 52 | 2021-01-07 | weakness |
HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSE...
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HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSEA AND VOMITING STOPPED ON 1-2-21 BUT RETURNED ON 1-8-21.
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| 52 | 2021-01-07 | weakness | Chills, vomiting, fever 104, upset stomach, low energy level, headache |
| 52 | 2021-01-07 | burning sensation | Temp 102.3 ,Severe headache, whole body muscle aches, felt like I was on fire from the inside out. |
| 52 | 2021-01-07 | feeling cold, tremor |
Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer ...
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Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231, Expiration Date: 30Apr2021), via an unspecified route of administration in left arm, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure. The patient had unspecified concomitant medications. The patient took this shot on 31Dec2020 at her job at medical center (EDF, environmental service; it's housekeeping). The patient was fine during the daytime. The patient made it to her home and now she got the chills and was shaking on an unspecified date. When the patient was asleep, that is when she started feeling chills and the shake. The patient was bad and cold, and she got a bad chill. The patient wanted to report and asked if it was going to go away. No treatment was administered for the events. The outcome of the events was unknown.
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| 52 | 2021-01-07 | feeling hot |
Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins ...
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Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins & then returned to work. on 12/30/2020 patient was at work in Presurgical testing dept & experienced near syncope, dizziness & elevated BP. reported to ED & was admitted to telemetry unit.
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| 52 | 2021-01-07 | numbness |
After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mout...
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After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mouth. My bones hurt, and my neck hurt really bad. that lasted for three days. I developed chills and a fever, I felt really sick. I had a COVID test and was positive.
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| 52 | 2021-01-07 | numbness | Mid back pain, Right hip numbness, macular rash on administered arm |
| 52 | 2021-01-07 | pain in extremity |
12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., i...
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12/28/2020 - Eye Swelling 01/05/2021 - Injection site: Redness, Sore arm. Hive in injection site., itching (Brazo caliente)
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| 52 | 2021-01-07 | tremor, muscle spasms, muscle twitching |
muscle spasming; muscle spasming or twitching; shaking; my muscles are weak; This is a spontaneous r...
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muscle spasming; muscle spasming or twitching; shaking; my muscles are weak; This is a spontaneous report from a contactable nurse (reporting for herself). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history was none. Concomitant medications were not reported. The patient started having like muscle spasming or twitching and like shaking a little bit like her muscles were weak on an unspecified date. Outcome of the events were unknown.
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| 52 | 2021-01-08 | feeling hot |
after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofra...
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after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofran 4mg, gave one dose epi-pen, and 50mg Benadryl. patient still complained of chest pain and was dry heaving. she was then transported by ems to the hospital at 4pm.
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| 52 | 2021-01-08 | flushing |
ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/9...
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ErythemaMultiform Pt complains of flushing; chest/neck/face/ears reddened; VS: P-126; R-16; BP-158/98;SAT-100%; Dr at bedside to evaluate pt. 1300- No repiratory distress;VS- 143/83; 104; 100%; 16; MD advised pt to take 25-50mg of benadryl every 6 hrs for 24 hr Narrative: Patient with flushed skin; VSS; denies difficulty breathing; advised by Dr to take 25-50mg benadryl every 6hrs and follow up if any change in or worsening of symptoms. Ambulated from clinic with husband. No assistance needed.
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| 52 | 2021-01-08 | muscle spasms, tingling |
HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after r...
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HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after receiving the vaccine she felt uneasy and experienced the sensation of throat tightness and numbness and tingling in hands and feet, also some rigidity/clonus in the hands. No rash, no wheezing, O2 sat 99%+. The team at the vaccination clinic checked her vital signs and her systolic BP was elevated to 220's. A rapid response was called and she was taken to the emergency room. In the emergency room, she received a neurology consult and head CT to rule out hypertensive bleeding. The scan was negative. She was given labetalol 10mg IV to lower BP, and also solumedrol 125mg, benadryl 25mg. No epinephrine given. Serum potassium was found to be low as well; given oral potassium repletion. Discharged from ER by noon same day, BP down to 160/79.
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| 52 | 2021-01-08 | pain in extremity, night sweats, night sweats, pain in extremity | Headache, Myalgia, Fever, chills, arm pain, nausea, cough, fatigue, night sweats |
| 52 | 2021-01-09 | feeling hot, pain in extremity |
Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night t...
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Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night that was 100.9 . Body aches, cold, headache, dizziness. Saturday ran fever off and on that never got above 100.9. Which broke Sunday am. Sunday just fatigue, sore arm that is warm to the touch, but not red.
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| 52 | 2021-01-09 | pain in extremity | Extreme fatigue, muscle aches, slight fever (99.0) and right arm soreness |
| 52 | 2021-01-10 | inability to speak |
Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortn...
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Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortness of breath that night. Next day still had fever, severe body aches and cough got worse with shortness of breath. I did home nebulizer several times and started prednisone 40mg. 1/6/21 shortness of breath worsened to the point I couldn't talk, chest tightness with burning. Went into ED at hospital where they gave me another breathing treatment x 2, magnesium sulfate, IV solu medrol. They were going to admit me but I decided against it with all the covid patients.
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| 52 | 2021-01-10 | weakness |
Approximately 5 minutes after receiving the vaccine patient began to feel very weak and drained and ...
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Approximately 5 minutes after receiving the vaccine patient began to feel very weak and drained and sleepy. Arms felt weak. Pain in the back of the neck. At 3:05pm, BP 155/88 HR=66 Temp 98.4F O2=95% Glucose=160. Patient reports taking Tylenol prior to receiving the vaccine. At 3:10pm, BP=148/95 HR=68, O2=95%. Patient was released from clinic at 3:17pm. Patient reports having similar symptoms following 1st dose of Pfizer Covid-19 vaccine occurring 1 hour after receiving the dose. Patient reports being very sleepy and fatigued. Fatigue lasted for 3 days. Per patient, symptoms resolved with Tylenol and rest.
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| 52 | 2021-01-10 | flushing |
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin...
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52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
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| 52 | 2021-01-10 | migraine |
Migraine headache began the next morning about 7am and increased as the day progressed including nau...
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Migraine headache began the next morning about 7am and increased as the day progressed including nausea and light sensitivity. Waves of nausea and headache continued into the next day. I had not had a migraine in over 2 years prior to this event. Treated with OTC Excedrin at first on Jan 10th, then when that was ineffective took butabital at lunch time and when that was ineffective took Maxalt with phenergan about 5p. The next day on Jan 11th, thought I was better but by 630a nausea returned in waves and headache began building again. Took Maxalt with phenergan about 930a and again at 9p.
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| 52 | 2021-01-10 | pain in extremity |
One week after first vaccine, sudden onset - with no trauma or new medications or other known provoc...
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One week after first vaccine, sudden onset - with no trauma or new medications or other known provocation developed significant pain at tendons- bilateral symmetrical - hands, wrists, elbows, neck, hips, knees, bottoms of feet
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| 52 | 2021-01-10 | pain in extremity |
sore arm after the first 6-8 hours that lasted maybe 8 hours. At approx. 30 hours post vaccination,...
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sore arm after the first 6-8 hours that lasted maybe 8 hours. At approx. 30 hours post vaccination, woke with fever, chills, rigors; took Tylenol and Benadryl and symptoms subsided after about 3 hours.
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| 52 | 2021-01-10 | tingling | Went into the ED for bilateral hand and feet tingling. Worked up for possible Guillain Barre. |
| 52 | 2021-01-10 | tremor |
Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Start...
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Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Started 12 hours after second dose of covid vaccine. No reaction to first dose.
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| 52 | 2021-01-10 | tremor |
ABOUT 10 HOURS AFTER SHOT RECEIVED I STARTED SHAKING VIGOUROUSLY AND DID NOT STOP FOR ALMOST 2 HOURS...
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ABOUT 10 HOURS AFTER SHOT RECEIVED I STARTED SHAKING VIGOUROUSLY AND DID NOT STOP FOR ALMOST 2 HOURS. THEN I DEVELOPED A SLIGHT FEVER - 100-101 - BAD HEADACHE, MUSCLE ACHES, BODY ACHES. TOOK TYLENOL REGULARLY, FINALLY EXCEDRIN FOR HEADACHE AND ICE PACKS FOR BACK OF NECK AND FOREHEAD. DIBILATING FOR THE NEXT DAY, THEN FEVER BROKE AND FELT BACK TO NORMAL.
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| 52 | 2021-01-11 | feeling cold, cold extremities, flushing, feeling hot, cold sweat |
Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated sh...
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Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated she was hot and her hands were sweaty. after 15 minutes post injection patient was red going down her neck. She was then evaluated by the EMTs. She stated she felt a little better by 9:45 but we continued to observe. By 10:05 patient was still flushed and was getting cold hand . Gave Benadryl 25 mg po at 10:17 AM. By 1035 Patient was very cold but her face was still flushed and felt hot to her. Her hands were clammy and cold. EMT transported to hospital at 10:45. This was her second dose of Pfizer.
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| 52 | 2021-01-11 | numbness |
Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving ...
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Numb cheeks, lips & tongue. Minor swelling of lips. Approx. 40 minutes post injection while driving home. Took 1 benadryl when I got home and all symptoms subsided approx 30 minutes later.
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| 52 | 2021-01-11 | tingling, burning sensation, hypersensitivity of all senses |
injection itself into L deltoid was not painful. 5-10 minutes after injection I experienced sharp ti...
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injection itself into L deltoid was not painful. 5-10 minutes after injection I experienced sharp tingling/burning over the medial clavicle and extending into the neck. there was no rash, redness, swelling, swallowing or breathing difficulty. At 21 days, I am still experiencing hyperaesthesia and some tingling over the medial clavicle, and a zinging sensation over the clavicle/sternoclavicular joint with L shoulder movement, valsalva or burping. evaluation on site by vaccine provider. telephone consultation with PCP 2 days and 1 week later, and brief telephone consultation with local allergist. gabapentin for discomfort
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| 52 | 2021-01-11 | cold extremities, tingling |
Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eye...
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Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eyes swelled. Significant scleral edema bilaterally but mostly left eye. Sudden chills and felt freezing in extremities. Face became tingly. Took 50 mg Benadryl, Claritin and rescue inhaler (2 puffs albuterol). Within 1.5 hours felt better and able to rest. Still Itchy but wheezing was better. On 1/12 woke with swollen eyes. Took 25 Benadryl and Claritin. Walked 1 mile and began to wheeze. Took albuterol and rested.
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| 52 | 2021-01-12 | burning sensation |
Dizzy, cloudy, burning sensation of right side of neck. BP is ordinarily 11/62, but was 135/85. Obse...
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Dizzy, cloudy, burning sensation of right side of neck. BP is ordinarily 11/62, but was 135/85. Observed, issues resolved at 12:46 pm/
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| 52 | 2021-01-12 | flushing | dizziness with perceived palpitations; facial flushing and headache |
| 52 | 2021-01-12 | numbness |
At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Use...
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At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Used medication for asthma. Flovent inhaler for 5 times. Used xyzal 5mgs via oral. These medications are used by doctor's orders.
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| 52 | 2021-01-12 | pain in extremity |
Patient reports arm and leg pain (aching), extreme pain along with chills and low grade fever, mild ...
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Patient reports arm and leg pain (aching), extreme pain along with chills and low grade fever, mild headache.
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| 52 | 2021-01-13 | numbness |
Received COVID vaccine on 1/7/2021 on 1/10/2021 I had a sudden onset of right side facial numbness....
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Received COVID vaccine on 1/7/2021 on 1/10/2021 I had a sudden onset of right side facial numbness. I was worked up in the ER for a possible stroke but all testing was negative. The numbness lasted 3 days and has now resolved. My COVID shot was given in the right arm.
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| 52 | 2021-01-13 | pain in extremity, facial pain, numbness |
PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on ...
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PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on injection side. Face /cheek feels sore, swollen and numb- coming from neck, into face, up to temple/forehand, into cheek and jawline. Is this possible Bells Palsy ?
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| 52 | 2021-01-13 | pain in extremity |
Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/...
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Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/29 around noon she started feeling tachycardic (resting heart rate was 107-125 bpm). She vomited and felt anxious. Developed fever of 101.8 and was very achy. Day 2: low grade fever treated with ibuprofen. Day 3: fever free but dizzy feeling. Day 4: symptoms resolved. Of note, patient was 30 days out from having had COVID-19 at the time of vaccination. Patient states her course of COVID was "serious" but did not require hospitalization.
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| 52 | 2021-01-13 | pain in extremity |
Received 2nd dose Pfizer lot EL0142 on 1-13-2021 on right arm. Has body aches, joint pain, muscle a...
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Received 2nd dose Pfizer lot EL0142 on 1-13-2021 on right arm. Has body aches, joint pain, muscle ache, head ache, fatigue, and arm pain.
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| 52 | 2021-01-14 | difficulty speaking |
1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor ...
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1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor as she was anxious prior to receiving vaccine 1444 states sxs are getting worse, still no swelling or SOB noted 1445 States she now feels like tongue is swelling and lump in throat is worse, cough noted. 99.5F, 97% RA, 102HR, 22 Resp, 146/99 BP 1448 Hoarseness in voice noted as associate getting into wheelchair 1449 Turn over care to ED
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| 52 | 2021-01-14 | muscle spasms |
Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of b...
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Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of both of my hands with itching and warm redness in them both (I have pictures) Within an hour it began feverish red itching and slight burning on both of The undersides of my forearms. I was advised by the pharmacists on duty in the covid clinic site to use topical Benadryl cream and or take Benadryl by mouth if it worsened. I was told to seek emergency dept help if any signs of breathing issues presented. The next morning the itching was gone the redness subsided and the rash was markedly better but still raised in the tops of my hands. By 1030am on 1/12/21, I could not detect taste or smell at all. I was advised then to report to employee healthline for further instruction. I was told to leave work and proceed to our employee Covid swab testing drive thru facility for Covid testing and remain home for results the following morning on 1/13/21. At approximately 10am 1/13/21 I was confirmed positive for COVID-19 via the swab results. I was told to quarantine and given a return to work date of 1/24/21 as long as my symptoms were resolved. I am currently in home quarantine still suffering no taste or smell, muscle cramps in legs, thighs and back. Fatigue, Loss of appetite, sinus pressure and headache not relieved with medications.
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| 52 | 2021-01-14 | pain in extremity |
Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge b...
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Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge bump on her face that is very painful; she cannot walk straight or without assistance anymore; Vertigo; Weakness in the muscles; a little arm soreness; Body aches; Chills; Could not sleep; Fever; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine), Batch/lot number: EK9231, Expiry Date: 31Mar2021, via an unspecified route of administration on 06Jan2021 09:00 at single dose in deltoid right for COVID-19 immunisation. Medical history included heart attack from Jul2019. Concomitant medication included diltiazem from 2019 and ongoing at 120mg tablet taken daily for abnormal heart rhythm she did not know of until had heart attack, acetylsalicylic acid (BABY ASPIRIN) from 2019 and ongoing at 81 mg tablet taken daily for heart attack. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation; she got the Flu vaccine every year and got shingles vaccine in Mar2020 for immunization. She did totally fine after receiving Flu vaccines and the Shingles vaccine. She had no side effects from the Flu vaccines except maybe a little arm soreness; she had arm soreness for a couple of days after the shingles vaccine; maybe a slight fever and took it easy. This Emergency Room Nurse (patient) received her second dose of Pfizer BioNTech COVID-19 Vaccine on 06Jan2021 around 9:00am. She went back to work, worked around 6-8 more hours that day and was fine. She went home and around 8-10 hours after she got the second dose on the evening of 06Jan2021 she had a little arm soreness and body aches. Last night all night she had chills; she could not sleep; fever. This morning: 07Jan2021 she was so nauseous that she got up and tried to get to the bathroom where she threw up a little. She reported as of 07Jan2021 she kept falling down: She fell in the bathroom this morning first when she was trying to get to the bathroom to throw up; During the second fall she was going on the stairs and fell, and hit her head; she had a huge bump on her face that was very painful now that she thought was from that second fall; and she had the third fall this evening; she cannot walk straight or without assistance anymore, she had been on the couch all day. She has had vertigo all day and weakness in the muscles. Chills was described as unbearable, heavy chills that she could not control. Fever: Temperature of 102-102.4 degrees Fahrenheit. The high fever hit around 3:00am on 07Jan2021. When her high fever hit around 3:00am she thought she would go to the emergency room but she did not want to scare her family so she stayed home and tried to pull through it. Today she took a Tylenol after she threw up this morning just to get through the day. Since she cannot walk without assistance or walk straight today that's the only lingering symptom that really worries her; she may go to the emergency room tonight if she did not get any better. She just did not want to scare her family and the emergency room was another copay cost so she really did not want to go to the emergency room at her workplace; but she may go there tonight and be kept overnight under observation. Prior to taking this second dose of Pfizer BioNTech COVID-19 Vaccine she was completely fine. She expected to have body aches, chills and fever; but she never thought the Pfizer BioNTech COVID-19 Vaccine would put her into a place where she is falling like this with the nausea and vertigo; she has never in her life had vertigo or falling like this. She reported she had no other vaccinations on the same date as Pfizer BioNTech Vaccine second dose. Has had no other vaccines in the recent past. She had never felt like this before with any other vaccines; she had never felt so weak in her muscles and never fallen down like this with any other vaccines. Seriousness criteria and outcome of all events unknown. The reporter considered all events were related to Pfizer BioNTech COVID-19 Vaccine.
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| 52 | 2021-01-14 | pain in extremity |
neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder a...
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neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder and over to right ear; left arm sore; neck sore to left shoulder and over to right ear; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number EK4176, Expiry Date: Mar2021, via an unspecified route of administration on 21Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband was calling for his wife that had the second shot. He stated that she was a nurse. He stated that she came home from work with her arm and neck sore. He stated that the neck soreness was causing ear ache. He stated that her fever was 102.9 and stated that they put a cool rag on her head. He stated that she had the shot yesterday and stated that she had her first shot 21Dec2020. They stated that arm sore at 1:00 in morning and stated sore neck at 11:30 this morning. Fever started at 11:30 and was 99.7 and about 15 minutes later was 99.9 and stated that was with having three Aleves. She stated that it is back up to 102.9 and stated that the right ear ache started at 11:00am today. The patient underwent lab tests and procedures which included body temperature: 102.9 on 08Jan2021, 99.7 on 08Jan2021 and 99.9 on 08Jan2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of events was not recovered.
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| 52 | 2021-01-14 | pain in extremity | onset same day of vaccine, c/o chills, no fever, pain in hips and legs and low BP 80/52 |
| 52 | 2021-01-14 | pain in extremity |
Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate f...
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Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate fatigue, nausea, more severe arm pain than day before; Felt sweaty/chills, neck lymph glands tender; Felt sweaty/chills, neck lymph glands tender; neck lymph glands tender; Moderate arm pain that night; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), intramuscularly on 04Jan2021 16:30 at single dose for COVID-19 immunization. Anatomical Located at Arm Right. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication which the patient received within 2 weeks of vaccination included colecalciferol (VITAMIN D), tocopherol (VITAMIN E), magnesium, ibuprofen, paracetamol (TYLENOL). The patient previously took amoxicillin and experienced allergy. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced Moderate arm pain that night on 04Jan2021 19:00 and woke up with moderate fatigue, nausea, more severe arm pain than day before on 05Jan2021. At 23 hours post injection on 05Jan2021, the patient also felt sweaty/chills, neck lymph glands tender. All symptoms gone at 48 hrs post injection. The patient did not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021. This case reported as non-serious.
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| 52 | 2021-01-14 | tingling |
23 minutes after the patient receive the shot she complained of tingling at the site and down her ar...
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23 minutes after the patient receive the shot she complained of tingling at the site and down her arm. Provided patient with 2 25mg Benadryl to self administer. Upon checking at 1pm and 7:00pm patient was feeling better.
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| 52 | 2021-01-14 | tingling |
About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of...
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About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of distal arm. Vital signs within normal limits. Patient improved.
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| 52 | 2021-01-14 | unresponsive to stimuli, grand mal seizure |
THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD ...
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THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD WORK WAS DONE AND CT SCAN. SENT HOME AROUND 6:30 AM ON JAN 1ST. (I DO NOT REMEMBER MUCH JUST WHAT MY FAMILY HAD TOLD ME) . I DO REMEMBER BEING SEVERLY SICK WITH VOMITING IN THE ER. CURRENTLY FOLLOWING UP WITH MY FAMILY MD AND HAVE MRI AND EEG TESTS SCHECULED WITHIN THE NEXT COUPLE OF WEEKS.
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| 52 | 2021-01-15 | tingling |
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms ...
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11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest. Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM. 911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
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| 52 | 2021-01-16 | flushing |
received vaccine at 1330. Observed until 1350. After leaving building, noticed redness/flushing on f...
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received vaccine at 1330. Observed until 1350. After leaving building, noticed redness/flushing on face and chest. Came back to building for additional observation at 1400. Given Benadryl and observed.
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| 52 | 2021-01-17 | depressed level of consciousness |
Patient received the 2nd dose covid 19 vaccine at 12:07 and at approximately 12:10 began to feel nau...
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Patient received the 2nd dose covid 19 vaccine at 12:07 and at approximately 12:10 began to feel nauseated. Patient immediately began vomiting copious amounts and had a decreased level of consciousness. Pt was responding to painful stimuli and then after a minute to verbal commands but remained with an altered mental status. HR tachycardia at 118 bpm, pulse oximetry initially 96 on room air. The rapid response team arrived, an IV was established, cardiac monitor placed, Oxygen at 15 lpm via non rebreather mask. Zofran IM given prior to IV being established. Zofran IV given next. Solumedrol given IV. Bolus of Normal Saline given. Patient transported to the emergency department via stretcher.
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| 52 | 2021-01-17 | difficulty speaking |
Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Ben...
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Received vaccine at 11:30 on 1/15, at 5:30pm developed itchiness from head to toe, took 25mg of Benadryl 1/15 at 9:30pm developed hives on back, stomach, hips and upper thighs,, hands were swollen took 25mg of Benadryl 1/16 at 3am took another 25mg Benadryl hives and itching. 1/16 630am took 25mg Benadryl and Claritin hives and itching improving. 1/16 at 9am all but 2 hives resolved to oatmeal bath and applied hydrocortisone. 1/16 at 630pm felt throat was swelling, voice change, tingling lips and thick tongue took 50 mg of Benadryl went to ER around 730pm. Was given Pepcid and 50mg prednisone in the Emergency Room. 1/16 11pm.Discharged home with prescriptions for prednisone, Benadryl and epi-pen and Pepcid. Continues now with lingering sore throat
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| 52 | 2021-01-17 | flushing |
Pt. C/O flushing, sweating and feeling feverish, an exaggeration of her reaction to the first vaccin...
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Pt. C/O flushing, sweating and feeling feverish, an exaggeration of her reaction to the first vaccine. She denied pain, difficulty breathing or other complaints. She lay down, got a cold compress and felt significantly better
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| 52 | 2021-01-17 | pain in extremity | Sore arm Tingling lips |
| 52 | 2021-01-17 | tenderness |
Headache the next day, chills, low grade fever less than 100.3, body aches, fatigue, pain/soreness u...
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Headache the next day, chills, low grade fever less than 100.3, body aches, fatigue, pain/soreness under arm/side of breast.
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| 52 | 2021-01-18 | weakness |
After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45...
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After having the vaccination, felt woozy, headache. Went to bed, up Sunday morning, about 1:30, 1:45 had sever headache, feverish, no energy, sick to her stomach. Monday morning, excessive heart rate. Did not go to work. Was pale looking. By Monday evening, felt better. Today, wasn't feeling 100% but did go back to work.
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| 52 | 2021-01-18 | facial pain, numbness, pain in extremity |
Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side...
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Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included fluticasone propionate (FLONASE), pantoprazole. The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.
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| 52 | 2021-01-18 | numbness |
constant nausea, extremely fatigued, malaise ever since injection. body aches, chills, numbness i...
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constant nausea, extremely fatigued, malaise ever since injection. body aches, chills, numbness in hands all went away but had them for over a week
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| 52 | 2021-01-18 | tingling |
Severe Headaches, Dizziness & facial tingling 10 minutes after recieving 2nd Covid Vaccine. Transpor...
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Severe Headaches, Dizziness & facial tingling 10 minutes after recieving 2nd Covid Vaccine. Transported to ER for further evaluation / treatment
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| 52 | 2021-01-19 | feeling cold | DIZZY, CHILLS, FATIGUE |
| 52 | 2021-01-20 | difficulty speaking |
Patient started getting very hoarse about 1.5 hours after vaccination. When clinic pharmacist questi...
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Patient started getting very hoarse about 1.5 hours after vaccination. When clinic pharmacist questioned patient about condition, patient only reported hoarseness and did not report any difficulty breathing or swelling in the throat or face at that time. Pharmacist discussed what to monitor and when patient should seek immediate medical attention. Patient asked if she could take any OTC products. Pharmacist discussed OTC options with patient and re-iterated what to monitor and when patient should seek immediate medical attention.
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| 52 | 2021-01-20 | feeling hot |
Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left...
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Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left anterior chest wall; Underarm and neck with pain; Underarm and neck with pain; Heat; Redness; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 08Jan2021 (15:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 10Jan2021 (15:00), the patient had severe swelling on the left upper arm and left anterior chest wall; underarm and neck were with pain; was in heat; and had redness. The adverse events resulted in the patient having a visit on the doctor or other healthcare professional office/clinic. The patient had received treatment for the reported adverse events. The outcome of the events, 'severe swelling on the left upper arm and left anterior chest wall', 'underarm and neck were with pain', 'heat' and 'redness', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
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| 52 | 2021-01-20 | flushing |
The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart wa...
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The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart was racing and very shaky. I work at a clinic, so my blood pressure was taken and it was 160/100, pulse was 120. Had a bad head ache and continued to have waves of this for about an hour.
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| 52 | 2021-01-20 | flushing |
10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 1...
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10 min. after vaccine injection: headache, scratchy throat and throat tightening lasting for about 10min and subsided. 50 min. after vaccine injection: flushed, redness in face, ears, and neck progressing to rash on chest, neck. Lasted for about 10min and subsided. Never progressing into full anaphylaxis reaction. No treatment taken.
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| 52 | 2021-01-20 | muscle spasms, pain in extremity |
Received vaccination #2 1/18/21 at 1000am. Dr. appointment at 1pm. EKG no known abnormalities. 1530 ...
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Received vaccination #2 1/18/21 at 1000am. Dr. appointment at 1pm. EKG no known abnormalities. 1530 feet achy R arm where got shot - had muscle spasms in back, Body aches, heart rate 110. 1/19/21-worked 1/19/21 no muscle spasms.
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| 52 | 2021-01-20 | pain in extremity |
She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous rep...
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She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the right arm on 09Jan2021 at single dose for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. The patient took the first dose of the Covid-19 vaccine and was fine. The lot for the first dose of the vaccine was EH9899. She received it on 19Dec2020 (at the age of 51 years). She took the second dose on Saturday (09Jan2021). She experienced nausea and had a sore arm on 10Jan2021. It was not death defying. She was also really tired on 10Jan2021. She was advised by her employer to report this information. She took some Tylenol and relaxed. She was no longer nauseated or tired. Her arm was not sore only tender. She woke up thinking she didn't sleep on an unspecified date. The patient added that her boss said she might have to be tested. The patient asked if that was something that she needs to do. The outcome of the events nausea and tired was recovered on 11Jan2021. The outcome of the event sore arm was recovering. And the outcome of the event "She woke up thinking she didn't sleep" was unknown.
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| 52 | 2021-01-21 | weakness |
Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Aro...
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Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Around 3 am, I awoke with chills and low grade fever. Tmax 103.8F, chills, pressure headache, neck/back pain, and fatigue that lasted ~30 hours. Still have mild pressure headache with mild back/neck pain and weakness.
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| 52 | 2021-01-21 | burning sensation |
2 days past vaccination shoulder pain started. Pain is burning and sharp in nature and radiate from ...
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2 days past vaccination shoulder pain started. Pain is burning and sharp in nature and radiate from the top of the shoulder to occasionally near the back shoulder blade. Range of motion is affected as it is painful to reach backwards or straight out laterally. Taking 800 mg of Ibuprofen every 6-8 hours to help ease burning sensation. Not always completely helps.
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| 52 | 2021-01-21 | flushing |
52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today d...
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52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today developed chills and fever. 101.5 now. Also has rash on breast and stomach. Flushed. Headache, nausea and myalgias.
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| 52 | 2021-01-21 | numbness, sensory loss, tingling |
immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my ...
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immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my left arm and into my left jaw. i started to have tingling and loss of sensation to the left side of my face that extended from the left lower eyelid to 4 cm down the left side of jaw, midline to trachea, midline to left nare and radiating to the mid inner left ear canal. I had a burning sensation in the inner left ear canal as well as the left lower lid. Spoke with Dr and was placed on Prednisone 60mg po daily x 10 days with a taper and Valacyclovir 1gm po bid x 10 days. The degree of parenthesis as of 1-22-21 is improved to now encompass from the edge of left nare to the outer canthus of left eye, into the edge of the left ear canal and the edge of the jaw.
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| 52 | 2021-01-21 | pain in extremity, feeling cold |
Sore arm started on evening of January 20th (date of injection), 2:00 p.m. January 21st severe body ...
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Sore arm started on evening of January 20th (date of injection), 2:00 p.m. January 21st severe body aches, chills and extremely tired. Around 3 a.m. of January 22nd those symptoms where getting better but just below the injection site there is a large red area that is hot and swollen and that is still continuing as of 7:08 p.m. January 22nd
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| 52 | 2021-01-21 | pain in extremity |
Early morning of January 21st right arm very sore from injection then at 2:00 p.m. January 21st almo...
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Early morning of January 21st right arm very sore from injection then at 2:00 p.m. January 21st almost exactly 24 hours after the shot, I started feeling very tired, severe body aches and chills. The next morning on January 22nd about 3:00 a.m. those symptoms where much better BUT down below the injection site is swelled up, red in the size of about a softball and very hot. It is now 5:40 p.m. January 22nd and no improvement with that.
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| 52 | 2021-01-22 | tingling |
paresthesia arms and legs for 2 days following Covid vaccine - Day 3 upper body only (has not gotten...
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paresthesia arms and legs for 2 days following Covid vaccine - Day 3 upper body only (has not gotten worse - just a mild tingling sensation) - no pain
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| 52 | 2021-01-23 | pain in extremity |
After receiving 2nd dose of Pfizer vaccine, within 5 minutes, c/o chest pressure, tachycardia (P=105...
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After receiving 2nd dose of Pfizer vaccine, within 5 minutes, c/o chest pressure, tachycardia (P=105) and left arm pain. team was called and was taken to the ER.
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| 52 | 2021-01-24 | weakness | Generalized weakness,and muscle/bone aches , slightly dizziness, loss of appetite for 3-4 days |
| 52 | 2021-01-24 | burning sensation |
headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petec...
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headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petechiae on abdomen abd burning pain (lymph nodes) in right underarm.
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| 52 | 2021-01-24 | feeling hot |
My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a ...
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My face felt hot; face and lip were slightly swollen; face and lip were slightly swollen; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) via an unspecified route of administration at left arm on 12Jan2021 17:00 at single dose for COVID-19 immunization. Medical history included COVID prior vaccination. Concomitant medication included unspecified medications. The patient previously took hydrocodone bitartrate paracetamol (VICODIN) and experienced known allergies. After approximately 45 minutes after vaccination, her face felt hot and her face and lip were slightly swollen from 12Jan2021 18:00. No treatment received. No other vaccine in four weeks. No COVID tested done post vaccination. The outcome of the events was recovering.
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| 52 | 2021-01-24 | numbness, throat numbness | Systemic: Other- numbness/tingling of face and throat and neck; symptoms lasted 1 day |
| 52 | 2021-01-24 | pain in extremity, muscle spasms |
The evening of injection, started with muscle spasms and aching in deltoid. Over the next day the p...
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The evening of injection, started with muscle spasms and aching in deltoid. Over the next day the pain worsened and spread up into my neck, shoulder and down into elbow and forearm. The pain is intense 7/10 and constant. Pain is disrupting my daily activity and sleep. I?ve tried ibuprofen, Tylenol, voltaren gel, lidocaine patches, icy hot, Celebrex, bio freeze, steroid injection, toradol injection, tramadol, multiple massages, hot showers, ice, tens unit, cbd oil. All of these treatments have done very little for the pain
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| 52 | 2021-01-24 | pain in extremity |
Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provide...
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Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provider informed me I was there on the wrong day but told me she would fit me in so I would not have to come back. After receiving the 2nd dose and waiting the 15 minutes, I realized that the time between shots were 14 days instead of 21. The HCP was contacted and was to reach out to vaccine provider. 1/23/2021 = date of receiving shot = no symptoms 1/24/2021 = 3:10 am woke with 102.1 fever, sore arm, body aches, and my skin hurt. Woke again at 8:00am with fever of 101.3 and the same symptoms. Alternated Tylenol and Ibuprofen every 2 yours. Fever went away around 10:00am but went still had body and skin aches and tired. 1/25/2021 = woke with no fever, but arm still hurt and so does the gland in my armpit. Still have body & skin aches. I am tired and I feel slightly off. My eyes are very tired.
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| 52 | 2021-01-24 | pain in extremity | Lump on the left side of neck, pain on the underarm |
| 52 | 2021-01-24 | pain in extremity |
Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and ...
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Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..
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| 52 | 2021-01-24 | tremor |
Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Musc...
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Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Muscle aches; Fever finally broke at 3pm on the next day 17 hours after symptoms began; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on the left arm on 09Jan2021 at 11:00, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 22Dec2020 at 11:00 for COVID-19 immunization. On 09Jan2021, the patient had shot at 11am with no reaction then at 10pm when started shaking/shivering violently for 2 hours and then developed very bad headache, muscle aches. The patient's fever up to 101 then the fever finally broke at 3pm on the next day (10Jan2021) 17 hours after symptoms began. As treatment, patient took Tylenol and Excedrin for headache, muscles aches and fever. No treatment was reported for the events shaking/shivering. The outcome of the event fever was recovered on 10Jan2021 15:00 while the rest of the events was recovered on Jan2021.
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| 52 | 2021-01-25 | weakness |
had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous ...
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had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous report from a contactable other hcp (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 4176), via an unspecified route of administration on the left arm on 12Jan2021 13:15 at a single dose for covid-19 immunisation. Medical history included PCN allergy from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications included multivitamins, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685) on 22Dec2020 13:00 on the left arm for covid-19 immunization and stated that had no issues after first vaccination. On 12Jan2021 21:00, the patient had fever max 100.8 (no unit reported), chills, severe body aches, headaches, weakness, and fatigue. The patient underwent lab tests and procedures which included body temperature: max 100.8 (no unit reported) on 12Jan2021 21:00. As treatment, patient received OTC NSAIDS. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 52 | 2021-01-25 | numbness |
I received the Covid-19 vaccine at noon today and at 7:30 pm I began having significant bilateral fa...
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I received the Covid-19 vaccine at noon today and at 7:30 pm I began having significant bilateral facial numbness, left side greater than right side with lower lip numbness greater than upper lip numbness.
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| 52 | 2021-01-25 | pain in extremity | fever chills body aches nausea headache arm pain |
| 52 | 2021-01-26 | burning sensation |
1/20: spot on back burning, right side only. 1/21: chest pain from burning 1/22: Lyrica and Valcyclo...
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1/20: spot on back burning, right side only. 1/21: chest pain from burning 1/22: Lyrica and Valcyclovir started, spread to other dermotones. 1/23: burning face/arms. was seen by PCP 1/25: burning on other arm, right. Seen by provider in ED at place of work.
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| 52 | 2021-01-26 | facial paralysis | facial droop Left |
| 52 | 2021-01-26 | feeling hot | Swollen arm, redness, hot Headache Chills Body aches Runny nose Sneezing |
| 52 | 2021-01-26 | numbness, hot flush, cold sweat | Face swelling and numbness, lightheaded, hot flashes with cold clammy skin |
| 52 | 2021-01-27 | weakness |
After leaving injection center (after waiting 15 min) while driving down the road started getting th...
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After leaving injection center (after waiting 15 min) while driving down the road started getting the feeling of my throat swelling. This progressed and got very light headed and weak for about 2 minutes. Throat tightness continued for about 1 hour but did not cause trouble breathing. At one point felt like I was unable to swallow. Monitored by coworkers when arrived at work and chose not to go to ED unless symptoms worsened which they did not.
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| 52 | 2021-01-27 | feeling hot, numbness |
slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right sid...
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slightly light headed; rt hand got red & hot; rt hand got red & hot; numb, heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
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| 52 | 2021-01-27 | flushing, feeling hot |
Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post ...
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Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post vaccine observation. At 0935 provider notified that customer was feeling sweaty with tingling in her tongue. Customer appears mildly flushed, calm. States that she chose to wait a little longer in the observation room because she does not ?feel right.? Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. She reports ?tingling? in the middle of her tongue and is feeling hot and diaphoretic ? different from the same menopausal symptoms that has been experiencing prior to this appointment. BP 120/78, HR 71, O2 95% RA, RR 18. Lungs CTA, RRR. Customer accepts Benadryl 50mg PO @ 0939. No rash, hives noted on exposed skin or at site of injection in left arm. Customer monitored at site. Over the course of the next 40 minutes, she reports feeling better. BP 120/70, HR 78, O2 97% RA, RR 16 @ 1022. She states that her tongue is still a bit tingly but denies feeling other worrisome symptoms she was previously experiencing. She denies feelings of facial/tongue/throat swelling, CP, SOB. Reports slight dizziness that she feels is related to Benadryl. Customer's husband (medical provider) present to drive her home. Customer states she will not be home alone. Customer aware that this provider will notify PCP Team of incident for post vaccine check in. Customer denies questions/concerns at this time. Customer released from site at 1025 ambulating independently with steady gait, no escalation of symptoms reported, no obvious s/sx of distress.
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| 52 | 2021-01-27 | numbness |
By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop ...
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By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop at stop sign, and my daughter in law told me she wanted to drive me because I was scaring her and I was being mean to her, very snappy. The next morning I had a fever 100, muscle ache, heart racing, headache and I stayed in bed all day. I took 2000mg Ibuprofen, 800mg Tylenol, Benadryl 10mg. On the 20th I was still lethargic had body aches and heart was racing, I took 800mg Tylenol that day. The 21st I had dizziness, brain fog, heart racing, lethargic. The 22nd I contacted the work Nurse and let her know what was going on, my heart rate was 140. They told me I was probably having a reaction and would go away in a couple days. On the 24th,25th,26th,27th I started having chest pain, lethargy. I had a clinic visit with my PCP on the 28th and she said my BP was 160/90, I never had BP issues. She ran test. The 29th I still had brain frog, lethargy, chest pain. I could feel my heart beat in my ear especially at night, I have never has BP issues in my life. On the 30th my heart ponding sound was in my ear. January 16th I went to the ER my heart was 130 and BP 187/108, they did a full work up on me. She started me on Metprolol-50mg(extended release). I seen the cardiologist on 1/20 and told me I had left atrial enlargement , mitro-valve regurgitation . I had an echo- cardiogram on 1/25. The medicine has definitely helped me .
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| 52 | 2021-01-27 | pain in extremity | Arm pain, nausia, vomiting, fatigue and slept for 18 hours straight. |
| 52 | 2021-01-27 | seizure |
Petite mal seizure blank stare with poor respond to staff. Has not experienced this effect under cur...
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Petite mal seizure blank stare with poor respond to staff. Has not experienced this effect under current med regimen in 3 years according to caregiver.
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| 52 | 2021-01-28 | burning sensation |
Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritatio...
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Started to feel an irritation behand my right ear, then along my jaw line. Thought it was irritation from mask wearing. Then I had a burning sensation in my hair. Similar to a sunburn then getting chills. Wednesday night I noticed three pimple like bumps in my hair--right posteriorly. A bit itchy at times. Thursday right under my jaw line seems to have swelling. This morning it feels the same. Burning like irritation in my hair.
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| 52 | 2021-01-28 | feeling cold |
Extream fatigue and chills unable to continue work. I am on day 3 now at home coming in and out of ...
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Extream fatigue and chills unable to continue work. I am on day 3 now at home coming in and out of sleep and freezing cold. Hoping it won't last much longer.
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| 52 | 2021-01-28 | numbness, tingling |
1/25/2021 11:59:51 AM > 1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c...
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1/25/2021 11:59:51 AM > 1145: BP 138/74, P 73, O2 98 Five minutes after receiving vaccine patient c/o numbness and tingling in L arm where vaccine was administered with radiating pain to L shoulder, RN added 10 minutes to observation and educated patient to go to the nearest ER if symptoms aren't resolved 1/26/2021 09:08:07 AM > called to check on patient, message left
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| 52 | 2021-01-28 | pain in extremity |
Vaccine was on Wednesday 1/27/21 at 8:30. Felt a little off and sore arm during the day Wednesday....
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Vaccine was on Wednesday 1/27/21 at 8:30. Felt a little off and sore arm during the day Wednesday. Started with some body ache during night ( approximately 13:30 a.m.) at sleep. Woke up at 5 a.m. with fatigue, significant nausea and a headache. Unable to go into work. Headache improved by mid day. The fatigue and nausea continued and gradually decreased, lasted until laterThursday evening. Returned to work at 6:30 a.m. on Friday.
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| 52 | 2021-01-29 | feeling cold |
Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevat...
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Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevated systolic BP, better within 30 mins. Also mild body itching, still having. Woke up this morning, ~24 hours post- injection with sever joint and muscle aches, chills etc. had to cancel work.
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| 52 | 2021-01-30 | feeling hot |
Pt received Pfizer COVID-19 vaccine. Approximately 8 minutes after administration, pt alerted me to ...
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Pt received Pfizer COVID-19 vaccine. Approximately 8 minutes after administration, pt alerted me to feeling hot with mild chest tightness. She stated she has anxiety and was anxious about receiving vaccine. She confirmed no swelling of the tongue, no SOB, no itching or other signs of anaphylaxis. Pt given diphenhydramine x2 and famotidine x1 along with a cup of water. Pt requested O2 and BP be monitored. O2 sat never below 97, BP was high initially at 153/112. Pt also had jacket on initially. Pt advised to breath and relax. Pt reassessed after 10 minutes. Removed jacket for BP check which had come down to 132/94 which pt states is baseline for her as she does have a bit of high BP. She also reported at that time feeling better and had calmed down. She stated she really felt it was anxiety. She left with instructions to call 911 or seek emergency attention if Sx reoccur.
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| 52 | 2021-01-30 | feeling jittery | Upset stomach, jittery feeling, mild headache |
| 52 | 2021-01-30 | pain in extremity | Chills Headache Soreness in arm |
| 52 | 2021-01-31 | weakness |
fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous ...
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fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 07Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included Meniere's disease, and allergies to Latex. The patient previously took cefalexin (KEFLEX) and codeine and experienced allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 17Dec2020 17:30 in the left arm for COVID-19 immunization. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications. On 08Jan2021 03:00, about 10 hours post vaccine, the patient experienced fever between 103 to 103 f, severe body aches, fatigue, and generalized weakness which lasted until about 60 hours post vaccination. The patient has not undergone COVID testing post vaccination. The outcome of the events was recovered on 10Jan2021 15:30.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-31 | weakness |
Bouts of vertigo; Dizziness; Weakness; Nausea; This is a spontaneous report from a contactable nurse...
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Bouts of vertigo; Dizziness; Weakness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 52-years-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: e10142) via an unspecified route of administration on 13Jan2021 09:15 at single dose in left arm for COVID-19 immunisation. She received the first dose (Lot number: Ej1658) in left arm on 23Dec2020 06:30 PM for COVID-19 immunisation. Medical history included diabetes, hypertension. The patient was not allergic to medications, food, or other products. Concomitant medication included metformin, metoprolol tartrate (METPROLOL), triamterene, rosuvastatin, pyrvinium (TRU). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the 2nd dose on 13Jan2021, experienced weakness, dizziness and nausea at around noon next day (14Jan2021 12:00 PM) then at around 6:00 pm bouts of vertigo. Up to now 5 day after the onset dizziness and vertigo still present. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for events. Events outcome was not recovered.
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| 52 | 2021-01-31 | weakness |
Approx 4pm 1-31-2021, I began to feel aching and weak. About 5 min later severe chills and fever en...
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Approx 4pm 1-31-2021, I began to feel aching and weak. About 5 min later severe chills and fever ensued. Fever was 101.8 F. Extreme fatigue. Went to bed at 6:30pm as headache came on also. Middle of the night woke up soaking we as fever broke. Feel just a bit aching and fatigued today 2/1/2021
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| 52 | 2021-01-31 | weakness |
Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chil...
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Pt states first s/s at 1500 she started to feel body aches, HA, dizzy, nausea, loss of appetite chills and fever of 100.7 with episodes of sweating profusely. 1/19/21 Pt states fever continues, body aches, (L) axillary lymph node swelling, HA, Nausea and a episode of Tachycardia that she recorded temp. ranged 101-102.2. 1/21/20 Pt stated to have cont. fever 102.2, HA, BA, sweating and lymph nodes swelling from (L) axillary to back painful. Pt States on 1/21/21 cont. sweating loss of appetite, nausea, weakness, fatigue injection site pain, no redness, warm, and palpable lump. Pt stated 1/23/21 body aches and fever. Pt resting drinking fluids as tolerated and taking advil 400 mg PRN 4mg Zofran
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| 52 | 2021-01-31 | discomfort |
initially felt very nauseated, later that day had cold chills, felt like she had a fever, always run...
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initially felt very nauseated, later that day had cold chills, felt like she had a fever, always runs 96.6, temp was 99.5, went to bed, woke up thru the night with 'restless legs' could not get comfortable, joint/body pains, fatigue, as of today 2/1/21 still has joint pains and restless leg syndrome, needs sleep aids, taking several supplements for inflammation, omega 3, turmeric, vit C, apple cider vinegar, Tylenol and Advil (starting to upset stomach), going to MD this week
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| 52 | 2021-01-31 | feeling hot, numbness |
"Felt a funny sensation in my arm. It goes all the way down to my fingers. Its a dull numbness sen...
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"Felt a funny sensation in my arm. It goes all the way down to my fingers. Its a dull numbness sensation." She has full ROM & and feels warm. Hasn't had this before. More noticed on lateral position left arm. Only fingers affected: pinky and ring. 06:14PM SpO2 100%, HR 72, BP 120/83
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| 52 | 2021-01-31 | feeling hot, pain in extremity |
Day after vaccine, severe arm pain to the extent left arm was minimally functional. Moderate arm pai...
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Day after vaccine, severe arm pain to the extent left arm was minimally functional. Moderate arm pain 2 additional days. Minor arm pain for few more days. Fatigue, general tiredness, sore throat for a week, although still experiencing sore throat. Unsure if that's environmental. Back pain (kidney area) beginning few days after injection, lasting several days. Non-muscular pain, more internal such as kidney pain. Worst symptoms: Itching, redness, swelling, inflammation below the injection site, approx 3"Hx7"W band across my left arm,beginning about 2" below the point of injection. Today is day 12 and I'm still experiencing this. Moderate itching 24 hrs, mild swelling, red, hot, inflamed. Symptoms are less severe at this point.
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| 52 | 2021-01-31 | migraine | Pfizer-BioNTech Covid-19 vaccine EUA HA and migraine |
| 52 | 2021-01-31 | migraine |
39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), di...
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39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), diarrhea, nausea, had temp of 99.5F for one day, fatigue.
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| 52 | 2021-01-31 | tremor |
Chills & shaking-lasted 24 hours Severe congestion-lasted 2 days Throat swelling-this happened the s...
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Chills & shaking-lasted 24 hours Severe congestion-lasted 2 days Throat swelling-this happened the same time as the congestion started and made me feel like I could not breathe. It only lasted a few minutes. Fever of 102.9-fever lasted less than 24 hours Severe headache and body aches-lasted 72 hours Nausea and vomiting-could not even keep anti-emetics down. Lasted 48 hours. I know many of these effects are considered a normal reaction to the vaccine. However, the throat swelling and feeling like I could not breathe was concerning. It happened about 30 minutes after the chills/shaking started and right before I actually began to feel sick.
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| 52 | 2021-02-01 | weakness |
I felt weak; hard to focus; fatigued; This is a spontaneous report from a contactable healthcare pro...
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I felt weak; hard to focus; fatigued; This is a spontaneous report from a contactable healthcare professional (the patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 19Jan2021 at 12:45 (at the age of 52-years-old) as a single dose for Covid-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient's concomitant medications included omeprazole (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Jan2021 at 13:30, the patient experienced felt weak, hard to focus, and fatigued. It was reported that the shot was at 12:45 pm, the patient had to lay down until she went to bed. Felt 80% better in the morning. The patient did not receive any treatment for the events. The clinical outcome of the events asthenia, disturbance in attention and fatigue was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 52 | 2021-02-01 | pain in extremity |
painful arm; fatigue/body fatigue/she felt fatigued; sick; abdominal cramping; diarrhea; This is a s...
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painful arm; fatigue/body fatigue/she felt fatigued; sick; abdominal cramping; diarrhea; This is a spontaneous report from a contactable nurse, the patient. This 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3246), dose 1, single dose via an unspecified route of administration in the left upper deltoid on 18Jan2021 at 18:00 (at the age of 52 years-old) for COVID-19 vaccination. Relevant medical history included ongoing diabetes type 2 in 2011. Concomitant medications were unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021, the patient experienced a painful arm, more painful than other vaccines and then she had body fatigue about 2 hours after the injection. illness, diarrhea 3 times and abdominal cramping that was painful. Seriousness was not provided. It was unknown if any treatment was given. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of events, painful arm and fatigue/body fatigue was not recovered. The clinical outcome of events sick, abdominal cramping and diarrhea was unknown.
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| 52 | 2021-02-02 | weakness |
I exp fever greater than 100.9, fatigue, screaming headache,chills,weakness lasting about 4 day. Als...
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I exp fever greater than 100.9, fatigue, screaming headache,chills,weakness lasting about 4 day. Also around the injection site was extreme pain. I missed 2 days of work.
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| 52 | 2021-02-02 | burning sensation | 4 days post vaccine developed front and back torso rash with burning and itching |
| 52 | 2021-02-03 | burning sensation |
Normal vaccine related symptoms 24-48 he following vaccine, seemed resolved by day 5. On day 6 start...
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Normal vaccine related symptoms 24-48 he following vaccine, seemed resolved by day 5. On day 6 starting feeling a burning sensation, a sore developed at the injection site. Today is 17 days post injection, the sore is scabbed and resolving, burning has subsided, but shoulder is tight and somewhat painful when doing something like yoga.
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| 52 | 2021-02-03 | numbness, tingling |
Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS ...
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Within 10 mins I had swelling, tingling and some numbness in my face and neck. I was checked by EMS at the site. Waited another 20 mins and the symptoms did not get worse or rapidly improve. I had a prescheduled doctor appointment and went directly to the doctor's office after the vaccine. Dr. confirmed that I had swelling and redness in my face and prescribed Methylpredsisolone 4mg 21 pack of steriods to take. That medication removed the symptoms. On 02/01/21, 24 hrs after the last dose of the pack, the face swelling and tingling returned. As recommended I took Benedryl 2 tablets / 3 doses. I returned to Doctor's office on Tues 02/02 where she prescribed Presnisone 20mg for 5 days after seeing the swelling in my face and she said my lymph nodes were swollen as well.
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| 52 | 2021-02-03 | muscle spasms, feeling of body temperature change |
allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vac...
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allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. They evaluatedI started feeling better towards the end of last week. Additional information for Item 18: allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. me for another 15 minutes and they recommended that I be evaluated in the ED. The right arm was noticed to be red. The injection site was painful. I was evaluated by the MD and given medications per their protocol (epi, Benadryl, famotidine, steroid). I was discharged home around 1830 (with a ride) after my throat seemed to be getting better. I was discharged with an Rx for steroids, blockers and and epi pen. Later that night at about 2200, I woke up with my face/scalp itching. I continued feeling achy, intense headache, hot/cold, foggy mind. I called in sick for my shift on 1/19. I returned to work on 1/20 with minor symptoms.I was evaluated by my MD on 1/21 and had minor expiratory wheezes (I have asthma). I seemed to be feeling better until Saturday and then stomach cramping/muscle cramping (noticeable on the right hand/injection side), bad headaches, fatigue have resumed. ; 2/2 I started feeling better towards the end of last week. Still feeling off but able to do my normal routines.
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| 52 | 2021-02-03 | muscle spasms |
felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Be...
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felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Became limited in movements such trying to picking up items from the floor; difficulty running or walking fast as I usually do; Lots of spasms in the sacral area; Difficulty sleeping; Difficulty sleeping and going from sitting to standing; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in the left arm, on 09Jan2021 15:30, at single dose, for COVID-19 immunization, at the pharmacy. There was no medical history and no known allergies. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), diphenhydramine hydrochloride (BENADRYL), herbal nos, minerals nos, nutrients nos, vitamins nos (CATALYST) and "Muscle Strength". The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccines in four weeks. The patient reported that on 12Jan2021 at 14:00, "I ardently felt a tinge of pain in my sacral area. Then it got worse each hour. Then I became limited in movements such trying to picking up items from the floor and difficulty running or walking fast as I usually do. It worsened daily. I would workout and then I experienced lots of spasms in the sacral area. It became painful. The patient experienced difficulty sleeping and going from sitting to standing." The events resulted to "Doctor or other healthcare professional office/clinic visit". Treatment for the events included prescription muscle relaxants (unspecified), ibuprofen and "topi". The patient was recovering from the events.
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| 52 | 2021-02-03 | pain in extremity |
Day of shot, slightly sore arm. Next day, very sore arm so much so that I was unable to sleep on tha...
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Day of shot, slightly sore arm. Next day, very sore arm so much so that I was unable to sleep on that side, plus mild headache, feverish, chills, and body aches. The headache, feverish, chills and body ache lasted all day until I took 400 mg of ibuprofen.
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| 52 | 2021-02-03 | pain in extremity |
I received vaccine on 2/3/21 at 10:35 am. That evening I was tired and had arm tenderness. The next...
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I received vaccine on 2/3/21 at 10:35 am. That evening I was tired and had arm tenderness. The next morning (4:30 am), when I woke up for work, I was unable to walk without assistance due to dizziness. If I do not move my head, I am able to sit or walk slowly.
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| 52 | 2021-02-03 | tremor |
Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Mediu...
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Systemic: Headache-Severe, Systemic: Other- Heart palpitations, dry/burning lips, hand tremors-Medium; lasted 1 day
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| 52 | 2021-02-04 | pain in extremity |
Developed immediate left arm pain that worsened to rotator cuff injury and decreased range of motion...
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Developed immediate left arm pain that worsened to rotator cuff injury and decreased range of motion at left shoulder. Patient went to see orthopedic physician on Jan 29, 2021 and started physical therapy Feb 2, 2021. Currently physicl therapy is ongoing.
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| 52 | 2021-02-06 | weakness |
Around 11am: Chill, fever 1-2 hours later: started to cough, had fatigue, body aches, temp went up ...
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Around 11am: Chill, fever 1-2 hours later: started to cough, had fatigue, body aches, temp went up to 102.1 F (ear) Around 4pm: took theraflu and fell asleep Around 10pm: ate some soup, took theraflu and fell asleep (temparature: 100.2 F) Next day (2/5/2021): felt better except weakness, rested whole day Next day (2/6/2021): went back to almost normal condition
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| 52 | 2021-02-06 | pain in extremity, tremor |
1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel so...
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1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel soreness and ache - day#2- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish - day#3- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish, plus irregular heart beat - day#4- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish intensified - day #5- body ache subsided, Headache and nausea continued to feel intensified. Fever now turn into chills - day#6- unbearable headache and worse nausea feeling, chills, need to leave work in the afternoon. Throwed up and shaking. Took many headache medications and antinausea medications but nothing work. 2. 2/5/2021 @1630- received 2nd dose Pfizer COVID 19 vaccine - day#1, 1 hour into receiving vaccine, feeling dizzy and "hangover" type reaction. 2 hours into receiving vaccine, developed irregular heart beats. Left arm injection pain and sore arm. - day# 2: entire body ache, joint pain, headache and nausea - day#3: severe headache and feeling nauseous. Took many headache and antinausea medications. - will continue to follow adverse reactions.
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| 52 | 2021-02-07 | slurring |
As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and wen...
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As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and went into the kitchen to make coffee. She states she woke up 15 minutes later and had lost consciousness. She went to her husband who said her words were slurred. She did not seek medical help until the following day when urged by her co-workers to do so. Then she brought a note back to work that stated she had a concussion and nothing of how or why she got the concussion. On February 4th i received a copy of her office visit that state she is alright to return to work and get the 2nd dose of vaccine with stipulations of having the following day off from work.
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| 52 | 2021-02-07 | migraine | Migraine |
| 52 | 2021-02-07 | tremor |
This was my second dose. Fever as high as 103.4F. Fever lasted 24 hours above 100.0F Chills, Sha...
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This was my second dose. Fever as high as 103.4F. Fever lasted 24 hours above 100.0F Chills, Shaking for 4 hours from about 8/9 pm to 12/1am. Nausea, vomiting, bowel pain, inflamed rectum after bowel movement the next day, loss of hearing, dizziness, Trying to sleep and waking up gasping for air about 5 times though out the early morning. Sever Headache which lasted Two and a half days. About 2 pm on 2/5/21 I took some Emetrol for the Nausea, and Tylenol for headache and fever. I took Tylenol again the evening of 2/5/21. On 2/6/21 I Tylenol and then Ibuprofen then Excedrin. On 2/7/21 I took Excedrin once and my headache was finally gone.
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| 52 | 2021-02-08 | feeling hot |
Patient received 1st dose 3 weeks prior without reaction. She received second dose today at approxim...
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Patient received 1st dose 3 weeks prior without reaction. She received second dose today at approximately 11:30am. She felt fine after the second vaccination, until about 1:30-1:45pm. Patient c/o a "heat rush", headache, and hives on BUE. Patient vitals were WNL except HR was slightly tachycardia at 107bpm. Respirations were baseline at 18. Patient denies sob/anaphylaxis. Benadryl administered orally, and monitored. No reaction was had with the first vaccine.
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| 52 | 2021-02-08 | pain in extremity | Sore arm Tired feeling Body malaise |
| 52 | 2021-02-09 | numbness, bell's palsy |
On February 4, 2021, patient woke up at 3 a:m, left eye kept opening and closing, vision was blurry,...
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On February 4, 2021, patient woke up at 3 a:m, left eye kept opening and closing, vision was blurry, and left side of face numb by lips and jaw. She took 2 Benadryl and took a nap Thursday afternoon. She went to the ED later and was told it may be Bells' Palsy but was referred to PCP. She is on 5 mg Prednisone but rheumatologist increased dose and put on 5 day regimen. She saw PCP and he told her she had Bell's Palsy and just to follow regiment prescribed by rheumatologist.
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| 52 | 2021-02-09 | pain in extremity |
Moderate pain in arm of the injection, some all over body aches, fatigue approximately 1 day after t...
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Moderate pain in arm of the injection, some all over body aches, fatigue approximately 1 day after the second injection. After the first injection only pain in the arm which received the injection. Took 2 Tylenol with onset of the pain and repeated when necessary with the first injection. For second injection took 2 Tylenol pills and arm pain and body aches subsided. After both injections, side effects only lasted a day.
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| 52 | 2021-02-09 | pain in extremity | Sore arm, full body aches and extreme fatigue for 24 hours starting 2/6. |
| 52 | 2021-02-09 | tingling |
History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years a...
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History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years ago. Developed nausea, lightheadedness, headache, and shortness of breath 14 min after vaccine. Vital signs stable on admission to observation area and heartrate regular with apical auscultation. Forty-five min after vaccine, began having some chest pressure and tingling in her arms. Her heart rate irregular at 68 bpm. Employee called her cardiologist who advised her go to the emergency room. No history of angioedema.
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| 52 | 2021-02-11 | tremor |
12:30 EE state feeling "weird" dizzy and shaky. EE was seated with legs elevated. Provided juice an...
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12:30 EE state feeling "weird" dizzy and shaky. EE was seated with legs elevated. Provided juice and cool compress HR 68 RR 16 12:43 feeling "back to normal" Increased sneezing and nasal congestions NKA continue to monitor 13:00 Hr 80 RR 18 SPO2 100% BP 184/89 EE reportedly hypertensive at baseline 13:05 Benadryl 25mg po provided 13:10 Continues to feel "back to normal" Ambulating well. Escorted to parking structur by RN.
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| 52 | 2021-02-14 | tingling, burning sensation, feeling cold |
1 hour post injection, patient returned to the vaccine clinic c/o burning and tingling (L) side of f...
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1 hour post injection, patient returned to the vaccine clinic c/o burning and tingling (L) side of face near cheek bone & eye. While talking, she developed a "cold sensation, like when you get IV fluids" on her left side.
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| 52 | 2021-02-14 | tremor, feeling cold, discomfort, pain in extremity |
At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; ...
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At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; Both arms as well as pectoral muscles hurt; Very dizzy; fever up to 102.1 Fahrenheit; uncomfortable like I needed to get something out my body; This is a spontaneous report from a contactable nurse reported for herself. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 29Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included HTN (hypertension). Concomitant medication included losartan and hydrochlorothiazide (HCT) received in two weeks. There was no other vaccine received in four weeks. At approximately 29Jan2021 16:00, the patient started shaking and extremely cold. The patient experienced both arms as well as pectoral muscles hurt. The patient experienced very dizzy and uncomfortable like she needed to get something out her body. This lasted for over 24 hours with fever up to 102.1 Fahrenheit. All events occurred on 29Jan2021 16:00. The events resulted in congenital anomaly or birth defect (pending clarification). No treatment received for the events. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-02-15 | numbness, burning sensation |
approx 4-5 hours after vaccine I began to have burning on the soles of my feet when I walked. It fel...
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approx 4-5 hours after vaccine I began to have burning on the soles of my feet when I walked. It felt like I was walking on hot coals. This continued in both feet for approx 24 hours. It never went away completely in the R foot. My right foot continues to have burning pain, inflammation, and occasional numbness in my toes. It is more localized to plantar fasciitis area now. I have had a cortisone shot, muscle rub salve, anti-inflammatories with no relief in R foot. I have another podiatry appt tomorrow and an appt with neurologist on Thurs. PCP and podiatrist said they think it may be an inflammatory response to the vaccine that irritated something that was "already brewing" in that area.
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| 52 | 2021-02-15 | muscle spasms, tremor |
(during the night of sleep only) Fever, violent shaking, head ache, charlie horse in calves; (daytim...
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(during the night of sleep only) Fever, violent shaking, head ache, charlie horse in calves; (daytime) achy, sore joints, head ache, fever
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| 52 | 2021-02-16 | tingling, numbness |
Patient experiences numbness and tingling on left side of face 3-4 hours after vaccination. She ment...
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Patient experiences numbness and tingling on left side of face 3-4 hours after vaccination. She mentioned it felt like going to the dentist and having numbing medicine. She states it lasted for 3 days without medical intervention. Shed stated that on Monday the 8th she went in for estrogen and testosterone "pellets", Symptoms of numbness and tingling returned on Saturday the 13th with numbness, tingling on left side of her face and roof of her mouth. On Sunday the 14th she started getting a rash on the left side of her face and jaw line. She called today to report these symptoms and will be speaking with her PMD tomorrow.
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| 52 | 2021-02-16 | seizure like phenomena | not feeling well , seizure like activity. I ER itch feeling. treated with Benadryl. |
| 52 | 2021-02-17 | discomfort |
I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfor...
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I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfort; blood in my urine; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Jan2021 at 10:30 AM as a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient ha d no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, has not been tested for COVID-19 since the vaccination, and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine and also did not receive any other medication within two weeks of vaccination. The patient had a headache on 22Jan2021 for 5 days. She also had stomach bloating and pressure and discomfort on 22Jan2021. It was reported that when she saw blood in her urine, she went to a walk-in and was diagnosed with a UTI on 22Jan2021. She did 7 days of an antibiotic. Then on 30Jan2021, she had an abscess tooth that became infected. It was reported that the patient received antibiotics for both infections. It was reported that the events result in a doctor or other healthcare professional office/clinic visit and an Emergency room/department or urgent care. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 52 | 2021-02-17 | facial pain |
chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and i...
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chills; temp got to 103.5 (fever); swollen, sore glands to the left side of my jaw, underneath and in front of my ear; swollen, sore glands to the left side of my jaw, underneath and in front of my ear/gland pain; nasal drainage to my left sinus/nostril; inside of her left cheek felt like there were lesions breaking out but there were none; her cheek and teeth were sore, as if she had a sinus infection; her cheek and teeth were sore, as if she had a sinus infection; sinus drainage became blood tinged. It is pale pink in in color, not constant/bloody drainage; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unspecified date and appendectomy in 1991. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE). The patient previously took atropine sulfate (SULFAS ATROPINE, reported as Sulfa), quinolones and doxycycline and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (lot number: EL0142, expiry date not reported) in the left arm on 30Dec2020 at 5:30PM at single dose for COVID-19 immunisation. On 19Jan2021 02:00, she started with chills and by 24 hours, her temp got to 103.5 (fever). The patient took Tylenol. The temp stayed in the 100-101 range for the next 24 hours. Then, she started to have swollen, sore glands to the left side of her jaw, underneath and in front of her ear. The inside of her left cheek felt like there were lesions breaking out but there were none. She then had copious amounts of thin nasal drainage to her left sinus/nostril. Over the next few days, the gland pain subsided but she still had drainage and her cheek and teeth were sore, as if she had a sinus infection. She would occasionally take Tylenol and on occasion, took cold and flu medicine. Then, her sinus drainage became blood tinged. It was pale pink in in color, not constant, but when the drainage started, it was sudden and just drained with no warning. She smelled old blood. She turned in bed and the drainage occurred suddenly and she can taste old blood. Almost two weeks later, and she still had bloody drainage. Clinical outcome of the events was not recovered.
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| 52 | 2021-02-18 | feeling hot |
Immediately felt heart tightness/warmth; completely resolved the following morning Delayed- itching ...
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Immediately felt heart tightness/warmth; completely resolved the following morning Delayed- itching (full body); Began after 15-20min lasted the remainder of the day and nearly completely resolved the following morning. Delayed Hives (to neck/face above neck); resolved the following morning Delayed injection site soreness; Began 4-5hrs after the injection worsened, extremely tender to touch Following morning the injection site is slightly raised, red to pink, warm to touch, swollen 2-2.5cm in circumference around the injection site, some itching remains. General fatigue 4-5hrs following the injection. Resolved the following morning
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| 52 | 2021-02-18 | tingling |
I awoke at 3 pm with a mild pain/ tingling of nerve from left elbow to fingers that is constant that...
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I awoke at 3 pm with a mild pain/ tingling of nerve from left elbow to fingers that is constant that increases in intensity if my arm hands down at side (feels like the sensation after striking your elbow). Can?t stop thinking about this sensation/pain no matter what I am doing.
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| 52 | 2021-02-18 | tremor |
Severe headache, body aches, chills, and fever. Fever reached 107.1 but was reduced with Tylenol and...
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Severe headache, body aches, chills, and fever. Fever reached 107.1 but was reduced with Tylenol and cold compresses. Chills and shaking started approximately 10 or 11 hours after vaccine. Temperature is now fluctuating between normal to 100. Severe headache and body aches persist.
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| 52 | 2021-02-18 | tremor |
On 2/16/21, the morning after the vaccine I had a bad headache and spontaneous nose bleed. That even...
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On 2/16/21, the morning after the vaccine I had a bad headache and spontaneous nose bleed. That evening I had upset stomach, exhaustion and loose stool. The next day, 2/17/21 I had headache all day and continued exhaustion. In the evening, I took my blood pressure and it was 156/98. An hour later, it was 165/98. By 9:30 p.m it had risen to 172/98 and I was shaking and having difficulty walking/talking. I went to the emergency room. My blood pressure was still 172/98 upon arrival so blood work, EKG, chest X-ray, and CT scan were performed. I was released later that evening when my blood pressure came down to 156/98 . My normal blood pressure is always 120/80 or lower.
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| 52 | 2021-02-21 | pain in extremity |
02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Ap...
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02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Approx. 5:30pm: cramp type pain in spleen area that subsided in approx. 15 minutes. 02/20 Approx. 6:00pm: arm pain & swelling at injection site that slowly increased over time. 02/21: Arm pain increased - very painful, swelling, limited ability to move arm without pain. 02/22: At the time of this submission, the arm pain & swelling is not as bad - it's minor now.
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| 52 | 2021-02-21 | cold extremities |
Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the to...
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Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the touch was warm but it felt like it was in ice bucket. They kept me for 2 hours. Started to resolve in those two hours but didn't go away completely. By evening it was mostly returned to normal. Next day, I woke up with flu-like symptoms - felt like I had the flu. Every hair on my head hurt; wanted to sleep; no appetite. Three in afternoon - I felt much better. As quickly as it came on, it went away quickly.
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| 52 | 2021-02-22 | burning sensation | Burning itchness all over body |
| 52 | 2021-02-23 | numbness |
Cuyamaca team 2 was notified of a potential adverse reactions of a patient whom just received the se...
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Cuyamaca team 2 was notified of a potential adverse reactions of a patient whom just received the second dose of vaccine. The patient was found in her car with husband onscene appearing to be in minor distress. Per the patient she has a history of anxiety and feels that she is having a anxious epsiode. Patient admits to having a similar effect post first dose. Patient admitted to " fluttering in the chest" as well as numbness in the fingers, patient was slightly tachypnic upon inital contact. Patient was advised of calming measures and symptoms began to subside. A full 911 response was started and performed a AMA, Heartland CAD # 2021-00012209. "PFIZER COVID 19 VACCINE EUA"
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| 52 | 2021-02-23 | pain in extremity | I exp fatigue, arm soreness, body ache and flare of Psoriasis lasting 48 hours, |
| 52 | 2021-02-24 | feeling hot, cold sweat |
Felt lightheaded, dizzy, hot clammy, feeling pressure in chest. HR down to 28. BP 90/40. Laid on bac...
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Felt lightheaded, dizzy, hot clammy, feeling pressure in chest. HR down to 28. BP 90/40. Laid on back with feet elevated. 911 called. EMS evaluated and pt was better and signed for no transport.
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| 52 | 2021-02-24 | numbness, feeling hot, tingling |
Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all ...
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Hard to breath, itching .. hot feeling from left arm area spread to neck face head. Itchying all over, pins and needles feeling in my hands, numbness in lips ear cheek , headache neck pain. Tiredness.
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| 52 | 2021-02-24 | pain in extremity, burning sensation |
Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up ...
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Eyes have gotten worse; red streaks going up arms and splotches/ splotchy red whelps and streaks up her arm; real red spot on wrist; her arms started stinging and itching; Hand and feet were itching off; burning; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1283) intramuscular on the left arm on 13Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included acid reflux, antidepressant, normally wears contacts and puts reading glasses on over it. Family medical history of cancer. Concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]) for acid reflux and bupropion hydrochloride (WELLBUTRIN) as antidepressant. The patient went and got her first shot 2 weeks ago. She is a dental assistant. She woke up between 2am-3am on 13Jan2021 and her hands and feet were itching off. They were burning and itching and she did not have any rash. So Thursday, she had to work until 1. Her hands itched and she went home, took Benadryl and put Cortisone cream on hands and feet. She does not have a dose, lot or expiration for either. It would take 2 doses of Benadryl. They just continued to itch until Saturday and she went to a doc in the box and the doctor felt it was a reaction from the vaccine. You could not see anything except red where she scratched it. She gave her some medicine and she just went to pharmacy and the pharmacist said that is just like Benadryl. She started taking it and it immediately helped, but she only gave it to her for 5 days and when she finished, the itching started again. On 27Jan2021, her hands were itching off and she has red streaks going up arms and splotches. She does not have the name. It was like hydro something. She threw bottle away. She does not have a dose, lot or expiration. It improved and stopped when she was taking the medicine and on 26Jan2021, she had a real red spot on wrist, her hands have itched and itched. When her arms started stinging and itching, she pulled her sleeve up and it looks like streaks on her arms and elbows. She has these splotchy red whelps and streaks up her arm. She also noticed she had itching on her torso the day before. She needed to get glasses to see vaccine card. This was required before she took the vaccine, but she did feel like her eyes are worse all of a sudden. She normally wears contacts and puts reading glasses on over it. It has only been in the last few weeks that she has noticed this. Now, her arms were starting to itch again after a dose of Benadryl. She was worried about 2nd shot. She does not want it to get worse and continue. She would like to speak with someone to find out if it would be recommended for her to get second dose or not. No ER or physician's office required: Doctor visit on 16Jan2021 and they prescribed a medication to help with itching and burning for 5 days and it worked and when she stopped taking it, it started back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was at a Clinic for the hospital. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events itching and eyes have gotten worse was not recovered, events burning and pain in arm was unknown and recovering for the other events.
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| 52 | 2021-02-25 | numbness | Numbness in jaw, lips, neck on left side. Tachycardia |
| 52 | 2021-02-25 | tremor |
Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/2...
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Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/21. She reports doing well and better today. She still has a sore arm where the injection site is. No redness or swelling nor fever. She also states that her cotton mouth sensation is gone. She is overall well. Pt is appreciative for the phone call. Denies any other concerns. Progress Notes (Nurse Practitioner) Attempt to reach patient for follow up. No answer. Progress Notes (Nurse Practitioner) Cosign Needed Expand AllCollapse All Date: 2/24/2021 Subjective Pt is a 52 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience chills/shaking "as if my internals are trying to come out.". She also reports of R arm pain "as if someone socked me in the arm" at injection site. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency room area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. PMH: depression/PTSD, recovered alcoholic and pill user x 8 years come this April. Currently on Zoloft, Abilify, Wellbutrin. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, muscle aches (R arm pain where injection site was) and headaches (she developed a headache later while she was in the bay about 15 minutes into her visit. Rates pain at 8/10) Patient denies fever, malaise/fatigue, facial swelling, ear pain, itching in ears, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain She reported about 15 minutes into her visit with me of "Sudden onset of dry mouth.": Previous Reactions: when she was younger, she had an adverse reaction, unable to recall what, to the chicken pox vaccine. She's only been able to get one shot. She's tolerated other vaccines w/o issues. Objective Vitals Vitals: 02/24/21 0907 02/24/21 0926 02/24/21 0943 02/24/21 1000 BP: 135/84 128/71 120/73 101/71 BP Location: Left arm Left arm Patient Position: Sitting Sitting Pulse: 93 82 68 SpO2: 97% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not diaphoretic. Comments: intially appeared fatigued, not as alert. After drinking water, eating a granola bar. She started to come around HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Comments: R arm inspected. Warm, no erythema, swelling nor rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Comments: initially flat/anxious. Pt was able to have normal mood by end of visit. Assessment/Plan Treatment included: water, snacks and ibuprofen for headache Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Doing well after observation. She has a ride. She was able to ambulate out to the front with co-worker. She is aware of precautions to watch for. Advised to place warm compress or ice to R arm. F/up with pcp as needed. Electronically Signed 2/24/2021 12:50 PM
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| 52 | 2021-02-27 | weakness | Dizziness, Short of Breath and Weakness (Tired) |
| 52 | 2021-02-27 | numbness, weakness | SOB, chest pain, numbness, tingling in mouth, nausea, weak. Cleared by EMS |
| 52 | 2021-02-27 | tingling |
The night after the shot I became ill with mild flulike symptoms: headache, fever of 101, aches, chi...
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The night after the shot I became ill with mild flulike symptoms: headache, fever of 101, aches, chills. This seemed fully within what I had expected and been told might happen, but as these symptoms eased up over the next 48 hours, I experienced, and continue to experience, a weird neurological paresthesia-type symptom where it feels as though my skin is covered in some kind of cold minty lotion. (Not the same as chills, though it sounds like it, I realize.) Mostly on my upper back, but also at the injection site, and sometimes other places too. Not painful, just distracting and kind of worrying. Not anything I have ever experienced before, and not related to any sort of external variable. I consulted with both a doctor and my brother and his wife (both doctors) by telephone. Everyone has advised a wait and see approach, but my brother (an epidemiologist) recommended that I report this as an adverse event.
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| 52 | 2021-02-28 | numbness, tingling |
Left arm tingling slightly numb and left tip of my pinky is totally numb! It dissipated a bit mid d...
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Left arm tingling slightly numb and left tip of my pinky is totally numb! It dissipated a bit mid day and now it is numb again so I thought I would fill this out because it?s abnormal
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| 52 | 2021-02-28 | pain in extremity, weakness | Severe diarrhea, chills, lack of balance, weakness, arm pain. Pain in the back of my head. |
| 52 | 2021-02-28 | tingling |
Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and b...
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Numbness of lips and tongue, paresthesias in upper extremity, nausea; LIP, and AMR gave Zofran and breathing technique - reaction resolved. Extended monitoring was provided.
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| 52 | 2021-02-28 | tingling |
Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arm...
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Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arms/chest, and feeling like moving through water.
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| 52 | 2021-03-01 | cold sweat, tingling, flushing, feeling hot, slurring |
Complained of warm feeling after receiving first dose of Pfizer COVID-19 vaccine (lot EN6205, exp 6/...
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Complained of warm feeling after receiving first dose of Pfizer COVID-19 vaccine (lot EN6205, exp 6/30/2021). At 1029, EMT was checking in on client since she was in post vaccine waiting area for 30 min observation. EMT noticed flushed face and neck. Per client felt warm sensation and at 1031 stated metallic taste in mouth, feeling clammy with sweaty hands. PHN joined EMTs. First set of vitals: blood pressure 120/80, temperature 101.7 F. Alert and oriented, no shortness of breath, rash, itching, swelling, blurry vision, or tingling noted per client. Per client sulfa, shellfish, and contrast IV dye allergies. Medication client took this morning: Synthroid 75mcg. Clt reported she ate breakfast at 9am consisting of cereal and coffee, client reported a history of Bell's palsy 20 years ago with full recovery. 1034 temp 100.0 F. Assessed for arm drift, no tongue deviation, clt stated no tingling, able to move all extremities. 1042 vitals: blood pressure 120/100, pulse 77, o2 98, temp 99.0 F. Alert and oriented, clammy hands, no shortness of breath, no swelling. PHN offered client Benadryl, client declined. Informed client she would be kept longer for observation and client agreed. At 1047 temp 98.9 F, respiratory rate 24. At 1051 client stated tingling sensation on inner lips, metallic taste, dizziness, and mild burning sensation around eyes and nose area. PHN assessed for swelling in mouth, lips, face. PHN offered Benadryl again and client accepted. Client called husband who was in parking lot, client not driving. At 1054 Benadryl 50mg/ml IM on left deltoid. Vitals 1056: blood pressure 118/90, pulse 70, o2 98. Client informed vitals would be reassessed every 5 minutes. 1101 vitals: 99.1 F temp, blood pressure 118/78, pulse 77, o2 98. Per client dizziness and metallic taste were improving. 1106 vitals: pulse 75, o2 98, respirations 14, EMT unable to obtain blood pressure. Client complained of tingling on left index finder, PHN assessed bilateral grip strength, equal on both sides. 1114 vitals: blood pressure 128/72, pulse 74, o2 99. Per client, improvement of tingling sensation on lips, no metallic taste, no dizziness, no headache. Per client felt Benadryl effects. Vitals 1118: blood pressure 124/82, pulse 76, o2 96. Vitals 1124: blood pressure 128/78, pulse 75, o2 98. Client able to stand, denied dizziness. At 1133 noticed change in speech, slurred. Per client voice was different. called 911 at 1134. Paramedics arrived at 1142 and assumed care. Client transported to Hospital per client's husband request at 1149.
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| 52 | 2021-03-01 | flushing |
Patient received covid vaccine and experienced flushing immediately post vaccination and about 20 mi...
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Patient received covid vaccine and experienced flushing immediately post vaccination and about 20 minutes after vaccination had onset of headache. Felt like a band was wrapping around right side of head, pressure over right eye, and numbness/tingling of right eye noted. No loss of vision noted, no facial drooping noted. Complained of numbness and dryness of right eye continuing at least 30 minutes after vaccination. Noted it started to burn or itch 30 minutes after vaccination.
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| 52 | 2021-03-01 | tingling, sensory loss |
Within minutes of getting the vaccine I was on the floor. I was taken to the hospital and am still ...
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Within minutes of getting the vaccine I was on the floor. I was taken to the hospital and am still here. I can't feel anything below my knees and have weekness in my hands. I can't walk and have difficulty moving my legs. Doctors are saying that they don't know if I will ever walk again.
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| 52 | 2021-03-02 | breast pain | Left axilla and breast pain since injection received. |
| 52 | 2021-03-02 | flushing |
itching to bilateral axilla and neck, itching to injection site (left deltoid), light headed, itchin...
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itching to bilateral axilla and neck, itching to injection site (left deltoid), light headed, itching to head, back, and bilateral legs. Reports flushed to face. Bumps to forehead.
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| 52 | 2021-03-02 | numbness |
15 minutes after receiving her first dose of COVID-19 vaccine in her L arm, patient developed numbne...
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15 minutes after receiving her first dose of COVID-19 vaccine in her L arm, patient developed numbness in the L side of her face down to her shoulder. Her CN2-12 were grossly intact, her muscle strength was 5/5 in her UE. Patient denied any SOB, difficulty swallowing (able to swallow water), or swelling of neck. Her airway was patent and she had a normal oropharynx. Patient had another 10 minutes of additional observation. Her symptoms slightly improved prior to leaving.
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| 52 | 2021-03-02 | muscle spasms |
I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasm...
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I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasms; Headache; Tired; I had a 100.4 temperature for 2 days; This is a spontaneous report from a contactable consumer (reporting for herself). A 52-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unspecified indication. On 30Jan2021, the patient stated that "I slept all day, I could not eat, I could not get out of bed, I hurt so bad and has body aches, muscle spasms, headache, tired and I had a 100.4 temperature for 2 days." The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Nov2020. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 52 | 2021-03-02 | tingling |
Unable to move arm the day after. Had to get help getting dressed. Tingling feeling in arm, similar...
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Unable to move arm the day after. Had to get help getting dressed. Tingling feeling in arm, similar to how a body part feels if it had fallen "asleep". Tingling feeling ended March 2nd. Arm still feels tender.
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| 52 | 2021-03-02 | speech disorder, bell's palsy, face paralysis |
Left sided facial weakness, tongue feels numb on left side, speech just a little off but no left ar...
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Left sided facial weakness, tongue feels numb on left side, speech just a little off but no left arm weakness or anything else. Ear pain on the left side and headache. CT Head done on 2/26/21 at ER resulting in no acute intracranial process. Diagnosed with Bell's Palsy and started on 7 days of Valacyclovir HCL 1 gram - 3 times a day and Prednisone 20mg - 3 in the morning for 5 days. Completed course of Prednisone morning of 03/03/2021. Symptoms no better with medications.
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| 52 | 2021-03-03 | numbness |
An hour after my shot my left check was numb, lower left eye numb, left ear numb and left side of my...
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An hour after my shot my left check was numb, lower left eye numb, left ear numb and left side of my tongue is numb. It is still numb as I type this.
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| 52 | 2021-03-03 | unresponsive to stimuli, seizure |
About 10 mins after vaccination patient stated she wasn't feeling well. When pharmacist went to chec...
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About 10 mins after vaccination patient stated she wasn't feeling well. When pharmacist went to check on the patient she was seizing. 911 was called. Patient's eyes were fluttering and unresponsive, but breathing. Patient came in and out of seizure a few times. 1 full body seizure about 20 to 30 seconds. Patient was laid on the ground on her side till paramedics arrived. She was then taken by ambulance.
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| 52 | 2021-03-04 | difficulty speaking, feeling cold |
At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021...
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At Approximately 1140, patient finished getting her 1st dose vaccine Pfizer (Lot# 6201 Exp. 06/2021) and went to EMT observation area. At approximately 1210, patient informed EMT that she was not feeling well. Patient was given the zero gravity chair to sit in. Per EMT, patient c/o fast heart beat. EMT took vitals and assessed patient: BP systolic of 128, HR 88, pupils equally reactive, LOC X4, skin warm, RR of 8. Per EMT, patient was anxious and complaining of discomfort from occipital area of her head and nape. Per EMT, patient was instructed to do deep breathing exercises and patient was given some ice to initiate vagal response. Approximately 15-20 mins later, patient complained that she was not feeling well. At 1235 EMT came over to lead RNs stating that she was having difficulty getting an accurate BP reading due to the lack of having the proper size of BP cuff onsite. RN used personal BP cuff to take patient's vitals. Per RN, At 1238, patient's BP was 170/100, HR 88, RR 12, regular breathing. Per RN, Patient c/o swollen tongue, throat itchiness, and feeling cold, patient's skin showed visible cold urticaria. After assessment, RN instructed RN to call 911. EMT gave report to 911 operator. After the medics were on their way to site, Patient insisted needing to go to the bathroom to urinate, RN and EMT assisted patient to the bathroom. Patient was ambulatory. At 1244 Fire paramedics and AMR arrived. Patient relayed to medics that her tongue is swollen, that she is feeling itchiness in her throat, and that she has a raspy voice. Medics gave patient Benedryl IM in L arm at 1248. Patient refused to be transported to a hospital per Medics recommendation. Patient signed documents declining further medical care. Patient was instructed to call 911 for any difficulty breathing and any throat swelling. Medics and AMR left at 1258. At 1300 niece came from parking lot to assist patient to go to her car to go home.
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| 52 | 2021-03-04 | hot flush | Hot flashes multiple times a day since the date of vaccination |
| 52 | 2021-03-04 | numbness, tingling |
About 1 hour after vaccine I experienced a severe headache, low grade fever and chills. Two hour af...
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About 1 hour after vaccine I experienced a severe headache, low grade fever and chills. Two hour after injection I experienced a sudden onset of sever tingling and numbness in my left foot, leg, arm and hand which rapidly got worse. I had trouble stepping on the foot and walking. I decided to rest for the remainder of the day and called my primary care physician the following day. I never received a call back from her as promised and called again by end of day around 5pm CT to be told by the front desk to go to the ER. I held off from doing so for financial reasons and decided to make an appointment with an neurologist instead. Today (day 3 after the vaccination my symptoms are still present but have not worsened). I am still very concerned to potentially develop paralysis or GBS and therefore wanted to report the issue.
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| 52 | 2021-03-04 | numbness |
Episodes of unilateral facial numbness and tingling. Occurred in 3 separate episodes: First one bein...
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Episodes of unilateral facial numbness and tingling. Occurred in 3 separate episodes: First one being 30 minutes after administration of vaccine, 2nd one 8 days later, and 3rd one 10 days later. Each episode lasted about 5-10 minutes. Also reports constant pressure behind both eyes.
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| 52 | 2021-03-04 | muscle spasms |
PATIENT REPORTED FEELING DIZZY AND LIGHT-HEADED WITHIN TEN MINUTES OF RECEIVING VACCINE. SHE FELT NA...
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PATIENT REPORTED FEELING DIZZY AND LIGHT-HEADED WITHIN TEN MINUTES OF RECEIVING VACCINE. SHE FELT NAUSEATED AND STATED SHE FELT LIKE SHE DID WHEN SHE HAD AN ALLERGIC REACTION TO A BEE STING THAT REQUIRED AND EPI-PEN. WE BEGAN ASSESSING THE PATIENT FOR ANAPHYLAXIS. WE GAVE DIPHENHYDRAMINE 50 MG ORALLY AND MONITORED HER HEART RATE AND BLOOD PRESSURE. HER BLOOD PRESSURE AND HEART RATE STAYED WITHIN NORMAL RANGE FOR THE NEXT 45 MINUTES. SHE REPORTED NO ANGIOEDEMA OR ANY OTHER SYMPTOMS OF ANAPHYLAXIS. WE ALSO ADMINISTERED FAMOTIDINE 20 MG TABLET. SHE CONTINUED TO DO WELL AND DID NOT EXHIBIT ANY OTHER SIGNS OF ANAPHYLAXIS. AFTER 45 MINUTES OF MONITORING THE PATIENT WITH SYMPTOMATIC QUESTIONS FOR ANAPHYLAXIS, MONITORING HER BLOOD PRESSURE AND HEART RATE, AND WITH NO OTHER SIGNS OF ANAPHYLAXIS, THE PATIENT WAS RELEASED FROM OBSERVATION. SHE REPORTED TO OUR PHARMACY ON 3/5/21 THAT SHE HAS CONTINUED TO HAVE SEVERE MUSCLE CRAMPING, SOME NAUSEA AND OVERALL FATIGUE. I COUNSELED THE PATIENT TO CONTINUE TO MAKE SURE SHE CONTINUES TO STAY WELL HYDRATED. SHE CONSULTED WITH MD AND HE ADVISED HER TO STAY HYDRATED. SHE ALSO TOOK PREDNISONE PRESCRIBED FOR A PREVIOUS KNEE INJURY, THAT THE PATIENT REPORTED.
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| 52 | 2021-03-04 | seizure | Systemic: Seizure-Medium |
| 52 | 2021-03-05 | pain in extremity |
Headaches that would come and go Fast heart beat Dizziness Heartburn that came and went twice Sore ...
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Headaches that would come and go Fast heart beat Dizziness Heartburn that came and went twice Sore calf Sore quad Sore arm (injection site) Sore neck left side. Fatigue
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| 52 | 2021-03-06 | feeling hot |
After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With i...
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After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With in a minute my throat got scratching and had a hard time Swallowing. My Tongue Swelled and my lips felt Numb.A Medic doc was called over to me. I was immediately taken to a tent with other Doctors. The doctor immediately gave me a Epipen in my right upper thigh. With in a few minutes EMS was there they tried to put a IV IN me but was unsuccessful. The EMT gave me a shot of Benadryl in my right arm. EMT rushed me to Emergency room. At the ER they put an IV in and gave me Dexamethasone and Pepcid. I was closely watched and was released after around 5 hours.
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| 52 | 2021-03-07 | bell's palsy | Bells Palsy, treatment started 3/8/21 with prednisone |
| 52 | 2021-03-07 | bell's palsy | Bell's Palsy |
| 52 | 2021-03-07 | burning sensation |
A few days after vaccine I started having pain, burning in my right wrist, shoulder, and elbow. Now ...
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A few days after vaccine I started having pain, burning in my right wrist, shoulder, and elbow. Now having severe burning and pain in both wrists, elbows, and shoulders. Difficulty picking up items, grasping, pushing up. Have never had these symptoms. Now about 5 weeks since vaccine and still remains. Have not seeked medical attention. Wanted information in data base in case it is common.
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| 52 | 2021-03-07 | flushing, weakness | weakness, flushing. Evaluated by EMS-Cleared |
| 52 | 2021-03-07 | hot flush |
Progress Notes Family Medicine Pt called to follow up on covid-19 vaccine done on 02/26/21. She ...
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Progress Notes Family Medicine Pt called to follow up on covid-19 vaccine done on 02/26/21. She reports she felt a little run down on Saturday (the following day of the injection). She feels well today. Denies any further questions or concerns. Pt is appreciative of phone call. Progress Notes Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes Family Medicine Cosigned by: Expand AllCollapse All STORMONT VAIL COVID VACCINE CLINIC DOB: 2/1/1969 Date: 2/26/2021 a 52 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience feeling flushed. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: anxiety/panic attacks. HTN on amlodipine since 3-4 months. 10 mg. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, dizziness and headaches Feels flushed and hot Not diaphoretic: Previous Reactions: none. States she was anxious prior to her visit today about the vaccine. Objective Vitals Vitals: 02/26/21 1326 02/26/21 1336 02/26/21 1339 02/26/21 1351 BP: (!) 155/96 (!) 187/121 (!) 156/97 (!) 154/97 Patient Position: Sitting Pulse: (!) 109 99 Resp: (!) 24 SpO2: 100% 100% Physical Exam Constitutional: General: She is in acute distress (anxioius affect). Appearance: She is obese. Cardiovascular: Rate and Rhythm: Tachycardia present. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Tachypnea (slightly 24) present. Comments: Pt asked to remove mask to reduce her hyperventilation. Neurological: Mental Status: She is alert. Psychiatric: Attention and Perception: Attention normal. Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Cognition and Memory: Cognition normal. Comments: Tearful and slightly anxious Assessment/Plan Treatment included: water, snacks and ice pack Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) (elevated blood pressure) Pt observed approx 30 minutes. Pt improved in symptoms after rest, food, water and ice pack. Her bp was coming down. HR and RR normal. Pt felt better. She wanted to leave as staying here is making her more anxious. Recommended that she monitor her bp at home. If persists to be elevated of 140/90 that she follow up with her pcp. Pt voices understanding. Pt has co-worker here with her whom walked out with her.
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| 52 | 2021-03-07 | pain in extremity |
Patient reported mild fatigue and arm soreness until the following afternoon when her left eye bega...
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Patient reported mild fatigue and arm soreness until the following afternoon when her left eye began to burn which progress to the right eye. Later in the evening the left upper eye lid began to swell extending into the lower lid along with right upper lid swelling. She contacted medical through our COVID hotline where I was notified around 9 pm Thursday night ( 03/04/2021). She denied an respiratory or cardiac symptoms and was mostly concerned about the periorbital edema. She did not feel she needed to go to the hospital. She was advised to take Benadryl 50 mg every 6-8 hours and apply cold packs. A follow up call was made by me at 07:30 am on Friday and was instructed to contact her PCP. Later that day she called me indicating she went to Urgent Care and was seen by Dr.
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| 52 | 2021-03-07 | tingling, feeling hot, numbness, weakness, difficulty speaking |
03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint,...
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03/04/21 No symptoms until 9:15 a.m. (approximately 30 mins after vaccination), began feeling faint, weak, rapid pulse, heart skipping, numbness and tingling in fingers and toes, ringing and heat in ears, rash/redness on chest, neck and ears, intermittently "seeing stars", extremely dry mouth, hoarseness in voice and dry cough when speaking. Made my way to my sister's dental office nearby, where approximately 1 hour later, she gave me 50 mg of Benadryl and 99% Oxygen 2L/min via nasal cannula. BP 131/82, pulse 81, blood sugar 126 ml/dl. When not resolved after approximately 1.5 hours, I proceeded to the hospital Emergency Room. They did an EKG (normal), gave me famotidine and a steroid and observed me for a couple of hours. Most symptoms had subsided and was released at approximately 2:30 or 3:00 p.m.
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| 52 | 2021-03-08 | pain in extremity | Right arm pain, headache, fatigue |
| 52 | 2021-03-08 | tenderness, burning sensation | Arm burns and is still sore to touch |
| 52 | 2021-03-08 | tenderness, pain in extremity |
I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt q...
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I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt quite a bit. My arm started hurting right away. Over the course of the afternoon, I felt achy and tired. I went to bed about 9:30 pm. During the night I suffered nausea, headache (on the left side), bad chills and then sweats. Fever of 102.4. Arm so sore can even sleep on it. By the am, 10:20 am, still massive fatigue, aches, fever (still between 100.9 and 102.4), chills and earache. .
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| 52 | 2021-03-09 | numbness, feeling hot |
about 2 minutes after receiving the vaccine i felt a heatwave starting at left arm going through my ...
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about 2 minutes after receiving the vaccine i felt a heatwave starting at left arm going through my whole body, with dizziness and and a feeling of panic. was about to ask for water but panic feeling subsided after roughly one minute. slight dizziness remained. 15 minutes later I felt a slight numbness in my face and right hand
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| 52 | 2021-03-09 | muscle spasms |
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side...
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glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-09 | muscle spasms |
she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at ...
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she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at the injection area; severe back spasms in the thoracic and lumbar; made a different in the vision, it was throbbing; back pain; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL0140), intramuscular on 04Jan2021 at single dose at left arm for covid-19 immunization. Medical history included diabetes (diagnosed six years ago. Her last A1C was 6.1 in Dec2020), chronic edema since her last child was born 26 years ago. Concomitant medications included ongoing furosemide (LASIX), ongoing potassium, ongoing omeprazole (PRILOSEC), ongoing metformin, and paracetamol (TYLENOL). Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose on 04Jan2021 and second dose on 27Jan2021. Caller reported to have experienced back pain 2-3 days after the first dose, and a sharp stabbing back pain with moist cough for almost a month now after the second dose. Caller was diagnosed with COVID-19 in between. With the first vaccine she had headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given diclofenac (VOLTAREN) and cefixime (FLEXERIL). She was taking 1 gram of paracetamol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. Seriousness criteria for back pain, it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor; for event arm pain at the injection area, gripping was not easy and moving her arm was painful. She was left handed. Heat worked better than ice. Ice made things worse; for event headache, made a different in the vision, it was throbbing. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of paracetamol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She had been taking 1000mg paracetamol three times a day and now she was taking it two times a day. She was taking cefixime at bedtime because she can't stay awake when she took it. She can't take it and work. She had missed work because of this. She was taking diclofenac twice a day. Patient didn't have the first bottle of paracetamol she used because she had gone through it. Current bottle of Tylenol was the generic, SunMark Acetaminophen. She had to get her glasses to read the lot number. It was made by (Pharmacy name), Lot number: OLE2349B, expiry: Sep2022. She didn't feel like the medication she took were relevant because she had been taking them for a very long time. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021. She got the results of her PCR test on 13Jan2021. Outcome of event back pain was not recovered, outcome of events headache, arm pain at the injection area and severe back spasms in the thoracic and lumbar was recovered in 2021, and outcome of other events was unknown. Relatedness of drug to reaction(s)/event(s): Events headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar: source of assessment: primary source reporter; Method of assessment: global introspection; Drug result: Related.; Sender's Comments: Event back pain represents an intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-09 | pain in extremity, tingling, weakness | R hand pain, redness, swelling, weakness, tingling |
| 52 | 2021-03-09 | tremor |
10 hours after vaccination experience severe shaking, fever of 102.6 Took 2 (500 mg) Tylenol. Fever ...
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10 hours after vaccination experience severe shaking, fever of 102.6 Took 2 (500 mg) Tylenol. Fever kept climbing to 104.5 Took 25 mg of Benadryl for red color of face and small rash on abdomen. Placed call to Dr. Advised every 8 hours Tylenol (1000mg) and cycle with Ibprofen- 2 (200mg). Fever remained at 104 till morning, then 103.1. Fever down for 2 hours and spikes to 104. Took cold bath, reduced fever to 102. Chills, violent shaking a headache behind eyes, very dehydrated. Drank Gatorade and with fatigue slept off and on for 48 hours. Fever finally down by 03/10/2021 to 98.9 with mild headache. Did not have any body or muscle aches during this event.
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| 52 | 2021-03-10 | pain in extremity |
Employee received the first dose of the COVID 19 vaccine on 1/22/2021 in her left deltoid. At the ti...
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Employee received the first dose of the COVID 19 vaccine on 1/22/2021 in her left deltoid. At the time she received the first dose she only had a sore left arm. Two days after receiving the vaccine she experienced shooting, sharp pain when she tried to lift her left arm forward or to the side. Pain was 8 out of 10. She saw her primary care doctor, on 2/1/21. He advised her to wait to see if the symptoms got better. She continued to have decreased range of motion and shooting, sharp pain when she moved her left arm. She saw an orthopedic doctor on 2/10/2021 who did an x-ray and MRI. The MRI showed calcification of the bursa in her left shoulder. This doctor recommended cortisone injections. Employee received the first dose of the COVID 19 vaccine on 1/22/2021 in her left deltoid. At the time she received the first dose she only had a sore left arm. Two days after receiving the vaccine she experienced shooting, sharp pain when she tried to lift her left arm forward or to the side. Pain was 8 out of 10. She saw her primary care doctor, on 2/1/21. He advised her to wait to see if the symptoms got better. She continued to have decreased range of motion and shooting, sharp pain when she moved her left arm. She saw an orthopedic doctor on 2/10/2021 who did an x-ray and MRI. The MRI showed calcification of the bursa in her left shoulder. This doctor recommended cortisone injections, but the employee did not want to do that. On 3/10/2021 she saw an orthopedic surgeon who specializes in shoulders. Drtold the employee she had a shoulder injury related to vaccine administration (SIRVA) because the needle from the COVID 19 vaccine went into the bursa sac in her left shoulder. He is recommending physical therapy for treatment. Employee reports currently the shooting, sharp pain is gone and now there is a dull ache in her shoulder. The employee states she received the second COVID vaccine, with a smaller needle, with no adverse effects.
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| 52 | 2021-03-10 | tremor, feeling cold |
At 7:00am I had the chills, shaking so bad, could not get warm, vomiting, continued nausea , diarrhe...
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At 7:00am I had the chills, shaking so bad, could not get warm, vomiting, continued nausea , diarrhea and headache and continue ribgibg4in my ears into Thursday and
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| 52 | 2021-03-11 | weakness, feeling hot, pain in extremity |
Fever 102, Severe Chills, Feeling hot, Aches & Pains, Extreme Tiredness (thursday 3/11), Sore Arm w...
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Fever 102, Severe Chills, Feeling hot, Aches & Pains, Extreme Tiredness (thursday 3/11), Sore Arm where it was difficult to lift (only lasted 4 hours), Extremely weak unable to reach for my cell phone, Headache, Very bad neck pain, Feeling like I had the flu, Sweating, nauseous and couldn't eat. Did not sleep at all Wednesday 3/10 night due to the aches and pains, could not get comfortable. Couldn't lie down or sit up comfortably and barely able to stand. I slept most of the day on Thursday 3/11 and was so tired I would fall asleep in mid sentence. Took ibuprofen 200mg and helped SLIGHTLY and wore off very quickly. Couldn't wait to get to the four hour mark to take more. I was so sick my husband wanted to take me to the ER. I woke up on Friday 3/12 feeling back to myself. I was told by my Rheumatologist to stop take HP Acthar Gel and Xeljanz for one week after the vaccine.
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| 52 | 2021-03-11 | breast pain |
pt states that she started itching between the left shoulder and left breast. As she scratched her ...
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pt states that she started itching between the left shoulder and left breast. As she scratched her breast she felt a small bump and noticed a brown spot. She contacted her OB/GYN via portal to let her know that about these symptoms. The Doctor advised her to see a Dermatologist. She contacted her once again since she felt like something was wrong and was told again to see a Dermatologist. Pt saw Dermatologist on 3/4/2021 and was told it did not look skin cancer and ordered some cream. Pt let Dr. know that she had taken the vax recently and that she also has breast implants. The Doctor did a small exam but did not feel a lump, but this doctor is not an OB/GYN. Pt went to an already scheduled mammogram on 3/11/2021 but they would not complete the annual exam since she was having pain issues so she was rescheduled for a diagnostic exam on 3/17/2021. Pt believes she has felt swollen lymph nodes under her left arm and has had intermittent pain for about 3 weeks now. The pain seems to move around from breast to her back.
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| 52 | 2021-03-11 | difficulty speaking |
Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stat...
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Approximately 30 minutes after receiving the vaccination, the individual got out of her car and stated she felt her tongue swelling. There was a noticeable voice change, expiratory wheezing and pallor. BP 122/86, HR 84. At 10:10am, 0.5mL epinephrine was administered intramuscularly in the opposite deltoid, and EMS was called. Patient reported improvement in symptoms. EMS took over care of the patient, and transported her to the local hospital. She was discharged from the emergency room.
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| 52 | 2021-03-11 | numbness, tingling |
Receive 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of...
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Receive 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Tingling/numbness on same arm as injection. Reports feeling odd. Observed and symptoms resolved within 20 minutes. Released home
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| 52 | 2021-03-11 | numbness and pain in extremities, numbness, tingling |
1. TINNITUS (ringing in the ears) - bilateral, persistent: both ears, continuous ringing, high-pitch...
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1. TINNITUS (ringing in the ears) - bilateral, persistent: both ears, continuous ringing, high-pitched sound. began intermittently, then progressed to continuous. 2. PERIPHERAL NEUROPATHY (tingle/numbness) - bilateral, hands and feet: began intermittently, then progressed to continuous.
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| 52 | 2021-03-12 | pain in extremity, burning sensation |
Sore arm day after - no other affect. 9 days later I started to get rash on face. but day 10 , I...
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Sore arm day after - no other affect. 9 days later I started to get rash on face. but day 10 , I had a full allergic reaction. burning, itching face. I went to my dermatologist and he believes it was a delayed reaction to the vaccine. Nothing new was introduced to my world. I started a regime of Prednisone . Day 11 the redness was gone but residual effects were apparent Day 12 my skin was flaky but otherwise normal
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| 52 | 2021-03-12 | pain in extremity, flushing |
15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my f...
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15 min. after shot, my neck became warm and flushed, slightly red. By 30-40 minutes after shot, my face was also flushed and the inside of my mouth (mostly roof of my mouth) and lips were itchy/tingly. Then, I took 2 Zyrtec 10 mg. as instructed by my allergist if I had a reaction. Within an hour, the flushing and itchiness were gone. 2 days later - had strange pain, swelling, and warmth in upper left shin below knee. Worried about possible blood clot, I took 2 baby aspirin. Pain and swelling went away. Not sure if related to vaccine but unaware of anything else that could have been different.
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| 52 | 2021-03-12 | tingling, pain in extremity |
One week after vaccine woke with large round, very itchy rash at injection site. Area was swollen an...
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One week after vaccine woke with large round, very itchy rash at injection site. Area was swollen and warm with a very small hard area directly at injection site. It was very itchy for about 8 hrs and then it was only sporadic at best. The rash was very red at beginning but has faded continually since. The area is a very distinct oval or circular shape, approx. 4 inches in diameter. It is almost hard to call it a rash as the itchiness, swelling and "prickly" type skin were very short lived, 2-4 days, but the discoloration is still very distinct although faded considerably since the first appearance. I did have moderate headache and arm soreness with the first vaccine, short lived. With the second dose I had headache and then extreme axillary and neck soreness on second day. The rash did not appear until one week after the 2nd dose. It has been approx one month and the 4 inch "rash" is still apparent but faded .
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| 52 | 2021-03-12 | tremor, feeling cold |
10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse...
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10 minutes after the shot was given, I felt a release and my heart rate increased, I went to a nurse and let them know I was having a reaction, and they took me to a bed, I had brought my Benadryl with me and took 5 ml, I became very cold and began to shake, some shortness of breath, tongue became thick feeling, I am not sure of the time schedule, but I also had my Cromolyn and took 5 ml, I was still having problems after an hour and I took 5ml more of Benadryl and cromolyn, after about 2 hours in the covid area I felt good enough to go home
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| 52 | 2021-03-13 | weakness |
Headache, chills, nausea, vomiting, aches and pain, severe pain in kidneys, eye pain, weakness, loss...
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Headache, chills, nausea, vomiting, aches and pain, severe pain in kidneys, eye pain, weakness, loss of appetite,
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| 52 | 2021-03-13 | discomfort |
Symptoms Not feeling right -within 5 minutes Heaviness in appendages-15 minutes little dizziness 20 ...
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Symptoms Not feeling right -within 5 minutes Heaviness in appendages-15 minutes little dizziness 20 min Heart Rate increase 25 min Pressure on chest 25 minutes Severe shivers-30 minutes
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| 52 | 2021-03-13 | feeling cold, tremor |
This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both va...
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This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both vaccines gave me a reaction, and both around the same time the next morning. My reaction to my 1st vaccine included slight fever, aches, and chills. Both doses were administered around 3:30pm and reaction was approximately 10:30-11am the next morning. On this 2nd dose, roughly 40 minutes after waking from sleep, I became mildly nauseas. I sensed I would vomit, so I sat down on the commode with a bucket in front. I started getting the sweats, got very cold, and my arms starting shaking. I started to feel the room spin, saw big black dots, and after banging on the wall to alert my husband something was happening, I fainted and passed out cold. My husband saw me fall face down, and after waking me, I was in a panic, did not know where I was, or how I was on the floor. I passed out a 2nd time, at which point, my husband was able to get me to the car and he took me to the local hospital. I was incoherent on the car ride, moaning, and not knowing what was happening. My eyes remained closed until I was wheeled into the emergency area and they asked me my name. I was taken to a private room, where they hooked up a blood pressure cuff, an oxygenator on my finger, and took several viles of blood. I was then taken to the cat scan room for a brain scan, and several hours later, was given a chest xray. I remained in the room for approx 6 hours, where I was becoming more and more aware of where I was. I had not eaten/drank anything, except a cup of water. I had not used the lavatory. The PA came to me hours later stating all my tests came back negative, and they could not determine what happened, xrays and blood tests were good, and cat scan was good. He said that while they couldn't determine what happened, they would recommend a stay, so they can do more extensive testing. I contacted my husband via cell, told him what they said, and after another 1 1/2 hours, I made the decision to release myself as I was feeling more like myself again, albeit tired. I went home that evening, ate a small dinner, went to bed, and by 12 Noon the next day, I was fine again.
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| 52 | 2021-03-13 | numbness, tingling |
Nausea, diarrhea, chills, tingling and numbness,in feet and hands, could not sleep, all within 24 ho...
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Nausea, diarrhea, chills, tingling and numbness,in feet and hands, could not sleep, all within 24 hours 48 hours tingling and numbness but not as severe, body aches, sore
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| 52 | 2021-03-13 | muscle spasms, pain in extremity, hot flush |
Within an hour of shot, fever, dizziness, nausea, hot flashes, sleeplessness, body pain, arm pain, h...
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Within an hour of shot, fever, dizziness, nausea, hot flashes, sleeplessness, body pain, arm pain, headache, leg cramps, and feeling like it was the worst flu I've ever had (minus respiratory issues). On day 5, it started to lessen to general malaise and a slight headache.
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| 52 | 2021-03-13 | pain in extremity |
Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below kne...
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Very bad pain in left arm, swelling from shoulder to elbow, swelling in left leg from just below knee to toes feels like my skin is going to split. Right side is fine.
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| 52 | 2021-03-13 | tingling |
Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took ...
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Patient reports long history of taking ibuprofen/NSAIDS. After 2nd dose of vaccine 2/2/21 she took took ibuprofen about 27-28 hours later on 2/3/21 due to aches/headache. She developed face/lip swelling and tingling. She was seen by provider via video visit and told she needed to be seen in person. She went to urgent care and was prescribed EpiPen PRN. On 2/22/2021 she was having some back-pain and took ibuprofen. About 1 hour later she developed same response with face swelling/tingling. She does feel her reaction is caused by the ibuprofen but she reports this being a new reaction since the vaccine since she routinely took ibuprofen prior to the vaccine.
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| 52 | 2021-03-14 | flushing | feels like throat swelling, flushing, waited 15 minutes, cleared |
| 52 | 2021-03-14 | numbness, tingling |
Immediately after injection, patient felt tingling all the way down her arm after her vaccine was ad...
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Immediately after injection, patient felt tingling all the way down her arm after her vaccine was administered. She alerted a pharmacist about 15 minutes after her dose that her right hand felt numb. She waited an additional 15 minutes and said her hand felt better and she was comfortable leaving the vaccination site.
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| 52 | 2021-03-14 | migraine, hot flush |
Migraine, nausea, hot flashes, fever, high blood pressure, fatigue. Treated at ER, with benadryl, ib...
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Migraine, nausea, hot flashes, fever, high blood pressure, fatigue. Treated at ER, with benadryl, ibuprofen and something for nausea on Friday the 12th of March.
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| 52 | 2021-03-14 | pain in extremity |
Day of vaccine thru day 3 - tired, headache, both arms sore at same location as injection in left ar...
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Day of vaccine thru day 3 - tired, headache, both arms sore at same location as injection in left arm. Day 4 - present - both arms sore/achy at approximately same location as injection site.
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| 52 | 2021-03-15 | feeling cold, tremor, pain in extremity |
Unable to lift arm within 10 hours. In 18hrs was shaking and extremely cold. Had temp of 100.9. That...
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Unable to lift arm within 10 hours. In 18hrs was shaking and extremely cold. Had temp of 100.9. That lasted for 6 hours and transitioned to burning up. During this time I had severe pain in all joints from my neck to my hips. My fingers swelled as well. My legs felt fine and no headache. Tylenol and ibuprofen helped my fever but did not alleviate my pain symptoms. My shot was Friday evening. By sunday afternoon my fever was gone as well as the pain in all but my arm. But is was down to manageable.
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| 52 | 2021-03-15 | pain in extremity |
Shot received at 4pm 3/12. Sore arm evening of shot, very tired next 2 days and sore arm. Only sligh...
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Shot received at 4pm 3/12. Sore arm evening of shot, very tired next 2 days and sore arm. Only slight soreness in arm on 15th & 16th
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| 52 | 2021-03-16 | difficulty speaking |
Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both ...
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Patient received vaccine at 12:30. Symptoms began at 14:00. She noticed a faint pink rash on both arms and feels itchy all over. Her tongue feels numb, but not swollen. Her voice is hoarse. Her heart was racing initially, but that resolved quickly. She also felt short of breath for a few minutes, but that also resolved prior to her seeking medical care. She has numerous medication allergies and states this feels similar to a reaction she has when she is allergic to a medication.
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| 52 | 2021-03-16 | facial paralysis, numbness |
5 hours after injection patient experienced numbness on right side of face as well as facial droopin...
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5 hours after injection patient experienced numbness on right side of face as well as facial drooping. This lasted about 2 hours. About 7 hours after injection patient experienced labored breathing, chills and body aches; these symptoms lasted for about 36 hours.
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| 52 | 2021-03-16 | feeling hot, pain in extremity |
Day 1 = Arm pain and body aches Days 2-4 = like a MS flair I have had before + itchy mouth MS flair...
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Day 1 = Arm pain and body aches Days 2-4 = like a MS flair I have had before + itchy mouth MS flair - lower right leg hot and tightness and a little weak both legs, but right was more severe Itch mouth got better with Benadryl. I had not issues breathing or swelling. It wasn't bad, just annoying. By day 5, I was back to normal.
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| 52 | 2021-03-16 | migraine |
I have to say my symptoms started with my first dose vaccine 12-18-2020, lot#: EH9899 and it has con...
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I have to say my symptoms started with my first dose vaccine 12-18-2020, lot#: EH9899 and it has continued on to my second dose vaccine. On 12-23-2020 after my first dose I started to have daily headaches. I received my second vaccine in 01-08-2021, also experienced daily headaches. I went to see my PCP on 02-19-2021 who referred me to a neurologist. I saw a neurologist on02-22-2021 and was diagnosed with occipital neuralgia and migraine headaches. I tried different medications but they have not yet worked. I also had a occipital nerve block with no improvement. My BP is high probably secondary to the pain and anxiety I experience from my daily headaches. Today I am still having the daily headaches.
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| 52 | 2021-03-17 | weakness |
patient became diaphoetic, pale, and reported feeling weak immediately after vaccination. Blood pres...
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patient became diaphoetic, pale, and reported feeling weak immediately after vaccination. Blood pressure 79/41 mmHg, heart rate 45-50 beats per minute. Patient reports not eating eating anything yet that day. On arrival to emergency department (ED) patient was awake, alert, and oriented. No respiratory, gastrointestinal, or respiratory symptoms noted. Administered diphenhydramine and IV fluids. Patient's symptoms and vital signs improved and discharged to home stable.
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| 52 | 2021-03-17 | flushing |
ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper...
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ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper chest/throat discomfort. TENT NOTE: PT. COMPLAINED OF TIGHTNESS IN UPPER CHEST AND FEELING FLUSHED. ASSISTED TO GURNEY AND ADULT EMERGENCY CALLED
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| 52 | 2021-03-17 | grand mal seizure |
Pt had a tonic clinic seizure in the observation area. Pt was brought to the ground and EMS called. ...
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Pt had a tonic clinic seizure in the observation area. Pt was brought to the ground and EMS called. Vital signs stable. Cold compress to forehead . Transported to hospital.
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| 52 | 2021-03-17 | hot flush, migraine, feeling cold |
After 24 hours of my vaccine at about 4pm the following day at my work, I started to feel like I was...
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After 24 hours of my vaccine at about 4pm the following day at my work, I started to feel like I was getting a cold, my face was hot. I went to the station to take my temperature, it was 98.4F and then I did a re-check 15 minutes later it was 97.2F. I was still feeling under the weather and left work a little before 5pm. I started to drive to the pharmacy when I got there I felt dizzy, I still went in and bought Tylenol cold and flu PM. When I got home, I still was feeling bad, I had severe headaches, migraines and also pain to base of my neck and my chest felt very heavy, like someone was sitting on top of me. I then went to bed early, was lying flat on my bed when I started to feel my heart, shaking my whole body. I felt really scared, these were strong palpitations. I then woke up around 3am, still having persistent headaches 10/10 pain level. I woke up because I could not sleep and went to my living room, still having chest pain and pain in my neck with headaches that did not go away. My BP in the morning was high for me was 132/96, then 133/98 and at 730am it was 137/100 with a pulse of 80. I went to the emergency room where I received IV medication, blood tests, triponents and EKG were performed which came back negative. After an hour of my iv medication, I still continued with headaches, neck pain and my blood pressure was still high. My doctor said that i had a severe reaction to the vaccine. I was discharged to go home after a few hours and I rested then I slowly started to fee better.
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| 52 | 2021-03-17 | numbness, tingling |
started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives ...
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started with tingling, numbness, and redness around the mouth and face. quickly progressed to hives and difficulty breathing. EMS administered benadryl, solumedrol, and epinephrine and transferred to ER. She responded to treatment quickly and was discharge from the ER same day.
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| 52 | 2021-03-17 | migraine |
The day after vaccination I was sleepy and the next day I felt normal. On the third day that I start...
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The day after vaccination I was sleepy and the next day I felt normal. On the third day that I started to get the Migraines. It started on the left side. It was similar to my other migraines. It did not respond to my normal medication. I was nauseous but no aura. The Migraine lasted a week before I was headache free. I After the second dose of my vaccine I had the same pattern of Migraines for 5 or 6 days. I also had some head cold symptoms with the headaches after the second dose.
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| 52 | 2021-03-17 | migraine |
migraine within 24 hours of 2nd vaccine, migraine 4 days after 2nd vaccine, migraine 5 days after 2n...
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migraine within 24 hours of 2nd vaccine, migraine 4 days after 2nd vaccine, migraine 5 days after 2nd vaccine
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| 52 | 2021-03-17 | pain in extremity, muscle twitching |
Had the 2nd Pfizer Covid shot on 3/14/2021 around 5:30pm. Typical arm soreness and all body achiness...
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Had the 2nd Pfizer Covid shot on 3/14/2021 around 5:30pm. Typical arm soreness and all body achiness from 1am 3/14/21 til 3/16/21 morning. On 3/16/21 evening, right calf muscle started twitching a lot and feeling like it would cramp although it wasn?t painful. This happened throughout the day and night; slept with right leg raised on a pillow on 3/17/21 evening. Today, 3/18/21, right calf and leg feel better. Not sure if the muscle twitching and feeling like it would cramp (not painful, just uncomfortable; no swelling, no warmth on leg, no hard veins or arteries) was related to the shot.
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| 52 | 2021-03-17 | pain in extremity |
I received the Pfizer vaccine on Saturday March 6th. My arm was sore just at the injection site for ...
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I received the Pfizer vaccine on Saturday March 6th. My arm was sore just at the injection site for 2 days and that went away. Tuesday, the 15th, 9 days after receiving the injection, I woke up and my whole arm hurt from my shoulder to my wrist. I thought I?d just slept on it wrong but that usually gets better as the day goes on and is gone the next day. This got worse as the day went on and I have both muscle pain that feels neurological, like a pinched nerve, and joint aches. It?s now Thursday the 18th and my arm still hurts although not as bad as it did Tuesday and yesterday. I don?t know if it?s unrelated but I see many reports of arm paid days later, so I thought it best to report.
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| 52 | 2021-03-17 | pain in extremity |
Patient reports receiving COVID-19 vaccination on 03/05/2021. Reports that the following morning, 03...
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Patient reports receiving COVID-19 vaccination on 03/05/2021. Reports that the following morning, 03/06/21, she had "severe arm pain rated 7/10 and she couldn't lift her arm as high as normal". Reports using ibuprofen and ice as needed over the weekend "made it a bit better, but was still there". Reports it did not interfere with her ADLs. Reports she "cannot lift her arm high without pain in her shoulder and top of the arm". Denies redness, swelling, bruising, or rash at injection site, but describes injection site as "high up" on her arm. At time of interview on 3/10/21, patient states her pain is 2/10 and has not used ibuprofen for the day. Reports she did not seek medical care.
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| 52 | 2021-03-17 | tingling | tingle in the right arm that the vaccine was given. |
| 52 | 2021-03-17 | tremor, numbness |
3/13 12 pm I got the shot. 30 mins after the shot, I got strong numbness for the whole body(especia...
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3/13 12 pm I got the shot. 30 mins after the shot, I got strong numbness for the whole body(especially face and arms), palpitations, dizziness, shaking chill at a time. I called 911 and went to ER. I got an IV. My symptoms were getting minor and I went home. The doctor said my symptoms are from a bad reaction to the medicine," Adverse Drug Reaction". I still have numbness on my face(left side cheek) a little bit.
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| 52 | 2021-03-18 | discomfort |
feeling off; light body ache discomfort; light body ache discomfort; left arm swollen-pain; left arm...
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feeling off; light body ache discomfort; light body ache discomfort; left arm swollen-pain; left arm swollen-pain; headache; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261), via an unknown route of administration on 03Feb2021, 13:15, Left arm at single dose for covid-19 immunisation at Hospital. The patient was not pregnant. Medical history included Diabetic type 2, HBP (high blood pressure), Depression. Not aware of known allergies. Concomitant medications received in two weeks included losartan 50mg, escitalopram 10mg. The patient didn't received any other vaccine in four weeks. Historical vaccine included first dose (at the age 52 years) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on Left arm on 13Jan2021 19:00 at single dose for covid-19 immunisation. The patient experienced fatigue, headache, feeling off, left arm swollen-pain, light body ache, discomfort on 03Feb2021 at 19:00. No covid prior vaccination. Covid wasn't tested post vaccination. No treatment was received for events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 52 | 2021-03-18 | feeling hot |
Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneou...
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Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneous report from a non-contactable consumer reporting for herself. This is the second of two reports. A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot En6201, via an unspecified route of administration in left arm on 23Feb2021 13:40 (at the age of 52 years) at single dose for covid-19 immunisation. The patient previously received the first dose of bnt162b2, Lot En9264, via an unspecified route of administration in left arm on 02Feb2021 13:30 (at the age of 52 years) at single dose for covid-19 immunisation and experienced injection site pain for 1 day. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Allergies to medications, food, or other products were none. Concomitant medication included losartan, vitamin d3, ubidecarenone (Q10). The patient experienced injection site pain on 23Feb2021, body warmer than usual on 24Feb2021, feel an armpit swollen lymph lump on 25Feb2021. Laboratory data included body temperature 37.3C on 24Feb2021, and normal on 25Feb2021. No treatment was received for the events. The events were non serious with outcome unknown. No follow-up attempts are possible. No further information is expected.
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| 52 | 2021-03-18 | migraine, pain in extremity, flushing |
Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue...
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Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
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| 52 | 2021-03-18 | pain in extremity |
sore arm; sleepy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant...
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sore arm; sleepy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 52-Year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in right arm, on an unspecified date in Feb2021 at 5:00pm (at the age of 52 years old) as a single dose, for COVID-19 immunization. Medical history included diabetes. The patient did not have any known allergies. The patient did not experience COVID-19 prior to vaccination nor was tested for COVID-19 post vaccination. The patient did not take any concomitant medications in the past two weeks. The patient did not receive any other vaccines within four weeks prior to vaccination. The patient experienced sore arm and sleepy on an unspecified date. The patient did not receive treatment for the events. The clinical outcome of the events sore arm and sleepy were recovered on an unspecified date. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.
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| 52 | 2021-03-18 | tingling |
Patient received vaccine 03/18/21 at approximately 1200. At 1205 the patient reported a tightness in...
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Patient received vaccine 03/18/21 at approximately 1200. At 1205 the patient reported a tightness in her throat and a tingling in her arm. At 1209 Epinephrine 0.5 mg (0.5 mL) was administered IM. EMS called. At 1213 O2 saturation was 98 At 1215 BP was 169/87 HR was 73 At 1218 O2 saturation was 97 BP 167/83 HR 68 At 1220 O2 saturation was 98 BP 169/83 HR 76 At 1221 EMS arrived and took patient to the ED via ambulance. Update (03/19/21) Called patient to follow up and she stated she was evaluated at Medical Center ED and monitored for approximately an hour before being discharged home on 03/18/21. She stated she has had no further s/sx.
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| 52 | 2021-03-18 | tenderness |
Chills and Body Aches began the following morning after the injection and by 2:00 pm in the afternoo...
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Chills and Body Aches began the following morning after the injection and by 2:00 pm in the afternoon a large (ping pong ball sized) lump developed in the left axillary area that is very painful. The pain is constant when area is touched or with any arm movement. It feels like a knife is stuck inside my left axilla. I am guessing it may be a lymph node that swelled, but have not had it checked by a doctor. My last mammogram on November 16th, 2020 was clear and no indication of any lumps or swollen lymph nodes. This new lump appeared the following day after my Covid 19 vaccine.
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| 52 | 2021-03-19 | pain in extremity |
Both feet ache; can't stand, walk, or run without my feet aching afterward; they even ache when I am...
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Both feet ache; can't stand, walk, or run without my feet aching afterward; they even ache when I am not on my feet; I usually walk or run many miles every day. Perhaps this is unrelated to the vaccine but have never felt this before. The first day the symptoms developed by feet felt bruised on the bottoms. 10 days later and my feet still ache if I do any activity on them.
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| 52 | 2021-03-19 | tingling |
3/20/2021 The patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccinati...
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3/20/2021 The patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: difficulty breathing and tingling around face and mouth Assessment : Time of assessment . Actions taken: VS taken, BP- 129/62, P- 80, O2- 100% at 521 pm , recheck at 0531pm, BP- 109/61, P- 77, O2- 100%, 545pm, BP - 105/69, P- 72, O2- 100%. Medications administered: Famotidine (Pepcid) 10 mg by mouth. Time: np. Administered by NP.Benadryl 25mg 1 tab PO x1 by NP, and given water. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/20/2021 5:09 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER2613 NDC: 59267-1000-1
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| 52 | 2021-03-20 | feeling hot | Sweating and feeling warm occurred progressively |
| 52 | 2021-03-21 | inability to speak, numbness | Left side facial numbness and speech difficulty |
| 52 | 2021-03-21 | flushing | c/o chest tightness, throat swelling and flushing |
| 52 | 2021-03-21 | pain in extremity | Sore arm 5pm day of until Monday Fatigue Headache Saturday night Diarrhea on Monday |
| 52 | 2021-03-21 | pain in extremity |
Approx one moth post vaccine developed left arm pain radiating to neck and back, and decreased mobil...
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Approx one moth post vaccine developed left arm pain radiating to neck and back, and decreased mobility in arm.
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| 52 | 2021-03-21 | pain in extremity |
This was my second dose btw. Arm pain after first dose. No other noticeable symptoms. Second dose: H...
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This was my second dose btw. Arm pain after first dose. No other noticeable symptoms. Second dose: Headache almost immediately after being given the vaccine. Followed by arm pain/ache in BOTH arms, fatigue, lung pain, hip pain, general feeling of being unwell or having the flu. Went to work the next day. Still not feeling well. Felt even worse as the day progressed (with symptoms listed), went home early. Slept for twelve hours. Same symptoms the next day. Oddly, my symptoms seemed to relax a little after I ate lunch. Then returned a few hours later. Tomorrow will be 7 days after dose. I still have arm pain in both arms and extreme fatigue.
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| 52 | 2021-03-21 | tingling, discomfort |
Immediately after vaccine I became nauseous and dizzy with a headache. I went home and slept for the...
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Immediately after vaccine I became nauseous and dizzy with a headache. I went home and slept for the next three days. My body ached but the dizziness subsided. Today 03/22 I still feel nauseous and mildly aches. However my left elbow has now swollen up. It hurts to bed it and pressure hurts. I have pins and needles going through my wrist into my fingers along with a full ache.
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| 52 | 2021-03-21 | tenderness |
warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vesse...
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warm and itchy toes, look like chillblains, swollen, tender, red, and looking like burst blood vessels on 2 toes on one foot, and one toe on the other foot, started on 16 or 17th, March, still visible on March 22 - used some home made remedies and some triamcinolone, acetonide cream 0.1 % for the inflammation
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| 52 | 2021-03-22 | numbness |
the tech gave me a shot the pain was so intense and gave bad pain down my arm and have numbness in ...
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the tech gave me a shot the pain was so intense and gave bad pain down my arm and have numbness in my fingers. EMS at the site advised me to watch for potential hematoma and to go home and take tynelol and call primary physcian, Few hours passed pain persisted went to see a doctor she examined my arm and stated it is very possible that the she hit a nerve in my arm. She advised me to report this and to go back to the facility to report to supervisor. I went back to facility they advised to report on line and eventually it will feel better.
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| 52 | 2021-03-22 | tremor | shortness of breath, difficulty swallowing, headache, chest pain, anxiety, and tremor |
| 52 | 2021-03-23 | pain in extremity |
her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to spli...
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her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to split off. It was extremely painful; her arm was swollen/ It was extremely painful; had been awake two nights unable to sleep due to pain; The pain was also creeping up her neck; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En7200), via an unspecified route of administration in left arm on 16Feb2021 at 14:00 at single dose for covid-19 immunisation. The relevant medical history included latex allergy and bee allergy, all from an unspecified date. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), modafinil and unspecified thyroid medication. The patient stated that her arm was swollen and the joint in her shoulder felt like it was going to split off. It was extremely painful. Her hand was also swollen and she had to remove her rings. She had been awake two nights unable to sleep due to pain. The pain was also creeping up her neck. The events started on 18Feb2021 at 22:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment included steroids and pain killers sling for arm. No covid prior vaccination and no covid tested post vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
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| 52 | 2021-03-23 | pain in extremity | Chills, aching for 24 hours Sore arm for 24 hours then less intense for about a week |
| 52 | 2021-03-23 | pain in extremity |
Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. Aft...
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Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. After approximately 7 minutes, I felt my throat "swelling." I got up and went to the RN who administered shot. They called the RN over. Vital signs were stable, airway intact, able to speak full sentences. No shortness of breath. It took more effort to swallow. Right arm sore. They monitored me for another 15 minutes. No worsening symptoms. Swelling not improving. Recommended going to the ER (I'm an RN and this was administered at my hospital). Was escorted to ER. Hooked up to monitor. Slight redness noticed on both arms. No hives. IV started. Given IV Benadryl, famotidine, solu-medrol. No improvement. Hooked up to a monitor and given epi sub-Q. Monitored for approximately 60 minutes with improvement of throat swelling. Discharged to home with prescription for prednisone, famotidine and Benadryl x 5 days. At home, approximately 8 hours after shot, work up feeling itchy, took Benadryl PO with relief of symptoms approximately 45 minutes later. Followed up with MD on 1/21. No change in medications. Asymptomatic during the course of medications. Finished course of medications on the morning of 1/23. Later that evening started feeling tired, had chills, swollen glands. Went to bed early. On 1/24 symptoms continued including lack of appetite, increased fatigue, brain fog. Symptoms continued until 1/25 and gradually improved over the week.
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| 52 | 2021-03-23 | tremor |
Patient started feeling "lightheaded" and then felt as if hands were shaking. NO visible shaking not...
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Patient started feeling "lightheaded" and then felt as if hands were shaking. NO visible shaking noted. Feeling dissapeared within about two minutes.
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| 52 | 2021-03-24 | slurring, pain in extremity, tingling | Pain and tingling in my left are and shoulders, slur speech, stroke like symptoms |
| 52 | 2021-03-24 | feeling cold |
I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt...
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I felt my throat closing up, making it more and more difficult to swallow or breathe; my throat felt like a mild cold; more difficult to swallow; difficult to swallow or breathe; hives on my neck; swollen face and neck; swollen face and neck; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN 620H) as single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient previously took polio vaccine for immunization and experienced allergy, nickel and experienced allergy, chloroxylenol and experienced allergy, cetirizine hydrochloride (ZYRTEC) and experienced allergy, clarithromycin (CLARITIN) and experienced swelling face. The patient stated that, "After the vaccine was administered (18Mar2021 12:00) my throat felt like a mild cold making it a little more difficult to swallow. As I was sent to the high risk area I was monitored by a nurse. Upon leaving I got into my car that was warm inside. As I was driving I felt my throat closing up, making it more and more difficult to swallow or breathe. I went to a (store) and spoke to the pharmacist there. She advised me to take Benadryl immediately. She noticed hives on my neck and a swollen face and neck. As Benadryl took effect the hives receaded and the swelling of my face and neck went down. I went back to the vaccination site and seemed medical attention from the (Department name) Department team. They checked my vital signs and released me after a waiting period without any further medication being administered. I was given an appointment for 08Apr2021. I am concerned about an adverse reaction at the second appointment. Is it better to wait a little longer for the second dose to be given?" Patient is not pregnant. Therapeutic measures were taken as a result of the events included Benadryl. Outcome of the events was resolving.
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| 52 | 2021-03-24 | flushing |
Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a re...
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Flushing face, heavy tongue, light rash left arm, stomach irritation (nausea).Patient developed a reaction to COVID-19 vaccine 5 min. after injection administration flushing face, heavy tongue and light rash and nausea were the symptoms showed up by patient. V/S BP 198/886, P-63, Sat. 99%. Patient transferred to Hospital to get medical care and be under observation.
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| 52 | 2021-03-24 | hot flush |
Fever and moderate headache off and on for first 24 hours. Hot flashes starting day 2 around 1pm...
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Fever and moderate headache off and on for first 24 hours. Hot flashes starting day 2 around 1pm off and on. Rapid heart rate with chest pressure and sweating (measured 129) at about 5pm day 3. Lasted 25 minutes. Severe irritability at about 8am day 3 and ongoing
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| 52 | 2021-03-24 | night sweats | Stomach cramps, fever, headache, night sweats |
| 52 | 2021-03-24 | pain in extremity |
After 15 minutes of observation, patient complained of left arm pain and chest pain. Patient was tak...
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After 15 minutes of observation, patient complained of left arm pain and chest pain. Patient was taken into an exam room, EKG performed and reviewed by Dr. EKG was normal however given patients previous history and symtoms, 911 was called and patient was transported to the Hospital. Patient was later discharged based on "suspected anxiety and perhaps minor reaction to vaccination are at play here."
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| 52 | 2021-03-24 | pain in extremity |
I woke up about 12 hours after with a headache and chills. The day after, I only had some arm pain. ...
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I woke up about 12 hours after with a headache and chills. The day after, I only had some arm pain. A few days later, I had the diverticulitis flare up. I was place on antibiotics and that resolved the issue. I had Dose 2 (EL3246)on 1/26/21 and it was a similar situation, except that it was about 2 weeks later when the flare up occurred. I don't know if it was another reaction or it just wasn't resolved the first time.
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| 52 | 2021-03-24 | pain in extremity |
Sore arm the night of the vaccination, Hives developed 2 days after vaccinated. Hives spread all ove...
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Sore arm the night of the vaccination, Hives developed 2 days after vaccinated. Hives spread all over body. Very itchy. Hives stays more than 1 week after the vaccine.
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| 52 | 2021-03-25 | burning sensation |
Beginning at 9pm on 3/15/21, I had sharp pains in my chest and an elevated heart rate. Every day sin...
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Beginning at 9pm on 3/15/21, I had sharp pains in my chest and an elevated heart rate. Every day since, I have had chest pain/pressure, sharp pains in my head accompanied by a burning sensation throughout the top and back of my head and a burning sensation throughout my upper back and arms.
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| 52 | 2021-03-25 | cold sweat |
Complaints of headache, cool to touch, "body feels weird". Bp 140/90, HR 78, pulseox 100%. Rechec...
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Complaints of headache, cool to touch, "body feels weird". Bp 140/90, HR 78, pulseox 100%. Recheck at 5:35 BP 128/84 , HR 77 99%puse ox.
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| 52 | 2021-03-25 | electric shock sensation, numbness, feeling hot, hot flush |
Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face l...
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Flash of light and heat from head to toe 10 minutes after 1st dose. Numbness and tingling on face lips and tongue 60 minutes after 1st dose. Premedicated with Pepcid 20 mg and Benadryl 50mg 1 hour prior to 2nd vaccination with no adverse reactions occurring. Presented with popping, in ears, eye blurriness, numbness on face and head, swollen glands on bilateral neck, burning in chest happening in waves 2 -3weeks after 2 nd dose. Normal CPK, CBC and CMP results. 2/4/2021 episodes of heat throughout body, questionable palpitations, headaches, blurry vision, numbness on head and face, feeling faint and unbalanced during episodes. - comes in waves. Electric shocked under skin all over body and once in Bihar eyes. Normal brain MRI and follow up bloodwork. Visits to neurologist, GYN and ophthalmologist.
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| 52 | 2021-03-25 | flushing |
Patient received first Covid-19 vaccine at 2:47. Patient reports within a minute or two she began to...
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Patient received first Covid-19 vaccine at 2:47. Patient reports within a minute or two she began to feel flushed and faint. Patient did not have syncopal episode. Patient was taken to separate room where she could lay down. Patient given crackers and water. Vitals taken at 3:18 - BP 150/100, HR 82, SpO2 100%. Patient seen by Doctor. Vitals repeated at 3:30 - BP 155/95, HR 87, SpO2 100%, Temp 97.9F. Doctor reported patient feeling fatigued, but lightheadedness, flushing, and dizziness had resolved. Doctor advised patient contact someone to take her home. Also advised to follow up with her PCP for elevated BP. If symptoms worsen or new symptoms arise, patient advised to go to ED for evaluation. Patient verbalized understanding. BP checked once prior to patient leaving at 4:32 and was 142/100. Patient's sons came to clinic to drive her home.
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| 52 | 2021-03-25 | muscle spasms |
Severe muscle pain at injection site at 630pm. By 10pm my body started to ache from neck, shoulders,...
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Severe muscle pain at injection site at 630pm. By 10pm my body started to ache from neck, shoulders, body down to legs. Severe chills with shivering for almost 2 hours. Low grade fever 99. Could not walk or stand. Took tylenol at 11pm with little effect, then again at 330am due to chills, muscle aches n spasms in legs, slight headache, very tired and miserable feeling. Slept and woke up at 8am sweating under blankets and feeling less sore muscles. Hydrated with water, and by 9am just feeling tired. Soreness of injection site gone as well as body aches. Just fatigue feeling. Will still go to work on 3-26-2021 after thinking there was no way I can move my body. Not feeling 100% at 943am but much better than earlier flu type feeling.
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| 52 | 2021-03-25 | pain in extremity |
When leaving walking in parking lot very dizzy felt like I was drunk ( I do not drink at all) same w...
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When leaving walking in parking lot very dizzy felt like I was drunk ( I do not drink at all) same when I got home. Slept 2 days, woke up little wheezing, BAD headache....lasted 3days . Next day I had bad muscle pain, some bone pain, arm sore that wasn?t bothersome. EXTREME FATIGUE .....couldn?t get off couch bout 8 days. When I did very dizzy would stagger to the right. Fell into other couch trying to get up bout the 3 day. Fatigue was getting worse, hard to move body, VERY SLEEPY . Family insisted I go to ER or they would call EMS. I only will go if on death bed. This was 1st time in life I waited 8 days to shower, I?m a very clean person, I will even do my makeup almost daily. My biggest concern is the MALAISE AND FATIGUE WAS WORSENING AS DAYS WENT ON. I DO HAve Hx. Of reactions to tetanus but nothing like this. I?m waiting to go to dr to have labs drawn because of this. Thanks you
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| 52 | 2021-03-25 | throat numbness |
Client received vaccine approx 3:15pm. Reported throat and chest tightness and throat numbness at 3:...
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Client received vaccine approx 3:15pm. Reported throat and chest tightness and throat numbness at 3:25. V/S: HR 78, BP 133/76, RR 12. At 3:40pm, client reported diminishing symptoms and no new symptoms reported. At 3:50pm, client left site unassisted and with a steady gait, accompanied by husband. No medication provided
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| 52 | 2021-03-25 | unresponsive to stimuli |
Patient rec'd Pfizer Vaccine at site on 3/23/21 and was found unresponsive at home 4 hours later. Cu...
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Patient rec'd Pfizer Vaccine at site on 3/23/21 and was found unresponsive at home 4 hours later. Currently Hospitalized
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| 52 | 2021-03-26 | numbness |
Patient reports numbness on left arm (injection arm), positive PMS. Visual inspection reveals no sig...
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Patient reports numbness on left arm (injection arm), positive PMS. Visual inspection reveals no significant abnormalities.
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| 52 | 2021-03-26 | numbness | Severe numbness in the left side of face , tongue, mouth ,ear neck, arm and foot. |
| 52 | 2021-03-26 | pain in extremity, migraine |
Day 1 felt like my arm was in extreme pain, resolved a little over 24 hours. Day 2 I woke feeling li...
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Day 1 felt like my arm was in extreme pain, resolved a little over 24 hours. Day 2 I woke feeling like someone attacked the left back of my head with a hammer. It's now day 4 and my head still feels like a watermelon, about to explode. Tried migraine meds no help, heat send to be the only partial relief available.
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| 52 | 2021-03-26 | tremor | Chills, unable to stop shaking, extreme headache, fatigue, mild nausea |
| 52 | 2021-03-27 | discomfort |
Pain and discomfort in right arm pit with a noticeable large swollen lymph nodes. Currently still s...
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Pain and discomfort in right arm pit with a noticeable large swollen lymph nodes. Currently still slightly swollen but not painful as of today 03/28/21. Second dose is scheduled for 04/10/21.
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| 52 | 2021-03-27 | pain in extremity | Soreness in arm Diarrhea Dizziness |
| 52 | 2021-03-28 | bell's palsy |
Started with nausea at 1:30AM on 3/20/2021 and feeling unwell. At 10:00AM ON 3/21/2021 started havin...
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Started with nausea at 1:30AM on 3/20/2021 and feeling unwell. At 10:00AM ON 3/21/2021 started having pain in/behind left ear. This continued up to the time when on 3/24/2021 at 6:45AM my left eye was blinking slower than the right eye and the left-side of my mouth showed signs of drooping. I was admitted to the ER for possible stroke due to symptoms I was having but test results showed Bell?s Palsy. Treatment is acyclovir, ketorolac, prednisone and artificial tears ointment
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| 52 | 2021-03-28 | numbness |
Patient vaccinated 3/25/2021, states next day in the afternoon developed numbness to right face, arm...
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Patient vaccinated 3/25/2021, states next day in the afternoon developed numbness to right face, arm, leg, and body. No weakness.
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| 52 | 2021-03-28 | nerve pain, pain in extremity, tingling, numbness, facial pain |
By the evening of the first day: Severe headache, face pain, neck pain( both muscle and nerve), neck...
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By the evening of the first day: Severe headache, face pain, neck pain( both muscle and nerve), neck tension, left and right arm pain and tingling, pain and tingling in left leg( mild). Talking hurt my face, smiling hurt my face. Being in any position where my arms hung down at my sides hurt everything above my mid back. Took 200 mg of Gabapentin. This allowed me to sleep. At noon on Mar 21, starting taking Ibuprofen, 800 mg 3x daily. After most of a week of doing little other than sitting and reading, the pain seemed to subside somewhat. Sat Mar 27th evening : increase of upper body pain after small amount of light work with arms followed by nausea and vomiting. Visited Emergency room. Blood tests were taken. The tests were normal. Vomiting subsided after doses mof anti-nausea medication for 24 hours. Nausea has not returned. Started taking 500 mg of Methocarbamol nightly. Started taking Tylenol 3 x daily on Mar 28 Presently: The pain in my left leg has gone except for the foot pain that I have lived with for 2 years. The left leg tingles mildly once in a while. All other pain is nearly the same. I am unable to do much more than type or sit and read. If I look down to do a task, after a few minutes, I get a sharp nerve pain in my face, head, and neck. The skin on the back of my neck has been mildly numb for several days.
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| 52 | 2021-03-28 | tenderness |
medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to to...
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medium size red circle on arm-- with lump. Lump grape size/circle bigger than a plum. Tender to touch. No itchiness
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| 52 | 2021-03-28 | tremor, pain in extremity |
Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath ...
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Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath very quickly within 15 minutes. Normally do 30 minutes and can speak through it. Just thought I was tired. Overnight joint pain significant in knees, fingers and shoulder blades. Husband told me I was moaning throughout the night and turning from side to side. Got up to go to the bathroom once and head felt foggy. Morning got up as usual and quickly became light headed. Started to black out to the point where sitting down and putting my head down didn?t help. Was blacked out and yelled for my husband. Husband carried me to the couch what I was saying he thought I was hallucinating. Began to have whole body trembling - not necessarily chills just trembling. After about an hour subsided. Blacking out lasted on and off throughout the day. O2 stats between 91 and 94 throughout the day, fast heart rate 90+. No fever. Stayed in bed all day, barely moved. Restless and couldn?t get comfortable - very bad headache. Going in and out of sleep. Treated with Tylenol arthritis and ibuprofen. Drank water and some hot tea. Very hard to even drink anything. Next day felt like I had been sick although by 5pm seemed to be back to baseline.
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| 52 | 2021-03-30 | cold sweat |
my body was aching with cold sweat; my body was aching with cold sweat; fever; headaches; This is a ...
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my body was aching with cold sweat; my body was aching with cold sweat; fever; headaches; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 12Feb2021 08:00 on Left arm at single dose for covid-19 immunisation. The patient medical history included Asthma, Eczema, Peppermint allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), on 22Jan2021 15:45 on Left arm at single dose for covid-19 immunisation and experienced headache and Dizziness. Concomitant medications in two weeks include Montelukast (Strength: 10mg), Loratadine (Strength: 10mg) and cyclobenzaprine. On 12Feb2021 09:00, the patient reported, on his first shot he had headache and he was light head for 2 days. One the 2nd shot he was having headaches, my body was aching with cold sweat and he was having fever and temperature was 101. He states, he never had the covid at all. He started feeling better after 4th day. He started drinking emergency C one pack 1000 mg and had 3 packages in a 23oz water bottle. No other vaccine in administered in four weeks of vaccination. No treatment was given. No covid prior vaccination. Covid was not tested post vaccination. The outcome of events was resolving. Information on the lot/batch number has been requested.
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| 52 | 2021-03-30 | seizure, feeling cold |
feeling cold; running a fever 101.7; Headache; her muscles are seizing; she couldn't move her arms; ...
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feeling cold; running a fever 101.7; Headache; her muscles are seizing; she couldn't move her arms; muscles have gotten tired so she is a little sore; muscles have gotten tired so she is a little sore; seizures; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6199) via an unspecified route of administration in left upper arm on 16Mar2021 at 15:10 (at the age of 52-years-old) at a single dose for covid-19 immunization. Relevant medical history included typical soreness. She says her son has sensitivity to vaccines. But she only ever has like typical soreness and stuff but normally she goes through fine. She went through the first dose of the vaccine fine. Patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6200) administered on an unspecified date via an unspecified route. No prior vaccinations within 4 weeks were received. Patient reported that she had the second one yesterday and she is having some symptoms. It started with a headache, then running a fever of 101.7 on 17Mar2021. The things she is concerned about and she has been making all these calls about this morning is her muscles are seizing, like her whole body, down her back and derriere and her legs seize up and become like a board, it does not hurt but after a while she guesses her muscles have gotten tired so she is a little sore but it is not like a horse, her muscles just seize up, she couldn't move her arms on 17Mar2021. Its happened several times. She wanted to report it and make sure this is within the norm or if she should be going further with it. The headache started during the night, she says it was after midnight so 17Mar2021. It is ongoing but much less. Last night it was horrible, she confirms ongoing but improved. Her fever is ongoing at this time it is going up. Started out at 100.6 now it is 101.7, that also began 17Mar2021. It is getting worse. Her seizing muscles she noticed that at about 1 AM this morning so 17Mar2021 as well. It is ongoing but seems to be lessened. There is more time in between them. It was every hour but right now it is happening every 2-2.5 hours so it is improving. Patient stated that during the night/early this morning patient began experiencing feeling cold, seizures (undiagnosed. Muscle involvement), She explains seizures as not brain related, neck down to my leg, Tighten up. Hold for 10-15 seconds. Flatten out like a board, then it'll go away. Vaccination Facility Type was Hospital. No history of all previous immunization with the Pfizer vaccine. Additional Vaccines Administered on same date of the Pfizer Suspect was none. Adverse events do not require a visit to Emergency Room or Physician Office. The outcome of the events seizure, feeling cold, myalgia, muscle discomfort and limb discomfort were unknown, while for headache and muscle disorder was recovering and for fever was not recovered.
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| 52 | 2021-03-30 | tremor, pain in extremity |
high level of shortness of breath; Diarrhea; spinal column hurt the worst (the spine from the top of...
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high level of shortness of breath; Diarrhea; spinal column hurt the worst (the spine from the top of her neck to her butt); butt muscles hurt really bad; caller's spinal column hurt the worst, the front of her calves and hip joints; spinal column hurt the worst, the very edges of her back, the side of her back was excruciating; Dizziness; Vomiting; not feeling well enough; shaking; shivering/ chills; pulse ox and it dropped down to 93; Excruciating body pain; Headache; sore arm / front of her calves, front of her thighs, left arm, 3 left fingers; Exhaustion; no appetite at all; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 08Mar2021 at 10:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing epilepsy since Oct2015 (officially diagnosed in Oct2015, but the doctors believed it was in her early 20s but she was misdiagnosed for decades), post-traumatic stress disorder (PTSD) from 2020 (diagnosed a year ago), sleep apnea since 2016 (patient thought she was diagnosed in 2016), COVID-19 in Nov2020 from which the patient almost died, memory loss (left over COVID symptom) for which the patient was in speech therapy, intermittent body pain (aftereffects of COVID-19), relapse in seizures due to COVID-19, her eyesight was terrible, epilepsy migraines. Concomitant medications included unspecified epilepsy medications. There was no other vaccine given on the same day, or 4 weeks prior to the vaccination. The patient previously received a flu shot and fainted, on an unspecified date. On 08Mar2021 at 11:15, the patient experienced sore arm (pain 2/10). On 08Mar2021 at 22:00, the patient had headache which got progressively worse, then it got so bad she wanted to pop her head off at midnight. On 09Mar2021 at 00:00, the patient had shaking and shivering where it looked like she was convulsing (she had history of epilepsy and knew what a seizure felt like, her husband may have thought she was having a seizure). The patient had chills to the point where she had multiple blankets and could not stop shaking, took her pulse ox and it dropped down to 93. The caller's baseline temperature was 97.1 and her daughter took her temperature and it was 98.9, most people wouldn't consider that a temperature, but it was a temperature for her. The caller kept shaking like that for hours. On 09Mar2021 between 21:00-23:00, the patient had chills again. On 09Mar2021, the patient experienced excruciating body pain (pain 9/10) in very specific parts of her body. On 09Mar2021 by 12:00, the caller's spinal column hurt the worst, the front of her calves and hip joints, the very edges of her back, the spine from the top of her neck to her butt and then next to it was not so bad but the side of her back was excruciating, the butt muscles hurt really bad, the front of her thighs, left arm, 3 left fingers, but not the other 2 fingers. Oddly enough, she was considered a long hauler, it was the places that her occupational therapist and physical therapists were working on. On 09Mar2021 at 00:00, the patient experienced dizziness (that was on and off all day until bedtime last night on 09Mar2021) and vomiting (she couldn't hold down water). On 09Mar2021, the patient was not feeling well enough. On 10Mar2021 at 08:00, the patient experienced diarrhea (she's only gone to the bathroom twice). On Mar2021, the patient experienced exhaustion and no appetite at all. On an unspecified date, the patient experienced a high level of shortness of breath (patient was unsure if this was due to COVID-19). The patient underwent laboratory tests and procedures which included an echocardiogram on an unspecified date: her left atrium was enlarged and her cardiac numbers were high, they were going to monitor her heart and the doctors didn't know if it was because she had COVID-19 or if it was that the doctors got lucky and found it, they had nothing to compare it to because she only had this one echocardiogram. The patient had history of epilepsy migraines (can pinpoint the spot where it hurts), she thought she would try sumatriptan succinate (IMITREX) for this headache (her whole head hurt), as it didn't interact with her other medications. The patient also took acetaminophen/diphenhydramine (TYLENOL PM; Lot: GF6062, Expiry: Jun2022), ibuprofen (patient thinks the Lot is QWE2546A, but is unsure) for the headache. The patient took ondansetron (ZOFRAN) which she had from a previous prescription and that made the vomiting stop. The events did not require an emergency room or physician office visit. The patient did not think that the reactions were due to her epilepsy medication. The clinical outcome of excruciating body pain was resolved on 09Mar2021 (it's hard for the caller to say if she has recovered because she had COVID-19 aftereffects and had body pains that come back intermittently), sore arm / front of her calves, front of her thighs, left arm, 3 left fingers, shaking, shivering/chills, pulse ox and it dropped down to 93, spinal column hurt the worst (the spine from the top of her neck to her butt), butt muscles hurt really bad, caller's spinal column hurt the worst, the front of her calves and hip joints, spinal column hurt the worst, the very edges of her back, the side of her back was excruciating, dizziness, vomiting, not feeling well enough, no appetite at all was resolved on 09Mar2021; headache was not resolved (unless the caller was asleep, she felt the headache); exhaustion was not resolved; diarrhea and high level of shortness of breath was unknown. Information on the lot/batch number has been requested.
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| 52 | 2021-04-04 | tingling |
Severe tinnitus: Two days after receiving my first dose of the Pfizer Covid19 vaccine, the pre-exist...
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Severe tinnitus: Two days after receiving my first dose of the Pfizer Covid19 vaccine, the pre-existing tinnitus in my left ear, which has been stable and very mild for 35+ years, suddenly spiked to an almost unbearable level. It has remained consistently high ever since. New tinnitus symptoms presented in my right ear at the same time. I also experienced a sudden decline in my hearing acuity. I additionally experienced tingling and muscle weakness in my face, which has since resolved. However the severe tinnitus remains.
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| 52 | 2021-04-06 | weakness, pain in extremity |
weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do any...
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weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed; brain fog; she can't concentrate, it is affecting her head; dizziness/dizzy; exhausted/tiredness/tired; faint episode; achy arm; abdominal pain; her sugars really shot up in couple of hours, went to 220s; shivers, cold.; shivers, cold.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [22Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 52-year-old) at single dose for COVID-19 immunization. Medical history included Diabetes, ongoing PoTS diagnosed around Dec2020 or Jan2021, MTHFR (methylenetetrahydrofolate reductase genetic mutation) genetic mutation, Genetic/Chromosomal abnormalities and lost some weight. The patient had prediabetes for long time, in last year gotten little bit bad; back under control sugars running 125-130. That's not why she is feeling like this. Measures her sugar 3 times daily keeps Diabetes diet controlled mostly. With regards to her MTHFR: methylenetetrahydrofolate reductase genetic mutation. This genetic mutation makes her not methylate well, they told her she is a poor meythelator. Family history included diabetes and high blood pressure. Her dad passed away from either Diabetes or Lung cancer; she is not sure which-he had lung cancer but afterwards when patient talked to her sister, sister mentioned dad's diabetes got really bad after the chemo and everything; but that is neither here nor there in the end; it could have been from Diabetes or lung cancer. He was a smoker for his entire life, even though chemo he could not quit the cigarettes, could not give it up even on his death bed. Concomitant medications included ergocalciferol (VIT D), cyanocobalamin (VIT B12), and ongoing ascorbic acid (VITAMIN C); all were taken for vitamin supplementation. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 19Feb2021 for immunization and experienced achy arm and tired for a day. About 15 years ago when having her daughter, the patient had severe reaction to Magnesium sulfate for preeclampsia. They gave her Magnesium sulfate twice which made her comatose twice, she does not know why they gave it to her the second time. She also had a reaction to calcium levomefolate (DEPLIN), like a methylfolate thing. She reported she was on Glimepiride for Diabetes previously which was stopped a couple of weeks ago because she was having a lot of blood sugars that did not sit well with her. This consumer is the patient who called regarding symptoms she experienced following first dose of Pfizer-BioNTech COVID-19 Vaccine administration on 18Mar2021. The first symptoms she had were an achy arm later on that day of 18Mar2021. On 19Mar2021, the next morning she woke up totally exhausted. She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed. Some of the symptoms lifted yesterday, 21Mar2021 during the day. She kind of got up, was still kind of tired but pushed through it thinking she couldn't just sit in bed. She spent a little time outside while her daughter was at the pool; she was sitting in a chair away from other people. When she came home she was really tired and dizzy on 21Mar2021 and decided to go to bed. The patient also experienced weakness and nausea on unspecified date. After the Pfizer BioNTech COVID-19 Vaccine injection/shot on Thursday, 18Mar2021 she had a faint episode. They thought the faint episode was probably from anxiety, reason unknown; but she had a lot of faint episodes before she went to bed. She woke up 1-2 hours later on 18Mar2021 with really bad abdominal pain all night, shivers, cold. When she got up in the morning she was really tired; she had to take her daughter to school and barely drove to school half-way coherent because her daughter was talking to her. She was not doing great, she came back home, she is still tired, has been on the couch all day; her stomach is kind of queasy, not good. This is day 4 so she is concerned a little bit. She is too tired to go downstairs during this call; this thing is kicking her butt; she is having a brain fog with this thing, she can't concentrate, it is affecting her head. She has other medical condition Diabetes: After she got the Pfizer-BioNTech COVID-19 Vaccine her sugars really shot up in couple of hours, went to 220s on 18Mar2021; sugars back down the next day (19Mar2021). She is terrified of what is going to happen after the second dose of Pfizer-BioNTech COVID-19 Vaccine. She verified she has not had any visit to physician's office, emergency room or hospitalization related to these events; not yet, but she is considering whether to go or not. The outcome of the event exhausted/tiredness/tired was not recovered, and the outcome of the remaining events was unknown. Information about the Lot/batch number has been requested.
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| 52 | 2021-04-06 | facial paralysis, one side paralysis, numbness |
Patient was observed for 30 min after her second dose of covid-19 vaccine (note patient decided to t...
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Patient was observed for 30 min after her second dose of covid-19 vaccine (note patient decided to take diphenhydramine immediately after receiving this dose of vaccine because she experienced a spike in her blood pressure with her first covid-19 vaccine). Patient felt fine and left the vaccine clinic. But about 2 hours after receiving the second dose, patient developed numbness, right upper and lower extremity weakness and headache. Upon presentation to the ED, patient developed right sided facial droop and ongoing right upper and lower extremity weakness and headache. Stroke protocols were initiated including offering tPA for clinical stroke, but patient declined it. At workup, her EKG showed a sinus rhythm, she had not reported recent illness. A CT angiogram showed no significant flow limiting stenosis either in the neck or head and there was no perfusion deficit. However, incidental bilateral aneurysms were discovered at the anterior cerebral arteries at the junction of the A3 segments and pericallosal arteries. There was no evidence that they had hemorrhage and they are small, less than 5 mm in diameter and neurosurgery has evaluated the patient and is not recommending any urgent intervention. The next day the patient was doing well, presenting symptoms/deficits resolved except for ongoing mild headache. An MRI examination of the brain has shown no acute infarct and normal brain morphology was described. She had an echocardiogram, which showed grossly normal left ventricular size and systolic function with an estimated ejection fraction of 65%. Amlodipine was started for elevated blood pressure. Note: patient had a history of hypertension but was not on medications for this prior to admission. Neurology consult = ?This is a peculiar event. It is unclear if the patient had a TIA or COVID reaction to a COVID vaccination or a reaction to headache. She does not exhibit a completed stroke on MRI scan. She has recovered completely except for mild headache. Incidental aneurysms were discovered and at some point she should have follow up for that. She should have a follow up with the stroke service. In the meantime, I think it is reasonable to continue with daily aspirin on this patient. Note that she had a cryptogenic TIA.?
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| 52 | 2021-04-06 | numbness |
fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then ...
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fainting; dizzy; tachycardia; high blood pressure; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head; This is a spontaneous report received from a contactable nurse (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 12Mar2021 at 09:30 (at the age of 52 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 12Mar2021, the symptoms the patient had were fainting, feeling dizzy, tachycardia, high blood pressure, then numbness to left side of face swelling then progressed to left arm left leg with excessive pressure to head. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any treatment for the events (as reported). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel in Mar2021. Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event fainting cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-04-08 | migraine |
Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressu...
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Anaphylaxis fast heart beat sob like being on fast treadmill tongue swelling super high blood pressure the next two days after I had really bad migraine and high fever of 102.3° with bad fatigue for 4 days.
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| 52 | 2021-04-09 | weakness, tingling, pain in extremity |
got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up;...
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got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up; chest pain in my right side; my left leg started aching; my toes tingle like they have fallen asleep on that left side; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing; Redness; back was all red, really red; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 01Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer reporting for herself. This 52 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 31Mar2021 at 09:30, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the vaccine on 31Mar2021 at 9:30 and was fine all day until 7 o'clock at night. She went to take her shower and got extremely weak, very weak in the shower and didn't know if she will be able to keep standing up, so she got out of the shower, went upstairs; the weakness persisted and then she started feeling chest pain in her right side, her left leg started aching and her toes tingled like they had fallen asleep on that left side so she got scared and went to the emergency room where they kept her overnight. Her heart was beating faster than what it should have been, they said she was tachycardic and her heart was racing and that was why they kept her at the hospital. She also had redness, her back was all red, really red. They did lots of lab work and blood work, a stress test, an ultrasound on her left leg for blood clot and a CAT scan on her heart, all with unknown results. When probed about hospitalization, she stated to stay overnight. She was hospitalized on 31May2021 at about 19:30 and did not get out until 13:30 on 01Apr2021. Events outcome was unknown.
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| 52 | 2021-04-11 | inability to speak |
Pt received 1st dose of Pfizer dose. Allergies to iodine. Pt started exhibiting difficulty swallowin...
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Pt received 1st dose of Pfizer dose. Allergies to iodine. Pt started exhibiting difficulty swallowing. Pt was able to talk. BP 172/97. HR 78. SaO2 99%. Paramedics stayed with pt for 20 minutes until pt said the feeling had passed and she was able to drive home. Zero reports of difficulty breathing, no drop in SaO2
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| 52 | 2021-04-14 | weakness, tingling |
04.06.21 I received my 1st Pfizer shot at 3pm. At 5pm, I had a headache, my neck was hurting and I b...
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04.06.21 I received my 1st Pfizer shot at 3pm. At 5pm, I had a headache, my neck was hurting and I began feeling so weak I could barely talk, I couldn't hold my eyes open. I took 3 Aleve. At 8pm, I started with shortness of breath just going downstairs plus my entire body felt like I was hit by a truck. My 3lb. Chihuahua would get on me and it felt like I was hit by a bat with a ripple effect into the surrounding area. I took 2 Tylenol PMs. On 04/07, at 6am, I woke up to my limbs extremely swollen and throbbing, this included both feet and especially both wrists and hands. My hands were worse than my feet. My left wrist/hand also had tingling. I was so weak I could barely get out of bed or talk, this continued through to 5:30pm same day. I called an Urgent Clinic and told her all my symptoms, she said were all "normal" until I got to my wrists/hands and limbs. Urgent Care told me it would be best to be seen in ER and evaluated. I immediately went to ER . This approximate time was 6:30pm on 04/07/21.
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| 52 | 2021-04-15 | inability to speak |
Days 1-2; Extreme fatigue and chills. Day 3: Felt well. Starting on Day 4: Extreme Exhaustion, musc...
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Days 1-2; Extreme fatigue and chills. Day 3: Felt well. Starting on Day 4: Extreme Exhaustion, muscle weakness, extreme post-exertional malaise, headache, rash on left cheek, cognitive problems (word-finding difficulty). Symptoms severe for a month, and slow improvement. I'm 2 months out and am at less than 50% of previous activity level. Muscle weakness (especially legs), moderate fatigue, and worsening fatigue after even mild exertion persists. I have had ME/CFS for 25 years, but it was mild/moderate have been at a great functioning level for over 10 years, able to exercise, easily perform ADLS. No problems with muscle weakness, etc.
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| 52 | 2021-04-16 | numbness, tingling | left face, arm, leg numbness and tingling |
| 52 | 2021-04-19 | throat numbness, numbness |
At 10:15, writer arrived to resident's home. Resident made writer aware she was allergic to PNC and ...
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At 10:15, writer arrived to resident's home. Resident made writer aware she was allergic to PNC and had a hx of seizure. Writer continued registration process and flagged for 30 minute observation. Resident then received 1st dose of pfizer. Less than two minutes shortly after vaccine was administered resident verbalized that she was feeling numb starting from her throat and moving down her chest. She denied having SOB, was alert and responding to my questions. At 10:35 patient started gasping for air holding her throat. Epi pen was immediately administered to thigh and was not effective. Resident began to seize lasting for about 5 minutes. 911 called at 10:43 am. Resident turned on side resident continue gasping and started seizing again. All safety measures in place. At 10:50 am, 911 staff arrived provided and took resident to the hospital.
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| 52 | 2021-04-22 | breast pain |
Began a very heavy and unexpected bleeding period with cramping and sore breasts 2 days after shot. ...
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Began a very heavy and unexpected bleeding period with cramping and sore breasts 2 days after shot. I haven't had a period in 6 months. Far heavier than historic cycles beginning at age 13.
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| 52 | 2021-04-23 | pain in extremity |
All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the e...
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All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; vaccine site started being sore; This is a spontaneous report from a contactable consumer/ Non-HCP (patient). This 52-year-old non-pregnant female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in the left arm, on 12Feb2021at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. Patient's medical history included hypothyroidism, irritable bowel syndrome, primary hypertension, seasonal affective depression and flu. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in left arm on 22Jan2021 at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. The patient had no allergies with medications, food or other products. Concomitant medications in two weeks included levothyroxine sodium(thyroxine), sertraline, hyoscyamine and lisinopril. On 12Feb2021, the patient was a little sore that day, but not the next, vaccine site started being sore. On 14Feb2021 patient spent an hour shoveling snow in the morning, but wasn't sore afterwards. On 14Feb2021 (8 plus hours after shoveling snow), the vaccine site started being sore, but the pain was on again/off again. As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm. All of the joints in both arms ached, 600 mg ibuprofen didn't seem to help. On 15Feb2021(Morning), the injection site is a little sore, the joints in her left arm are sore, and, weirdly, her left hip aches. The throbbing pain last night wasn't like any over-used muscle soreness I've ever experienced and the joint aching was also unlike anything I've experienced outside of when I've had the flu. Patient did not receive other vaccines within 4 weeks or prior vaccination. No COVID-19 prior the vaccination and no COVID-19 test was done post vaccination. Patient's treatment medication included ibuprofen. Outcome of the events were recovering. Information on the lot/batch number has been requested.
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| 52 | 2021-04-24 | pain in extremity |
Leg pain. Started in calf. Moved to hamstring. Moved to glutes; Leg pain. Started in calf. Moved to ...
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Leg pain. Started in calf. Moved to hamstring. Moved to glutes; Leg pain. Started in calf. Moved to hamstring. Moved to glutes; Leg pain. Started in calf. Moved to hamstring. Moved to glutes; This is a spontaneous report received from a Non-contactable consumer (Patient). This 52-year-old female (non-pregnant) consumer reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7533) via an unspecified route of administration into the left arm on 07Apr2021 09:30 AM (at the age of 52-year-old) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included allergies to medications, food, or other products. Others included EGPA, asthma, bronchiectasis, vasculitis, eosinophilic granulomatosis with polyangiitis, aspirin [acetylsalicylic acid], iodine and antibiotics all for drug hypersensitivity. The patient concomitant medications included medications that the patient received within two weeks of vaccination which included mepolizumab (NUCALA), prednisolone acetate (PRED+), cetirizine hydrochloride (ZYRTEC ALLERGY), atorvastatin (LIPITOR [ATORVASTATIN]), diltiazem (CARDIZEM [DILTIAZEM]), budesonide, formoterol fumarate (SYMBICORT). On 08Apr2021 05:00 PM, the patient reported of leg pain which started in calf, moved to hamstring and moved to glutes. The patient did not receive treatment nor any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering for all the events. No follow-up attempts are possible. No further information is expected
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| 52 | 2021-04-27 | tingling | tingling on fingers, pain experienced at injection site, dizziness |
| 52 | 2021-04-28 | numbness |
TIA; a rush of numbness came over my whole left arm. My arm; My arm was numb, heavy and weak; My arm...
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TIA; a rush of numbness came over my whole left arm. My arm; My arm was numb, heavy and weak; My arm was numb, heavy and weak; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208, expiration date not reported), via an unspecified route of administration on 17Mar2021 (at the age of 52-years-old), 8:00am at single dose in the left arm for COVID-19 immunisation. Medical history included hypothyroidism and ADHD (attention deficit hyperactivity disorder). The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) 88mg and lisdexamfetamine mesylate (VYVANSE) 40mg both taken from unknown dates and unknown indication. The patient previously took clarithromycin (MACROBID) and experienced allergies. Historical vaccine included first dose BNT162B2 (brand: Pfizer) received on 24Feb2021 6:00pm (lot number: EN6202) at the age of 52-years-old in the left arm. It was reported that on Thursday, 08Apr2021 at approximately 7:00pm, the patient was standing in her kitchen when all of a sudden, a rush of numbness came over her whole left arm. The patient's arm was numb, heavy, and weak. She knew that this feeling was not normal, so she had her husband take her to the hospital, their local hospital. They arrived at approximately 7:30pm where the patient was took in right away. At that time, the feeling had returned to the patient's arm. The patient was taken back for a CAT scan on her head after which the doctor came to tell her that they would be keeping her overnight for observation since they think she had TIA (transient ischaemic attack). The patient was monitored overnight and at 6am the next day on 09Apr2021, she had an ultrasound on her carotid artery and later in the morning, at around 10am, the patient had an echo cardiogram. The patient was released at approximately 12pm on Friday, 09Apr2021. The events experienced resulted in "Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization from 08Apr2021 to 09Apr2021". The patient has no COVID prior vaccination and had not tested for COVID post vaccination. Outcome of all the events was recovering.
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| 52 | 2021-04-28 | pain in extremity |
blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremen...
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blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremendously; This is a spontaneous report from a contactable Nurse. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:45; at the age of 52-years-old, (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing memory impairment (She states that she was diagnosed either last year or the year before that she can't remember. She states that it is ongoing, but it is well controlled). Historical vaccine included vaccine to tetanus (About 3 or 4 years ago). There were no concomitant medications. The patient experienced blood clot (thrombosis) (disability) on 13Apr2021 with outcome of not recovered, swelling and pain in right leg (disability, medically significant) on 09Apr2021 with outcome of not recovered, right arm hurting tremendously (disability) on 01Apr2021 with outcome of recovered on 04Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: positive on 13Apr2021 had a blood clot. Therapeutic measures were taken as a result of blood clot (thrombosis) included Xarelto and due to pain in extremity the patient received ibuprofen (7 ibuprofen every day); Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Thrombosis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 52 | 2021-05-04 | discomfort, speech disorder, feeling of body temperature change, numbness, feeling hot |
allergic reaction; wasn't able to lift her hands; blood pressure was very low at about 80/59; tired;...
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allergic reaction; wasn't able to lift her hands; blood pressure was very low at about 80/59; tired; light headedness; Didn't feel very comfortable; weak in the legs; She was warm or cold, hot then suddenly cold; chills; fogginess; fainting reaction 15 minutes after getting the shot; palpitations for an hour; numbness in her lower jaw/bottom jaw was half numb; weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking; weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking; inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/Every next breath was getting weaker and they disappeared after an hour. She felt like someone was holding her chest, do not let her to deep breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 52-year-old female patient received BNT162B2, dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 08:30 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) (at the age of 52-years-old) as single dose for COVID-19 immunisation. She reported says she was getting it because people who were vaccinated are being less cautious and putting her at risk for COVID. The vaccination facility was organized through a pharmacy was not administered in a military facility. Medical history included measles on an unknown date (she was sick only once with measles). The patient reported no family medical history but the only thing to put about her probably was that she has maybe rare in a good way immune system. She thought children infections that kids usually get, some of them are very contagious, she was sick only once with measles. She says she has never had chicken pox, she was not vaccinated for chicken pox, she was in contact with multiple people with chicken pox, has antibodies with chicken pox but she never had symptoms, she was never sick. She said she was never sick with any children's infection, she usually did not get sick at all, no flu, no cold things, never. She was not sure if it was measles or if it was rubella as she was translating from another language. There were no concomitant medications. The patient previously took lidocaine and experienced allergy with symptoms of cold sweat and palpitations. She says this allergy started a very long time ago. She said it was affecting only dental procedures and that they know about so they just don't use it on her. She says they consider it not be the lidocaine but due to the ephedrine inside of the lidocaine. She lists her symptoms as cold sweats and palpitation, no pain. She reported they thought the reaction was just too strong, she had 2 episode in 2 different offices, they don't use it on her. The patient had no prior vaccinations within four weeks. The patient declined being sick at the time of vaccination. On 08Apr2021, the patient experienced fainting reaction 15 minutes after getting the shot , palpitations for an hour, numbness in her lower jaw/bottom jaw was half numb, weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking, inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/every next breath was getting weaker and they disappeared after an hour. she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing, tired, lightheadedness, didn't feel very comfortable, weak in the legs, she was warm or cold, hot then suddenly cold, chills, and fogginess. On 14Apr2021, the patient experienced blood pressure was very low at about 80/59, wasn't able to lift her hands, weak again and dizziness. The patient's second dose was supposed to be next Friday but her healthcare provider thought it was an allergic reaction (unspecified date) and advised her to not get the second dose. The patient wanted to know what would Pfizer advise. The patient did not know if it was because of COVID but thought those were the effects of any kind of vaccines. The patient clarified her jaw was only half numb. She reported the events started after 15 minutes, the jaw was later, palpitations started after she broke the pattern of her thinking, that wasn't right. She said we had the list but it was missing that it started with one symptom and was replaced by another symptom. She said the only 2 that were together was the jaw part and the palpitations. She says the jaw part was a very short period of time, she felt it and thought what was this, she did not know how long it was, maybe one minute, less than one minute. She reported her palpitations were periodical palpitations, every next breath was getting weaker and they disappeared after an hour. The patient also reported her legs part was after the palpitations were gone. She had talked to multiple nurses and she realized from telling the story 5 times that the symptoms started from up to the bottom; the reaction was from her head to her legs. She reported that she doesn't feel very comfortable, she doesn't know what will happen to her, no one knows. She says all symptoms were on the same day, she was able to move and felt comfortable to move after an hour and a half. She says she started to move after symptoms in the legs started to disappear, she was not able to take deep breath but she was able to breathe without destructions. She says she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing. She tries to explain the temperature situation, saying the feeling during this time was warm or cold, hot then suddenly cold, that there was no one explaining what happened with her. She says she she remembers noticing that suddenly she had chills. cold, she was talking to someone and she felt cold, she can't exactly say what. She says this probably lasted half a day, maybe 12 hours: She says she was very dizzy on that day, suddenly, and at night she measure her pressure to see what is going on. She says she she has been known for low blood pressure earlier in her life. She says 110/70 was her normal and she had around 80 something, 86/59, something like that, she hasn't had such a low blood pressure in 30 years, maybe since her pregnancy. She stated that she has recovered completely from everything. She says she is not sure if its coming back, she did not expect to have low blood pressure, but right now she is totally fine, a normal person. The patient confirmed her blood pressure was, she thought 86/59 on 14Apr2021. She said she took her blood pressure 2 times, a couple times, the first time was even lower on 14Apr2021. She says on the actual 08Apr2021 she took her blood pressure and it was 120 over something, a little bit higher than it usually would have been. She said she was usually running towards the lower acceptable range, 110 to 70, 110 to 75, something like at doesn't get more than 113. The events did not require a visit to emergency room nor a visit to physician's office. The patient wanted to know if these side effects were known to Pfizer and what happens to those side effects. She asked do they have information on if they increase with the second vaccine. The outcome of the events fainting reaction 15 minutes after getting the shot, palpitations for an hour, numbness in her lower jaw/bottom jaw was half numb, weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking, inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/every next breath was getting weaker and they disappeared after an hour. she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing, tired, lightheadedness, didn't feel very comfortable, weak in the legs, she was warm or cold, hot then suddenly cold, chills, and fogginess was recovered on 08Apr2021; outcome of events weak again, dizziness, wasn't able to lift her hands, blood pressure was low was recovered on 14Apr2021; while outcome of allergic reaction was unknown.
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| 52 | 2021-05-04 | tingling, pain in extremity |
pt complaining about arm pain- says too high in shoulder- felt tingling sensation as if she hit funn...
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pt complaining about arm pain- says too high in shoulder- felt tingling sensation as if she hit funny bone and states is in too much pain. it was explained that it has not been 24 hours yet, but wants her side effect reported
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| 52 | 2021-05-06 | cold sweat, pain in extremity |
lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomitin...
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lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomiting; vertigo; fell on the bathroom floor; had a little pain in the arm; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 at 08:15 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Mar2021 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced fever, chills, body aches, left arm pain, and diarrhea. Relevant medical history included COVID-19 infection on an unspecified date, lyme disease, seasonal allergies and penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm. The events resulted in an emergency room visit, however, the patient did not receive any treatment for these events. The outcome of the events lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm was unknown. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same patient/reporter, different AE/first dose.
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| 52 | 2021-05-06 | numbness and pain in extremities |
neuropathy on her left hand and foot, it never got better/got worse in her left arm and hand; had a ...
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neuropathy on her left hand and foot, it never got better/got worse in her left arm and hand; had a knot came up under her arm; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose on an unspecified date (batch/lot number and expiration date were not reported) and second dose on an unspecified date (batch/lot number and expiration date were not reported); both via an unspecified route of administration, administered in the left arm as a single dose for COVID-19 immunization. Relevant medical history indicated that the patient had suffered with neuropathy for years and her vitamin D levels were low; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After the first dose on an unspecified date, the patient had a knot came up under her arm within the first 24 hours and neuropathy on her left hand and foot; it never got better. She received the second dose and it got worse in her left arm and hand. She also got another knot under her left arm. The events took place after use of the product. The patient was not recovered from the events. Information on the batch/lot number has been requested.
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| 52 | 2021-05-06 | tremor, difficulty speaking, tingling, numbness |
24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was m...
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24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was my lymph node; I developed a headache over the whole left side of my head; I could hardly move my neck; All of a sudden I kind of broke out in the sweat; Left side of my head just went totally numb; Started feeling tingling in my left hand; I went to eat some yoghurt and I could not swallow at all; Airway is being compromised by the swelling in my neck; I cannot walk my left leg is dragging, so I am lurking around having to hold on; My voice was like had to whisper; Right side of my body started shaking; Later that evening the numbness subsided. I could speak better my left lymph node was still sore; blood pressure went up; white blood cells count was really, really extremely high; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 13Apr2021 (Lot Number: EW0153), at the age of 52 years, as single dose for COVID-19 immunization. Medical history included covid-19 in Sep2020. Concomitant medication was not reported. The patient experienced 24 hours later, after vaccination, her neck started swelling up, her left lymph node; abnormal mass in her neck which was her lymph node, which required hospitalization. The patient she developed a headache over the whole left side of her head. She could hardly move her neck. All of a sudden she kind of broke out in the sweat, left side of her head just went totally numb. Started feeling tingling in her left hand. She went to eat some yoghurt and she could not swallow at all, airway was being compromised by the swelling in her neck. She cannot walk her left leg was dragging, so she was lurking around having to hold on. Her voice was like had to whisper. Right side of her body started shaking, Later that evening the numbness subsided. She could speak better, her left lymph node was still sore. Blood pressure went up, white blood cells count was really, really extremely high. The patient was hospitalized from 14Apr2021 to 16Apr2021. The clinical course was reported by the patient as follows: When probed for the reason of hospitalization, consumer stated, "The symptoms I had was, I got the vaccination in my left arm, 24 hours after getting the COVID vaccination shot on 13Apr2021, almost exactly 24 hours later my neck started swelling up, my left lymph node, which I was expecting to have that problem. And I could hardly move my neck and then I developed a headache over the whole left side of my head and behind my eye and it was hurting and then it hurt my ear. So, I was having ear ache too. So, that went on for about an hour and a half and then all of a sudden I kind of broke out in the sweat and the left side of my head just went totally numb and then I started feeling tingling in my left hand and so I went to the bathroom to see if my face was numb, to see if I had any paralysis of my face which I did not have any at all, it was just numb. So, then I am concerned, so I decide I am going to take an Aspirin and so before I took the Aspirin I wanted to eat something because I had not had anything to eat that day. I went to eat some yoghurt and I could not swallow at all, I couldn't swallow the yoghurt. So, then I am concerned my airway is being compromised by the swelling in my neck. So, I got to call # and then I cannot walk my left leg is dragging, so I am lurking around having to hold on and then when I called # my voice was like had to whisper and it was hard to get an information where I was at. Finally they arrived and I was taken into the ambulance and when I was in the ambulance my blood pressure went up and also the right side of my body started shaking, they took me to the hospital. I was in the hospital. I had MRI, a CT scan and all of those things and it was negative for a blood clot or anything, heart problems or brain bleed. So, they ruled all of that out, my white blood cells count was really, really extremely high that is what the doctor said and anyway so I was admitted in the hospital and now I can talk better and the numbness is going away on the 14th a day later which went on for the symptom. So, later that evening the numbness subsided. I could speak better my left lymph node was still sore and everything and of course they did noticed that in the scan, MRI stuff about the abnormal mass in my neck which was my lymph node.". The patient stated, "I was hospitalized on 14Apr2021 and I was released the evening of 16Apr2021. Treatment: the patient stated they did not treat her for anything except for the high blood pressure when out there and that is it. The clinical outcome of Lymph node pain was not recovered. The clinical outcome of the remaining events was unknown.
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| 52 | 2021-05-07 | tingling, numbness, burning sensation |
I fainted( the day after 1st dose); When I regained conscious I started to feel numbness and tinglin...
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I fainted( the day after 1st dose); When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; My blood pressure was 89; When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; pain in joint; I have been feeling burn; This is a spontaneous report from a contactable consumer. A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration, administered on left arm on 19Mar2021 08:45 (Batch/Lot Number: EN6204) and second dose via an unspecified route of administration, administered on left arm on 09Apr2021 09:15 (Lot Number: EP7533) as single dose, for covid-19 immunization. The patient Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient concomitant medications were not reported. On 20Mar2021 02:00 PM, the patient fainted after the 1st dose. Her blood pressure was 89. When she regained conscious, she started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet. Since then, she had been feeling burn and tingling in her hands and feet. Some pain in her joint. The paramedic asked her to walk and then It went away on that moment. The patient underwent lab tests and procedures which included blood pressure measurement was 89. The patient did not receive any treatment for the events. The outcome of the events was reported was recovered /Recovered with lasting effects. Information about Lot/Batch number is obtained. Additional information has been requested
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| 52 | 2021-05-11 | pain in extremity |
had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; P...
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had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; Pain in arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Apr2021 (Lot# EW0162), at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, blood pressure. Concomitant medication included unknown blood pressure medicine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 19Mar2021 at 09:15 (Lot# ER2613) for COVID-19 immunisation with no adverse effect. The patient had an allergic reaction to the 2nd dose of the vaccine. She stated that it burned her skin, her skin came off, skin was burning and i red. She was burning on left arm/extremities burning sensation of. It opened up and made a wound. It spread from her inner arm gone on the top of her breast, it was warm to the touch, it was burning in the inside of her. She had redness that turned into bruising. She could see a red circle and a red circle going down her arm getting bigger and redder. There were bruise marks like a map on her arm. The symptoms were spreading more on her body, and it was redder and warmer to touch. The bottom of her arm where the muscle would be at like the bicep or whatever part this is, was burning to move her arm and just burning. Her arm was on fire. Looking at her chest where her armpit is going to the top of her shoulder there was a red big spot. There were 5 big spots that came overnight going down her right breast. It was red, like a burgundy bruise. It was a burning hot sensation and was hurting inside, not outside. It was burning on the inside, and that was what was making burns come on outside of the skin. While she was in the hospital they diagnosed cellulitis of the left upper extremity. A neurologist thought she had panniculitis on left arm. The doctors thought it was an infection. The events required emergency room visit and physician office visit such as personal care physician, a wound doctor, dermatologist, neurologist, allergist, epidemiologist and an infectious disease doctor. Therapeutic measures were taken as a result of the events and included treatment with Levaquin 750 mg oral, Vancomycin, steroids, sildersulsadiazine cream, Clobetasol Propionate cream, Silvadene, Polysporin (lot# 1480Z, Exp date 20Apr2022) or Bacitracin, ice, Curad things for her dressing. During hospitalization the patient underwent lab tests and procedures which included blood work, X-ray, ultrasound all with unknown results. The patient was hospitalized from 13Apr2021 to 20Apr2021 for drug hypersensitivity, skin burning sensation, erythema, skin exfoliation, burning sensation, contusion, wound. Outcome of all events was unknown except for erythema , burning sensation and contusion which was not recovered.
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| 53 | 2021-01-02 | tenderness |
I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nur...
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I noticed swelling of the lymph nodes under my left armpit, when i called my doctor's office the nurse told me to put ice for 20 minutes. Ice was applied every day for 20 minutes, the swelling finally went down some today but the vein under my left arm is still tender.
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| 53 | 2021-01-03 | flushing |
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,...
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Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
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| 53 | 2021-01-03 | tingling |
Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongu...
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Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongue. Pt given 10mg cetirizine. Pt observed for 30 minutes. Pt states feeling are resolved. Pt released to work.
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| 53 | 2021-01-03 | tremor |
pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 ...
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pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 hours after vaccine. Resolved in 5 days.
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| 53 | 2021-01-04 | weakness |
The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for ...
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The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for 2 days and on 12/20 feeling 100 ft walk was tired. Then on 12/21 started my exp body ache lasted 2 days. I spoke with my PCP and had a appt on 12/28. On 12/31 it felt as of my symptoms was subsiding. I started feeling better on 1/2/21. I missed 6 days of work.
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| 53 | 2021-01-04 | feeling hot, muscle spasms |
Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her l...
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Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her left trapezius, and headache. She experienced a warm sensation travelling down her left arm. She described a feeling of muscle spasms in her left upper and lower extremity and was unable to bear weight on her left lower extremity due to the altered sensation. She endorsed acute nausea and vomiting. She was transferred from vaccine clinic to emergency department at 1420. Patient received diphenydramine 12.5mg IV @ 1722, prochlorperazine 10mg IV @1733, Lactated Ringers 250mL IV bolus @ 1733, ondansetron ODT 4mg @1445. Patient was diagnosed with an acute anxiety attack in the setting of a novel vaccine administration. She was discharged at 1854.
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| 53 | 2021-01-04 | feeling hot |
Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 ...
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Very painful shoulder 24 hours later; pounding heart rate felt in my chest that lasted less than 30 sec; with in 5 minutes of inoculation experienced an odd taste in my mouth; Warm sensation in Left upper arm for at least 15 minutes.; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 at 13:15 (at the age of 53-years-old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included pneumonia, high cholesterol, eczema rashes from perfumes/beauty products/soaps and hand dermatitis all on unknown dates.The patient is allergic to amoxicillin (rash trunk) and experiences seasonal allergies in the eyes/nose/with coughing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 13:20 (reported as "within 5 minutes of inoculation") the patient experienced an odd taste in her mouth, a pounding heart rate felt in her chest that lasted less than 30 seconds (may have been shorter). She stated that she was trying to stay calm. Also, she experienced a warm sensation in the left upper arm for at least 15 minutes as well as a very painful shoulder twenty-four hours later; there was no swelling nor redness noted. Her shoulder was much improved by the third day.The patient did not receive any treatment for the events. The clinical outcomes of heart rate increased, taste peculiar, localized feeling of warmth and shoulder pain were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-04 | flushing |
heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrena...
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heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrenaline rush; Nasal congestion started after 30 min; within 3 min after injection, became flushed; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 19Dec2020 07:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Type 1 diabetes, hx of anaphylaxis to allergy shots and allergies to Latex, avocados, fluorescein dye (anaphylaxis), cats/dogs, environmental. Concomitant medication included ascorbic acid (VIT C), ergocalciferol (VIT D), fexofenadine hydrochloride (ALLEGRA), insulin lispro (HUMALOG), tocopherol (VIT E). The patient was not pregnant at the time of vaccination. Within 3 min after injection, the patient became flushed from 19Dec2020 07:33 AM; heart began racing, dizziness, lightheaded, felt foggy, became winded/short of breath and felt an adrenaline rush, was observed by med personnel x 30min from 19Dec2020 08:00 AM. Nasal congestion started after 30 min on 19Dec2020 08:00 AM. No treatment was received for all events. These events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 53 | 2021-01-04 | flushing |
it made me turned flushed, really almost purple/ My face was red, arms were red, my neck was red; Sw...
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it made me turned flushed, really almost purple/ My face was red, arms were red, my neck was red; Sweating; The initial case was missing the following minimum criteria: adverse event nos. Upon receipt of follow-up information on (27Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899, expiry date not reported), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol, hydrochlorothiazide, and lisinopril; all from unspecified dates for blood pressure high. The patient verbalized, "I had the vaccine on last Monday be 21st. I had an issue and ended up in the ER. It made me turned flushed, really almost purple, no anaphylactic nothing, just sweating, my face was red, arms were red, my neck was red but that is it. They gave me Pepcid and Benadryl in ER and watched me in the ER for about 40 minutes. I work at the hospital and I got it from them. I was fine the rest of the week, Thursday, my son came by to pick up a couple of holiday gifts only saw him for 5 minutes. He has now tested positive for COVID. We had masks on. I hugged him on his way out. He took the gifts and left. He is at home now. He got tested yesterday positive for COVID. My question is am I still at risk of getting it from that meeting after I only had one shot?" On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 133/85 and body temperature: 97.9. Therapeutic measures were taken as a result of the events that included Pepcid and Benadryl. Clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-01-04 | pain in extremity |
Very sore arm; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pr...
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Very sore arm; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the right arm on 28Dec2020 08:30 at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension (HTN) and diabetes mellitus (DM). The patient has no known allergies. The patient had received unspecified other medications the patient received within 2 weeks of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very sore arm on 28Dec2020 12:00. Outcome of the event was not recovered. No treatment was given for the event. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The event was assessed as non-serious.
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| 53 | 2021-01-04 | pain in extremity |
a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced s...
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a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced sharp pain in left ear radiating down to jawline and left shoulder and upper arm. Pain also caused severe headache relieved with high dose Tylenol. Symptoms lasted 24hrs. Headaches became mild lasted thru day of report reaction (1/4).
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| 53 | 2021-01-04 | tingling, numbness | Numbness and tingling in fingers and hand of same arm the vaccine was given in. |
| 53 | 2021-01-04 | tingling |
feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on th...
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feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as "about 5 minutes after shot"), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.
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| 53 | 2021-01-04 | tremor |
Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Withi...
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Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Within 5 minutes of receiving it, serial blood pressure readings began rising, her arm felt heavy, and she developed an uncontrollable tremor primarily in her left arm with what appears to be generalized shivering. Associated with significant anxiety. She has never had an allergic reaction before. No associated shortness of breath or wheezing. No lip tongue or throat swelling. No pruritus or hives. No nausea or vomiting. She was treated for possible dystonic reaction initially with two doses of Benadryl 25mg IV, then 1mg of IV lorazepam, and finally 125mg solumedrol. Symptoms improved significantly with Benadryl, and then resolved entirely after lorazepam. She was discharged home to complete 4 more days of 50mg prednisone.
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| 53 | 2021-01-05 | weakness |
Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and w...
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Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered. Information on lot/batch number has been requested.
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| 53 | 2021-01-05 | numbness |
associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of visi...
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associate states she has hx of allergic reactions to vaccines; i.e flu. patient came in c/o of vision problems and numbness to entire body. Benadryl 25mg PO given at 1106. VS: BP 149/122, oxygen 90%, and HR 77 at 11:14 1119: 186/116, HR 79, and oxygen 95%. 1123: 206/102, HR 89, oxygen 96% 1125: EMS called.
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| 53 | 2021-01-05 | pain in extremity |
In the end of December she developed right wrist pain and some mild swelling, then pain in both arms...
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In the end of December she developed right wrist pain and some mild swelling, then pain in both arms from elbows to hands, and then it started in the back on her thighs in hips bilaterally and her right ankle. She still has the headache that is unchanged x 1 month, but the other symptoms were new, and she had never had them before. She still has it and it is 1/6/21.
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| 53 | 2021-01-05 | pain in extremity |
Muscle pain; Got little ache in the back; Joint pain; Fever; Chills/felt like chills like when you f...
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Muscle pain; Got little ache in the back; Joint pain; Fever; Chills/felt like chills like when you feel cold; arm be sore from the shot; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home. Medical history included Blood pressure high. Concomitant medications included metoprolol for Blood pressure high, potassium. The patient had got her COVID-19 Vaccine yesterday (29Dec2020) and now (30Dec2020) she had a little muscle pain, guess from the arm. She got the shot in her muscle yesterday. Today (30Dec2020), spiked a little fever, and she got a little muscle pain, joint pain. She felt good, she just got little ache in the back. She took some Tylenol, it has all worked today. The patient also experienced "arm be sore from the shot". She got a little chill that's why she took the Tylenol. she had a little fever, she caught fever or felt like chills like when feel cold. Therapeutic measures were taken as a result of ache in the back, fever, and chills included Tylenol. The outcome of the events was unknown.
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| 53 | 2021-01-06 | weakness, hot flush |
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio...
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Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
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| 53 | 2021-01-06 | weakness |
Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and se...
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Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and self-care instructions: drink plenty of fluids, take motrin if needed.please return if symptoms worsen or persist.
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| 53 | 2021-01-06 | tingling, numbness, facial paralysis | Bells Palsy?left facial droop and left facial numb/tingling |
| 53 | 2021-01-07 | cold sweat |
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Pat...
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After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97% Â At 1642, patient was discharged to family's care and taken home.
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| 53 | 2021-01-07 | feeling hot |
My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; I...
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My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; My arm is rather red and huge; It is just red and swollen and warm; This is a spontaneous from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril for hypertension. On an unknown date, her arm was rather red and huge almost looks like a, not a Hematoma but its about that big. She didn't feel bad otherwise. It was just red and swollen and warm. The outcome of the event was unknown.
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| 53 | 2021-01-07 | muscle spasms, pain in extremity |
Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities...
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Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities Narrative: developed bilateral leg pain, tightness of calf muscles within one hour of receiving vaccine. Headache on 12/23/2020
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| 53 | 2021-01-07 | pain in extremity | chills, nausea, arm sore |
| 53 | 2021-01-07 | tingling | Felt severe itching pins needles on arms, wrists, chest & neck. |
| 53 | 2021-01-07 | tremor, feeling cold |
felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; ...
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felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; body aches; snoring bad; freezing/ can't get warm; shaking; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the right arm on 28Dec2020 13:15 at a single dose for COVID-19 immunization. She has had the Coronavirus before and wanted to know if previously having the virus might make her side effects worse. She had COVID 19. She got her positive result on 06Aug2020. Her husband had it too. She knows what it is like. She didn't have to go to the hospital, but she had a severe enough case. She had the fever, dry cough, body aches, nausea, and poops. She has been getting body aches after having COVID really intense. She gets tired very easily. She had fibromyalgia was diagnosed more than 10 years ago and ongoing, before the year 2000; acid reflux was diagnosed five or six years ago; high blood pressure was diagnosed back in 2007; high cholesterol; wheezing for a couple of years and depression. The patient was also taking a water pill. Concomitant medication included omeprazole ongoing for acid reflux, hydrochlorothiazide (HYDROCHLOROTH, 25 mg) ongoing, losartan 100 mg ongoing, desvenlafaxine 75 mg ongoing for depression, montelukast 10 mg ongoing for wheezing, atorvastatin calcium ongoing for cholesterol. When asked for the lot number the patient said that she thinks it is EL1284 but it could possibly be ELI284. On 28Dec2020, the patient felt really tired, has a sore arm with chills, fever and body aches. The same day she got the vaccine she had felt fine. She came home and did a few things. She sat down for a minute and then it was like wham. She told her husband she was done. She went to sleep fast and slept for a couple of hours. She went to work the next morning and her arm was sore to touch and to lift it up. Sometimes when you get the flu shot it is like that too. She does not have any red marks where it was injected. She only knows where it was because it hurt to touch. She got really tired at work about 11:30AM. Her body started aching. She was being tested twice a week for Corona COVID. She had just been tested on 28Dec2020 morning before the vaccination and was negative. On an unspecified in Dec2020, she was freezing and shaking. She cannot get warm. It was like that for a couple of hours. Usually her temperature runs low. It was up to 100.1 degrees Fahrenheit which is high for her because she usually is on the lower end. She felt really ugh.The symptoms after the vaccine reminded her of when she had COVID. She had a low fever and body aches and felt terrible. Her boss wanted to know if she had the flu. The patient does not think so because it would be ironic the day after she gets the shot. She was assuming it was the side effects from this. She further clarified wham as that she was really tired and it came over her really quick. She sat in the chair and got a blanket. Her husband said she was snoring bad (28Dec2020). Two hours later the dogs woke her up and she thought it was the middle of the night. It wasn't it was early. On unspecified date in Dec2020, she had a bout and her body started aching. A day after, she does not feel that bad, does not have fever and her body was not aching. That night when she got home she could not sleep on her arm because it was sore. The next day was when it was hard to lift it. She had the injection in the right arm, which is the arm she uses. It was still sore to touch. She has fibromyalgia. She is not sure if that is why she is aching. She is not sure if that kicked it in high gear. The vaccine was administered in a Long Term Care Center. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The events did not result to emergency room nor physician visit. The outcome of the event fever and body aches recovered on an unspecified date in Dec2020; outcome for all other events was unknown. Information on the lot number has been requested.
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| 53 | 2021-01-07 | tremor |
neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and s...
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neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-08 | weakness |
12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before...
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12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before fever was back to normal. Still have fatigue and weakness
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| 53 | 2021-01-08 | flushing |
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes...
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1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
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| 53 | 2021-01-09 | feeling cold | Fever Chills Aches Fatigue |
| 53 | 2021-01-09 | pain in extremity |
Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midn...
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Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midnight after received and still hurting, joint pain and headache began early AM 01/09/21. All have ended except pain at injection site and joints still achy.
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| 53 | 2021-01-10 | weakness |
1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever...
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1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.
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| 53 | 2021-01-10 | numbness |
Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red...
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Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism and chronic low back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness. She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
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| 53 | 2021-01-10 | pain in extremity |
90 minutes after the second vaccination in the COVID series, pfizer version, she developed right arm...
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90 minutes after the second vaccination in the COVID series, pfizer version, she developed right arm weakness. she could not lift her arm above her head. she then developed severe dull, aching pain. the pain became sharp with movement. she could not sleep because of the pain. no redness or edema at the injection site. she is slowly regaining strength and range of motion in the arm, however the pain still remains and full strength has not returned.
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| 53 | 2021-01-10 | pain in extremity |
Left arm pain; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old fem...
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Left arm pain; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL0142, intramuscularly in the left arm on 04Jan2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included an allergy to sulfa, from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 04Jan2021 at 09:45 the patient experienced left arm pain. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm pain was unknown.
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| 53 | 2021-01-10 | tingling |
A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours. I have ...
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A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours. I have had Bell's Palsy in the past (30 years ago)
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| 53 | 2021-01-10 | tenderness, pain in extremity | soreness in arm, not just to the touch, but hard to lift arm the next day. Better after day 2. |
| 53 | 2021-01-10 | tremor, weakness | Chills and shakes without fever, weakness, and headache |
| 53 | 2021-01-10 | tremor |
Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tyleno...
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Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tylenol/ zofran but felt like I was going to vomit. Went into the bathroom and sat down. Woke up on the floor shaking. Not sure how long I was down. According to my watch my HR was around 110+ for a hour and a half (3-4:30 am)
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| 53 | 2021-01-11 | feeling hot, pain in extremity |
Second dose: A few minutes after getting vaccine. I was sitting in the observation area and I start...
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Second dose: A few minutes after getting vaccine. I was sitting in the observation area and I started feeling a pinch in my arm, then I started feeling warm and light headedness. Then they checked my bp and it was 149/93 . Then I had to stay for 30 mins, then I left to go home. I had body ache and a mild temperature. It was 98.2 .My arm is sore, and my joints and body hurts. I have a headache too , and I just took an ibprophen. I am still not feeling well. I did not go to the ER, hospital or doctors office about this ae.
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| 53 | 2021-01-11 | flushing |
4/5 hours bad headache, flu symptoms , nausea, Later that night I had chills, fever and was flush...
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4/5 hours bad headache, flu symptoms , nausea, Later that night I had chills, fever and was flushed which all lasted two days
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| 53 | 2021-01-11 | migraine |
Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photo...
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Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photophobic), nausea & diarrhea. This occured 4 days after my second COVID-19 vaccine. I had no symptoms prior to this.
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| 53 | 2021-01-11 | pain in extremity | Fatigue, sleepiness, pain on left arm |
| 53 | 2021-01-11 | pain in extremity |
Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 wa...
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Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 was extremely tired. When getting out of bed in AM blacked out and fell to the floor. Was able to get up but head was cloudy all day long. She felt very sore and head hurt all day. The next am had headache.
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| 53 | 2021-01-11 | pain in extremity |
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ...
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A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
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| 53 | 2021-01-11 | tingling, burning sensation |
Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sens...
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Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sensitive from left flank down toward mid buttocks slightly toward anterior area; This is a spontaneous report from the Medical Information Team. A contactable nurse reported that a 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via intramuscular route of administration in the left arm, from 24Dec2020 08:15 at a single dose for COVID-19 immunization. Patient had no other medical history (reported as "none"). Concomitant medication included melatonin, calcium and bupropion hydrochloride (WELLBUTRIN). The patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Dec2020 09:00, the patient experienced shingle type pain burning, tingling and very sensitive from left flank down toward mid buttocks slightly toward anterior area. The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of events included motrin, tylenol and lidocaine. Patient was unable to go to work for a few days. No follow-up attempts are possible. No further information is expected. Information on the batch number has been obtained.
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| 53 | 2021-01-11 | tingling, flushing |
Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throug...
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Metallic taste in mouth; cotton/dry mouth while trying to swallow; flush/tingling sensation throughout body but especially extremities. Occurred within the 5-15 min observation period. I did not speak up about it as I was trying to analyze it myself and rationalize the symptoms. It did not cause tachycardia or SOB or intervention but it makes me a little hesitant for the 2nd dose due to my shellfish allergy/sensitivity. The sensation reminded me of the systemic response when receiving a contrast IV dye. I did leave a message at the VAERS 800# to ask if I should submit this form but did not want to delay any longer in case this information is helpful with the feedback/data for others. I understand it is not a true "adverse or sentinel" event but I wanted to report my reaction especially with the shellfish allergy (which I wasn't aware of to be a risk factor until I read more articles about it).
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| 53 | 2021-01-12 | muscle spasms |
12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND ...
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12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND DIZZY, THROBBING HEADACHE. CRAMPING/ACHING IN BACK OF CALVES. 12/24/2020 CONTINUED WITH DIZZINESS, THROBBING HEADACHE, BLOOD PRESSURE ELEVATED, CHEST PRESSURE 8:00 PM REPORTED FEELING THAT SHE WAS GOING TO DIE, WENT TO LAKE CITY MEDICAL CENTER- BLOOD PRESSURE ON ARRIVAL 184/101 HR. 117. GIVEN NITRO AND MEDICATIONS. ADMITTED, DISCHARGED 48 HOURS LATER ON 12/26/2020. DISCHARGED ON BLOOD PRESSURE MEDICATION 12/27/2020-LESS THAN 24 HOURS AFTER BEING DISCHARGED SHE WAS READMITTED TO MEDICAL CENTER WITH SAME SYMPTOMS. 36 HOURS AFTER ADMISSION, TRANSFERRED TO MEDICAL CENTER. FOR CARDIC WORKUP AND HIGHER LEVEL OF CARE.
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| 53 | 2021-01-12 | pain in extremity |
anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a co...
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anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, dizzy on 31Dec2020, arm was really sore on an unspecified date, tiredness on an unspecified date. Event details: She was dizzy that day especially with changing positions, she didn't need to go to the doctor or anything. It wasn't severe. She was just a little dizzy. It's probably just the vaccine and it did go away. Her arm was really sore and went away after a few days. the tiredness, it wasn't a big deal. She did feel better about. it wasn't a serious anaphylactic reaction. It didn't happen right away. She had arm soreness. it wasn't immediate. She usually didn't have. It was really weird. She thought she was well hydrated. The outcome of event was really sore was resolved, outcome of other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-12 | tremor, muscle spasms, burning sensation |
Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the j...
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Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the jaw line to under the chin, malaise, large muscle spasms and cramps, chills and shaking, soreness and swelling at injections site, burning in face and lips, and severe unexplained drop in blood sugar (56) that was very slow to bring back up.
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| 53 | 2021-01-13 | weakness, cold sweat, tremor |
Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm ch...
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Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm chills, temp 97.8 7:00pm warm shower 7:15pm diarrhea, shortness of breath, sweat dripping down body, dizzy, nauseated 7:45pm cool compresses on head and neck, clams, shortness of breath, still dizzy, weakened began shacking. 7:55pm. Dressed by husband and put in bed. Temperature 90.0 8:00pm 3 blankets on me, gloves on, socks and slippers on and heating pads to ankles and feet, still dizzy and shacking. no circulation to hand or feet. no capillary refill. 8:30pm Called nurse on Call who stayed on the phone with me for 45 minutes, two Advil taken. Trying to eat crackers and hydrate. 8:45pm. feeling blood flowing to hands but not feet. 9:45pm gloves off hands and heavy blanket off, toes still ice cold.10:15pm Up to bathroom with husbands help, no strength. Urinated, no more diarrhea. Stomach still making a lot of noise. Still sensitive to light and sound, feeling to toes, still dizzy.11:30pm Feeling more like myself. Just exhausted. Slept off and on throughout the night and hydrated and up to urinate on my own without assistance. Jan. 14, 2021 , 10:00am- Sitting up in bed. Very tired. Drinking water. 12:00 noon able to eat an egg and avocado sandwich
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| 53 | 2021-01-13 | breast pain, feeling hot |
FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, ...
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FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, CHILLS, SEVERE HEADACHE, ITCHY IN THE VACCINATION AREA AND PAIN IN THE VACCINE ARM AND RADIATES UNDER THE ARMPIT TO THE BREAST AND DIARRHEA
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| 53 | 2021-01-13 | burning sensation |
1/4/21 within 4 hours after receiving vaccine sole of right foot in the arch area began to itch. Mo...
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1/4/21 within 4 hours after receiving vaccine sole of right foot in the arch area began to itch. Morning of 1/5/21 sole of left foot in arch area began to itch. Upon a visual check a red rash is present approximately 1.5"-2" in diameter on the soles of both feet in the arch area. 1/6/21 blisters formed in rash area of the right foot. On 1/8/21 upon patient visiting her dermatologist, the rash was ruled out as not being caused by a bacterial infection or fungal infection. Dermatologist prescribed an antihistamine oral medication and a steroid cream. 1/9/21 patients reports burning and itching increased and she used a frozen foot roller to treat the burning and itching. 1/10/21 Patient states that itching and burning subsided and discontinued use of steroid cream. Patient continues to take oral antihistamine (Hydroxyzine HCL 25mg) prescribed by dermatologist . Patient reports there have been no changes in soaps or detergents being used and no changes in behavior prior to vaccination and therefore, patient and doctor can, but without certainty, conclude that the rash is a result of the COVID-19 vaccination. 1/11/21 patient took pictures of rash and are available for viewing. As of 1/14/21 rash still present but itching has stopped. This event is a non-severe adverse event. Patient is scheduled to receive second dose of vaccination on 1/25/21. Patient has been advised to take antihistamine prior to receiving second dose of vaccination and again 12 hours following the 2nd dose of vaccination.
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| 53 | 2021-01-13 | burning sensation |
1/4/21 within 4 hours of patient receiving 1st dose COVID-19 vaccination, itching began on sole of r...
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1/4/21 within 4 hours of patient receiving 1st dose COVID-19 vaccination, itching began on sole of right foot in arch area. Morning of 1/5/21 itching began on sole of left foot in arch area. Patient look at both feet and noticed a red rash on soles of both feet in arch area approximately 1.5" - 2" in diameter. 1/6/21 blisters developed on right foot in rash area. 1/8/21 patient went to dermatologist; the dermatologist ruled out bacterial and fungal infections. Dermatologist prescribed a topical steroid lotion and an oral antihistamine (Hydroxyzine HCL 25mg). 1/9/21 patient reported severe burning and itching of both feet and self-treated with a frozen foot roller which successfully subsided the burning and itching. 1/10/21 discontinued use of steroid lotion. Continues to take oral antihistamine. 1/11/21 blisters are gone but rash is deep red and still exists as of today without itching or burning.
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| 53 | 2021-01-13 | feeling hot |
Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a...
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Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a little bit of difficulty breathing. Symptoms except rash resolved after 30 minutes of observation. Patient discharged home from the vaccination clinic.
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| 53 | 2021-01-13 | hot flush |
Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on ...
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Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1284) intramuscularly at right arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies to opiate derivatives and penicillin. Concomitant medication included clopidogrel, sertraline, simvastatin. The patient previously received first dose of bnt162b2 (lot number: ELC5730) intramuscularly at right arm on 18Dec2020 13:00 at single dose for COVID-19 immunization. The patient experienced fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue, all on 07Jan2021 01:30. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
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| 53 | 2021-01-13 | migraine | stomach issues, migraines. body aches Fatigue |
| 53 | 2021-01-13 | migraine |
15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and...
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15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and muscle aches.
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| 53 | 2021-01-13 | pain in extremity |
Left arm soreness for 24 hours and low grade fever of 100 F; Left arm soreness for 24 hours and low ...
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Left arm soreness for 24 hours and low grade fever of 100 F; Left arm soreness for 24 hours and low grade fever of 100 F; This is a spontaneous report from a contactable nurse. A 53-year-old non-pregnant female received bnt162b2 (lot: EK9231), intramuscular in the left arm on 30Dec2020 14:30 at a single dose for covid-19 immunization. The patient's medical history included migraine, seizure (resolved x2years) from an unknown date and unknown if ongoing , and allergy to penicillin. There were no concomitant medications. On 30Dec2020 20:00, the patient experienced left arm soreness for 24 hours and low grade fever of 100 f. The outcome of the event was recovered on an unknown date. No treatment was given to the patient for the event. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and has not been tested post vaccination.
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| 53 | 2021-01-13 | tingling |
Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lig...
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Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lightheaded 1st, then headache, feels like someone is pressing down on head and neck- temples and note- feels like a band around head. Pain is 2/10, progessed to 6/10. States muscles are starting to get sore around trapezius region. Stated she had feeling of euphoria initially, BP 128/76, HR 66, 98% RA. Nausea, but no emesis. Metallic taste to mouth- pins and needles when drinking water.
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| 53 | 2021-01-14 | numbness |
Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- ...
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Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- Right Axillary lymph nodes swelling, grapefruit size, painful. Edema from injection site to fingertips with numbness to 3,4,5 digits. Fatigue and headache. Day 4- RIGHT sided lymph nodes swelling, palpable to neck, axillary and groin. Severe fatigue. Headache. Edema still complete to RUE- with numbness to fingers. Grapefruit sized axillary, slightly improved. NO FEVER, COUGH, DYSPNEA
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| 53 | 2021-01-14 | tingling, flushing |
fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in...
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fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-14 | tingling, pain in extremity |
shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontan...
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shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 10:30 in left arm at single dose for COVID-19 immunization. Medical history included mild hypertension, chronic migraine and recent elevated liver tests - Alk Phos (alkaline phosphatase) & GGT (Gamma-glutamyltransferase) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate 25 mgs daily and colecalciferol (VITAMIN D). On 07Jan2021 21:30, following shot for a few minutes, the patient experienced left arm tingled, had a brief period lasting a few minutes of shivering that evening and tachycardia. Noted at 9:30 pm, patient's BP 139/89, pulse 88 (BP 115/88 and pulse 76 4 days prior). Then BP 148/91, pulse 69 at 10 am on 08Jan2021 after two doses of Metoprolol Succinate ER 25 mgs at 9:45 pm on 07Jan2021 and at 8:30 am on 08Jan2021. The patient experienced left arm very sore on 07Jan2021 after receiving vaccine. Seems to be improving on 08Jan2021. The outcome of the events was not recovered. no treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 53 | 2021-01-15 | weakness |
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very...
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Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something. Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
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| 53 | 2021-01-15 | tingling |
Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 min...
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Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 minutes after receiving the 2nd COVID vaccine dose. Patient reported symptoms felt similar to times when she had exposure to cats or after exercising. She denies any previous treatments for anaphylaxis or any previous severe reactions. Vital signs at time of initial assessment were BP 147/100, pulse 80, O2 Sat 99% on room air. Patient was observed for 50 minutes and chest tightness/arm tingling symptoms resolved. Patient did also develop a dry "tickly" cough about 60 minutes post vaccination. Patient was administered albuterol 2 puffs via MDI and reported improvement of cough. She again reported the cough to be similar to the type of cough she had gotten when exposed to cats. No further treatment needed. Patient stable and released to go home.
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| 53 | 2021-01-16 | burning sensation | Hives on both arms redness itching burning |
| 53 | 2021-01-16 | feeling cold | Fever, chills, achey, underarm pain. |
| 53 | 2021-01-16 | muscle twitching, pain in extremity, feeling hot |
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the...
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Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
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| 53 | 2021-01-16 | pain in extremity, tingling |
I received the Covid vaccine. The injection itself was without any issues. However, 6-7 hours later,...
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I received the Covid vaccine. The injection itself was without any issues. However, 6-7 hours later, my entire upper arm began aching-pain from my trapezius down to my elbow. This continued throughout the weekend and then Monday, my index and middle finger began tingling (as if asleep). This symptom has never subsided. I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist. I have tired trigger injections in my trapezius, ibuprofen, muscle relaxers, heat, exercises, a steroid burst-all without relief of symptoms. I am able to move my arm and I do have strength in the extremity. I have seen a specialist in physical medicine and rehabilitation. What I believe may have triggered this reaction is that in October I had a radial and ulnar tunnel release in the same extremity. I wonder whether the medication has affected the nerves that had been manipulated during surgery. I am wondering if anyone participating gin the trial had recent surgery was well? if so, did they note any complication after receiving the vaccine. Any help you can give would be appreciated. Thanks you for your time.
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| 53 | 2021-01-16 | pain in extremity |
Not adverse. Arm pain the following day lasted approximately 2 days, no visible issues at injection ...
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Not adverse. Arm pain the following day lasted approximately 2 days, no visible issues at injection site.
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| 53 | 2021-01-16 | tingling, numbness |
I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower...
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I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower leg. Tingling spread to both feet & hands arms lower legs. Slight swelling of tongue/ throat but I could swallow and breathe. It is now 16 hours since I received the vaccine and I?m still experiencing tingling / numbness and slight tongue/ throat swelling. I have decided to take Benadryl to see if it helps.
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| 53 | 2021-01-17 | burning sensation, tingling |
neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain an...
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neck lymph node swelling; then 30 hours after receiving vaccine hands turned red and burned, pain and swelling in arm pits. currently have increased paresthesia arms, hands, legs and feet
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| 53 | 2021-01-17 | numbness, pain in extremity, facial pain |
soreness in entire arm similar to being stung by a wasp; numbness and soreness in left side of face ...
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soreness in entire arm similar to being stung by a wasp; numbness and soreness in left side of face similar to the feeling after dental work when the shot has worn off. It has been 3 hours that I've felt this. It is still that way.
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| 53 | 2021-01-17 | seizure | pt started having seizures and was given ativan. EMTs were called and patient was taken to the ER |
| 53 | 2021-01-18 | weakness, speech disorder |
right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing,...
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right side of tongue from midline, swollen approx. 3X size of left side. some difficulty swallowing, water. approx. 45-50 minutes after I woke with this, I noted a large sore area on the lateral left side of my tongue. Arrived at work 6:30am and noted I was speaking with a "lisp" and tongue was still the same, no changes noted. Very tired, no energy. Reported this to our employee health at 8:00 am when they opened. I then was offered a Claritin by a coworker. approximately 2 hours later the swelling and sore had completely subsided.
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| 53 | 2021-01-18 | weakness |
Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injec...
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Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injection site, swollen lymph nodes in neck, axilla, L breast, headache that started at 6 am the following day. I took Tylenol which did help fever and body aches. I had symptoms until 1/11/21 and started feeling better at 11 am.
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| 53 | 2021-01-18 | bell's palsy |
Went to Urgent Care 01/17/2021. High blood pressure and sent to ER. R/O stoke. Gave 3 steroids an...
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Went to Urgent Care 01/17/2021. High blood pressure and sent to ER. R/O stoke. Gave 3 steroids and antiviral for 10 days. Was diagnosed with Bells Palsy. Has facial and facial drooping. Left eye will not blink and has to use omit to keep eye moist.
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| 53 | 2021-01-18 | bell's palsy | On 1/17/2021 I woke up with my face drooping. I went to the ER and was diagnosed with Bells Palsy. |
| 53 | 2021-01-18 | feeling cold |
13 hours after receiving vaccine I woke up with uncontrollable chills lasting over 2 hours accompani...
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13 hours after receiving vaccine I woke up with uncontrollable chills lasting over 2 hours accompanied by severe body aches lasting over 24 hours, fever exceeding 103, headache and complete fatigue where I physically could not get out of bed. Tried to control fever and aches using both Tylenol and Ibuprofen simultaneously and lowest fever would go was 100.5. Fever broke after 26 hours . Two days later had labored breathing, headache and fatigue. All side effects went away except for severe headache which I have currently had now for 6 days .
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| 53 | 2021-01-18 | feeling hot |
Pt felt warm and dizzy. Shared had not eaten all day prior to vaccine. Hx of hypertension and bp was...
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Pt felt warm and dizzy. Shared had not eaten all day prior to vaccine. Hx of hypertension and bp was elevated. Observed in clinic and given food / gatorade. Pt recovered without incident and released.
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| 53 | 2021-01-18 | feeling jittery | c/o being anxious, jittery |
| 53 | 2021-01-18 | pain in extremity |
Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done...
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Right eye blood shot at 7:30 pm - went to ER with severe stomach cramps radiating the back. CT done. received dilaudid and Zofran for pain and nausea. Next day, had pain in bones, feet, knees, back and neck. Also sore throat, red throat, headache, nausea, and diarrhea. Doctor prescribe antibiotics and Norco. Stomach pain returned 12/31.
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| 53 | 2021-01-18 | pain in extremity |
headache; fever 102.7; Chills; vomiting; arm pain; body aches; This is a spontaneous report from a c...
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headache; fever 102.7; Chills; vomiting; arm pain; body aches; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 18Dec2020 15:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma and diagnosed with COVID-19 prior to vaccination. Patient has unspecified allergies. Unspecified concomitant medication were taken (List of any other medications the patient received within 2 weeks of vaccination: Yes). The patient experienced fever 102.7, Chills, vomiting, arm pain body aches and headache on 19Dec2020 03:00. No treatment received for the events. The outcome of the events was recovered with sequelae (Recovered with lasting effects). The events were considered as non-serious. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 08Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
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| 53 | 2021-01-18 | tingling, pain in extremity, flushing |
Patient experienced arm pain, paresthesia, facial flushing, lightheadedness and sensation of dysph...
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Patient experienced arm pain, paresthesia, facial flushing, lightheadedness and sensation of dysphagia for several minutes after vaccine was received. Benadryl PO given when symptoms began. Patient was evaluated in the EC and was discharged home without symptoms.
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| 53 | 2021-01-18 | tingling, pain in extremity, numbness | Tingling and numbness in |
| 53 | 2021-01-19 | weakness, muscle spasms |
chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a sp...
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chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension (HTN), high cholesterol. Concomitant medication included lisinopril, levocetirizine dihydrochloride (EURO ZYSOL), ezetimibe (ZETIA) and stool softner. No other vaccines within 4 weeks prior to the COVID vaccine. No diagnosed with COVID-19 prior to vaccination. The patient experienced woke up with chills, headache, muscle spasms, extreme weakness, for 24 hours continued with body aches, fever, sinus congestion. Still have sinus congestion, all other symptoms ended in 24 hours from onset. Events onset date reported as 09Jan2021 01:00. No treatment received for the events. Outcome of events was recovered with sequelae. Since the vaccination the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 53 | 2021-01-19 | weakness |
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin...
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? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
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| 53 | 2021-01-19 | facial paralysis | ON 1/20/21 DEVELOPED EYE/MOUTH DROOPING, VOMITING, NAUEA, CHILLS AND BODY ACHES. HAS CALL OUT TO PCP |
| 53 | 2021-01-19 | tremor | Shakes, fever of 102.8, sever body aches, diarrhea, headache, dizziness Lasted 24 hours. |
| 53 | 2021-01-20 | migraine |
Migraine; Mild pain at injection site; This is a spontaneous report from a contactable other healthc...
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Migraine; Mild pain at injection site; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 53-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 4178) Intramuscular on 08Jan2021 09:15 AM at left arm at single dose for COVID -19 immunization in Hospital. Medical history was none. No Known allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. Patient receive the first dose of bnt162b2 (lot number: EK5730), intramuscularly on the left arm on 18Dec2020 at 13:15 at single dose for COVID-19 immunization and experienced injection site soreness (Day 1 and Day 2) and mild headache (Day 2). Patient experienced mild pain at injection site (Day 1 and Day2, 08Jan2021 12:00 PM) and Migraine (Day 2, 08Jan2021 12:00). COVID was not tested post vaccination. No treatment received. Patient was recovered from the events in Jan2021.
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| 53 | 2021-01-21 | feeling cold | Reported extreme fatigue, chills, body aches, head ache, and fever 100.6 |
| 53 | 2021-01-21 | pain in extremity, weakness |
First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chill...
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First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chills, and her arm was very sore for a day. Second dose was given 1/15- On 1/19 she had body aches, chills, severe headache, fatigue, abdominal pain, stuffy nose and sore throat. Her arm was very sore for several days, she could not raise her arm. Treatment: took tylenol every 6 hours for 24 hours. on 1/19 and 1/20 she took Dayquil.
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| 53 | 2021-01-21 | pain in extremity | Approximately 11 hours after receiving vaccine developed chills,fever,headache,bodyaches,arm pain |
| 53 | 2021-01-21 | throat numbness |
Pt c/o tongue tingling and 'molars' numbness as with first injection in which she reported to after ...
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Pt c/o tongue tingling and 'molars' numbness as with first injection in which she reported to after sx started. This injection, sx started earlier. No soa, itching, throat tightness or distress. Pt numbness and tingling resolved and then returned with some throat numbness. Pt remained without distress and after observation period opted to be dismissed and no er visit, called for ride, stated sx almost resolved at time of dismissal, no distress. Dismissal vs- 117/83 bp 79 hr 98% sao2
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| 53 | 2021-01-21 | tenderness |
On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening e...
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On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening especially in back of neck, worsening headache. 1/7 awoke with nausea/vomiting lasting throughout the day and diarrhea also started. 1/8 continued vomiting but diarrhea stopped and also noted confusion and brain fog. 1/11 mostly recovered and back to work with slight headache and body soreness from exhaustion.
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| 53 | 2021-01-21 | tremor |
Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, ...
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Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, nausea, vomiting and diarrhea, continuous headache for 4 days. Then started with productive cough and dyspnea on exertion. Took Tylenol initially and then Proair inhaler starting 1/15
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| 53 | 2021-01-23 | feeling cold, pain in extremity, feeling hot |
No temperature prior to Vaccine. Track daily - run 97.4-97.7F normally Friday 1/22/2021: 1930 starte...
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No temperature prior to Vaccine. Track daily - run 97.4-97.7F normally Friday 1/22/2021: 1930 started feeling very tired 2030-2230: started to feel cold, skin sensitivity, developed into shaking chills, entire body shaking. Headache. Temperature rising 99F -- 100.4F --- 101.5F about every 1/2hr or so. 2100 Took Advil 600mg Midnight: Chills, HOT, Temp 102.4F. Dozing off and on through the night. Shaking and Hot. Headache. Feeling Nausea 0400: Temp 101.6F, tried to take Ibuprofen but dry heaved them back up. Sips of water. Took warm shower. 0500: back to bed, slept 1 hour 0600: saltines, gingerale - took Advil 600mg - laid back down. Head throbbing. Less Nausea. 0830: woke: Temp 100.4F Headache and hot, feel achy all over never leaves, feel woozy. Spent most of Saturday 1/23/2021 (My 54 Birthday) Laying and sleeping. Started taking Tylenol 1000mg (1/23 at 6pm) alternating with Ibuprofen 600mg every 6 hours exactly. Woke Sunday Morning - feeling less achy, but still with Temp 100.4-99.6F -- As Sunday went on - by afternoon/evening achy, skin sensitive, and Temp 100.4F, HEADACHING! Neck aching. Took Ibuprofen 600mg. Drinking gingerale and water through the day. Toast. Now almost Midnight 1/24/2021 Headache and feeling achy. (Right ARM only slight hurt this time. 1st Pfizer - hurt 8/10 day 2 &3)
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| 53 | 2021-01-23 | pain in extremity |
At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During ...
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At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During the night I woke up because my body was shaking from chills even thought I was under my comforter in a warm room. My injection arm was hurting more and my arm pit of the injection arm felt throbbing and painful. In the morning I still had body aches, temp 99.2, my injection arm and arm pit are painful, my arm pit was swollen. I took 1,000 mg Tylenol. Now at 03:40pm I still have body aches, arm pit still painful but not as swollen as before, chills less frequent, temp 98.4.
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| 53 | 2021-01-23 | tingling, flushing |
Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started...
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Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started a prickly tingle about 5 minutes and lasted about 3 hours, mild left palm and arm started a prickly tingle about 10 minutes after injection and lasted 1 hour, started feeling light headed about 10 minutes after and lasted about 1 hour with no blacking out, warm flush feeling started about 5 minutes after the injection and lasted for 32 hours (did not take temperature), my chest felt very heavy and breathing was a little diminished which lasted about 20 minutes. The following morning I felt some nausea with mild dizziness that lasted about 4 hours.
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| 53 | 2021-01-24 | burning sensation |
I called facility to check on everyone and see how they felt, and pt stated that her eyes looked ver...
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I called facility to check on everyone and see how they felt, and pt stated that her eyes looked very very red. She me a pic which I shared with. She has a burning sanitation and she bought over the counter eye drops.
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| 53 | 2021-01-24 | cold sweat |
became dizzy, clammy diaphoretic and nauseated at the end of her 15 minutes. This was her second do...
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became dizzy, clammy diaphoretic and nauseated at the end of her 15 minutes. This was her second dose and had no problems with the first COVID vaccine dose. Continued nausea with lightheadness and started to see visual spots when lifting head. Benadryl 25 mg 1 tab given by mouth at 1258 pm. At 1345 pm attempted to have her stand at stretcher and she continued seeing spots, dizzy. At 1406 transported to the ED for evaluation. She was seen, evaluated and released to home from the ED.
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| 53 | 2021-01-24 | pain in extremity |
I had, on the 21st, at about 6:00 pm or so I had left arm pain (upper). On the 22nd, at 5:00 am, I w...
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I had, on the 21st, at about 6:00 pm or so I had left arm pain (upper). On the 22nd, at 5:00 am, I woke up with chills, body aches and fever of 99.1 and then I took Tylenol. I had taken the morning off and I waited until 9:00 to see how I was feeling and I still wasn't feeling good. I ate breakfast and took another Tylenol and I was still having body aches, chills, fever was still 99.1. Had a little bit of headache also. So I called in work to cancel afternoon patients. At 1:00, I took two Tylenols because I had increased symptoms -about 99.3 or so fever. I went to sleep and woke up at 6:30 or so and was feeling better. After that I didn't have to use Tylenol. Arm pain was less stronger than the first dose on the second day (taken on the same arm).
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| 53 | 2021-01-24 | tingling, flushing, numbness |
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a...
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20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
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| 53 | 2021-01-25 | burning sensation |
Patient was given Pfizer Covid 19 vaccine, after administration she reported having burning to her t...
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Patient was given Pfizer Covid 19 vaccine, after administration she reported having burning to her throat, tingling of lips and tightness on her throat. Dr. was immediately called. Orders for Benadryl 100 mg IM was given and medication was administered on right gluteus. Vital signs were taken and recorded on chart. Patient was monitored and verbalized improvement within 5 minutes of adminstration. Patient was monitored for another 30 minutes. Patient stated that she was feeling better.
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| 53 | 2021-01-25 | flushing, cold extremities |
Dizziness, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, dizziness w...
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Dizziness, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, dizziness worse when standing, facial flushing
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| 53 | 2021-01-25 | flushing |
At 1:50 pm in post vaccine observation, patient reported metallic taste in mouth and warm flushing s...
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At 1:50 pm in post vaccine observation, patient reported metallic taste in mouth and warm flushing sensation from head to toe and tingling in lops. Vital signs taken at 1:50pm 158/92, pulse 71, resp 20, 1:55pm: 138/64, pulse 62, 2:05pm: 112/70, pulse 60, 2:15pm: 110/72, pulse 59, 2:28pm: 130/70, pulse 60, 2:40pm: 128/74 pulse 60, resp. 18. O2 sat remained 96-99% on room air. After 45 minutes patient reported feeling better and left with family member. Instructed to self monitor and to contact MD or report to ER if symptoms return or worsen. Patient verbalized understanding. Patient received Pfizer BioNTech Covid 19 vaccine EUA.
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| 53 | 2021-01-25 | pain in extremity |
Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; Thi...
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Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0142, expiry date not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose in the left arm for Covid-19 immunization (as patient works in a nursing home and wanted to get it). Medical history included ongoing asthma and had COVID back in Apr2020 to an unknown date. There were no concomitant medications. The patient previously had flu shot and had arm red and sore. Patient had a reaction after receiving her Covid shot yesterday at 11:30 AM. Patient mentioned that she woke up this morning (12Jan2021) at around 3 AM with chills, a headache and fever at 102-degree Fahrenheit and felt that she has to move her legs every time to feel better. She has asthma but stated that her breathing was fine. Patient wanted to know if this was normal and when this will go away. She called her doctor and left a message to let them know. She had COVID back in Apr2020, but got the vaccine yesterday, which she wanted. She was unsure what was going on. She was also shivering and cannot settle down, like her legs. She just has a massive headache with chills, shivering, and some sweating (12Jan2021). Her arm was also red and sore (12Jan2021). It was like she gets with the Flu shot, but she never has had any other symptoms with the flu shot. The events were reported as non-serious. Therapeutic measures were taken as a result of chills/shivering, fever at 102-degree Fahrenheit, headache, and arm was sore and red. Patient took Tylenol this morning when she woke up at 3 AM. She did not fall asleep until 5 AM. Then she got up at 7 AM and took some more. She will take more at 11 AM. The outcome of the events chills/shivering, fever at 102-degree Fahrenheit, headache, sweating, and arm was sore and red was not recovered.
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| 53 | 2021-01-25 | cold extremities, flushing |
Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone ache...
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Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, facial flushing. Missed work for 2 days and went to urgent care. Treated with APAP, Motrin, and meclizine
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| 53 | 2021-01-26 | flushing, pain in extremity |
I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting,...
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I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting, nausea, headache, stuffiness, congestion, swelling on the arm at the injection site, pain and rash around the injection site.
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| 53 | 2021-01-26 | pain in extremity, numbness |
dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side ...
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dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side numbness on my face limping leaning to the left side when walking tingling on my gums and teeth
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| 53 | 2021-01-26 | pain in extremity |
Low grade fever of 101.4, achy muscles, tiredness, and cannot lift left arm above my head without fe...
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Low grade fever of 101.4, achy muscles, tiredness, and cannot lift left arm above my head without feeling extreme pain.
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| 53 | 2021-01-26 | tingling, numbness |
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbn...
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elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-27 | pain in extremity |
Received dose # 1 at 7 pm. At 1 am woke up with severe left arm pain , and unable to move arm. Las...
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Received dose # 1 at 7 pm. At 1 am woke up with severe left arm pain , and unable to move arm. Lasted for 36 hours then gradually resolved. Now continues to be painful when raising arm and internal rotation .
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| 53 | 2021-01-27 | tremor |
Shaking in left arm 5-6 hours after vaccination, which later spread to abdomen and head. Felt like h...
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Shaking in left arm 5-6 hours after vaccination, which later spread to abdomen and head. Felt like head was vibrating or shaking on the inside, accompanied by nervous energy and feeling that something was not right. Interfered with ability to sleep. Seemed better in the morning but not completely resolved. Developed lower back/flank pain 5 days after vaccine.
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| 53 | 2021-01-27 | tremor |
couldn't breathe through nose, hands shaking, nausea, had elevated blood pressure and pulse when che...
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couldn't breathe through nose, hands shaking, nausea, had elevated blood pressure and pulse when checked. (162/104 and 122 hr)
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| 53 | 2021-01-28 | feeling cold |
Patient began to feel cold with severe headache and experienced nausea 5 minutes after injection. Be...
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Patient began to feel cold with severe headache and experienced nausea 5 minutes after injection. Benadryl was given. Blood pressure was 144/88. Patient was observed for 1 hour. Following 1 hour, she went to her office and planned to go home. Patient was later called to identify if symptoms were still occurring, but did not answer. Voicemail was left.
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| 53 | 2021-01-28 | migraine |
Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed bl...
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Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed blurry vison; 1/25/21 - had an e-visit ; 1/26/21 - evaluated by her PCP referred to ophthalmologist; 1/27/21 - evaluated by ophthalmologist and referred to retina specialist as she had pressure behind her eye; 1/29/21 - retina specialist used laser to decrease pressure behind her eye.
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| 53 | 2021-01-28 | migraine |
Bad headache about 45 minutes after shot. Had headaches for a few days after. Then after 3 weeks, ...
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Bad headache about 45 minutes after shot. Had headaches for a few days after. Then after 3 weeks, had a migraine - felt like the one I had the same day of the vaccine, but way more intense. I now wake up with headaches almost every morning.
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| 53 | 2021-01-28 | pain in extremity |
she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tigh...
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she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
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| 53 | 2021-01-28 | pain in extremity |
This is a spontaneous report from a contactable physician (patient herself). A 53-year-old female pa...
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This is a spontaneous report from a contactable physician (patient herself). A 53-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced a sore arm (added that she cannot move it from the pain) for 24 hours on an unspecified date. The patient did not receive any treatment of the event. The outcome of the event was recovered on an unspecified date.
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| 53 | 2021-01-28 | pain in extremity |
Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle ...
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Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle that is still present.
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| 53 | 2021-01-28 | pain in extremity |
mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pai...
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mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pain; Looked pale; was so hungry; This is a spontaneous report from a contactable physician (patient herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. The patient medical history included that the patient has a severe allergy cold and humidity and therefore before getting the vaccine she took an Advil and loratadine. There were no concomitant medications. The first dose of BNT162B2 for COVID-19 immunization was given on 23Dec2020 (Lot: EL0140) at the age of 53 years old and reported sore arm (added that she cannot move it from the pain) for 24 hours. In regards to the first dose, she only had a severe sore arm and couldn't elevate the arm but this only lasted for 24 hours and then she didn't have any soreness. She received the second dose on 13Jan2021 and experienced mild fever, chills, anorexia, headache, and myalgia. Her supervisor asked her to test positive for covid however she is wondering if she could get a false positive since it is still within 72 hours after vaccination. Patient asked if after vaccination do they not check for antibodies to make sure the vaccine is working. The patient reporting on COVID and who stated she got her second dose on Wednesday (13Jan2021) and who stated she has some questions about side effects and getting tested after vaccination. It was explained that she has had fevers, chills, headache, and discomfort in her chest (Jan2021). She was told to get a test by her job but wondered if she will test positive since it has been less than 72 hours since getting the vaccine. She got the second shot around 7:50pm or 8pm. At midnight she woke up with chills, mild fever, and severe muscle pain. Then she woke up in the morning early with a headache, severe muscle pain, it was very hard to make it. She had severe anorexia, she was so hungry she ate a little and went back to bed. Then she only woke up for lunch and ate something. At that time her fever was gone. She went back to bed but at 8pm she woke up and still had muscle pain. She had a very difficult time yesterday. In the night she woke up with leg pain, muscle pain. The patient explained she felt better today so she went to work and spoke to her supervisor who told her it was better to take a test for COVID. It was mentioned she looked pale and it was better for her to have a test just in case. The patient reported that she knows a bit about vaccines and the proteins and RNA. Since it has been less than 72 hours since she had the second dose, would she test positive if she had a COVID test. No treatment after the doses. Patient states she has no had any testing done at this point. Therapeutic measures were taken as a result of event so hungry. The event fever recovered on an unspecified date in Jan2021. The outcome of the events chills, anorexia, headache, discomfort in her chest and myalgia/muscle pain, leg pain, looked pale, and was so hungry was unknown.
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| 53 | 2021-01-29 | burning sensation |
2hrs after taking the 2nd shot of Pfizer vaccine experienced a burning sensation across my upper bac...
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2hrs after taking the 2nd shot of Pfizer vaccine experienced a burning sensation across my upper back and lower right back. It only lasted 10seconds but I have never ever felt something like this before. 2nd dose in the right arm.
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| 53 | 2021-01-29 | pain in extremity, muscle spasms |
Pfizer-BioNTech Covid Vaccine EUA On 1/29/2021, Fasiculations started in both legs (below the knees)...
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Pfizer-BioNTech Covid Vaccine EUA On 1/29/2021, Fasiculations started in both legs (below the knees) at 7pm, 5 hours after the shot. The gnarly, very painful cramps of my feet and ankles started in the right foot at 7:30pm.....last about 10-12 minutes, then the left foot/ankle, again for 10-12 minutes. I have and took Gabapentin 600 and had relief from the cramps by 9:30pm. The fasiculations continued for 24 hours. At this point (25 hours later) my feet and ankles have a dull ache but I do not expect anymore cramps. This is an autoimmune disease for me but I have not had an episode this bad in a year. PS - It?s worth it to take the vaccine!
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| 53 | 2021-01-30 | burning sensation, tremor, tenderness |
? Jan 21st, 2 hours after vaccine headache. 12 pm right side of back hurting last 2 hours, 3 pm nec...
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? Jan 21st, 2 hours after vaccine headache. 12 pm right side of back hurting last 2 hours, 3 pm neck hurting lasts 2 hours.6pm feet are burning hot to the touch. ? Jan 22, 12 am Arrhythmias, racing heart rate, uncontrollable shaking, throat is feeling sore and difficulty swallowing. I go to the ER . While waiting to see a doctor my symptoms subside. Dr. prescribes an epi-pen. Explains that they do not know about the vaccine. ? Jan 23, 3am uncontrollable shaking, neck hurting feet burning. 4am nausea, headache still continues. ? Jan 24, massive headache continues, nausea, diarrhea, I go to Urgent Care Center. They do a blood test must wait a few days for results. ? Jan 25, Massive headache continues, uncontrollable shaking ? Jan 26, 2am, headache continues, uncontrollable shaking, burning feet, blood pressure 164/103. Back to Urgent care. Add blood pressure meds. ? Jan 29, 12 am Shaking, blood pressure168/85 ? Jan 31st Sunday 7pm, Muscles tightening up in lower body, chest pain Symptoms ongoing, Doctors do not know enough about the vaccine to treat the problem.
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| 53 | 2021-01-31 | discomfort |
tested positive later in the day; tested positive later in the day; exposed to someone with covid vi...
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tested positive later in the day; tested positive later in the day; exposed to someone with covid virus; headaches in the back of head and ears; heaviness, it seems like pressure; Fever/101.6; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration, administered to the left deltoid, on 14Jan2021 between 2:30-2:45pm (14:30-14:45) at single dose for COVID-19 immunisation. It was offered at her worksite. The patient's medical history included ongoing Baker's cyst right knee. The patient had no family history. Concomitant medication included celecoxib (CELEBREX) from May2020 for Baker's cyst. The patient had no additional vaccines administered on the same date of the BNT162B2. The patient previously took flu shot and she got sick (in the 1980's or 1990's). The patient had no prior vaccinations that were within 4 weeks prior to the first administration date of BNT162B2. The patient, a Senior facility HCP, took a covid test on Monday and was negative. Yesterday (14Jan2021), she received the first dose and then tested positive later in the day. She wanted to know if she can get the next dose at the appropriate time or if she has to wait 90 days. On 14Jan2021, the patient experienced headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus. It was reported that the patient was debating on getting the Pfizer BioNTech Covid vaccine and so she finally decided to get it yesterday (14Jan2021). Two hours after getting it and getting home, her head started to hurt and fever, which she thought that was typical. That night the fever broke and it started again this morning (15Jan2021). She works at a senior facility and had to ask for an extended medical leave. She was tested yesterday for Covid that morning and had the vaccine in the afternoon. She was exposed to someone with the virus. She knows there are 2 shots and now she has had the one. She wanted to know if it's safe to get the second one since someone said she may need to wait 90 days since being exposed. She still has the headaches in the back of head and ears, heaviness, it seems like pressure. The fever has been under 100, it's been about 99 and the highest it got was yesterday at 101.6 degrees. By the time she went to bed last night it got down to 98.2 degrees. She has alternated Advil and Tylenol. She took temperature at 6am today (15Jan2021) and it was 99.8 and so she took a couple of Advil to help and by 7am it was down to 99.2. So, it's staying in the 99.2-99.3 range. The patient did not receive any other vaccines the same day or 4 weeks prior. The patient mentioned when getting the her very first flu shot, which she was hesitant about getting, she did get sick, but it wasn't immediately after. Since then she has been fine. She thinks this was in the 1980's or 1990's. She mentioned that this is a new vaccine and there is not a lot of information out there. She wanted to know if she will get immunity right away. She mentioned she was tested on Monday for Covid and told if she didn't get a call she was fine and she didn't hear anything. Then was told yesterday she was exposed to someone with Covid and so she had testing again yesterday. She is awaiting results (pending clarification). No further details provided. She was diagnosed around Memorial Day last year for right knee baker's cyst and given celecoxib. She went through physical therapy and has full range of motion, but cyst still there and tender. She may see a rheumatologist. She just finished her 30 days of celecoxib and didn't see any difference. It was reported that the events did not require a visit to emergency room nor physician office. The outcome of the event " tested positive later in the day" was unknown while the outcome of the events headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus was not recovered.; Sender's Comments: The reported tested positive on the same day that the patient received first dose of COVID 19 vaccine, BNT162B2, is considered unlikely related to the suspect. Of note, the patient exposed to someone with the virus.
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| 53 | 2021-01-31 | pain in extremity |
Fever, pain on left arm, body aches, back pain Used Tylenol , fever subsided on 1/30 pm but back p...
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Fever, pain on left arm, body aches, back pain Used Tylenol , fever subsided on 1/30 pm but back pain continued lightly and constant throughout 1/31/21. Flank pain (moderate) began on 2/1/21, consistent/current
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| 53 | 2021-01-31 | pain in extremity |
swelling and pain of first digit phalangeal-metacarpal joint, R hand, index finger (same side as va...
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swelling and pain of first digit phalangeal-metacarpal joint, R hand, index finger (same side as vaccine received)
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| 53 | 2021-01-31 | tingling, weakness |
not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she wa...
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not feeling good; feeling weak; Chills; hurt like someone hit her; feeling real thirsty; like she was going to pass out; Fever; Nausea; tingling on her face; This is a spontaneous report from a contactable consumer (patient). A 53 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date Apr2021) via Intramuscular on 14Jan2021 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's ongoing medical history heart murmur and high blood pressure diagnosed about 10 years ago. The concomitant medications was reported as none. Patient was still not feeling good. She said that she had side effects that started on Saturday 16Jan2021. Caller clarified that she had fever, nausea, and tingling on her face. Fever was noticed it on Saturday 16Jan2021 and gone by about 2am on Sunday 17Jan2021. Patient stated that she was feeling real thirsty. Nausea was still there and this morning, patient felt like she was going to pass out. She stated that she had weakness. She stated that she is trying to make an appointment to see her doctor. She stated that the nausea is persisting, but the nausea comes and goes. She stated that yesterday she felt ok, but this morning, she felt nauseated and like she was going to pass out. Patient said that the tingling stopped around 17Jan2021 02:00 along with the fever. Patient stated that she is drinking Gatorade and eating crackers and is staying stay hydrated. She stated that she is at work, but she feels weak. She stated that she had chills and she hurt like someone had hit her. She noticed these symptoms on Saturday 16Jan2021 and stated that this was ongoing and they come and go. The outcome of fever and tingling on her face was recovered on 17Jan2021 02:00. The outcome of not feeling good and feeling real thirsty was unknown. The outcome of other events was not recovered.
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| 53 | 2021-01-31 | tingling, tremor |
could not get out of bed; whole body aches; shaking; significant nausea; significant dizziness; head...
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could not get out of bed; whole body aches; shaking; significant nausea; significant dizziness; headaches; immediate reaction up to jaw, ear and shoulder/ she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands; not feeling well; very stressful; This is a spontaneous report from a contactable consumer for herself. A 53-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly at upper left arm, 12:45PM on 08Jan2021 to prevent Covid. The patient had no medical history. She did not get sick and had not taken a sick day in 5 years. Patient had not received other vaccines within four weeks. Patient had no concomitant medications. The patient had an immediate reaction up to jaw, ear and shoulder following first dose on 08Jan2021. When she got the injection, she could feel the stuff going in and something on the left side of her jaw, and she brought her right hand up to rub her jaw. She was not sure if a nerve may have been hit, but she felt it on the left side of her jaw and her left ear, and down her arm and it was tingling down her hands. This has recovered completely at the time of reporting. She had not been feeling well since that day and got worse. On Wednesday (13Jan2021), it started with significant dizziness and her headaches started toward the end of day. By Thursday (14Jan2021) she had the headache and significant nausea. The body aches started on Thursday. Her whole body ached so much that she was shaking. On Friday (15Jan2021) she could not get out of bed since the headache was intense along with the dizziness and nausea. She received Advil and Tylenol as treatment and was also taking clonazepam since it had been very stressful. She was worried since she felt safe going in to get the vaccine and she did not feel so safe now. At the time of reporting, she improved but not recovered. She would like to know what she is experiencing is a side effect or if she should be tested for Covid. The outcome of tingling feeling resolved, stressful was unknown and outcome of other events was resolving. Information on the lot/batch number has been requested.
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| 53 | 2021-02-01 | burning sensation |
Employee reported that she began dry, burning lips and neck which started day after covid vaccine ad...
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Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest. Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving. Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day. Did not have to seek emergency treatment but did miss 1 day of scheduled work. Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
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| 53 | 2021-02-01 | facial pain, numbness |
Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Seve...
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Systemic: Chills, Systemic: Joint Pain, Systemic: Other- Pain and numbness on the left jaw/face-Severe.
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| 53 | 2021-02-01 | facial paralysis |
Bell's Palsy; This is a spontaneous report from a contactable other HCP (patient). A 53-years-old fe...
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Bell's Palsy; This is a spontaneous report from a contactable other HCP (patient). A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL 3247), via an unspecified route of administration at Left arm on 15Jan2021 11:00 AM at SINGLE DOSE for covid-19 vaccination. The patient was not pregnant. Concomitant medications in two weeks included lithium, levothyroxine sodium (LEVOTHROID), omeprazole. Historical Vaccine included first dose of bnt162b2 (lot number EL 1284) on 29Dec2020 11:00 AM at Left arm for covid-19 vaccination. The patient previously took ziprasidone hydrochloride (GEODON) and experienced drug allergies. It was reported no other medical history. On 17Jan2021 the patient woke up with left side of her face dropping. She went to the ER. She was diagnoses with Bell's Palsy. The event onset date was 17Jan2021 04:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment drugs predizone and Acyclovir received for the event. The outcome of the event was not recovered. No covid prior vaccination, no covid tested post vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-02-01 | facial paralysis | Facial swelling, itching, tightness, eyelid dropping |
| 53 | 2021-02-01 | feeling hot, pain in extremity |
after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like ...
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after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like I had a fever but did not, extreme fatique
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| 53 | 2021-02-01 | numbness |
Complained of feeling "off and feeling like legs are falling asleep" and upset stomach. at 14 35 ...
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Complained of feeling "off and feeling like legs are falling asleep" and upset stomach. at 14 35 BP 179/102, Pulse 73, 98% on room air. Rested for approximately 45 mins. Bp 171/95 at 1455. Patient reported feeling better and agreed to follow up with primary MD or go to ER is symptoms worsened.
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| 53 | 2021-02-01 | tremor |
Approx. 25 mins after receiving vaccine. I experienced rapid heart, shaking, elevated BP. I was lea...
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Approx. 25 mins after receiving vaccine. I experienced rapid heart, shaking, elevated BP. I was leaving the hosp. and started feeling strange and my heart was racing and I felt shaky. I went to the ER at the hospital I received my vaccine at.
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| 53 | 2021-02-02 | cold sweat, feeling hot |
23 minutes following administration of vaccine began feeling nauseous, clammy, warm. Evaluated patie...
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23 minutes following administration of vaccine began feeling nauseous, clammy, warm. Evaluated patient BP 98/62 RA, wnl per pt. P 77, RR 16, O2sat 95-97%. During evaluation pt stated felt slightly itchy throat and itching in her ears. Pt given Claritin 10 mg po at 12:19 pm and remained under observation by RN. Pt began feeling better, sipping water. P 88-91, RR 16, O2sat 98%. Reviewed pt status with MD. Pt allowed to leave at 12:35 pm.
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| 53 | 2021-02-02 | feeling cold |
Woke up out of my sleep feeling horrible. For about 2 hours, from 3am until about 5am I was very col...
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Woke up out of my sleep feeling horrible. For about 2 hours, from 3am until about 5am I was very cold with excessive sweating and nausea. Did not vomit, but felt like I would and should. I had explosive diarrhea 4 times, each time thinking I was done, but then urgently having to go again. After the 4th time, I felt completely empty. During those 2 hours I felt horrible and was scared for the fact that I knew it was a result of the vaccine 12 hours earlier. I was able to get back to sleep and felt better the next day. I was tired, but not feeling sick for the rest of the day. I was 100% better the following day.
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| 53 | 2021-02-02 | flushing, tingling |
Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in che...
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Within one hour had tingling in right hand, tingling in tips and tongue, flushed and swelling in cheeks, throat tightness and lethargy
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| 53 | 2021-02-03 | weakness |
fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report fr...
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fever 101; headache; chills; muscle pain; weakness; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on an unspecified date at 10:00 at single dose on left arm for COVID-19 immunisation. Medical history included depression/anxiety, back pain, COVID prior vaccination and known allergies: sulfa and penicillin. Concomitant medication included naproxen, sertraline HCL (ZOLOFT), fish oil, ospemifene (OSPHENA) and docusate sodium (COLACE), all from unknown date for unknown indication. On 12Jan2021 at 17:00, patient experienced fever 101, headache, chills, muscle pain, weakness, nausea and fatigue. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. Nasal Swab on 14Jan2021 was negative. Patient recovered in Jan2021. Information on the lot/batch number has been requested.
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| 53 | 2021-02-03 | difficulty speaking, pain in extremity |
DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDE...
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DROWSY ITCHY THROAT (STARTED HERE) ITCHY NOSE (PROGRESSED HERE) GENERALIZED ITCHING EVERYWHERE (ENDED HERE) NUMB LIPS AND TONGUE THROAT HOARSE LEFT ARM ACHE
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| 53 | 2021-02-03 | pain in extremity, numbness |
first shot my arms and neck muscles went numb for several hours Second time my legs were in severe ...
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first shot my arms and neck muscles went numb for several hours Second time my legs were in severe pain and hard to make move-could barely walk. This lasted for about 8 hours. I had a small fever, my left leg and ankle swelled for several days and hurt mildly. I had a rash on my neck and body. I had fatigue like theonset of a fibro attack both times but second shot was much worst than first.
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| 53 | 2021-02-03 | pain in extremity |
Arm was getting sore and stiffing and as days went on till after second shot was seen by ED, and PT ...
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Arm was getting sore and stiffing and as days went on till after second shot was seen by ED, and PT have not Frozen shoulder Shot was close to Shoulder capulituits . I have received yesterday 2/3/2021 a cortisone shot to the shoulder and will receive PT
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| 53 | 2021-02-03 | pain in extremity |
arms pain, back pain, spine pain 4 hours only. pain dropped to lower back and hips and lasted for a ...
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arms pain, back pain, spine pain 4 hours only. pain dropped to lower back and hips and lasted for a few hours. Recurring pain since.
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| 53 | 2021-02-04 | weakness, feeling cold, muscle spasms |
She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrena...
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She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 53 | 2021-02-04 | feeling hot |
Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevate...
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Felt very hot after getting vaccine: drinking water> Then tasted metallic taste; BP slightly elevated 160/90; no other issues.Monitored; hot resolving, metal taste resolving
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| 53 | 2021-02-04 | numbness, tingling |
7 days following 1st vaccine started with aches and pains in muscles and joints. At 9 days following...
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7 days following 1st vaccine started with aches and pains in muscles and joints. At 9 days following 1st vaccine started having numbness/tingling and pins and needles in tips of toes and fingers. Over the next week this progressed into my feet and hands and is now up to my ankles and wrists. The aches and pains slowly got better, but did not resolve and worsened following second vaccine 2/4/21
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| 53 | 2021-02-04 | muscle spasms, numbness, tingling, muscle twitching |
1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple o...
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1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple of days muscle aches all over, bone pain, fatigue, 1/18 First Covid Test 1 Negative Continued symptoms 1/21 Went to PCP Covid rapid and Covid lab both negative Labs drawn all within normal limits Symptoms continued including occasional leg cramps, random muscle twitching, sharp needle like pain in foot, feeling shaky, waking to numbness hands
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| 53 | 2021-02-04 | night sweats |
Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red c...
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Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red circle at injection site warm to touch, itchy with lump under skin.
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| 53 | 2021-02-05 | weakness |
abdominal cramping x1day, vomiting, diarrhea x1day , upset stomach unable to eat x3days, weakness ...
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abdominal cramping x1day, vomiting, diarrhea x1day , upset stomach unable to eat x3days, weakness x2days, fatigue x4days, fever 102.6 x 1day, chills x1day.
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| 53 | 2021-02-07 | weakness, feeling cold |
Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for va...
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Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for vaccines, but did not this time due to recommendation of not doing so with this vaccine. One hour post vaccination, developed cognitive changes- deer in the headlight, unable to think/process information, lasting 4-5 hours. Later that evening, extreme fatigue. Resting respirations labored >20/min lasted most of the night along with chills with no fever x 3days. Dizziness with LOUD ringing in R ear started around 1-2am and lasted one week. Pain in joints/muscles of jaw. Next day both ears were hurting inside (eardrum, middle ear) x1week. HR elevated up to 135 bpm walking to bathroom x 2 days post vaccination. Felt sick/wiped out post vaccine for 3-4 days with no energy with muscle aches/stiffness.
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| 53 | 2021-02-08 | difficulty speaking |
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel...
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her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
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| 53 | 2021-02-08 | feeling hot |
Medical Complaint: Employee. I got my 2nd COVID vaccine on 01/29/2021. Feeling warm, low grade fever...
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Medical Complaint: Employee. I got my 2nd COVID vaccine on 01/29/2021. Feeling warm, low grade fever, congestion, runny nose, cough-clearing my throat. Had chills, not over 100.0 for my fever. What should I do? Got tested for COVID on 01/08/2021
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| 53 | 2021-02-08 | pain in extremity |
After receiving my vaccine, I had the normal arm soreness and low grade fever but the following day ...
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After receiving my vaccine, I had the normal arm soreness and low grade fever but the following day my fever went up to 102 even after taking Advil every 6 hours. On the 3rd day my arm continued to be sore and my fever continued but was between 100.7 and 101.4. On day 4 my fever started going down to 99 for the day but my arm continued to be sore where the injection was and my armpit was sore as well like something was swollen. Day 5, today, my fever finally broke but my arm has a red circle and knot where the injection was given, its still very sore and also itches and warm to the touch. Every time I raise it up, I get shooting needles in the area of the shot. I have severe fatigue and sweats when I get up to walk anywhere and I feel exhausted. I called and spoke to the nurse who spoke to my Dr. listed on this form. She told me all of my symptoms were normal and said that if I started throwing up or my arm got worse to call back. I was not asked to come in to have anyone look at my arm or see if there is something else going on with the symptoms I am having.
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| 53 | 2021-02-09 | difficulty speaking |
my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rat...
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my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rate went up, not extremely high but and EMT said it felt "racy".; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: RL3249) at left arm on 21Jan2021 12:15 AM at single dose for COVID-19 immunization. Medical history included asthma, allergies to sulfa, dairy, egg, peanuts. Patient is not pregnant. Other medications in two weeks included low dose naltrexone and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) and Herbals. No other vaccine in four weeks. Patient previously took erythromycin and epinephrine and had allergy to them. Within 5 minutes (21Jan2021 12:15 AM), her system felt ramped up. Her heart rate went up, not extremely high but and EMT said it felt "racy". She was told that her voice sounded worked up. she had slightly shallow breathing. It lasted about 30 minutes then began to subside. The next day she felt it somewhat. she was totally normal after 12 hours. She had a sensitivity to epinephrine and the Pfizer dose reaction reminded her of a milder version of the epinephrine reaction. No Covid prior vaccination, no covid tested post vaccination. No treatment received for the events; patient was recovered from the events in 22Jan2021.
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| 53 | 2021-02-09 | tremor |
Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling...
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Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 23Jan2021 (11:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included early diabetes and high blood pressure. Concomitant medications included valsartan, sitagliptin (JANUVIA) and rosuvastatin. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 02Jan2021 (when the patient was 53 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 23Jan2021 (19:00), the patient had chills; body aches; injection arm had begun to hurt; body tremble; armpit was very painful; and armpit was swelling. The patient had no fever. The patient had taken paracetamol (TYLENOL) as treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'injection arm had begun to hurt', 'body tremble', 'armpit was very painful' and 'armpit was swelling', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
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| 53 | 2021-02-11 | unresponsive to stimuli |
PATIENT REPORTED SYNCOPE TO CHILDHOOD IMM., BUT NOT RECENT FLU SHOT. PATIENT WAS OBSERVED TO BE FINE...
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PATIENT REPORTED SYNCOPE TO CHILDHOOD IMM., BUT NOT RECENT FLU SHOT. PATIENT WAS OBSERVED TO BE FINE FOR 20 MINUTES POST-VACC. SHE WAS ON HER WAY HOME AT 50 MINS. POST-VAC WHEN SHE BECAME UNCONSCIOUS, UNRESPONSIVE, & PRESENTED W/HIVES. SHE WAS TREATED AT EMERG. DEPT. AFTER 90 MIN, SHE IS CONSCIOUS & IMPROVING.
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| 53 | 2021-02-14 | feeling hot, weakness |
Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak...
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Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak. Patient was taken to Clinic for evaluation at onset of symptoms, approx 12 minutes after distributing vaccine. At Clinic, patient states her symptoms have improved. She states she thinks she got a little anxious and feels comfortable driving home at this time. Patient denies oral/throat/tongue/lip edema. No headache, vision changes, difficulty swallowing, difficulty handling oral secretions, chest pain, palpitations, shortness of breath, nausea/vomiting. No pruritus. Patient is siting comfortably in the chair and drinking water without difficulty. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss the second dose of the covid vaccine. Patient agreed to the plan. Patient ambulated out of clinic without difficulty. 1/1/21: Pt received 2nd dose of vaccine. Experienced some dizziness and slightly high BP. Both symptoms resolved within 30 minutes and patient was discharged home.
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| 53 | 2021-02-14 | migraine | Headaches and Migraines and vomiting, Maxalt 10 mg Tylenol |
| 53 | 2021-02-14 | tingling, weakness | Rash, lightheadedness, weakness and tingling, throat closing, elevated blood pressure |
| 53 | 2021-02-14 | tingling, numbness |
reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingl...
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reddened area with bruising with nodule; reddened area with bruising with nodule; numbness and tingling in right thumb; numbness and tingling in right thumb; EKG abnormal; large bruise on right buttock/right thigh/right arm; Chest discomfort; Heart attack; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 06Jan2021 (at the age of 53-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced electrocardiogram (EKG) abnormal and large bruise on right buttock/right thigh/right arm on 08Jan2021; numbness and tingling in right thumb on 10Jan2021; reddened area with bruising with nodule on 26Jan2021; chest discomfort and heart attack in Jan2021. The clinical course was reported as follows: Two days later after vaccination, she noticed bruising on various parts of body. The first bruise she noticed on the 08Jan2021. It was probably about 3.5 inches in length 2 inches in width. The patient stated that it did not necessarily have a shape. She had a large bruise on her right buttock. Two days later, she noticed a similar in size bruise on the front of her right thigh. Then a couple days later, she noticed three quarter size bruises on her right arm (two on the inner part of arm, and one on the outer, both on upper arm). The very next day, she developed the same sizing bruise. It was about the same size on her left upper arm. There were no other side effects besides the bruising. There was no itching or redness, no skin, respiratory, or neurological issues. The day before her second dose, on 26Jan2021, she noticed a 4 inch reddened area with a two centimeter nodule inside that bruise. The patient stated that the initial bruises began to heal. They are not as dark as they were. They were reported to have started out red and then turned black and blue. The patient also had numbness and tingling in her right thumb. She was having some chest discomfort after the initial vaccination that is still ongoing. The chest discomfort prompted her to go to urgent care on 08Jan2021, where she had an abnormal EKG on 08Jan2021. The patient was told to follow up with a cardiologist. The patient saw the cardiologist on 25Jan2021, where he did an EKG and ECHO. The EKG was abnormal and ECHO with unknown results on 25Jan2021, but the doctor was unable to determine when the heart attack occurred. The cardiologist also ran labs: a troponin to see if anything was acutely going on, and a D Dimer to evaluate her clotting factors; both were negative on 25Jan2021. The cardiologist recommended a computerised tomogram (CT) scan, which was still scheduled at the time of report. The clinical outcome of large bruise on right buttock/right thigh/right arm, chest discomfort, numbness and tingling in right thumb, and reddened area with bruising with nodule was not recovered and of heart attack and EKG abnormal was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-02-14 | seizure, weakness, numbness |
Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was giv...
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Initially reported numbness and tingling of lips and ringer after first dose of vaccine. She was given Benadryl 50mg IM. Within 15 seconds she reported not feeling well. Then she started seizing for about 30 seconds. Initial BP 148/88 and pulse ox 98. After 5 mins BP of 125/77 and pulse ox 99%. Patient regained consciousness, was A&O x3 but felt weak/tired. She was transported to the hospital.
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| 53 | 2021-02-15 | numbness | Facial numbness within 2 hours of administration with resolved within the hour. |
| 53 | 2021-02-15 | pain in extremity, feeling cold |
Sore arm, body aches, low grade temp, chills day after. On the 8th, I woke to cold sensation down l...
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Sore arm, body aches, low grade temp, chills day after. On the 8th, I woke to cold sensation down left cheek under eye, across lips and some chin, into nasal cavity. Has lasted a week so far and has not resolved. Also a continuous headache, worse when lying down. Tylenol eases it but never has gone away.
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| 53 | 2021-02-16 | weakness, feeling cold, tremor | Chills - violent shaking for 3 hrs Headache - 3 days weakness - 3days |
| 53 | 2021-02-16 | tremor | patient reports shaking and feeling like she can't breath (more like panic attack not anaphylaxis) |
| 53 | 2021-02-17 | feeling of body temperature change |
Injection site was moderately sore; I felt extremely tired and fatigued; chilled to the bone alterna...
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Injection site was moderately sore; I felt extremely tired and fatigued; chilled to the bone alternating with hot spells; This is a spontaneous report from a contactable consumer. A 53-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), into the left arm on 29Jan2021 at 10:30 at single dose for COVID-19 immunization. Age at vaccination 53 Years. The patient had received first dose of BNT162B2 on 09Jan2021. The patient had no allergies to medications, food, or other products. Medical history was none. Concomitant drugs included Prozac daily and Lyrica one daily. The patient reported that the injection site was moderately sore. The main side effect started 24 hours post shot. She felt extremely tired and fatigued as well as chilled to the bone alternating with hot spells. No body aches. No other effects. No treatment was received. Resolved in 24 hours.
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| 53 | 2021-02-18 | pain in extremity, nerve pain |
delayed adverse reaction to vaccine. experiencing severe neuropathy along my left arm. pain is prima...
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delayed adverse reaction to vaccine. experiencing severe neuropathy along my left arm. pain is primarily focused around my elbow to wrist area and then less on the upper arm area. Pain is present daily and I feel it most when I'm resting, relaxing and driving. I also feel pain in the Ulna area when Im typing at my computer at work. I've self medicated with motrin and topical analgesics. cold and hot compresses. give me some relief but pain comes back in a few hrs. I contacted my Doctor on Thursday 2/18/21 and she has recommended PT
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| 53 | 2021-02-18 | pain in extremity, tingling |
Vital signs: 124/74 right arm, HR 75, Pulse ox room air 99% Patient presented for 1st dose of COVID-...
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Vital signs: 124/74 right arm, HR 75, Pulse ox room air 99% Patient presented for 1st dose of COVID-19 Pfizer Vaccine. Post vaccination patient noted left arm pain to elbow and left supraclavicular swelling moving laterally. Noted tingling and pain then swelling in left neck/shoulder area. About size of a baseball. Patient given option to take benadryl 25 mg once before leaving or take it later if she is not improving. She prefers to take it now. Benadryl 25 mg PO x1 given at 1715 self-administered. Patient monitored for a total 40 minutes before being released. History of reaction to flu vaccination that resulted in arm swelling and high fever ~30 years ago. Vancomycin life threatening reaction.
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| 53 | 2021-02-19 | weakness | Prolonged fever, headache, fatigue, gen weakness, vomiting/diarrhea |
| 53 | 2021-02-19 | difficulty speaking |
Patient received 2nd dose of COVID 19 Vaccination at approximately 0800, 20 Feb 2021. While seated ...
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Patient received 2nd dose of COVID 19 Vaccination at approximately 0800, 20 Feb 2021. While seated in observation area patient began to experience difficult swallowing and a hoarse voice. 0.3 mg epinephrine administered, 4 mg Decadron IM and 25 mg diphenhydramine PO provided at 0830. Patient transported to local ER for further evaluation and care.
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| 53 | 2021-02-19 | pain in extremity | fatigue, chill, arm pain |
| 53 | 2021-02-21 | flushing |
Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with fl...
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Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 53 | 2021-02-22 | discomfort |
Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure w...
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Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.
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| 53 | 2021-02-22 | pain in extremity |
Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent ...
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Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent and looser stools and stomach cramping since the day of the vaccine .
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| 53 | 2021-02-23 | weakness | having flue symptoms, no energy began on 2/14/2021 consistant |
| 53 | 2021-02-23 | flushing | Patient complained of flushing, tingling tongue, dry mouth. |
| 53 | 2021-02-23 | migraine |
I had pain at the injection site which started about 2 hours after the shot. (I had had this after ...
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I had pain at the injection site which started about 2 hours after the shot. (I had had this after the first shot as well, but it happened faster this time and was a little more severe). About 12 hours after the injection, I started to feel feverish, and went to bed - fever seemed to spike during hours 12-16 post-injection. (I did not take my temperature because I was in bed and really not feeling well.) I had chills, sweating, muscle aches, restless sleep, and a headache. I remained feverish most of the next day and had a migraine level headache the entire day; temperature reads were in the 100-101 degree range for the entire next day, until about 10pm (a full 24 hours after the onset of symptoms, 36 hours from injection.), when it went down to 99 degrees, and then finally seemed to subside.
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| 53 | 2021-02-24 | pain in extremity |
Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, ch...
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Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.
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| 53 | 2021-02-24 | tingling | Tingling in L arm, lightheaded, dizziness, evaluated by EMS-cleared |
| 53 | 2021-02-24 | tremor, burning sensation, feeling hot, tingling |
Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything...
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Felt hot, burning sensation across chest, palpitations, dizziness, having sensation of everything smelling sweet, tingling in hands and feet, hands shaking, slight nausea. Evaluated by EMS. Had not eaten given water and tea. Ate protein bar. Feeling better, symptoms resolved. Discharged home at 9:45am.
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| 53 | 2021-02-25 | weakness |
Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; head...
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Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 53 | 2021-02-25 | numbness |
Arm went numb within first hour after dose, continued up through neck. Next morning I felt flu-like ...
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Arm went numb within first hour after dose, continued up through neck. Next morning I felt flu-like symptoms, Achy muscles and joints, fever that varies between 100° and 101.6°, bad headache, severe fatigue.
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| 53 | 2021-02-26 | weakness |
These symptoms were from the 2nd dose. Tenderness at injection site, fever, body aches, vomiting, se...
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These symptoms were from the 2nd dose. Tenderness at injection site, fever, body aches, vomiting, severe headache, fatigue, weakness - 3 days duration
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| 53 | 2021-02-26 | face paralysis, numbness, facial paralysis |
Numbing on left side of the face, unable to close left eye all the way no control on left side of th...
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Numbing on left side of the face, unable to close left eye all the way no control on left side of the lips; sharp pain on neck and jaw
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| 53 | 2021-02-26 | numbness | Numbness of the face. Numbness started to subside by 2:30 pm. |
| 53 | 2021-02-26 | pain in extremity, nerve pain |
Painful red blistered toes muscle aches and fatigue developed approximately 18 days after vaccine ac...
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Painful red blistered toes muscle aches and fatigue developed approximately 18 days after vaccine accompanied by painful sensory neuropathy. Covid test on 2/12/21 negative. Pain and rash persisted and worsened. I saw my primary doctor on 2/19/21 because my rheumatologist had left her practice. He checked my circulation and prescribed prednisone course to be taken if problem worsened. I waited another week because I am reluctant to take prednisone and was then advised by my friend who is a rheumatologist that I should go ahead with the steroid. This rash resembled the "Covid toes " phenomenon that has been reported in response to the actual Covid 19 viral infection and the neuropathic pain in my feet was very uncomfortable. I started prednisone course 40 mg QD on 2/26/21 with some improvement so far after one day.
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| 53 | 2021-02-26 | pain in extremity | Nausea, dizziness, aches, fatigue |
| 53 | 2021-02-27 | tingling, flushing, numbness |
Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: sk...
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Within 2 minutes of receiving the injection, I experienced the following symptoms simultaneously: skin flushed/got hot, hands got numb and tingly, back of and sides of my tongue got thick- felt like it was swelling, got more difficult to breathe, heartbeat started racing, felt light-headed. I sat up in the edge of my seat and almost called for help, however the symptoms subsided within 2-3 minutes and then I was fine. Had a lingering, very minor headache and no other symptoms. I didn't tell anybody and came home and took 1 benadryl just to be safe.
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| 53 | 2021-02-28 | inability to speak |
Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. N...
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Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. Nausea and fatigue persisted, along with the loss of appetite (as of this date, still no appetite...only being able to handle orange juice and saltine crackers); emotions are still a wreck; concentration level is still small; multi tasking is not doable; seem to lose words along the way in conversation.
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| 53 | 2021-02-28 | weakness |
I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the fol...
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I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the following morning at 5am. Body aches/mild. Worked the next day but had to leave an hour early due to fatigue and body pain. That evening developed nausea. (2-26). The 27th I had a terrible headache upon waking with increased nausea. Started vomiting around 10am. Unable to take in any liquid until that evening late. The 28th mild headache, more of a heavy headed feeling. Today, March 1st, nausea without vomiting thus far, weak & drained feeling.
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| 53 | 2021-02-28 | numbness, throat numbness, tingling |
Pt received first dose of Pfizer vaccine and was sitting in the observation area for about 5 minutes...
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Pt received first dose of Pfizer vaccine and was sitting in the observation area for about 5 minutes when she alerted staff that she was feeling numbness and tingling to lips that was moving up face and down to throat. Pt stated that she also had slight difficulty breathing which was relived when she took off her mask. She stated that she has allergies to papaya and cantaloupe and this reaction was similar. Pt was given 50mg Benadryl and stated that she was feeling much better about 15 minutes later. Vital signs WNL. Pt d/c home with instructions on when to seek medical care.
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| 53 | 2021-02-28 | numbness |
Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness ...
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Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness of face and neck; Swelling of face and neck; Swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot number EN6201), via an unspecified route of administration in right arm, on 10Feb2021 at 15:45, at single dose, for COVID-19 immunisation. Medical history included blood cholesterol increased. Patient did not have known allergies, did not have COVID-19 prior to vaccination and was not pregnant at time of events or vaccination. There were no concomitant medications. Patient did not receive other different vaccines in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot# EL3244), in arm left, on 20Jan2021 at 15:45, for COVID-19 immunisation. The patient experienced lost 100% of vision in left eye and 50% of vision in right eye on 10Feb2021 at 17:30 with outcome of recovered on 11Feb2021 at 07:30 (after 14 hours), numbness of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours), swelling of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours). Patient did not tested positive for COVID-19 after vaccination. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-02-28 | pain in extremity |
Muscular soreness in upper arm traveling up to shoulder and back of neck. No swelling or rash but i...
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Muscular soreness in upper arm traveling up to shoulder and back of neck. No swelling or rash but it's too the point where I can't lift my arm.
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| 53 | 2021-02-28 | pain in extremity |
Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer ...
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Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), intramuscular on the left arm, on 08Jan2021 16:29, at single dose, for Prevention/COVID-19 immunization, at a public health department. There were no medical history and concomitant medications. The patient did not receive other vaccinations within 4 weeks. On 09Jan2021 at 08:00, the patient experienced left arm soreness. On 27Jan2021 at 07:00, the patient felt dizzy. Shortly after, at 07:15, the nausea started. The patient wanted to know if these could be side effects and would it still be okay to get the scheduled second dose on 29Jan2021. The patient also asked if she can get the second dose if she has a fever on the day she is supposed to get the second dose. The events did not require emergency room or physician's office visits. The patient was recovering from the events. The reporter assessed the events as non-serious.
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| 53 | 2021-02-28 | tingling |
The patient reported tingling in left side of face from left ear to chin area after first dose of va...
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The patient reported tingling in left side of face from left ear to chin area after first dose of vaccine. (The lot number for Dose #1 is not readily available. The Lot # for dose number 2 was provided in this report.) She stated that after he left the gem to get in his car he chose to follow up on the tingling at home. The tingling in the jaw near the ear reduced after several days but remained in the left lower jaw area and has continued until now. The clinical nurse practitioner in the 2nd dose observation area asked patient to remove mask and there was no obvious paralysis in the left jaw area and no signs or symptoms consistent with typical Bell's Palsy presentation. 1st dose was in the left arm, 2nd dose was in the right arm.
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| 53 | 2021-03-01 | bell's palsy, facial paralysis, tingling |
tingling above lip on Sunday, went into left cheek, tightness in eye muscle, lymph node pain, lt-hea...
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tingling above lip on Sunday, went into left cheek, tightness in eye muscle, lymph node pain, lt-headache in occipital bone -2/26 went to hospital, paralyzed in left side of face, bells palsy
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| 53 | 2021-03-01 | muscle spasms |
I began menstruating after no menstruation cycle?s for one year. I also experience headache and cra...
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I began menstruating after no menstruation cycle?s for one year. I also experience headache and cramping.
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| 53 | 2021-03-01 | tingling |
Mild tingling sensation over the arm and redness over left hand right after receiving her second dos...
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Mild tingling sensation over the arm and redness over left hand right after receiving her second dose of Covid 19 vaccine. Adverse reaction occurred during observation. Benadryl 2 tabs (25 mg each) oral administered. Patient observed for 45 mins. Symptoms cleared. Patient left home verbalizing feeling safe and cleared of any symptoms.
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| 53 | 2021-03-02 | grand mal seizure |
Patient experienced tonic clonic seizure within a few minutes of receiving first dose. I was informe...
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Patient experienced tonic clonic seizure within a few minutes of receiving first dose. I was informed at upon arriving at the scene that she had history of seizure but I cannot validate this information. She was evaluated by the emergency department immediately.
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| 53 | 2021-03-03 | pain in extremity, weakness, numbness, muscle spasms, tingling |
Cannot determine if last digit is a U or J. 10 days post injection acute onset of pinched nerve i...
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Cannot determine if last digit is a U or J. 10 days post injection acute onset of pinched nerve in lower neck/ upper back where left arm connects. Numbness/weakness in left arm and pain upon lifting arms above shoulders. Either side but significantly worse on left side. Limited mobility to move neck and head without pain unless medicated. Muscle spasms left of spine in upper back/neck and tingling down left arm. Severe pinched nerve pain that got progressively worse from onset.
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| 53 | 2021-03-03 | tremor, migraine, feeling hot |
March 2, 2021 1. At vaccination site, severe itchiness, dizzy, felt really hot, sweaty. Nurse too...
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March 2, 2021 1. At vaccination site, severe itchiness, dizzy, felt really hot, sweaty. Nurse took blood pressure 120 over 80. Stayed for 1/2 hour (9:10-9:41 a.m.). 2. Drove to work . All symptoms persisted, entire body turned bright red (like sunburn), extreme shaking. Checked in with school MA (nurse) . Blood pressure 140 over 80. Temperature 100. Extreme agitation and heightened senses. 3. sent me to Urgent Care seen at 11:35 a.m.. Same symptoms persisted. Blood pressure 143/94. Temperature 98.8. Was prescribed 2 Benedryl now, 1 every 4-6 hours as long as have itching. 2 at night for next 7 days. Prescribed Prednisone (10 mg) 4 one day, 4 next day - decrease dosage for 8 days. 4. Took prednisone- heightened senses, agitation increased. Migraine. Outer body exhausted, inner pure adreneline that would not decrease. March 3, 2021 1. Most symptoms lessened. Went to work . Checked in with MA (nurse) and told her that I wanted to stop the prednisone. She recommended that I take the dose. Took 4 tablets (10 mg) at 9:40 a.m. Heightened senses (light, sound, touch, taste), agitation, shakiness. brought me to in . Doctor told me to stop the prednisone as I have a history of anxiety. Exhaustion, heightened senses, agitation remained the rest of the day. March 4, 2021 1. Lessened symptoms. Four 20-minute recurrence episodes between the hours of 9 a.m. and 5 p.m.
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| 53 | 2021-03-04 | burning sensation, pain in extremity |
Within a few minutes of getting the injection my face began tingling. A few minutes after that the ...
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Within a few minutes of getting the injection my face began tingling. A few minutes after that the tingling turned into a burning feeling. My cheeks were slightly flushed but felt like I had a bad sunburn. At the same time my throat felt thick. I could talk and breathe but it definitely felt like it had swelled inside my throat. I also felt shaky. My hands were not shaky but I felt shaky on the inside. I didn't report this to the people working the vaccine clinic (but in retrospect I should have) The thick throat feeling resolved within one hour and the face burning feeling was gone by the next morning. Then I just had the typical sore arm, a few body aches and nothing else. Note: never a vaccine reaction but I had an anaphylactic reaction requiring treatment when receiving a 2nd dose of chemotherapy
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| 53 | 2021-03-06 | pain in extremity |
Woke in middle of night with pain down left arm clear down to my fingers. Could not lay on left side...
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Woke in middle of night with pain down left arm clear down to my fingers. Could not lay on left side due pain. All day on the day after vaccination had nausea, fatigue, tiredness and aches. No fever. Symptoms went away on the following day-02/22/2021
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| 53 | 2021-03-06 | tingling, numbness |
Within 10 minutes my face and head was tingling and went numb. Eyes felt swollen/numb. This lasted ...
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Within 10 minutes my face and head was tingling and went numb. Eyes felt swollen/numb. This lasted for 4 hours. Both hands also were numb even longer. EMT's on site checked my vital signs. My blood pressure and oxygen were OK so they said I could drive home when I felt ready.
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| 53 | 2021-03-06 | seizure |
Patient had seizure 5 min after receiving shot. Lasted 2-3 minutes, given versed IM and started to ...
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Patient had seizure 5 min after receiving shot. Lasted 2-3 minutes, given versed IM and started to improve. Monitored through post ictal phase - blood glucose was 186, BP 176/90. Was able to walk after about 20 minutes but taken by ambulance to hospital for further monitoring.
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| 53 | 2021-03-07 | tingling, hot flush |
I took one Aleve for my arm Pain near the injection site. Then I got a Rash and itch that traveled d...
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I took one Aleve for my arm Pain near the injection site. Then I got a Rash and itch that traveled down my left side, my throat started to feel funny so I took a Benedryl. Then my cheeks felt like they were hot and tingly.
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| 53 | 2021-03-08 | feeling hot, burning sensation, tremor |
FEW MINUTES AFTER VACCINE PATIENT STATED SHE FELT HOT , THAT THE ARMS HAS A BURNING SENSATION, SHE W...
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FEW MINUTES AFTER VACCINE PATIENT STATED SHE FELT HOT , THAT THE ARMS HAS A BURNING SENSATION, SHE WAS ALSO COLD AND SHAKING. BLOOD PRESSURE HIGH ( 911 WAS CALLED PT REFUSED TO GO TO THE HOSPITAL). WE KEPT HER IN OBSERVATION WITH EMS ONSITE, AFTER MORE THAN ONE HOUR SHE COMPLAINED OF CHEST PAIN, TRANSFERRED TO ER VIA AMBULANCE.
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| 53 | 2021-03-08 | tingling, numbness, flushing |
Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protoc...
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Vaccine was admin. at 1310 via LPN. Pt. then waited until 1325 in the clinic waiting room per Protocol for observation of serious adverse reaction to vaccine. At 1325, pt. reported feeling well and left the clinic. After returning to her private vehicle from vaccine clinic, pt. states that she noticed her face was flushed and her tongue "felt funny." At 1337, the pt. returned to the front entrance of hospital reporting that she thought she may be having a reaction to the vaccine. Pt. was immediately taken to the ED for evaluation. According to the patient, she was given 50 mg IV Benadryl and observed for a short time. Her symptoms of tongue swelling, itchiness with no hives, mild numbness/tingling in extremities bilat., tingling at top of head all resolved. Pt. was then discharged to home with a prescription for Prednisone and instructed to return to ED with any new/worsening symptoms. Pt. also instructed to f/u with PCP regarding advice for admin. regarding second dose of Covid-19 vaccine.
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| 53 | 2021-03-09 | pain in extremity | Soreness in arm, headache, fogginess |
| 53 | 2021-03-09 | pain in extremity |
Starting shortly after the injection she had severe left arm pain. Symptoms have varied over the las...
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Starting shortly after the injection she had severe left arm pain. Symptoms have varied over the last 2 months, but she has noticed decreased ROM in the shoulder, pain sleeping on the left side at night, a lump at the site of the injection and ongoing pain. She has taken Aleve and ibuprofen intermittently with some relief.
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| 53 | 2021-03-10 | facial paralysis, bell's palsy |
Patient reports that about 3-4 days after receiving the first dose, she started experiencing difficu...
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Patient reports that about 3-4 days after receiving the first dose, she started experiencing difficulty in chewing and drooling out of the left side of her face. She then noticed a mild facial droop. On March 7th, 2021 she was evaluated in the Emergency room and diagnosed with Bells' Palsy. Shewas discharged home the same day and was prescribed Valtrex and Prednisone. On March 9th, 2021 she consulted with a neurologist. She came in for consultation with us (infectious disease) on March 10th, 2021.
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| 53 | 2021-03-10 | flushing | feels flushed, lips tingling, reports feeling throat closing. Evaluated by EMS-Cleared |
| 53 | 2021-03-10 | pain in extremity, weakness |
This was my second vaccine. The day after the shot I had the typical headache, sore arm, low energy....
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This was my second vaccine. The day after the shot I had the typical headache, sore arm, low energy. Then at this time mentioned I woke up with my head spinning and it made me nauseous. It is now 4 days later and I am still dizzy if my head isn't pushed against a pillow or it standing. I went to doctor, he called it vertigo, I went to physical therapist to see if he could fix it, he said my crystals were not out of place to be fixed.
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| 53 | 2021-03-10 | pain in extremity |
pain and swelling in underarm area of same arm where received vaccination. This started approximatel...
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pain and swelling in underarm area of same arm where received vaccination. This started approximately 36 hours after vaccination. Has continued for more than 24 hours. Still swollen and sore at this time. Injection site is also still sore, but not severe, and no swelling or redness at the injection site.
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| 53 | 2021-03-10 | tingling | SOB, sensation of throat closing, tingling in the arms, evaluated by EMS, transported to nearest ER |
| 53 | 2021-03-11 | weakness, feeling cold | Pain at the injection site?pain and weakness all over?feel the cold |
| 53 | 2021-03-11 | flushing |
Flushed face, neck and itchy face(8 hours) started 30min. after vaccination Fever(48hours) starting ...
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Flushed face, neck and itchy face(8 hours) started 30min. after vaccination Fever(48hours) starting 03/07/2021 Body aches(48 hours) Chills(48 hours) starting 03/07/2021 Severe Headache(36 hours) started 30 min. after vaccination.
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| 53 | 2021-03-11 | numbness |
Approximately 5 minutes post vaccination patient had numbness from shoulder to hand. Numbness impro...
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Approximately 5 minutes post vaccination patient had numbness from shoulder to hand. Numbness improved approximately 15 minutes post vaccination.
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| 53 | 2021-03-11 | seizure | Itching all over, while being evaluated by EMS, patient began seizing-transported to nearest ER. |
| 53 | 2021-03-12 | pain in extremity |
Mouth sores - three of them on tip of tongue I took a pic if you want it. They don?t hurt much just ...
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Mouth sores - three of them on tip of tongue I took a pic if you want it. They don?t hurt much just wanted to let you know because I did not see this listed. Still there as of today 3-13-2021. Also sore arm and some tiredness
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| 53 | 2021-03-12 | tingling, numbness and pain in extremities |
I HAVE HEADACHES AND NAUSEA THAT WAX AND WANE SINCE I RECEIVED MY SECOND SHOT ON JAN 31ST. THE HEADA...
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I HAVE HEADACHES AND NAUSEA THAT WAX AND WANE SINCE I RECEIVED MY SECOND SHOT ON JAN 31ST. THE HEADACHES ARE PRESSURE HEADACHES THAT ARE MOSTLY ON THE TOP OF MY HEAD BUT CAN MOVE AROUND MY HEAD AND FACE. THEY RANGE IN SEVERITY FROM SEVERE AND INTERFERE WITH MY ABILITY TO THINK TO MILD AND ABLE TO FUNCTION BUT THEY ARE ALWAYS PRESENT. I WAKE UP WITH THE HEADACHES AND NAUSEA. MY NEUROPAHTY ON MY LEFT ARM,WHICH RECEIVED THE SHOT, HAS GOTTEN WORSE WITH INCREASED TINGLING AND A FEELING LIKE A BAND IS SQUEEZING AROUND THE TOP PART OF MY ARM.
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| 53 | 2021-03-12 | tenderness |
Woke up the morning at 7:30 after the 2nd vaccine yester at 1:30 and had a deep bruise on left eye ...
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Woke up the morning at 7:30 after the 2nd vaccine yester at 1:30 and had a deep bruise on left eye lid only. No puffiness, slightly sore to the touch, eye is a bit watery, vision is currently unaffected.
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| 53 | 2021-03-13 | feeling cold |
I woke up at one with a stomachache and slight headache. My 7, i experienced aches in joints and bo...
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I woke up at one with a stomachache and slight headache. My 7, i experienced aches in joints and body. I did experience chilling off and on and no appetite. The next day, I experienced diarrhea and stomach ache. No appetite. On Saturday, I was feeling better. By mid morning, my stomach was hurting, and I was cold. Still not much of an appetite. On Sunday,I woke up feeling good. By 3, I was experiencing extreme exhaustion, chilling, and difficulty breathing.
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| 53 | 2021-03-13 | feeling hot |
Severe chills from 10am-3pm on 3/13/21 along with fatigue. At 4pm I got extremely hot and started w...
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Severe chills from 10am-3pm on 3/13/21 along with fatigue. At 4pm I got extremely hot and started with back and chest pain along with not being able to get a good breath in.
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| 53 | 2021-03-13 | hot flush |
It was painful the injection at all point but I didn?t complaint as I was able to support the paint ...
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It was painful the injection at all point but I didn?t complaint as I was able to support the paint in my 15 min wait my pain in the arm was what I consider strong but still able to support, 25 min after the injection I started hot flash and redness in face and neck, The reaction was only 5% of the reaction I experimented with Chemo so I knew I was ok and I did not have to run to the medical center again. In the hour after the injection the paint in the arm intensified and it was from the base of the neck to the lower back, during the weekend I lost some moved of my arm and I took Tylenol every 8 hours as per the post vaccine indicator, and slept a lot as I was too tired and having a little of running nose, by the Monday (72 hrs) w Most of the hot flashes and running nose stopped and the pain was under my pain threshold and I managed to reduce Tylenol only to one before bed time, however last night pain intensity and arm movement reduce again. i will be calling my primary doctor on Monday to review
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| 53 | 2021-03-14 | migraine |
Started with migraine, fever, chills after three hours of injection, night two same, night three sam...
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Started with migraine, fever, chills after three hours of injection, night two same, night three same, four night histamine levels were high and developed hives on back and chest area, fever, five night same, sixth night shortness of breath, fever, seventh night shortness breath, fever. Night eight same, tenth day went to urgent care x-ray lung had fluid and pneumonia . 12 day blood pressure was 80/50 and admitted in ER.
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| 53 | 2021-03-14 | muscle spasms, pain in extremity |
Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like s...
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Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like something in my throat and it's still there, my arm was hurting, that night I was able to sleep, Friday it started getting more sore, Saturday I noticed I could not sit because my butt cheeks were hurting, then I started feeling leg and hand cramps on my left side, Then Sunday my arm, leg, back, spinal cord everything was hurting and I was extremely thirsty and I couldn't lay down, sit or even walk. I have not been feeling good at all. Also, I have lupus
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| 53 | 2021-03-14 | pain in extremity |
Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment ...
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Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment required. Headache within 2 hours. Very distracting although not severe. Prevented sleeping. Took 1x advil 200mg. Resolved. Foggy head within 4 hours. Trouble focusing eyes and thoughts while having a conversation with neighbor. Resolved at 48 hours. Tiredness within 6 hours. Resolved at 54 hours. Chills but no fever starting at ~27 hours from shot and lasting 4 hours. Resolved.
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| 53 | 2021-03-14 | pain in extremity |
PT CALLED ON WEDNESDAY MARCH 10TH WITH A LOT OF SORENESS IN HER ARM AND THE PHARMACIST TOLD HER TO T...
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PT CALLED ON WEDNESDAY MARCH 10TH WITH A LOT OF SORENESS IN HER ARM AND THE PHARMACIST TOLD HER TO TAKE TYLENOL OR IBUPROFEN TO HELP WITH THE PAIN. SHE CAME TO THE PHARMACY TODAY MARCH 15TH WITH THE SAME COMPLAINT AND SAID IT HAS GOTTEN WORSE. I TOLD HER TO GO TO URGENT CARE IF IT REMAINS THESAME OR GETS WORSE.
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| 53 | 2021-03-14 | pain in extremity |
I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:...
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I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:00 that morning itching all over. At 6:30 am I was covered in painful rash from behind my knees to my shoulders. It itches and hurts. I went to immediate care at which time they gave me a steroid shot, antihistamine tablets and a cream. Today it got so painful I went back to immediate care and was given a shot of epinephrine and given an epipen. The rash is raised and deep red. Very itchy and painful. It is now on my hands as well and they are stiff and swollen. Both doctors that I seen suggested going to regular physician before taking second dose of vaccine
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| 53 | 2021-03-15 | weakness |
Severe nausea after first shot 3 days after 1st Vaccination ~ dizziness, weakness, exhaustion, heada...
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Severe nausea after first shot 3 days after 1st Vaccination ~ dizziness, weakness, exhaustion, headaches, using albuterol inhaler in the morning for shortness of breath, bad taste in the mouth and stomach described as the taste of burnt rubber and smell and taste of ignited /lit matches, excessive thirst and dry mouth that has prevented me doing normal activities ~ general malaise and feeling unwell
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| 53 | 2021-03-15 | burning sensation |
Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in ...
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Burning in the arm of injection. Slight red rash, itchy. Tingly lips, fever, headache. Went away in two days
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| 53 | 2021-03-15 | electric shock sensation, slurring |
2 hours after vaccine -fever, chills muscle aches adn stiffness. treated with ibuprofen and cold p...
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2 hours after vaccine -fever, chills muscle aches adn stiffness. treated with ibuprofen and cold pack. Next day - difficulty swallowing, chewing and speaking, alot of mucus in throat, difficulty breathing . Was lethargic, dehydrated. Used inhalers , benedryl, musinex, Still have chills and fever, and headaches. and aches. Difficulty eating and drinking. Was gagging and dry heaves. Called neurologist and family doctor and suggested go to ER. (did not go because of fear of getting covid) Too fatigued and week to walk. No Balance. Had electrical shocks up and down body. Immobile. Still experiencing immobility a week later
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| 53 | 2021-03-15 | nerve pain, weakness, pain in extremity |
3/9/21: 1:05pm: Nerve-like pain immediately neck to fingertip. 5pm--extreme arm soreness for 3 days;...
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3/9/21: 1:05pm: Nerve-like pain immediately neck to fingertip. 5pm--extreme arm soreness for 3 days; less extreme soreness still present at 7 days. 3/10/21: 2am: fever, chills, body aches, headache, fatigue, weakness for 48 hours. 3/13/21: golf ball sized redness at site of shot, intermittent itchiness/soreness
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| 53 | 2021-03-15 | night sweats |
Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous...
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Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231), via an unspecified route of administration (left deltoid) on 09Jan2021 at single dose, for COVID-19 immunization. Medical history included celiacs, hypertension (HTN), thyroid disease, gastrooesophageal reflux disease (GERD), migraines, allergies: celiacs (gluten), and allergies: culturelle. Concomitant medications included levothyroxine and prednisone which was stopped 4 days prior. The patient previously took dilaudid and experienced allergies and received first dose of bnt162b2 for COVID-19 immunization on 18Dec2020, 13:15, left arm (lot ELO140). On 11Jan2021, the patient experienced severe night sweats, body aches and low grade temps continuing growth off and in since second vaccine. Patient reported to have missed work. This has been going on for 3.5 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. Outcome of events was not recovered.
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| 53 | 2021-03-15 | tingling, numbness |
Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye w...
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Within 30 minutes of vaccine entire left side had numbness and tingling from left toes to left eye with radiating pain in head and swelling of neck and throat. Numbness subsided within 24 hours followed by pain and sensitivities on entire left side for the next 24 hours. Swelling in throat continued for the next 24 hours following vaccine peaking the next day 36 hours after vaccine. Significant trouble swallowing liquids including salvia. Choking on solid foods the day following vaccine. Lips tingling continued for 48 hours after vaccine and subsided at end second day 3/12. Throat and esophagus swelling continues to this day - 6 days after vaccine with only slight improvement in swelling. Swallowing is still difficult as of 6 days following 1st vaccine. Spoke with EMT at vaccine site who recommended Benadryl. Benadryl started within 1.5 hours of vaccine administration. Contacted allergist who recommended 2-3 x dose of antihistamines for swelling. A dose of 3x was done for 4 days and decreased to 2x dose of antihistamines on Monday and continue at that level at time of report today.
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| 53 | 2021-03-16 | one side paralysis |
12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collaps...
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12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collapsed under her. She hit her head at that point. Her leg remained unable to bear weight and Monday morning we went to the emergency room where they diagnosed her with a stroke. Her right leg is paralyzed and her right side weak.
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| 53 | 2021-03-16 | pain in extremity |
As soon as I got to my car in the parking garage my left knee started hurting, like aching. Went to...
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As soon as I got to my car in the parking garage my left knee started hurting, like aching. Went to the store when I got home my left ankle and the top of my left foot started to hurt. Fell asleep took a nap and woke up and my whole body hurt left arm was really hurting. Woke up Sunday morning and whole body hurt X10! Back, knees, hands, wrists, fingers, shoulders, shoulder blades, neck, left arm. Woke up Monday and could hardly move right arm and this is Wednesday and it still hurts, hands and wrists still ache, not as bad but still do. It seems like it really got to my joints, which I already have issues with but since the shot the issues have increased X10.
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| 53 | 2021-03-16 | pain in extremity | Arm pain within 2 hours, extreme fatigue, malaise, vivid dreams, headache lasting 10 hours |
| 53 | 2021-03-17 | discomfort |
Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chil...
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Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chills; funny taste; dizziness; itchy feelings; tired; discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202, expiry date not reported), via an unspecified route of administration administered in arm right on 26Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and known allergies: arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hallucinating, lot of pain all over her body, chills, funny taste, discomfort, dizziness and feel like her body is having a allergic reaction and itchy feelings and tired on 27Feb2021 01:00. The patient did not recover from the events.
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| 53 | 2021-03-17 | numbness and pain in extremities, pain in extremity |
neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM...
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neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM PAIN AND JOINTS/PAIN PROGRESSING TO CONSTANT SEVERE PAIN AND HAS MOVED INTO UPPER ARMS WITH PAIN WORSENING DAILY; BILATERAL LOWER ARM PAIN AND JOINTS; SWOLLEN LYMPH NODES IN ELBOWS; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284, expiration date: not reported) intramuscular in the arm left on 01Feb2021 08:00 at single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and lamotrigine (LAMICTAL). The patient previously took codeine and experienced allergic reaction to drug; naproxen and sulfur and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the hospital. On 02Feb2021 06:00, the patient experienced neuropathy in left foot, headaches/intermittent headaches, nausea, muscle aches, bilateral lower arm pain and joints, swollen lymph nodes in elbows, pain progressing to constant severe pain and has moved into upper arms with pain worsening daily. No treatment received for the adverse event. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event neuropathy peripheral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-03-18 | weakness |
received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minute...
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received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minutes. Symptoms increased and continued through out the night, childs and sweats , overall feeling of weakness. Mentally slow processing, feeling foggy. Symptoms Cleared on Monday evening around 9pm. New symptoms on March 19th swollen glands roof of my mouth, neck, underarms. Painful, brain fog, exhaustion, chills and sweats, stuffy nose, headache.
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| 53 | 2021-03-18 | pain in extremity |
On the night of the 15th when i received the vaccine my arm was sore and i was very tired. I woke up...
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On the night of the 15th when i received the vaccine my arm was sore and i was very tired. I woke up next day after a great sleep and arm was just a little sore but I was totally exhausted and napped through the day and went to sleep that night. Wednesday the 17th of march I woke up at 4:30 in morning with a screaming headache and my neck and shoulder muscles were extremely tight. I felt like my head was going to explode! I am not used to headaches but this one hurt pretty bad. I took Tylenol and used ice packs on head and neck and back shoulders. I used Electronic Muscle Stimulator Pads for 12 minutes on middle shoulder back area. That evening I was feeling a little better with small headache but when i was rubbing
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| 53 | 2021-03-19 | muscle twitching | Continual involuntary twitching of chin area & one leg; never twitched like this before |
| 53 | 2021-03-21 | weakness |
Patient was at the vaccine site. Patient was in waiting area after receiving vaccine, and reported t...
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Patient was at the vaccine site. Patient was in waiting area after receiving vaccine, and reported to me, she felt a little weak because she had not eaten yet that day. Patient then reported she felt like she was going to pass out and grabbed on to my legs. I held her with my hand on her back, and I waved and shouted for help. The Paramedics on site came to assess patient, and took over caring for the patient. The patient never lost consciousness, she was fed a granola bar, and was able to leave on her own.
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| 53 | 2021-03-21 | weakness | Lightheaded, dizzy, weak, headache -10:00am Left work by noon. Feeling same |
| 53 | 2021-03-21 | bell's palsy |
Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms ...
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Transient face swelling, right eye dryness, cluster headaches since 03/05/21. Bells palsy symptoms right side of face since 03/07/21. Swelling is transient symptom. Cluster headaches are transient symptoms. Bells palsy symptoms have not resolved. Treatment from PCP is steroid prescription started 03/20/21.
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| 53 | 2021-03-21 | feeling hot |
The patient had her covid 19 vaccine. Shortly after that she got hot in the face, fuzzy headed, and ...
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The patient had her covid 19 vaccine. Shortly after that she got hot in the face, fuzzy headed, and nauseated. Her pulse ox was 99 percent. Pulse 73. BP 134/93. Once we laid her down and got her some juice and crackers, her symptoms quickly resolved. Her current meds are lisinopril 20mg, synthroid, and isosorbide.
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| 53 | 2021-03-21 | numbness |
Vaccinated 1 min. c/o dizziness, hn R side @1340 BP 145/80, P 80, O2 100%, BS 107. 1403 hn now backh...
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Vaccinated 1 min. c/o dizziness, hn R side @1340 BP 145/80, P 80, O2 100%, BS 107. 1403 hn now backhead. 1405 BP 145/74, BS 107. denies need for transport. Advised to call 911 if conditions change.
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| 53 | 2021-03-21 | migraine |
Migrain on day 1 &2 after vaccine; Lightheaded and slight dizziness on day 1; Drowsiness on Day 1 af...
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Migrain on day 1 &2 after vaccine; Lightheaded and slight dizziness on day 1; Drowsiness on Day 1 after; This is a spontaneous report from contactable Other Health Professional, the patient. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 16Feb2021 at 12:45 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as "none." The patient has no allergies. Historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on 28Jan2021 at 09:00 in the right arm. The vaccine was administered to the patient at a workplace clinic. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as "none." The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she experienced a migraine beginning at 3:30 AM on 17Feb2021 (reported as "on Day 1 and 2 after vaccine") Additionally, she experienced being lightheaded and having slight dizziness and drowsiness beginning at 3:30 AM on 17Feb2021 (reported as "on Day 1"). The patient did not receive any treatment for the events. The clinical outcomes of the events migraine, dizziness and drowsiness were reported as recovered (date not specified). It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 53 | 2021-03-21 | muscle spasms |
Follow up on report 370952: 03/21 arm pain & swelling at injection site - swelling increased, pain t...
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Follow up on report 370952: 03/21 arm pain & swelling at injection site - swelling increased, pain the same, now itchy. 03/21 as with the first shot (Report: 315416), today I developed increased heart rate (I have SVT but controlled with meds), upper abdominal pain, cramping, diarrhea, bloating, inability to eat/drink without stomach pain. It took me 3 weeks to get back to almost normal but to me it appears both shots causes gastrointestinal issues or aggravates existing issues like IBS (which I have). 03/22: At the time of this submission, the heart rate is back to normal, the arm pain & swelling is not as bad but still there. The itching has gone away. The gastrointestinal issues are ongoing.
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| 53 | 2021-03-22 | flushing, feeling hot |
I stayed at the facility for about ten minutes and didn?t have an issue. They wanted me to stay long...
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I stayed at the facility for about ten minutes and didn?t have an issue. They wanted me to stay longer but a homeless person was coughing on me maliciously. I had an epipen and a cellphone with me and walked 3 or so blocks home. On the way home, I noticed my forearm was red and felt hot, though not the side that got the shot and I had a single hive. I thought maybe I had scratched myself. I came home, and my face was very flushed and my skin started burning and itching, mostly my scalp and face, but also my body. I had already taken Pepcid and Xyrtec for allergies I had in the early morning. I added Singulair and Benadryl. I would have called 911 if my breathing had been impaired but I was not asthmatic. The symptoms resolved by later that day after a few hours but I do not believe I will be getting another shot as allergies are often worse on second exposure. It was scary though considering I was already in strong allergy meds. I had some asthma later that night and the following day but not bad. Was very fatigued and dizzy all day.
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| 53 | 2021-03-22 | flushing |
1600: Patient c/o feeling increased heart reae, resting HR 57 usually, Now currently 92 and 110 bpm,...
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1600: Patient c/o feeling increased heart reae, resting HR 57 usually, Now currently 92 and 110 bpm, flushing. PMHx: SVT, Asthma Meds: Flonase, Flovent, HRT, Levothyroxine Allergies: Sulfa Patient A & O x 4, skin pink, warm and dry, able to tolerate water well. B/P: 192/118, 173/108, 158/100 Provider on duty cleared patient to leave and instructed patient to follow up with PCP for b/p monitoring. Patient communicated understanding and was discharged home.
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| 53 | 2021-03-22 | pain in extremity |
Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to h...
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Left leg started hurting, and swoll up from my knee to my foot, and the next day was told to go to hospital. They found a blood clot in my leg .
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| 53 | 2021-03-22 | pain in extremity |
Extreme fatigue first 3 days that I couldn't get off bed for long; with body aches, arms pain where ...
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Extreme fatigue first 3 days that I couldn't get off bed for long; with body aches, arms pain where the shot was given, head aches, sore throat, chills, but had no fever. Arm pain went away after 3 days, body ache wasn't as bad after one week but still had it. But head ache and sore throat every day in the evening. off and on chills continues. and fatigues hits from normal chores. Just walking in grocery stores floors me, or just cooking something.
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| 53 | 2021-03-22 | tingling |
FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREAT...
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FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREATHE. OVER THE NEXT 48 HOURS MY OTHER AREAS WHERE I HAD BEEN BITTEN BY FIRE ANTS AND A HORNET STING BEGAN TO SWELL AGAIN AND MORE BENADRYL AND PEPCID
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| 53 | 2021-03-22 | speech disorder |
After receiving the COVID immunization client complained of tightness in chest. She had a hard time...
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After receiving the COVID immunization client complained of tightness in chest. She had a hard time swallowing and speaking. RN asked if she could swallow Zyrtec and client shook head no. RN asked if she was OK having epinephrine injection and client shook head yes. Three minutes after epinephrine 0.3 injection in left thigh client was able to answer questions appropriately and stated she could breathe better. Vital signs were taken at beginning of client complaints and continued throughout event. EMS called and client was transported to hospital.
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| 53 | 2021-03-23 | feeling cold, cold sweat |
Symptoms: cold&clammy, lethargic. 2:24pm-per client's son, Paramedics assessed client on site, vital...
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Symptoms: cold&clammy, lethargic. 2:24pm-per client's son, Paramedics assessed client on site, vital signs: BP 51/40, pulse 56,O2sat 98, blood glucose 107. 2:27pm Pt. transport from passenger side of personal vehicle to ambulance via stretcher. 2:35pm per Paramedics "client was placed in Trendelendurg position and 500 cc of normal saline given." 2:45pm Final BP 137/87, pulse 68. 2:47pm Client refused to be transported to hospital. Fire Rescue arrived on scene to transport to hospital. Per client, "No". 3:00pm Per Paramedics client stable no further. Evaluation needed client signed a released form. 3:05pm Client released for home at 3:05pm accompanied by son.
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| 53 | 2021-03-23 | numbness, tingling | facial and tongue numbness with tingling |
| 53 | 2021-03-23 | pain in extremity |
Rheumatoid arthritis mostly on left hand Ankle pain on left foot felt like I sprained my ankle. Cou...
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Rheumatoid arthritis mostly on left hand Ankle pain on left foot felt like I sprained my ankle. Couldn?t put full weight. Lasted til 2nd vaccine then I got it again even worse on both hands. Could not manipulate a spatula very well, close my hands or grip an object after 2nd vaccine. Left pinky still hurts.
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| 53 | 2021-03-23 | tingling | Error: Shoulder Joint Injury (prolonged pain, tingling, etc.) |
| 53 | 2021-03-24 | feeling hot |
Dizzy, anxiety, R.S., feels lightheaded, Hot, Rested, gave water, calmed pt down, pt is nervous, no...
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Dizzy, anxiety, R.S., feels lightheaded, Hot, Rested, gave water, calmed pt down, pt is nervous, normal behavior for pt per the pt. Nervous for the last 3 days
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| 53 | 2021-03-24 | pain in extremity |
?Pfizer-BioNTech COVID-19 Vaccine ? Tremendous pain #7 left wrist and hand. Couldn't make a fist an...
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?Pfizer-BioNTech COVID-19 Vaccine ? Tremendous pain #7 left wrist and hand. Couldn't make a fist and couldn't grip anything. This pain lasted 2 days. I took advil and iced which didn't ease the pain. I'm on day 3 and still have slight pain when I use my left hand?
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| 53 | 2021-03-24 | tingling, flushing |
1. Within the hour started feeling lightheaded and on and off feeling like I was going to faint but ...
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1. Within the hour started feeling lightheaded and on and off feeling like I was going to faint but didn?t 2. Also feel flushed across my cheeks face that sort of feels hot/prickly -you can visibly see it red across my cheeks 3. Headache Today is day 4 and my lightheaded feeling is worse and I am feeling nauseous and headache is worse.
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| 53 | 2021-03-24 | tingling | warm and tingly resolved within minutes after symptoms started |
| 53 | 2021-03-24 | tremor, flushing |
Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 ...
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Post COVID Vaccine injection 1639 numbness left lips, tingling in throat and feels tight BP 148/86 - HR 75 1643 Epi 0.3 via pen Right thigh Feeling shaking Medical emergency called 1645 Benadryl IM right arm. Feeling flushed ED clinical staff here and transferred in own electric wh/chair. Husband with patient Allergy to CT Contrast - completely swollen shut
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| 53 | 2021-03-25 | discomfort |
Pfizer-BioNTech COVID-19 Vaccine EUA was administered at 1 pm. Within 10 minutes or less, my vision ...
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Pfizer-BioNTech COVID-19 Vaccine EUA was administered at 1 pm. Within 10 minutes or less, my vision blurred and the store darkened and felt like it was closing in. I felt dizzy and nausea. I sat down away from people and let someone know. I got a pink in my eyes and some parts of my body. I waited about 45 minutes and my vision cleared and the dizziness faded considerably. The nausea remained and some pinkness remained. Slight headache off and on for two days. Had minor discomfort for two days.
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| 53 | 2021-03-25 | feeling hot |
Right after I got it, my heart started to beat really fast and I got hot. I called my doctor and he ...
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Right after I got it, my heart started to beat really fast and I got hot. I called my doctor and he told me to make sure that I'm limiting caffeine. I noticed that it's still happening off and on, so he's ordering a Holter Monitor. Currently waiting for approval to have it done.
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| 53 | 2021-03-25 | feeling hot |
Patient states her feet started swelling instantly and she felt nauseated and also felt warm. When ...
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Patient states her feet started swelling instantly and she felt nauseated and also felt warm. When her vitals were taken everything was normal. She asked to be transported to have further observation.
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| 53 | 2021-03-25 | flushing, burning sensation |
Extreme flushing and fatigue, nausea, cough, headache, brain fog, burning sensation in both lungs. T...
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Extreme flushing and fatigue, nausea, cough, headache, brain fog, burning sensation in both lungs. The fatigue and nausea still present one week after vaccination.
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| 53 | 2021-03-25 | flushing |
Patient states she felt flushed, slightly lightheaded and felt short of breathe. Patient taken to am...
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Patient states she felt flushed, slightly lightheaded and felt short of breathe. Patient taken to ambulance. no resp. distress noted. no wheezing noted. vital 164/84, 84, 16,100 % RA blood sugar 121 Patient refused transport.
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| 53 | 2021-03-25 | numbness | 2 fingers (middle and pointer) on left hand keep going numb. |
| 53 | 2021-03-25 | migraine, pain in extremity |
Patient experiences chills, fatigue, nausea, migraine, and sore arm. This started the evening of vac...
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Patient experiences chills, fatigue, nausea, migraine, and sore arm. This started the evening of vaccination and continued for approximately three days. Symptoms got worse until about day 2-3 when they began to subside more rapidly.
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| 53 | 2021-03-25 | pain in extremity |
Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in...
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Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in my left side of my arm, Shoulder; Dizziness; Very tired; Sleepy; Anxiety; Not knowing where she was; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on 22Jan2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included anemia, gastritis, and peptic ulcer. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received penicillin from an unknown date for an unknown indication and experienced allergy. On 23Jan2021 at 21:00 the patient experienced severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month. The patient went to a doctor or other healthcare professional office/clinic visit as a result of the events. The patient did not receive any treatment for the events. The outcomes of severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month were recovered with lasting effects. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 53 | 2021-03-26 | weakness |
03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face ...
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03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face especially around my eyes and slight swelling of my eyes, weakness.
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| 53 | 2021-03-26 | discomfort |
Pain, swelling, lump in left armpit lymph node. Muscle pain and discomfort in body. Pain in left ar...
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Pain, swelling, lump in left armpit lymph node. Muscle pain and discomfort in body. Pain in left arm at vaccine location.
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| 53 | 2021-03-26 | flushing, feeling cold |
Client waited for 15 minutes after vaccine, said she felt "off," but proceeded to her car. Once in h...
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Client waited for 15 minutes after vaccine, said she felt "off," but proceeded to her car. Once in her car she noticed she was red, flushed, had one hive on her chest. AT 2:20 She proceeded back into the building and was taken to the emergency area for observation. 2:30 pm, she had bilateral redness in cheeks, BP 138/85, 97% O2, 74 HR., red spot on chest. 2:47pm 97% O2, BP 178/98. 2:55 BP 182/102, Dr called for consultation. Dr. gave verbal order to proceed with IM Benadryl, and monitor for another 15 minutes to see if epi pen was indicated. 3:01, Benadryl given IM in left deltoid. Lot# 080012, expiration: 08/2022. 3:03 O2 97%, HR 80. 3:04, patient became panicked that she could not swallow, Nurse administered Epinephrine autoinjector into left thigh. Lot # 0FM534, Expiration: 9/2022. EMS called 3:06pm. Vital signs stable, client reported feeling cold and had chills. Client reported ease in swallowing almost immediately. Client taken to hospital around 3:15.
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| 53 | 2021-03-26 | migraine |
Chills, fever, extreme muscular pain all over enter body, extreme fatigue, migraine, stabbing pain i...
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Chills, fever, extreme muscular pain all over enter body, extreme fatigue, migraine, stabbing pain in inner ears. Most severe symptoms persisted for 2 days and began to subside on day 3. Fatigue remained for an additional 2 days for a total of 5 days.
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| 53 | 2021-03-26 | muscle spasms |
After 12 hours, lost consciousness for approx 2 min, body had spasms. Had no weakness prior to the e...
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After 12 hours, lost consciousness for approx 2 min, body had spasms. Had no weakness prior to the episode, arm wasn?t sore either.
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| 53 | 2021-03-26 | pain in extremity | Sore arms, extreme fatigue, hunger, dry mouth/thirst. Symptoms persisted for about 2 to 3 days. |
| 53 | 2021-03-26 | tingling, numbness |
Facility asked to stay for 15 minutes to track for any adverse events. Left the hospital after 20 m...
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Facility asked to stay for 15 minutes to track for any adverse events. Left the hospital after 20 min. While driving home approximately 25 after the shot, left hand tingling, left arm numb. Approximately 10 hours pain between shoulder and elbow like someone punched me hard, also nasal congested. The next day I have symptoms like a cold: Nasal congested, voice sounds like I have laryngitis, nasal phlegm is yellow, coughing yellow phlegm, sneezing. Feeling of exhaustion
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| 53 | 2021-03-26 | tenderness |
Swollen and painful lymph node on left collarbone, plus tender-to-the-touch nodes in left armpit. I...
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Swollen and painful lymph node on left collarbone, plus tender-to-the-touch nodes in left armpit. I consider this minor compared to contracting COVID-19
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| 53 | 2021-03-27 | seizure |
Systemic: Seizure-Severe, Additional Details: around 5:30pm patient was sitting after her covid vacc...
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Systemic: Seizure-Severe, Additional Details: around 5:30pm patient was sitting after her covid vaccine. patient fell face first to the ground and begin to have a seizure. 911 was called and patient was taken to the hospital. Before leaving patient's vitals were back to normal, but was taken to the hospital for obseravation. RPh, and ARNP were performing immunizations at the time.
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| 53 | 2021-03-28 | pain in extremity |
I received the 2nd dose on March 24th around 1:30. The 25th I became extremely tired and extremely c...
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I received the 2nd dose on March 24th around 1:30. The 25th I became extremely tired and extremely cold. That lasted throughout the night and into the next day where I could not work. I then felt fine, but on Friday evening my right arm throbbed and ached and nothing I took would relieve the achiness and pain. I then developed a raised rash that started around my injection site and has worked it's way to my thumb and pointer finger on my right arm only, They keep multiplying and are raising like hives with little water blisters. They are painful and feverish.
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| 53 | 2021-03-30 | migraine |
COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; sho...
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COVID-19 confirmed by positive COVID-19 test; high levels of histamine; hives on back and chest; shortness of breath; blood pressure of 80/50; pneumonia; fever; chills; migraine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205, expiry date: unknown), via an unspecified route of administration in the right arm, on 26Feb2021 14:30, as single dose, for covid-19 immunization, at a health department. Medical history included known allergies to latex and egg whites. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in 4 weeks. On 26Feb2021 at 17:00, 3 hours after the vaccine, the patient experienced fever, chills and migraine which went on for 4 nights (as reported). On 03Mar2021 (reported as "fifth night"), the patient started to have high levels of histamine, hives on her back and chest and shortness of breath for three days (as reported). In Mar2021 (reported as "by the weekend"), the patient went to urgent care, underwent x-ray of chest, and had pneumonia. In Mar2021 (reported as "Monday"), the patient came back with blood pressure of 80/50 and was sent to the emergency room (ER). It was reported that the events pneumonia, fever, chills, migraine, high levels of histamine, hives on back and chest, shortness of breath and blood pressure of 80/50 required physician office and emergency room visits; treatment for these events included fluids, potassium and antibiotics (unspecified). On 06Mar2021, the patient underwent COVID nasal swab which resulted to positive. The patient recovered from events fever, chills and migraine on 02Mar2021; and from high levels of histamine, hives on her back and chest and shortness of breath on 06Mar2021. The outcome of the events pneumonia, "blood pressure of 80/50" and "COVID-19 confirmed by positive COVID-19 test" was unknown.
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| 53 | 2021-03-30 | pain in extremity |
swelling to left underarm lymph node; pain at site; left arm "ache" with decrease in strength; This ...
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swelling to left underarm lymph node; pain at site; left arm "ache" with decrease in strength; This is a spontaneous report from a contactable other hcp. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El3249, expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 27Jan2021(at the age of 53 years) as single dose for COVID-19 immunization. Medical history included hypothyroidism , migraine and rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included thyroid taken for an unspecified indication, start and stop date were not reported. The patient also took BCP in two weeks. The patient previously took cipro and experienced drug hypersensitivity, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ek9231, expiration date: not reported) via intramuscular route of administration, administered in Arm Left at 09:15 on 06Jan2021 as single dose for COVID-19 immunization and experienced malaise. The patient experienced swelling to left underarm lymph node, pain at site and left arm "ache" with decrease in strength on 28Jan2021. The outcome of events was recovering.
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| 53 | 2021-03-30 | tingling |
right leg paresthesia; This is a report from an interventional study managed and reported by Pfize...
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right leg paresthesia; This is a report from an interventional study managed and reported by Pfizer on the sponsors behalf. A 53-year-old female subject received the first dose of blinded vaccine therapy (BNT162;PLACEBO) on 14Aug2020 at 11:33 and the second dose on 04Sep2020 at 13:13, both via intramuscular (IM) in the left deltoid as single doses for immunization. The subject's medical history includes ongoing chronic migraines (from 2008); neck pain since 2008 with temporary relief from chiropractic manipulation; osteopenia; vitamin D deficiency (2013 to 2014) controlled with Vit D supplements until now; Vit B12 deficiency. In 2014, the subject was diagnosed with occipital neuralgia, right greater than left. She got a steroid injection and did a one-month oral steroid taper, both without relief. She declined to try gabapentin, pregabalin (LYRICA) or other neuropathic pain medications. In addition, the chronic migraines occur 1-2 times per month requiring multiple therapeutic interventions (including B2/Mg, doxepin, zolmitriptan (ZOMIG) as needed (PRN)) and had an episode of intractable chronic migraines without aura and status migrainosus treated with botulinum toxin type A (BOTOX) in 2016. She had experienced relief with botulinum toxin type A and zolmitriptan. Per neurology visit on 01Mar2016, the subject did not feel a typical aura for the migraines, she may have some scalp tenderness or neuralgia-like feeling. She had never had a complicated migraine. Subject's family medical history relevant to adverse event was none. The subject had no concomitant vaccines or prior vaccines (within 4 weeks). Concomitant medication included zolmitriptan for migraines from 2008, vitamin D from 2013 as supplement, both ongoing. On 20Oct2020, the subject started experiencing right leg paresthesia, which required a visit to the physician's office and was considered as an important medical event. On 28Oct2020 the subject underwent a nasal/sinus surgery after which she was given codeine phosphate/paracetamol for three days. On 02Nov2020, she had lower back pain and bilateral lower extremities pain including a shooting "patchy" pain, worse on the right side. Her legs and parietal scalp were sensitive to touch with an associated burning pain. She also reported tenderness in bilateral inguinal area. Symptoms had a gradual onset approximately 3 weeks before. Subject had a magnetic resonance imaging (MRI) of her back which appeared "ok" but she had not seen her primary care physician (PCP) or a neurologist. She denied a history of neurologic or lower back problems. Investigator had a follow-up on 10Nov2020. The paresthesia and skin sensitivity on head had improved but not resolved. Subject still required use of analgesic daily. At its worst, her pain was 6-7/10 in severity. When symptoms started, pain severity was 8-9/10 for a couple of weeks. Without use of analgesic, she had significantly decreased level of activity. But the pain did not prevent activity. With analgesics, she was able to function adequately despite persistence of a mild constant pain of lower back and legs which rates as 1-2/10 in severity. She had required use of some form of analgesic since pain started on approximately 20Oct2020. She had used paracetamol (TYLENOL), ibuprofen (ADVIL), codeine phosphate/paracetamol (TYLENOL#3), and most recently celecoxib (CELEBREX). She said the pain started on approximately 20Oct2020 but then said it started closer to 5 weeks after vaccination 2. She had not noticed any exacerbating factors. Subject denied any recent injury, travel, infection, or change in diet. She went for a walk on 10Nov2020 and walked approximately one mile without a problem. She stopped walking by choice not due to pain. Initially, adverse event was not reported since there was no official diagnosis and symptoms were believed to have occurred approximately six weeks after second vaccination. Despite still not having an official diagnosis, investigator had opted to report this as an important medical event since symptoms had persisted and the subject believed they started closer to five weeks after vaccination which was close to the four week post-vaccination observation period. Medical records from the neurologist were obtained. Per the note from 06Nov2020, MRI of cervical spine done several years before showed mild degenerative changes and spondylosis. MRI of lumbar spine recently done by subject showed: "degenerative discopathy, small left central disc protrusion at T5-T6 with minimal indentation thecal sac; No spinal cord compression, spinal canal stenosis or neural foramina narrowing; Multilevel hypertrophic changes of the facets within the lumbar spine with no neural foramina stenosis; Incidental finding multilevel small hemangiomas in cervical and thoracic vertebral bodies." Neurologic exam on 06Nov2020 was normal Including gait and tandem walk. Tenderness was noted in lower extremities musculature bilaterally throughout and large mobile inguinal lymph nodes palpable bilaterally. Lab ordered by neurologist were normal including Vit B12 635 (200-960PG/ML), Folate 19.6 (equal and more than 6.0UG/L), Vit D 25-Hydroxy 33 (30-100NG/ML), Total creatine phosphokinase (CK) 45 (28-176U/L), erythrocyte sedimentation rate (ESR) 15 (0-20MM/HR), C-Reactive Protein 0.3 (less than 0.5MG/DL), serum aldolase 3.9 (1.5-7.2U/L), thyroid stimulating hormone (TSH) 1.130 (0.400-4.100UIU/ML), FREE T4 1.42 (0.80-1.90 NG/DL), lyme antibody 0.25 (Negative less than 0.9), antinuclear antibody (ANA) negative; serum protein electrophoresis normal, no monoclonal protein seen. Neurologist impression included possible post-viral syndrome or an autoimmune process. There was no mention of concern for myelitis or plan for further work-up. Neurologist's recommendation was to continue celecoxib, PRN and follow-up with primary care physician if labs were unrevealing. Plan to have subject return to clinic to obtain more in-depth history and possibly some labs as well as request reports of MRIs. On 01Mar2021, the subject was seen for visit4, it was confirmed that the event was ongoing but continuing to improve. The action taken for blinded vaccine therapy in response to the event was not applicable. The outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event "right leg paresthesia" was related to blinded vaccine therapy (temporal relationship only, possible due to no other obvious potential etiologies), but unrelated to concomitant drugs or clinical trial procedure. On 18Nov2020, the blinded code was broken due to serious, related, unexpected event. Follow-up (10Dec2020): This is a follow-up report based on the receipt of the publication: No new information provided. Follow-up (23Mar2021): New reported information included: clinical course (on visit4, confirmed that the event was ongoing but continuing to improve).; Sender's Comments: The event Paresthesia Lower Limb is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product blinded therapy vaccine (BNT162;PLACEBO). There is not a reasonable possibility for the event paresthesia lower limb to be related with the blinded therapy vaccine (BNT162; PLACEBO). As an individual case report, there is not enough evidence to establish a causal relationship with the study vaccine apart from a chronological association at this time of the report. Based on the information currently available, it is more likely that the event is associated with the subject's underlying known neurological conditions. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.
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| 53 | 2021-04-01 | speech disorder, electric shock sensation |
difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty s...
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difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
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| 53 | 2021-04-06 | flushing, feeling hot |
This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-p...
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This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, lot number, expiration date: not available) via an unspecified route of administration on left arm on 24Mar2021 09:15 at single dose for COVID-19 immunisation. The patient's medical history included Gastroparesis, allergies to medications, food, or other products: latex, yeast, wheat, guafanisen and Dextromethorphan. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:15 AM, patient experienced anaphylaxis within minutes of having the injection and began to feel flushing down throat, then down to chest. That was concerning but when suddenly, patient got really hot, ripped her mask off, and she realized that she was having difficulty breathing and it got worse as time went on, it was resulted in Emergency room/department or urgent care. Patient received Epi-pen, Benedryl, fluids as the treatment for the events. The outcome for the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 53 | 2021-04-08 | migraine |
site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm com...
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site of injection, LUA, muscle soreness and unable to life L arm. Still unable to life left arm completely without pain. I'm a nurse, so doing my own physical therapy. BUT, main issue has been daily headaches. I've had more headaches in the last 3 months since vaccine, then I have had in my entire life. no treatment except Tylenol or ibuprofen. Although, the other day I had a severe headache, with visual disturbance, vertigo with dizziness and nausea. Was treated at local ER for possibly stroke. MRI showed no issues. I am now diagnosed with migraines.
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| 53 | 2021-04-11 | tingling, flushing, numbness |
Painless paresthesia glove and stocking distribution. Developed into painful paresthesia that persis...
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Painless paresthesia glove and stocking distribution. Developed into painful paresthesia that persists to current (4/12/2021). Intermittent sinus tachycardia and flushing. Diagnosed with autonomic dysfunction.
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| 53 | 2021-04-12 | tremor |
Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/...
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Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/was very pale and noted shaking. EMT took BP which was high (I'm typically on lower end of average). Observed me for 45 minutes as BP came down to normal range and asked if wanted to go to hospital. Declined as had appointment later that day with my electrophysiologist at Hospital. As day went on, became increasingly tired and had bouts of uncontrollable shaking. Thought it would wear off so just went home to rest. On 3/31/21, BP was high again, tremors were getting worse, had leg weakness, double vision, brain fog, dropping things, loose stools, felt off. Went to Hospital and was admitted for 3 days. Neurloigst, Dr., said it was due to Covid vacccine and NOT to get the second shot, and the hospital internist agreed (MRI of brain and cervical spine showed no new lesions). Wanted todo heart procedure but they are not my private cardio group so checked myself out and went to Hospital the next day (admitted 4/3-4/5/21)
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| 53 | 2021-04-13 | burning sensation, tremor, tingling, pain in extremity, muscle spasms |
Beginning 4 hours after the injection I experienced flu-like symptoms; muscle aches and pains, feve...
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Beginning 4 hours after the injection I experienced flu-like symptoms; muscle aches and pains, fever (took Tylenol to control did not go over 100), brain fog, fatigue, abdominal pain and diarrhea. These symptoms lasted for 3 days. In addition, during that time I started to experience difficulty walking; stiffness in my legs, cramping, burning in my feet, toes, aches and pins and needles in my toes and hands and fingers, overall shaky, with poor balance. The fever, brain fog, fatigue, abdominal pain and diarrhea resolved by Day 4; however all of the other symptoms difficulty walking, stiffness, cramping, burning, pins and needles throughout my body remain. The pain level has been as high as a 9 on a scale of 1 to 10. The widespread pain continues all day and night. Prior to the vaccine I was cycling an hour a day and now I have difficulty walking in my house and performing daily tasks and have so much pain in my hands I'm having trouble with computer skills for my job.
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| 53 | 2021-04-13 | migraine |
Tuesday Feb 9, 102 Fever, sweats , Migraine headache, Chills, Same symptom's10th 11th 12 Nausea, Vo...
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Tuesday Feb 9, 102 Fever, sweats , Migraine headache, Chills, Same symptom's10th 11th 12 Nausea, Vomiting Diarrhea , Went to ER. Symptoms continued for another week. Went to ER again Feb20, same got worse returned to ER, they performed MRI, found liver & spleen enlarged on February 23rd, was admitted for 5 days of fluids. Was advised that something had triggered CMV in my body. After eye exam they found CMV Retina, I am still being treated for this condition currently with Valganciclovir. Per Dr. I may have to take meds for 6 months. I was released from Hospital on Feb27th, I still had fevers over 100 and could not take tylenol or advil, I had to ice down my body for over a week fevers continued. They finally went away and I was able to return to work on March 5th with restrictions as I was not fully recovered
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| 53 | 2021-04-15 | breast pain |
After patient received the vaccine the following events occurred: - Office visit with PCP 4/14/2021...
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After patient received the vaccine the following events occurred: - Office visit with PCP 4/14/2021. Complaints consisted of chest pain, SOB, left shoulder and left breast soreness and pain, difficulty sleeping. CT and EKG test ordered and performed. - CT result showed bilateral Pulmonary Embolism. - Lower extremity doppler ultrasound was also performed and negative. Patient is still admitted to hospital and awaiting overall outcome.
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| 53 | 2021-04-15 | seizure, one side paralysis |
received her 2nd dose of Pfizer on 4/8@8:32am, was given discharge information, education and direct...
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received her 2nd dose of Pfizer on 4/8@8:32am, was given discharge information, education and directed to our monitoring area. About 8:40am the clinic RN, went to assess the patient as she began to feel nauseated, began dry heaving without vomiting, had generalized redness, then complained of feeling light headed. She passed out so the RN eased her to the floor. A Rapid Response(RR) was called and the patient was moved to the stretcher. VS were taken and at about 8:50am the RR team arrived and assumed care. Once they arrived the patient began to seize. She was taken to the ER where she had another seizure. She remained in a post-ictal state for most of her stay at our facility.
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| 53 | 2021-04-17 | burning sensation |
constipation; Severe lower right side pain, felt like burning and stabbing, thought my appendix was ...
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constipation; Severe lower right side pain, felt like burning and stabbing, thought my appendix was rupturing; felt like burning and stabbing; appendix was rupturing; This is a spontaneous report from a contactable consumer (reported for herself). A 53-year-old female non pregnant received second dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number ER2613, expiry date: unknown) via an unspecified route of administration at left arm at a single dose on 19MAR2021, for covid-19 immunization. Medical history included Gastrooesophageal reflux disease, diverticulitis, Graves Disease in left eye, full hysterectomy, high bp, high cholesterol, depression, hypothyroidism, Gastric bypass and heart ablation. Concomitant medications included an unspecified 5 different medications and daily vitamins. Historical vaccine includes first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number EN6203, expiry date: unknown) via an unspecified route of administration at left arm at a single dose on 25FEB2021 06:00 PM, for covid-19 immunization. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Neither was she tested for it since the vaccination. On 24Mar2021 19.00, she experienced severe lower right sided pain, felt like burning and stabbing, thought her appendix was rupturing. On an unknown date, she went to an emergency room (ER), had a computerized tomography scan that showed constipation. Her pain was at a level 9, was doubled over for 6 hours while seeking care. She had complete sudden onset of pain, with no warning. She was treated with Fentanyl shot that took almost an hour to provide minimal pain relief. Had continuing pain for three days after the initial onset. No real treatment other than pain medication were given at ER. She was told to get collace and mirilax. The outcome of the events of severe lower right sided pain, felt like burning and stabbing, thought her appendix was rupturing was recovering. No follow-up attempts are needed. No further information is expected.
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| 53 | 2021-04-17 | tingling, muscle spasms |
the contractions and cramping sensation went trough out her entire chest region and her back (like h...
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the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms); the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms; in the left arm it was cold and tingling; in the left arm it was cold and tingling; experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours; diarrhea on the weekend; strong cramps in her stomach (stomach flu-like symptoms); This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 23Mar2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included ischemic colitis in the past and she thinks that maybe the cramping started triggering it again. The patient's concomitant medications were not reported. On 02Apr2021 strong cramps in her stomach (stomach flu-like symptoms) and on an unspecified date, the patient experienced the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms), in the left arm it was cold and tingling (vaccination site coldness), (paraesthesia), experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours (muscle spasms) and diarrhoea on the weekend. Her second dose is scheduled on 13Apr2021, she would like to know if there are recommendations for her second dose because she heard that with the second dose the side effects are worse, she would like to know if someone else has reported these symptoms. She would like to know if she should possibly receive the vaccine in her thigh instead of her arm and if that would be helpful. The outcome of the events diarrhoea was recovered on 05Apr2020 and outcome of contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms) was not recovered and rest of the events was unknown. Information on the Lot/Batch number has been requested
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| 53 | 2021-04-17 | tremor |
passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contacta...
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passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contactable consumer reporting for self. A 53-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:00 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient received the first dose, administered in Arm Left on 08Mar2021 09:45 (Batch/Lot Number: EN6205). The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported. The patient experienced passed out, chills, shakes, fever, headache, tiredness 30Mar2021 08:30. Outcome of events was recovering. Follow-up attempts are needed. Information on lot/Batch number was obtained.
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| 53 | 2021-04-18 | seizure, unresponsive to stimuli |
53yo female with a Hx of migraines/seizures/normal pressure hydrocephalus received her second dose o...
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53yo female with a Hx of migraines/seizures/normal pressure hydrocephalus received her second dose of COVID-19 vaccine 04/08/2021. 10 minutes after vaccination she started feeling nauseated and then doesn't remember what happened next. Was transported "unresponsive" to ER. CT MRI negative. Upon lab exam it was noted that her platelets had dropped from 245K to 86K. Received dose of epinephrine/solumedrol, pepcid. Diagnosed with having a seizure and thrombocytopenia. The next day her platelets had recovered to normal. Patient recovered and was discharged.
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| 53 | 2021-04-18 | seizure |
Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and...
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Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and arms were seizing; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0150), via an unspecified route of administration, on 02Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included seizures (but they are rare). The patient had unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 03Apr2021 at 10:30 AM, the patient stood up and became very dizzy, she fell to the floor and was unconscious. When she came to a few moments after (unknown time), her legs and arms were seizing. The patient did have a history with seizures, but they are rare. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
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| 53 | 2021-04-19 | weakness, numbness |
Stroke from a blood clot that went to the left side of my brain causing the right side of my body to...
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Stroke from a blood clot that went to the left side of my brain causing the right side of my body to be numb , weak and to lose a range of motion. Event date: 3/24/2021; hospitalized 3/24/21, 3/25/21, and 3/26/21.
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| 53 | 2021-04-24 | weakness, feeling cold, tremor |
rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating pr...
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rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
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| 53 | 2021-04-24 | migraine |
she began to feel like she was straining to take a deep breath. When she would take a deep breath (l...
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she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply/diagnosed with pericarditis; fluid had accumulated around her heart; headache/migraine; patient's lymph nodes on neck were causing her discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 25Mar2021 10:45 (Batch/Lot Number: ER8730) as SINGLE DOSE for covid-19 immunization. Medical history included "Hypothyroid" (hypothyroidism) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took guaifenesin (MUCINEX) and experienced allergies. On 31Mar2021, the patient's lymph nodes on neck were causing her discomfort which continued throughout. Around 1:00 am on 03Apr2021, she began to have a very intense headache/migraine. She began a regimen of Tylenol (8/day) and Advil (6/day) to mitigate the pain. Although the pain would diminish when she took these over-the-counter medicines, the headache never went away. In the evening of Sunday, 04Apr2021, she began to feel like she was straining to take a deep breath. When she would take a deep breath (like a yawn), she would do her best to stifle it as her chest would experience an immense pain while inhaling deeply. On Monday, 05Apr2021, went to a Clinic as she was straining so hard to breath. After numerous tests, she was diagnosed with pericarditis and, because of this, fluid had accumulated around her heart which was drained in a procedure called pericardiocentesis. They initially drained 230 ml and then 74 additional ml from a drain they had placed. The patient was hospitalized due to the events. The patient underwent lab tests and procedures on 05Apr2021 which included Nasal Swab (sars-cov-2 test) with negative result. The outcome of events was reported as "recovering". The patient did not receive treatment for "patient's lymph nodes on neck were causing her discomfort" but received treatment for all of the other events. Follow-up attempts are completed. No further information is expected.
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| 53 | 2021-04-26 | feeling hot |
This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her...
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This is a spontaneous report from a contactable consumer. A 53-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 11Apr2021 09:15 (Lot Number: EP7533; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 53 years). Medical history included asthma, Blood pressure high, acid reflux , allergies: Sulfa, Lactose intolerant and allergies: Latex. The patient's concomitant medications were not reported. The patient had a historical vaccine of Flu shot (INFLUENZA) on an unspecified date for immunisation and experienced bad side effects. The patient previously took bactrim, minocycline, doxycycline, ciprofloxacin, Moxifloxacin, demerol, avelox, nitrofurantoin, naprosyn, motrin, perocet, tramadol and aleve and experienced allergies. The patient experienced anaphylaxis on 11Apr2021. It was also reported that she had an appointment for COVID Vaccine at 9:15AM. Received COVID Vaccine and was told to wait for 30 minutes. Within 10 minutes her chest starting getting tight with difficulty of breathing. Her throat was closing up, and she was light headed. She explained this to the administrator who asked if caller could get up to see the paramedic. As caller tried to stand up, she almost passed out. Had to sit there for a second and the second time was able to get up and made it in to the room. Was going in and out of consciousness. Had to stab her with an Epi Pen. She couldn't breathe. Her throat was closing up. Her tongue was swollen. She was in and out of consciousness. First Epi Pen didn't work. An IV was put in and was given something through it. She was jabbed with a second Epi Pen. Was still in and out of consciousness but she was starting to come back. Was given oxygen and a nebulizer. She does have asthma. Ambulance was called. Was told she was worked on for 20 minutes. When ambulance arrived she was able to get up and get on the cart. She was taken to the hospital. Was given medicine through her IV. Had to be kept at hospital because she had two Epi Pens and medication at the vaccine facility. Hospital wanted to make sure when the Epi Pens wore off she didn't go back into anaphylaxis. Was kept in ER for over four hours. Was given IV fluids. Her oxygen, heart rate, and blood pressure dropped at vaccination facility. Oxygen was 81. Blood pressure was 94. At hospital, her levels started to get better. Once she was given the second Epi Pen and whatever else she was given, the medication started to work and she had come through. At the hospital, someone came in and did bloodwork for research to see why this happened. Was prescribed Epi Pens by the doctor in the hospital and was advised to carry Epi Pens with her at all times. If she has another anaphylaxis, was advised to jab herself with Epi Pen and call right away. Was told her tongue was swelling. Attempted to obtain the outcome of the anaphylaxis. At the hospital, she was so out of breath walking to the bathroom. Was told at hospital now she is having side effects from the COVID Vaccine including the tiredness and headache she is experiences. Was told to take Tylenol and Benadryl, lay down and rest, and to make sure she drinks so she does not get dehydrated. Today, she feels nauseous, lightheaded and tired with a little headache. She feels better from yesterday. Is getting better and is having a little chills maybe an hour ago. She checked her temperature and does not have a temperature, but her insides feel warm . The patient was hospitalized for the event anaphylaxis on an unspecified date. Therapeutic measures were taken as a result of was going in and out of consciousness. Events for anaphylaxis, consciousness fluctuating, chest discomfort. dyspnea, throat tightness, presyncope and swollen tongue occurred on 11Apr2021 while the remaining events occurred on an unspecified date. The patient underwent lab tests and procedures which included blood pressure: dropped and 94, blood work: unknown results, heart rate: dropped, oxygen saturation: 81 and dropped on an unspecified date. Therapeutic measures were taken as a result of all the events. Outcome of the events was unknown.
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| 53 | 2021-04-30 | tingling, pain in extremity |
swollen joints; her back condition and may have "pinched a nerve or something; describes it as the w...
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swollen joints; her back condition and may have "pinched a nerve or something; describes it as the worst pain; the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot; leg pain; also has some tingling on the skin; It feels like a Charley's horse; had a horrible flu; Her every muscles and every joint hurt, and her head hurt; Fever; body aches; chills; joint pain; Her every muscles and every joint hurt, and her head hurt; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 (Batch/Lot number was not unknown; Expiration Date: 31Jul2021), at age of 53 year-old, as 0.3 mL single, for Covid-19 immunisation. Medical history included liver disease from 2016 and ongoing. There were no concomitant medications. The patient previously took the first dose on 17Mar2021 for Covid-19 immunization and experienced fever. The patient received her second dose of the Pfizer BioNTech COVID-19 vaccine on 07Apr2021 and reports having side effects after. She is specifically worried about the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot and if she needs to be worried about it. She stated that with the "swollen joints" and everything from the vaccine, it is possible that it worsened her back condition and may have "pinched a nerve or something." She describes it as the worst pain she's ever felt in her life and states it "comes out of the blue" so she does not have time to prepare for it. She likens it to a "Charley horse" but a "really bad one" that goes away and has no pain afterwards. She states she is scheduled for an MRI next week of her lower back to investigate. The patient also mentions that she thinks she had COVID-19 at the time of her vaccine because "when I got the shot, I had a super strong response." On 07Apr2021, the patient had body aches, chills, she was on the couch for quite a while. The joint pain was incredible, even in her toes. She felt like she had a horrible flu. Her every muscles and every joint hurt, and her head hurt. She was on the couch for like 4 days. On day 3 or 4 she developed intermittent pain in the leg and shin on 08Apr2021. It feels like someone is drilling a jackhammer in it. It feels like a Charley's horse, but not, more like it's in the bone. She didn't associate it with the vaccine at first, even though she had never had this pain before until she got the vaccine. She said that she has had some back problems and scheduled a MRI to see if she had pinched nerve or something. On 08Apr2021, she also has some tingling on the skin. She read about side effects of blood clots and doesn't know if this leg pain could be related to a blood clot. She assumed it could be from her back. She read that with blood clots there is usually an ache and discoloration, which she does not have now. She also read that intermittent Charley's horse could have something to do with blood clots. She has pins and needles on the skin. She also had a headache after the vaccine, but she does not have it now. She said that the pain in her leg that shoots on and bangs in her tibia hurts when bending over, lifting her leg to her chest, squatting to pick up something, and going up and down the stairs. She said that the pain is horrible and it is worse than leg pain, it is worse than a charley horse, it is the worst pain she has ever felt in her life. She cannot stop screaming when it happens. States with the joint pain that she had, there may be a nerve that's being pressed on her back. She said that with all of the information being reported in the news about blood clots, she asked is that something she needs to be concerned about. She said that she did a virtual visit with her doctor and notified her of the leg pain and asked the doctor to schedule her for an MRI because of the pain. She stated her hemoglobin and hematocrit, MCV are high. She also said that the clotting is affecting her red blood cells. She ran a fever with the first vaccine, but she had a high fever between 103-104 degrees Fahrenheit after the second vaccine that stopped on 12Apr2021 or 13Apr2021. Her high fever lasted for about 3 days. She had a low grade fever that lasted for about a week. Her body aches resolved completely on 12Apr2021 or 13Apr2021. Her joint pain is in her back and elbows. She also had lot of joint pain in her shoulder and arm and radiates to her neck on the left side. She still has some muscle pain in her leg, but overall her muscle pain is gone. For treatment she used Ibuprofen 600 mg by mouth and fluids. The day before her shot, her son called and told her he tested positive for covid. She got a PCR test immediately on 07Apr2021 and the next day she was told it was negative. She thinks she might have tested too soon. She also says her response to it was so strong, she must have been getting covid and didn't know it. She might have tested negative because she had the first shot already. She wasn't worried about exposing others and went to get her second shot, but she got really sick after that and it kicked her butt pretty hard. The outcome of the events for leg pain and tingling on skin was not recovered, fever, body aches and headache recovered in Apr2021, chills on 11Apr2021, muscle hurt/pain on 12Apr2011, joint pain was recovering, and outcome of other events was unknown.
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| 53 | 2021-05-03 | pain in extremity |
lost weight; tested Covid-19 Positive; Left arm sore; Sleepy; This is a spontaneous report from a co...
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lost weight; tested Covid-19 Positive; Left arm sore; Sleepy; This is a spontaneous report from a contactable consumer or other non-HCP. A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), intramuscular, administered in Arm Left on 02Apr2021 01:00 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 02Apr2021 the patient experienced sleepy, headache. On 02Apr2021 15:00 the patient experienced left arm sore. On 02Apr2021 20:00 the patient experienced nauseous, achy, chills, fever. On 03Apr2021 the patient experienced fever started at 100 degrees. the highest fever was 101.8 and one time it went to 102 and never peaked at 102 again. On 03Apr2021 18:00 the patient experienced vomiting. On an unspecified date the patient experienced lost taste, smell, lost weight, tired. Upon follow-up received on 21Apr2021 the patient experienced tested covid-19 positive on 05Apr2021. She had the first dose on 02Apr2021, and tested positive for Coronavirus on Monday, 05Apr2021. She can't go for second dose until it has been 90 days. She is completely better and her taste, smell and all of that is back. She also received the antibody treatment infusion the following Tuesday. She stated she is a little chunky. She lost weight after getting the COVID, so that was a plus. She did not eat for about a week. She also experienced Arm pain, sleepiness, headache and fever. The fever kept increasing. Fever started at 100 degrees. The highest fever was 101.8 and one time it went to 102 and never peaked at 102 again. That was early in the morning hours 02:00 on 03Apr2021. She also had chills, and they did not stop until she got antibody infusion treatment and was in the hospital for that. It was outpatient. She does not have the name, dose, lot or expiration. She went to the hospital on Tuesday, 06Apr2021, around 2:30, and got one whole IV bag of Saline like water. They wait about an hour and they give you the other bag all through IV of that medicine. The monoclonal antibody is what she had. Wednesday, 07Apr2021 is the last day she had fever or chills. She was tired. She lost taste, smell and just started getting it back this week. When Saturday came, the fever was all day long. It was 100 to 101. Saturday night is when she started to throw up. The patient underwent lab tests and procedures which included covid-19: positive on 05Apr2021, pyrexia: high on 03Apr2021 The highest fever was 101.8 and one time it went to 102 and never peaked at 102 again. That was early in the morning hours 02:00 on 03 Apr 2021. Therapeutic measures were taken as a result of tested covid-19 positive, left arm sore, sleepy, fever started at 100 degrees. The highest fever was 101.8 and one time it went to 102 and never peaked at 102 again, nauseous, achy, vomiting, chills, lost taste, smell, lost weight, tired, fever. The outcome of event left arm sore,tested covid-19 positive was recovered. The outcome of event sleepy,fever started at 100 degrees. the highest fever was 101.8 and one time it went to 102 and never peaked at 102 again, nauseous, achy, vomiting, chills, fever was recovering. The outcome of event headache, lost taste, smell,lost weight, tired, was unknown. Follow-up (21Apr2021): New Information received from the contactable consumer includes updated events and dates, of lab data and questions regarding events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 53 | 2021-05-04 | tingling |
Headache; tingling in arms and hand; severe lethargy; fever 101.8; This is a spontaneous report from...
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Headache; tingling in arms and hand; severe lethargy; fever 101.8; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247),via unspecified route of administration, administered in left arm on 21Jan2021 at 13:00 (at the age of 53 years) as single dose for COVID-19 immunization. The patient medical history included vertigo, migraine, asthma. The patient had an unknown allergy to medications, food, or other. The concomitant medication that the patient received within 2 weeks of vaccination included pseudoephedrine hydrochloride (SUDAFED) and ibuprofen (ADVIL). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 the patient experienced headache, tingling in arms and hand, severe lethargy and fever 101.8. The patient did not receive treatment for the events. On 22Jan2021 the patient underwent lab tests and procedures which included body temperature was 101.8. fever. The outcome of event was recovered in 2021. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-05-05 | tremor |
The patient is a 53yo F with history of asthma, non-epileptic seizures who on 5/4/21 received the 1s...
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The patient is a 53yo F with history of asthma, non-epileptic seizures who on 5/4/21 received the 1st Pfizer vaccine of her vaccination series. Immediately afterward, she developed full-body shaking and SOB. She was immediately sent to the ER where she was found to have stridor but without angioedema, hypoxia, urticaria, vomiting, hypotension, or other signs of anaphylaxis. During her stay in the ER, I oversaw her care and her symptoms completely resolved after IM Epi, benadryl, famotidine, albuterol/iptratropium, steroids, and magnesium. After an observation period in the ED, she had no recurrence of symptoms and was ultimately discharged.
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| 53 | 2021-05-07 | pain in extremity |
got COVID tested and they had COVID; got COVID tested and they had COVID; sore arm; stuffy nose; sin...
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got COVID tested and they had COVID; got COVID tested and they had COVID; sore arm; stuffy nose; sinus infection; upset stomach and chills; chills/was so cold teeth were chattering; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the second of two reports. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 53-year-old, via an unspecified route of administration, administered in left arm on 18Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included she had colonoscopy and anaesthesia. Concomitant medication included daily vitamins. The patient previously took oxytocin (PITOCIN) and experienced uncontrollable shaking. The patient got chills, was so cold teeth were chattering, sore arm, muscle aches, tired, and stuffy nose after the first dose on an unspecified date in 2021. She got it late in the day, but she didn't noticed symptoms until the next morning. It was complicated because her and her husband got the shot on 18Mar2021 and didn't feel well from it over the weekend. She thinks 18Mar2021 was on a Thursday. They knew they would be down for the weekend. They started to feel worse and worse. She went to a (institution name) because she thought she had a sinus infection on an unspecified date in 2021. She got some medication. The next day she lost the sense of smell and taste. Then her husband and her got COVID tested and they had COVID on an unspecified date in 2021. Somewhere around the time she got the first shot she had been exposed to COVID. She had COVID for 2 weeks. She didn't have to be hospitalized and her oxygen levels were fine on an unspecified date in 2021. She had all other symptoms except fever, diarrhea, and oxygen depletion. She called and the vaccine was scheduled out far enough and she was past COVID so she could come and get second dose. With the first dose, it was hard to tell what was a reaction to the shot when it was actually her coming down with COVID. She did have an upset stomach and chills and the worst headache of her life, she had no energy on an unspecified date in 2021. The sore arm was obviously was from the shot. The sore arm was clearly a side effect, but it was hard to tell when the side effects were ending and when it was COVID. It was a weird coincidence that they got exposed and she feels that it was not related to shot. The events got COVID tested and they had COVID and sinus infection resulted in physician office visit. The outcome of the event got COVID tested and they had COVID was recovered on an unspecified date in 2021 after two weeks and for the rest of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460871 same reporter, drug , event; different patient
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| 53 | 2021-05-10 | weakness, tremor |
swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremo...
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swooning feeling when elevating body temp (taking a bath); Fever; chills; body ache; headache; tremors; swollen sore lymph nodes (one week later under LEFT arm); swollen sore lymph nodes (one week later under LEFT arm); dizzy; extreme fatigue; elevated/irregular resting heart rate; elevated/irregular resting heart rate; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:15 (Lot Number: Ep7533) as SINGLE DOSE for covid-19 immunization. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of vaccine in Arm left on 11Mar2021 08:15 AM (Lot Number: En6201) also at age of 53 years old for covid-19 immunization, experienced elevated resting heart rate, weakness, dizzy, extreme fatigue, headache. Medical history included Hashimoto hypothyroidism. Concomitant medications included levothyroxine; estradiol; progesterone; testosterone, all taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, chills, body ache, headache, tremors, swollen sore lymph nodes (one week later under left arm), dizzy, extreme fatigue, elevated/irregular resting heart rate, swooning feeling when elevating body temperature. The events onset date were reported as on 09Apr2021 06:00 AM. It's unknown if patient received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 54 | 2021-01-01 | weakness |
Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe head...
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Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe headache, muscle and joint pain, chills, fever (temperature-102.8),and exhaustion. Redness, pain, and swelling at injection site that has continued to worsen even after 48 hours. Could not perform regular activities of daily living. I could not drive home from work the day after the injection because the adverse reactions were getting more severe, especially after the 24 hour mark. Treatment: treated my symptoms at home with medications (I am a nurse), after researching possible adverse reactions. I figured there was not anything someone else would to treat me besides treat my symptoms.
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| 54 | 2021-01-01 | pain in extremity | Body aches, fatigue, arm pain(first couple of days), diarrhea and nausea |
| 54 | 2021-01-02 | tingling |
Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, a...
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Tingling feeling like I'm being stuck with pins/needles over my body- hands, fingers, feet, toes, arms, legs, lips, face, mouth. Started Friday morning January 1st 2021. I went to the ER on Friday January 1st 2021 and was given Prednisone. I'm still having symptoms today Sunday January 3rd 2021.
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| 54 | 2021-01-02 | tremor |
5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31-...
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5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31- 2020, no adverse reaction. Friday, 1-1-2021 , entire body, including internal organs were trembling. Saturday, 12-31-2020, extremley dizzy, unable to stand, function. Nauseated, extremely dehydrated, extreme exhaustion. This lasted 24 hours. Sunday, 1-3-2020, still exhausted, but not to extreme. All other symptoms have subsided.
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| 54 | 2021-01-03 | weakness |
12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with lo...
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12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95
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| 54 | 2021-01-03 | tenderness |
I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of ...
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I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of shot. Mild lower back pain that evening (vaccine on left arm and pain on same side). On 12/30 soreness was only to palpation. Rhinorrhea all day long, took NyQuil, moderate back pain, took naproxen and did some back stretches. On 12/31 no sore arm but little tender. Increased back pain , used back brace , took naproxen not that much help though. used heat pack finally fall asleep around 3 am. on 01/01/2121 around 6 am woke up with excruciating left lower back pain, could not move, get off the bed. took a while to get off the bed. Have to drag my legs very slowly to walk. Went to ER. X-ray did not show anything. In ER took Narco 5 and Baclofen. MD thinks that it might not be side effects of vaccine. But I wonder, I never had left lower back pain before. Taking Baclofen and Advil TID since 0101/2021. 01/04 still in pain. increase pain after 6-7 hours after meds. Sitting or standing more than 30 mins Increases pain. Going to see PMD today
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| 54 | 2021-01-04 | pain in extremity, weakness |
chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fa...
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chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fatigue tiredness
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| 54 | 2021-01-04 | pain in extremity |
When I first received shot my left arm start hurting. I was in contact with someone that had COVID-1...
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When I first received shot my left arm start hurting. I was in contact with someone that had COVID-19 , which I was tested positive with COVID-19.
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| 54 | 2021-01-04 | tremor |
she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/Sh...
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she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting for herself. A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm on 23Dec2020 07:00 at single dose for covid-19 immunisation . Medical history included covid-19 from Jul2020 to an unknown date. There were no concomitant medications. The patient experienced chills on 24Dec2020 with outcome of recovering , nausea on 23Dec2020 23:00 with outcome of recovering , headache on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit on 24Dec2020 with outcome of not recovered , feeling unwell on 23Dec2020 with outcome of not recovered , resting heart rate went to 130 on 24Dec2020 with outcome of recovering , she could not stop shaking on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit, 100.4 Fahrenheit, heart rate: 130 (66-72. Normally) , sars-cov-2 test: negative on 21Dec2020 , sars-cov-2 test: negative on 24Dec2020 . Information on the lot/batch number has been requested.
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| 54 | 2021-01-05 | flushing, feeling hot | LEFT SIDED CHEST PAIN, SHORTNESS OF BREATH, FELT WARM AND FLUSHED |
| 54 | 2021-01-05 | pain in extremity, weakness, night sweats |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); ...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); night sweats; Soreness at injection site; slight temp 99.5 degrees/her temperature was 101 degrees Fahrenheit/it was 102.5 degrees Fahrenheit/99 degrees Fahrenheit and then 98 degrees Fahrenheit; Tiredness she related to giving blood; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular on 19Dec2020 15:45 on left deltoid at a single dose for prevention as frontline health worker at hospital (COVID-19 immunisation). The patient donated blood on 18th and no antibodies were present then. The patient was a former smoker and quit 2 or 3 years ago. Patient diagnosed Osteoporosis in 2015, benign heart arrhythmia in 2005. The patient took 70 mg alendronate sodium (FOSAMAX) once weekly and just a regular OTC daily multivitamin. Caller reported she was having the covid vaccine on 19Dec2020 and began having fever, night sweats, loss of taste and smell and then tested positive for covid. The patient received the Pfizer COVID 19 vaccine through work on 19Dec2020. She received it at 3:45 pm and should have taken temperature before, but she was afebrile the day before because she donated blood. At 7pm, she had slight temp 99.5 degrees Fahrenheit and by 10:30, her temperature was 101 degrees Fahrenheit and she still felt fine. She was surprised that it was that. She woke up at 2:30 am on 20Dec2020 and took her temperature and it was 102.5 degrees Fahrenheit. She took 2 Tylenol and went back to bed and felt fine. By morning it was 99 degrees Fahrenheit and then 98 degrees Fahrenheit a little later. She has been afebrile since then. She was a little tired because she gave blood and though it was related. She does not know if it was a side effect or not. It was not significant tiredness and was just not having energy in the evening of 19Dec2020. She also had soreness at injection site that night after 22:00 and the next day. It did not bother her until she woke up in the middle of night, and she noticed her left arm was sore. She received the vaccine at 3:45pm and started with low grade fever at 6:30 pm, earlier stated at 7:00 pm. There was no prescriber. She tested for COVID (PCR) on Saturday, 26Dec2020 at 14:50and it came back positive 28Dec2020 18:45. At 10pm on 19Dec2020, her temperature was 101 degrees Fahrenheit. If she had not been monitoring her temperature, she would not have known. She has been Afebrile since morning of 20Dec2020. Tiredness she related to giving blood and the holidays. She was a little stressed about the holidays and running around. It was very mild. Soreness at injection site was during the night after 10pm when she went to bed. On Wednesday, 23Dec2020, she woke up congested, sniffly, sneezy, with a runny nose. This persisted through Wednesday night. Her sense of taste was off. She had no problem with that on Tuesday. She had some horrible smell at work she recalled, so she knew her sense of smell was fine. On Thursday, 24Dec2020, she had no sense of taste or smell. She could not smell a pine candle. She was congested on Thursday and called employee health on 24Dec2020. This both improved and persisted. She is still congested but it has improved. She has never had a complete loss of sense of taste or smell before. Mild cough started yesterday morning. On the night of 20Dec2020, and 21Dec2020, she developed night sweats. She had not had any night sweats before this since menopause and she woke up really wet. The patient was not hospitalized and not admitted to an Intensive Care Unit. NO ER or physician's office required. She did not know if she was exposed on the day of the vaccine or if a couple of days later if the fever is from the vaccine. She stated what are the chances she goes 10 months and is super careful and then gets the vaccine and test positive. The patient did not display clinical signs at rest indicative of sever systemic illness. The patient did not require supplemental oxygen nor receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID- 19. No initiation of new medication or other treatment or procedure. Not any preexisting diseases worsen during the SARS-CoV2 infection. She would like to know if there is a chance of false positive for this. It would just be her luck to be 10 months and not getting it. She has not gone anywhere without her N95 and then gets the vaccine and gets COVD. She wears mask and face shield at work always. She also wanted to know if she should get the second dose. The outcome of the event slight temperature was recovered on 20Dec2020 and the other event was recovering.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
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| 54 | 2021-01-05 | pain in extremity |
PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THA...
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PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY. SHOOTING PAINS UP HER NECK AND DOWN HER ARMS. DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES. CRP WAS 3.6 AND SED RATE 25. COVID TEST WAS NEGATIVE. PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS
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| 54 | 2021-01-05 | pain in extremity | After vaccine patient reported ankle, leg and hip pain. Taking Motrin |
| 54 | 2021-01-05 | pain in extremity |
patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joi...
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patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days
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| 54 | 2021-01-05 | tingling, pain in extremity |
I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon w...
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I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon when my arm became sore, which I expected to happen so I took Tylenol. By mid afternoon, my 4th and 5th finger on my left had began to tingle and I was having difficult typing with that hand on my keyboard. By late afternoon, the left side of my face began to tingle like paresthesia. I took more Tylenol at dinner but the sensation in my face lasted until I went to bed around 10:00. I woke up in the night and my face felt fine but my 2 fingers were still tingling and I felt like I had no control over them. When I woke up this morning, I took to more Tylenol and the symptoms have subsided. Also, when the nurse swabbed my arm with alcohol, I asked?Isn?t that a little high for the injection, and he said no?it?s right in the deltoid. It felt like the injection site was close to the bones in my shoulder but that may have had nothing to do with these symptoms.
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| 54 | 2021-01-05 | tingling |
Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands ...
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Approximately 10 minutes after injection tingling in right hand, red splotchy skin on palm of hands and forearms. Approximately 15-20 minutes after injection. Tingling in feet and lower extremities. Thirty minutes after injection slight itching at injection site. Approximately 1 1/2 hours after injection splotchy red skin inside both thighs and mild generalized itching. At 2:00 pm that day of injection tingling began in face with slight swelling in cheeks. Itching lasted 3 days. Currently intermittent itching since Monday 01/03/2021.
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| 54 | 2021-01-05 | tremor, hot flush, feeling hot |
About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme he...
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About 30 to 40 mins after receiving vaccine i began to experience acute rapid heart beat, extreme heat or hot flash, shaking, almost hyperventilating but was able to control breathing. Episode lasted 10 mins Immediately with vaccine I noted an antiseptic taste in my mouth and this continues.
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| 54 | 2021-01-06 | numbness |
shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles ...
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shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles in the L shoulder, numbness into both hands...of the left arm. And neck pain... cervical radiculopathy in the L arm... pain and pins/needles into L thumb. It reached its peak with 4 nights of disturbed sleep starting on the date mentioned. I didn?t keep track of the symptoms other than that because I didn?t initially associate the symptoms to the vaccine until early this week. Symptoms have since improved and are (almost) resolved; I was advised to have the the 2nd vaccine today as scheduled - which was recommended lower on the deltoid and on the opposite shoulder.
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| 54 | 2021-01-06 | pain in extremity |
Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th ar...
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Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th arm was very sore, runny nose, shoulder/neck aches, severe N/V/D, severe fatigue Narrative: Did not need to seek medical care. Stayed at home.
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| 54 | 2021-01-06 | tremor, feeling cold, numbness |
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le...
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her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-06 | tremor, pain in extremity | Fever, chills, headache, dry cough, left calf pain, tremor in left thumb |
| 54 | 2021-01-07 | weakness, pain in extremity |
chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; diz...
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chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; dizziness; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient (not pregnant at the time of report) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EL 3246) on 04Jan2021 12:00, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EK 5730) on 18Dec2020 11:00, both intramuscularly on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included migraine, known allergies: kiwi. Concomitant medications were not reported. The patient experienced chills, fever, headache, muscles pain, joint pain, difficulty of breathing, arm pain, tiredness, dizziness and weakness, all on 04Jan2021 19:00. Treatment received for all events included Ibuprofen, Alive. The outcome of all events were not resolved.
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| 54 | 2021-01-07 | cold sweat, weakness |
dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; c...
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dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; cold-clammy skin; headache; exhaustion; nausea; Redness and swelling at injection site that is still getting more severe after 48 hours; Redness and swelling at injection site that is still getting more severe after 48 hours; This is a spontaneous report from a contactable nurse reporting for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899, intramuscularly from 30Dec2020 13:00 (age at vaccination: 54 years old) at single dose in left arm (dose 1) for COVID-19 immunization. There was no other vaccine administered in the 4 weeks prior to COVID vaccination. The patient was not pregnant. Medical history included hypertension, arthritis, degenerative disc, CRPS/RSD, thyroid cancer, thyroidectomy during 2007, and Crohn's disease. Known allergiesincluded insect stings and environmental allergies. The patient had COVID prior to vaccination. Concomitant medication included thyroid (THYROID); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); meloxicam (MOBIC); vitamin D; alpha lipoic acid (ALPHA LIPOIC ACID); duloxetine hydrochloride (CYMBALTA); and pantoprazole sodium sesquihydrate (PROTONIX). Within 24 hours of receiving COVID vaccine, the patient experienced dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, and nausea, from 31Dec2020 at 08:00. These continued to worsen over the next 24 hours. Redness and swelling at injection site that was still getting more severe after 48 hours. The patient was unable to drive home from work the day after injection due to adverse reactions getting worse throughout the day. The patient self-treated at home with medications (not further specified). The outcome of the events dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, nausea, and redness and swelling at injection site were not recovered. The events were reported as non-serious. The patient was not COVID-tested post-vaccination.
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| 54 | 2021-01-07 | feeling cold | body chills aches and headace |
| 54 | 2021-01-07 | feeling hot | Warm neck and face. Burning sensation in eyes. |
| 54 | 2021-01-07 | feeling jittery |
About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. ...
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About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. She was in the parking garage and called 911. She was taken to ED and treated with IV fluids. Her potassium was low and was replaced. Felt better after fluids and was discharged
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| 54 | 2021-01-07 | pain in extremity |
some arm pain (unspecified) following the injection; shoulder and neck stiffness after going to slee...
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some arm pain (unspecified) following the injection; shoulder and neck stiffness after going to sleep that night; This is a spontaneous report from a non-contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on 03Jan2021 (Sunday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported some arm pain (unspecified) following the injection on 03Jan2021 and shoulder and neck stiffness after going to sleep that night. The nurse reported that her arm pain resolved the next day on 04Jan2020. The outcome of event "shoulder and neck stiffness after going to sleep that night" was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 54 | 2021-01-07 | pain in extremity |
Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ p...
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Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ pain in her arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Right Upper Arm on 03Jan2021 (around 9:15 to 9:30AM) at single dose for COVID-19 immunization. Medical history included ongoing lupus (diagnosed about 2-1/2 years before 04Jan2021) and fatigue with lupus. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient said later in the evening of 03Jan2021, she got pain in her arm she got the COVID-19 Vaccine. She received her first check-in call after receiving the COVID-19 Vaccine, and at that time she had no pain in her arm. She clarified the pain in her arm at the injection site started in the evening of 03Jan2021. On 04Jan2021 she had fatigue. She stated she got fatigue sometimes with her lupus. No treatment received for the adverse events. No emergency room or physician office involved. The patient reported she saw her rheumatologist and had blood work done. The outcome of pain in arm at the injection site was recovering, of fatigue was not recovered. The information on the batch number has been requested.
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| 54 | 2021-01-07 | pain in extremity |
Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approxi...
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Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approximately 8:00 PM. EE reports arm soreness and pain at injection site. EE reports she woke up around 04:00 with flu like symptoms, body aches (reporting so bad she is barely able to get out of bed), fever (Tmax 101.4). + runny nose, congestion and headache. EE reports + exposure to pt with only wearing surgical mask approx. 3 weeks, and was contacted by EH and was considered low-risk and not scheduled for testing. Last day of work and shift - ? yesterday left work at approx. 8:00 PM Home remedies? - Tylenol at 0700, 600 mg ibuprofen at 11:30 Any improvement? - none Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.
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| 54 | 2021-01-07 | tingling |
right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. ...
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right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. Took Benadryl and Zyrtec...symptoms subsided.
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| 54 | 2021-01-07 | tremor |
Symptoms started 1/5/2021 around 6:00pm lasted about 36 hours. headache mild fever fatigue Lt calf p...
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Symptoms started 1/5/2021 around 6:00pm lasted about 36 hours. headache mild fever fatigue Lt calf pain tremors on Lt thumb - until today still with mild tremors episodes of dry cough
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| 54 | 2021-01-08 | migraine |
12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning ...
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12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning fever 101.9, severe chills, severe aches of lower back, hips, joints, loss of appetite these symptoms continued thru 01/02/21 01/03/21 fevere abated, still body aches but much less severe, fatigue 01/04/21 fatigue only slowly resolving
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| 54 | 2021-01-08 | tingling, numbness |
Had COVID vaccine #1. Developed a numbness and tingling sensation in hands and legs at 10:45a. Deni...
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Had COVID vaccine #1. Developed a numbness and tingling sensation in hands and legs at 10:45a. Denies any rash, mouth/throat swelling, difficulty breathing, itching, wheezing, or racing heart. Check vitals: O2 98% HR 72 BP 118/80 Monitored until 11:20. Rechecked periodically and her symptoms resolved. Advised that if symptoms return then go to ER. Discharged home.
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| 54 | 2021-01-09 | hot flush |
Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-l...
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Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-like sx) with first dose. She began experiencing feeling like she was outside of her body about 10 min after receiving her booster. BP was taken and was slightly elevated 140s/90s. Ice packs were provided for hot flashes. Warm blankets provided for chills. BP was trending up to SBP 160s then started to decline to normal. Patient was accompanied to restroom by clinic staff and was able to walk without incident. Patient was observed in covid clinic for total of 2 hours and reassured that she was not likely to have worsening of sx at this point. Patient was walked to mother's car by clinic staff and left feeling better. 1/10 - patient presented to ED with low grade fever (100.4), chest pain, severe joint and muscle pain, nausea and "fog brain." She reports BP being 187/101 in ED. Given 1L of normal saline, zofran, toradol, and dilaudid. Observed until BP drcreased to SBP 140s. Nausea improved enough to allow her to eat. Labs were WNL, CK normal. Discharged home with diagnosis of "adverse effect of COVID-19 vaccine"
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| 54 | 2021-01-09 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA Beginning the day of vaccine, very sore upper left arm for 2 d...
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Pfizer-BioNTech COVID-19 Vaccine EUA Beginning the day of vaccine, very sore upper left arm for 2 days. Moderate headache beginning on day after vaccine, lasting for one day.
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| 54 | 2021-01-10 | feeling hot, tingling, flushing, numbness |
30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and...
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30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and tingly, she passed out at her desk and was taking to the ER for evaluation. Benadryl & Solumedrol Admin with hydration with NS. Pt discharged from ER. Pt in ~10am discharged from ER ~2hrs later.
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| 54 | 2021-01-10 | hot flush |
Within minutes I became flush and very hot. My heart starting racing. I had blood pressure check an...
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Within minutes I became flush and very hot. My heart starting racing. I had blood pressure check and heart rate.
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| 54 | 2021-01-10 | pain in extremity, numbness, muscle spasms |
Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps ...
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Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps in arms and legs. Feelings of restless, stomach upset. Knee charley horses.
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| 54 | 2021-01-10 | pain in extremity |
Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she descri...
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Pt received second dose of Pfizer COVID vaccine and felt fine. About 10-15 minutes later she described arm pain that radiated up to her left jaw and chest. At this time we recommended she be escorted to the Emergency Department for assessment. This was completed and she was later released home without any longstanding concerns.
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| 54 | 2021-01-10 | pain in extremity | Fever and headache next day; sore arm next day; headache and sore arm lasted through 1/11/21 |
| 54 | 2021-01-10 | cold extremities | Rigors, hands and feet felt frozen Temp spikes up to 103.7 lasted 2 days |
| 54 | 2021-01-11 | weakness |
crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; havi...
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crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.
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| 54 | 2021-01-11 | bell's palsy | Bell's Palsy |
| 54 | 2021-01-11 | flushing |
Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right...
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Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right after injection for 2 days Moderate Pain at the injection site for 5 days Muscle weakness and aches, mild for 2 days Difficulty with concentration Feeling tired for a few weeks
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| 54 | 2021-01-11 | hot flush, pain in extremity |
Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soren...
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Approximately 2 hours after the vaccine, I had flushing feeling, no elevated temperature. Arm soreness, nausea. I also checked my b/p. It was more elevated than usual. (130/90?s). These symptoms subsided 24-48 hours after the vaccine.
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| 54 | 2021-01-11 | migraine |
I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that ...
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I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that helped. A little soreness at the injection site nothing extraordinary. I had the vax on a Monday and the last migraine I had was maybe on Friday the same week. I received the second dose yesterday and now I have a headache, low grade fever (99.9F about 8AM this morning) and body aches. Just treating myself at home. The headaches I have now are different, in a difference place in my head, they are lighter, it feels more like the headache you have when you have fhe flu.
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| 54 | 2021-01-11 | night sweats |
Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizzi...
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Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizziness, joint pain
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| 54 | 2021-01-11 | pain in extremity |
I had soreness in my left arm for 2 days. Muscle aches for 1 day. I had a headache on 12-24-2020. I ...
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I had soreness in my left arm for 2 days. Muscle aches for 1 day. I had a headache on 12-24-2020. I also had chills on 12-25-2020 with muscle aches. The muscle aches got worse on 12-26-2020 and that's when I visited an urgent care center. At the ER they did a nasal swab test, covid test.
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| 54 | 2021-01-11 | pain in extremity |
rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable...
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rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) via an unspecified route of administration in left arm on 28Dec2020 11:15 at single dose for COVID-19 immunisation. There was no medical history. The patient only takes vitamins; has no underlying conditions. There were no concomitant medications. 20 years ago, the patient had flu like symptoms after the Flu vaccine. Last vaccine was a Tetanus shot 8-10 years ago. The patient received COVID-19 vaccine through hospital on 28Dec2020 at 11:15 in left arm. Left arm soreness noticed in morning on 29Dec2020. Forty-eight hours later (15:00 on 30Dec2020) had a rash on her belly and torso area. Rash was no where else. Is due to get second dose on 18Jan2021. She wants to know if it is OK to receive second dose. Clarified she is referring to the Pfizer COVID-19 Vaccine. Clarified soreness was noticed only in the injection arm. Was noticed in morning. Noticed rash at 15:00 on 30Dec2020. She took benedryl x 3 doses and the rash and symptoms were gone on 31Dec2020. Event outcome of rash on her belly and torso area was recovered on 31Dec2020, while for others was unknown.
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| 54 | 2021-01-11 | pain in extremity |
HA resolved with Tylenol. Achy, chills and arm soreness resolved with Ibuprofen. All symptoms comple...
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HA resolved with Tylenol. Achy, chills and arm soreness resolved with Ibuprofen. All symptoms completed resolved.
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| 54 | 2021-01-12 | weakness | NAUSEA AND VOMITING, WEAKNESS AND DIZZINESS, FATIGUE, SORE MUSCLES |
| 54 | 2021-01-12 | pain in extremity, cold sweat |
Vaccine was given 1/12/21 at 10am, 3pm having chills and slight sore on L arm, 6pm chills continues...
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Vaccine was given 1/12/21 at 10am, 3pm having chills and slight sore on L arm, 6pm chills continues and head pressure ( took Tylenol ) 8pm body aches, stiffness back of my neck, soreness on L arm worsen. Next morning 1/13/21 L side arm, back and neck stiff, soreness and backaches, and also chills, hands are clammy and headache.
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| 54 | 2021-01-12 | pain in extremity, feeling cold |
Chills and headache. Took extra strength Tylenol for the headache shortly after going to bed (around...
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Chills and headache. Took extra strength Tylenol for the headache shortly after going to bed (around 10pm). Still felt a slight headache the next morning (5:30am) and took two more tablets. Felt fine after that. I felt kind of cold during the evening, but by the time I went to bed around 10pm, that was when the chills had hit full force. I could not get warm enough. I continued to increase the temperature of my electric blanket and was not comfortable until I was at a 6 out of 10. When I woke up the next morning the chills were gone. Also experienced soreness in the left arm.
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| 54 | 2021-01-13 | feeling cold |
Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing,...
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Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing, shooting pain in right parotid glands; General feeling of unwellness; This is a spontaneous report from a contactable nurse. A 54-years-old female patient started to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL0142, on 06Jan2021 (at the age of 54-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included chronic granulomatous disease. Concomitant medication were unspecified. The patient previously received the first dose of BNT162B2, Lot number: EK5730, on 17Dec2020, administration time: 08:00 AM, in the left arm for covid-19 immunization. The patient previously took Oxacillin and Levaquin and experienced allergies. The most recent COVID-19 vaccine was administered in the workplace clinic. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Jan2021 09:30, the patient experienced arm soreness, huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellnessThe events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness was recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 54 | 2021-01-13 | flushing | c/o dizziness, SOB, hives, "flushed" |
| 54 | 2021-01-13 | muscle spasms | TEMP LOSS SENSE OF TASTE BODY ACHES, MUSCLE CRAMPS, FATIGUE SEVERE HEADACHE DIZZINESS LIGHT HEADED |
| 54 | 2021-01-13 | pain in extremity |
sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling we...
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sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling well
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| 54 | 2021-01-13 | pain in extremity | Rash and redness around injection site Arm soreness Chills Fever |
| 54 | 2021-01-13 | pain in extremity | Arm soreness |
| 54 | 2021-01-13 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-ye...
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Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), via an unspecified route of administration on 22Dec2020 at 13:30 at single dose at left arm for COVID-19 immunization. Medical history included hypertension and hypothyroidism. The patient had no known allergies and no allergies to medications, food or other products and patient was not pregnant. The patient's concomitant medications were not reported. On 22Dec2020 at 13:30, the patient experienced sore arm. There was no therapy received for the event. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had other medications that was received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
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| 54 | 2021-01-13 | pain in extremity |
I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within...
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I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within 24-48 hours ~ except the Right Axillary Lymph Node Swelling and Pain ~ This is still currently present, please let me know if you want me to let you know when this last symptom/reaction resolves?) Fatigue Sore Right Arm (injection) Chills Fever Headache Cough Right Axillary Lymph Node Swelling and Pain
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| 54 | 2021-01-13 | pain in extremity |
Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm ...
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Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm pain. Took tylenol and tramadol for pain and fever.
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| 54 | 2021-01-13 | tenderness, pain in extremity |
1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this...
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1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this document 1/14/21 08:00 07:30 increased dry cough, scratchy throat 08:30 sore throat 09:30 mild headache and muscle aches, sore throat, cough when talking 10:30 increasing muscle aches and headache, laryngitis, cough resolving, mild intestinal discomfort 11:00 left work 11:30 all symptoms at 10:30 continuing, increasing fatigue; took 1000mg acetominophen slept most of the time noon - 4 pm 4pm cough resolved, muscle aches continued, headache improved, laryngitis continued. mild fatigue 6:00 pm noted loss of smell (could not smell cooked garlic - my husband could) Laryngitis & muscle aches continued throughout evening 7:30 pm 2nd dose 1000mg acetaminophen 1/14/20 - 06:00 am laryngitis resolved Ongoing scratchy throat, mild muscle aches, mild nausea/intestinal discomfort. Laryngitis and cough mostly resolved - but i am not talking much; speech is an irritating factor for both symptoms. Fatigue improved. Headache mostly resolved. Took 1000 mg acetaminophen.
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| 54 | 2021-01-13 | tremor, feeling cold |
She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; s...
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She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-14 | weakness |
Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She ...
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Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She felt a sudden weakness from head to toe and felt an impending sense of doom. She began to feel dizzy and panicked. EE moved to evaluation area at 1333. HR78 BP 174/96 O@ 97%RA. Pt was anxious and noted BP was high for her. FNP continued chatting to EE. EE declined the ED at this time. A&O x4. 1350 HR 75 BP 151/94 O@97%. EE reports feeling much beter. EE opted to wait in the observation area an additional 30 minutes, declining again to go to ED for further evaluation. EE will call if her condition changes.
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| 54 | 2021-01-14 | cold sweat, flushing |
Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccin...
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Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccine.
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| 54 | 2021-01-14 | facial paralysis |
1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen,...
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1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen, headache and chills by afternoon mouth and right eye was drooping. Was prescribed RX prednisone on 1/15/2021. Current symptom (1/15/2021) is mouth drooping, other swelling and eye drooping resolved. Reports has occurred twice before. About 7 years ago with unknown etiology, lasted for about 6 months, Occurred again about 5 years ago with unknown etiology and lasted about one month.
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| 54 | 2021-01-14 | one side paralysis |
Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakn...
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Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakness in my right hand had become progressively worse since dec 30 or 31 st . Had the second shot on Jan 11 . In last 2 data I am having trouble holding a mug or iPhone in right hand . It feels very numb From Jan 12 to today my right hand is having trouble gripping pen , hair brush , difficult to open doors .
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| 54 | 2021-01-14 | pain in extremity |
Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hour...
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Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hours. Mysugar climbed to 250 by dinner time. By bed tme my sugar was 300. I did not eat dinner. I had no appectite. I increased my insulin and metformin dose. I had chills and fevery thru the night and the next day. High fever 101. I treated this with tylenol and showers. I was really sleepy all day. I had little to eat and still my sugar was 300 most of the day. on Jan 6. I woke up and had a hemmorrhage in my right eye. I called my retinol specialist and and received an injection of Eylea on Jan 7, 2021
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| 54 | 2021-01-14 | pain in extremity |
Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, head...
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Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Nauseous with injection.; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), intramuscular at left arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included migraine and No known allergies. Concomitant medication included sumatriptan succinate (IMITREX), fluoxetine hydrochloride (PROZAC). The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization at right arm on an unknown date. The patient experienced nauseous with injection on 08Jan2021. Next day (09Jan2021), she had sore arm, neck, body, headache, tired chills, afebrile. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information about lot and batch number was requested.
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| 54 | 2021-01-14 | pain in extremity |
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose...
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Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose was 89 in the morning. by 1400 hours my glucose was 250. By bed time it was 300. I did not eat dinner and adjusted my insulin and took an extra 500mg metformin. I had chills and fever through the night and all the next day. Fever 99 to 101. Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also. I woke up on Jan. 6, 2021 with a hemorrhage in my right eye. I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021., He asked that I report this advers reaction.
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| 54 | 2021-01-14 | pain in extremity | Fever 100.4, headache, nausea, body aches, right arm soreness |
| 54 | 2021-01-14 | tingling, pain in extremity |
12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet...
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12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet to legs. I called office and put on prednisone for 3 days. Then another 7 days prescribed; 12/23rd 1st vaccine; The same day, I was having the tingling and pain came back after the shot. But I still had had from flu shot, it just came on stronger. It wasn't as bas as after the flu shot. Took another 10 days of prednisone. 1/13/2021 2nd vaccine; sore arm, little tired. But could be as I had to wake up early.
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| 54 | 2021-01-14 | tremor, feeling cold, numbness |
I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate...
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I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate 1/2 banana and drank some water. I started to drive home. It felt like a huge cold railroad spike was being driven up the top of my shoulder to my neck, it was a cold sensation anteriorly and posteriorly on my neck. Then my face (left side) started to go numb, it started just about the top of my left ear and went all the way to my lips. It stopped midline. It felt like a dental block. I could still swallow and breathe. I started shaking, felt nausea, my upper esophageal sphincter started to spasm. I kept checking my tongue and airway to see if I should pull over and call 911. I drove to the ER. My left side of face was numb, I was trembling, tremoring. They gave me small dose of IV Bendadryl (12.5 mg) and Pepcid, I slowly started to feel better and the feeling came back to my face moving from midline lip to cheek. It still felt "funny" but much better. I was in the ER for around 2 hours. I have had more tremoring since my vaccine in my neck and hand (I do have primary essential tremors but it is tremoring much more now) and more neck pain (could be due to the increased tremors)
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| 54 | 2021-01-14 | tremor, numbness |
1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SV...
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1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SVT with first dose of some new medications. Pt reports intermittent SVT and PVCs post ablasion. HR 136, regular rhythm. 1828: 176/101 (119), HR 108, Resp 22, 99% on room air Pt reports feeling like her HR is returning back to normal, hand tremors continue. Reports mild shortness of breath, which is typical with her SVT episodes. 1831: 151/82 (98), HR 81, regular rhythm, Resp 12, 98% on room air. Denies any worsening or any additional symptoms. Hand tremor no longer present. 1839: 151/104 (113), HR 76, regular rhythm, Resp 10, 98% on room air. Pt reports headache and mild nausea that is typical with her SVT episodes. Pt appears relaxed sitting in chair. 1845: HR 78, regular rhythm. Pt remaining in monitoring area for 15 additional minutes. No s/s further distress. Pt calling husband to take her home. 1905: BP 157/91 (107), HR 87, regular rhythm, 98% on room air, Resp 14 Pt c/o numbness to L arm with some L chest tightness. Reports this sometimes happens with her SVT episodes. 1907: No further chest tightness or L arm numbness. Pt reports feeling anxious. Does not want to go to the ED for further monitoring. Continues to report that her symptoms feel typical after her SVT episodes with some additional nausea. 1910: 132/112 (117), HR 78, regular rhythm. Pt reports improvement of symptoms. Pt relaxed in chair. Instructed pt to stop and call 911 if she has any concerning symptoms after leaving clinic including difficulty breathing or HR abnormalities.
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| 54 | 2021-01-17 | weakness |
I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed...
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I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed. I woke up again at 6:30 with the same horrible headache not relieved at all by Maxalt so I took another dose. I had vertigo so I went back to bed. I woke up at 8:00 still with the horrible headache and vertigo but had horribe nausea. I never vomited. I felt weak all day, had no appetite and my neck felt very stiff all day. In the evening my knees were aching. The next day I continued to have a mild headache and neck stiffness.
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| 54 | 2021-01-17 | feeling cold | Fever, chills, body aches, malaise, headache |
| 54 | 2021-01-17 | pain in extremity |
54-year-old female presents for evaluation and treatment of right arm pain. Received the 1st dose of...
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54-year-old female presents for evaluation and treatment of right arm pain. Received the 1st dose of her covid-19 vaccine on 01/07. She initially had some soreness but that resolved over the following days. Her pain returned couple of days ago and has been significantly worse. She has not noticed any systemic signs of illness. No darkening of her urine. She has tried heat and ice. She took 1 dose ibuprofen. Pain is radiating up to her shoulder. It is worse with any kind of movement. Recommend ibuprofen 400 mg 3 times a day and given the muscle soreness will treat with a muscle relaxer.
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| 54 | 2021-01-18 | flushing | Flushed, elevated heart rate |
| 54 | 2021-01-18 | migraine, pain in extremity |
Fever; Severe chills; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips,...
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Fever; Severe chills; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; started with slight headache by that evening migraine level headache; started with slight headache by that evening migraine level headache; Fatigue; This is a spontaneous report from a contactable other-HCP (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was hospital. Medical history included degenerative disc disease, obesity, high cholesterol, high blood pressure, migraines. The known allergies included adhesive, mango, banana, compazine, demerol, codeine. Concomitant medication included gabapentin and meloxicam. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 29Dec2020 with outcome of recovered, started with slight headache by that evening migraine level headache on 31Dec2020 with outcome of recovered, fever on 01Jan2021 early am with outcome of recovered, severe chills on 01Jan2021 with outcome of recovered, severe aches low back, legs, hips, joints on 01Jan2021 with outcome of recovered. The outcome of event was recovered in 03Jan2021, other events were recovered in 02Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
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| 54 | 2021-01-18 | night sweats |
severe headaches; night sweats; severe bone crunching chills; light headedness/feeling faint; fever;...
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severe headaches; night sweats; severe bone crunching chills; light headedness/feeling faint; fever; muscle and joint ache/pain; muscle and joint ache/pain; nausea; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162b2 (lot: EK 9231), via an unspecified route of administration in left arm on 26Dec2020 12:30 at single dose for covid-19 immunization. Medical history included subclinical hypothyroid, Premature ventricular contractions (PVC's), Migraines. Concomitant medication included metoprolol succinate (TOPROL), fesoterodine fumarate (TOVIAZ), levothyroxine, omeprazole, "multi v". The patient experienced severe headaches, night sweats, severe bone crunching chills, light headedness/feeling faint, fever, muscle and joint ache/pain, nausea on 28Dec2020 02:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received the urgent care, lab tests for these events. The patient's results of covid tests (Nasal Swab, covid swab) were Negative on 31Dec2020 and 05Jan2021. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
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| 54 | 2021-01-18 | pain in extremity | sore arm for 24-48 hours...like a bruise, but it didn't keep me from doing anything. |
| 54 | 2021-01-18 | tingling | Body aches, Chills, fatigue, joint pain, arm tingling, sneezing. Took Tylenol and Claritin |
| 54 | 2021-01-19 | inability to speak |
On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and...
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On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and shoulders. Along with aching all over. Over the course of the day, I started to feel bad. Then on Monday January 18, 2021, in addition, to the joint pain, I started feeling disoriented, dizzy like spells of vertigo. I went to my PCP who did lab work and all was normal. He said it muse be delayed reaction to the vaccine. Later in the day, I was having difficulty putting words together and more dizzy and very lethargic. I laid down and slept until the next morning. (Tuesday 1/19/21) On Tuesday 1/19/21, they symptoms were improved but still had some dizziness. On Wednesday 1/20/21, the symptoms have improved except for an occasional dizzy spell.
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| 54 | 2021-01-19 | flushing |
Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest ...
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Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest pain, palpitations--Treated with EpiPen onsite, Ambulance--Epi/O2/Monitoring---ER IV benadryl/ IV Solumedrol/ IV dexamethasone--Sent home 5 hrs later with oral benadryl and predinsone
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| 54 | 2021-01-19 | pain in extremity |
2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat any...
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2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat anything). Started on 1/6 in morning and gone by night of 1/6.
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| 54 | 2021-01-20 | pain in extremity |
sore and swollen left arm within a couple hours, later same day some fatigue, next day some aches, ...
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sore and swollen left arm within a couple hours, later same day some fatigue, next day some aches, and low grade temperature. Mild headache started suddenly around 8 hours after injection and continued for about 16 hours.
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| 54 | 2021-01-20 | tingling |
Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identifie...
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Patient reported throat and mouth tingling approximately 10 minutes after vaccination. She identified herself to staff. She stated that she usually takes Benadryl when she has these symptoms. She had an elevated blood pressure at the time (BP= 180s/110s. She proceed to take 50mg Benadryl. Approximately 20 minute later, she developed coughing and continued tingling of her perioral area and that the tingling was extending to her nose and forehead. At which time, she said that she would use her Epipen at such a time. She self administered an Adult Epipen. Approximately 10 minutes, her symptoms improved. She continued to cough and have elevated BP. She was transported via EMS to the nearest ER in stable condition.
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| 54 | 2021-01-21 | weakness | SORENESS AT SIGHT, NO ENERGY/ SWOLLEN LYMPH NODES |
| 54 | 2021-01-21 | numbness |
It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food ...
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It felt similar to the beginning of an anaphylactic reaction I had a few years ago to a random food (never found out what the allergen was). About 20 minutes after receiving the vaccine, my throat felt strange, my sinuses started getting congested, my ears started plugging. I felt dizzy when walking. I spent extra time at the clinic under observation. About 40 minutes after receiving the vaccine, I suddenly felt like I was being sucked into a vacuum and thought I was going to pass out. I alerted the nurses, who checked my vital signs and put me on O2. My heart rate was normal, my BP was high, my O2 sat was 100%. After about 5 minutes I started to feel normal, they removed the O2. They continued to observe me for another 15 minutes, until I felt better. As I drove home (about 1 hour 10 min after receiving the vaccine), my face and lips became numb. I continued driving home and the numbness resolved in about 10-15 minutes. I notified my doctor of the event and she advised me not to get the second dose and to report the event.
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| 54 | 2021-01-21 | muscle spasms, numbness |
Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk...
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Two hours after the injection both of my leg seized. The muscles so tight that I was unable to walk (like a spasm). There was no twitch the a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body) . I also had bilateral jaw pain (not sure if its was because I was in so much pain in the legs that I was clenching my teeth) I also had slight numbness on by left face and by the evening I had redness on my left cheek but it went away. My face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw.
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| 54 | 2021-01-21 | pain in extremity |
Extreme arm soreness, body aches, joint pain, headache, chills , congestion, runny nose, and fever u...
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Extreme arm soreness, body aches, joint pain, headache, chills , congestion, runny nose, and fever up to 100.9 even on Tylenol. Symptoms were more than moderate. Had to alternate Tylenol and Advil every 3 hours for fever. Arm soreness started just hours after shot and hurt even when arm was stationary. Other symptoms started overnight and lasted through the next night. Received shot We?d at 4:30 and took until Friday for major symptoms to subside. Still with some congestion, runny nose and tiredness as of today (Friday).
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| 54 | 2021-01-21 | tingling, difficulty speaking, flushing, numbness |
Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezin...
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Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezing, difficulty breathing. Transported to ER
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| 54 | 2021-01-21 | tremor |
was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with s...
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was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with slight low blood sugar , known by slight tremor in hands and body and also resolving 30 min after eating proteins and drinking orange juice. A few hours later around 5pm began getting headache, ate dinner and did not resolve so I took 100mg of Tylenol . could not sleep and was awake until 1am woke at 930 am with low sugar again resolved after eating and drinking orange juice. Had a headache less severe only took 500 mg of Tylenol it resolved. Stayed awake all day was fatigued. no other remarkable symptoms the rest of the day. the next day was about the same only less severe and by the fourth day I only noticed being tired during the day. I think it resolved completely by the 7th or 8th day I lost track due to my step mother coming out of rehab after having had COVID in December. as I write this I am fine and it is 1/22/21
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| 54 | 2021-01-22 | difficulty speaking, tingling, pain in extremity, numbness |
Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45...
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Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45 while driving home, experienced numbness and tingling in my whole face like receiving a novacaine injection at the dentist. A few minutes later experienced tachycardia. A few minutes later, experienced a walnut sized lump in my throat that was more evident with swallowing. Voice was also raspy, but did not experience any difficulty breathing. Got off the highway and went to a hotel lobby to call 911 as my cell phone battery was about to die. This was around 12 noon. BP was 160/94 which is high for me; usually runs 90-95 systolic. Was transported to the ER. Next BP was 150/84. Upon arrival to the ER, the symptoms described had not worsened. Was discharged later that day around 5 PM. No treatment was administered. The next day, arm very sore, had joint aches and felt tired. By 1/23/2021 had mild arm soreness without other symptoms.
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| 54 | 2021-01-22 | pain in extremity | Fever, chills, body aches, fatigue, left arm pain, nausea |
| 54 | 2021-01-23 | pain in extremity |
The day after injection I had the normal soreness of left arm, achiness , and fatigue that lasted al...
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The day after injection I had the normal soreness of left arm, achiness , and fatigue that lasted all day. At approximately 6:00 pm I noticed some red spots on my abdomen and by 10:00 pm the rash/hives had spread all over my abdomen. The next morning (Friday 1/22/21) it had spread to my chest and back areas and small areas on my legs. A PA recommended I take Zyrtec and Pepcid. I called my PCP's offices and they recommended I continue doing that. Saturday I continued to have rash all over and itchiness and some soreness. I went to an Urgent Care at 5:30 pm) and the PA there gave me a shot of epinephrine and called in a Rx for a stronger antihistamine. Today, Sunday (1/24/21) I still have the rash/hives. I'm not sure what Rx was called in, I have to pick it up this morning.
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| 54 | 2021-01-24 | numbness, pain in extremity, tingling, tenderness |
The evenin of receiving vaccination I felt "normal" discomfort; pain, tender to touch and movement. ...
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The evenin of receiving vaccination I felt "normal" discomfort; pain, tender to touch and movement. The following morning I felt pain/discomfort radiating from should downward but also felt a tingling/numbing sensation radiating down left arm. Arm tingling subsided by end of day of 1/20/21, however, two fingers continue to have a tingling/numbing sensation - ring and middle finger of left hand
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| 54 | 2021-01-24 | pain in extremity, breast pain |
Very sore right arm radiating under my arm, neck, and right breast area. Very tender to palpate lym...
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Very sore right arm radiating under my arm, neck, and right breast area. Very tender to palpate lymph nodes under right arm and neck. Tender right breast as well. Symptoms from the first night after the second vaccine and still 13 days later.
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| 54 | 2021-01-24 | pain in extremity |
Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm...
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Extreme pain with swelling of left upper arm at injection site. Pain and swelling continues down arm to hand. Started 1/20/2021 and continues to worsen. Pain unbearable.
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| 54 | 2021-01-24 | pain in extremity |
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continu...
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On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain. Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week. Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/ arm and neck. Clicking in the joint with rotation movement. Spoke to Director of Rehab and advised to contact CDC and seek medical care. Call placed to PCP 1/23/21 with office closed for weekend. Due to non-urgent symptoms, opted to wait for appointment on Monday. Continued pain and symptoms through the weekend with feeling of instability in the shoulder. Spoke to CDC for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
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| 54 | 2021-01-24 | pain in extremity |
I had a sore arm for the day and then it was gone. Sunday morning, I woke with my face hot and red w...
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I had a sore arm for the day and then it was gone. Sunday morning, I woke with my face hot and red with a rash on my chin, forehead and left cheek. The second week, my chin started burning and my face was covered in a dermatitis rash. I saw the dermatologist for this.
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| 54 | 2021-01-24 | tingling, difficulty speaking, numbness |
Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg ...
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Patient had her second dose of Covid Vaccine.. She has hx of anaphylaxis, so she took bendryl 50 mg before bed last night and then took 10 mg Zyrtec before getting the shot. She states about 15 mins after administration she began to have numbness and tingling of her hands, forearms, lower legs, neck, face and lips. She came to ER was monitored for a few hours, about 3 hours post administration while in ER her voice became more hoarse and she noticed edema under her eyes bilaterally. Pt was given 25 mg IV bindery and remained under observation for another 1.5 before being DC. She maintained airway the entire time, VSS and AOX4;
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| 54 | 2021-01-25 | discomfort |
I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid...
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I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid-19 and I was having some of those symptoms- very painful headache, terrible lower back pain , very tired, upset stomach and sore at injection site. I couldn't get comfortable . I started taking 3 Tylenol ES, Ibuprofen 800mg, and Pepto Bismol at same time every 4 hours. After about 18 hours I started feeling normal. The testing site told me some people are having reactions.
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| 54 | 2021-01-25 | feeling hot, feeling cold |
After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your abo...
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After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your about to pass out. Then tightness of chess where its hard to breath. EMS were around to give me 2 shots of Epi one at a time with the interval of about 5 to 15 minutes. the first Epi was OK but still having hard time breathing and the second one feels a lot better but cant stop shivering's. then I was transferred to emergency room and treated also with some allergy med. (Benadryl administer through IV)
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| 54 | 2021-01-25 | flushing | Felt flushed and nauseated |
| 54 | 2021-01-25 | pain in extremity |
axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection ...
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axillary was tender and occasionally painful; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; 50 cent size lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site; patient received the covid vaccine on the 30Dec had a sore arm; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at single dose on the arm for COVID-19 immunization. The patient medical history included "had classic symptoms of COVID, but had a negative COVID test" on Dec2020. Concomitant medications were not reported. The patient previously had a Tetanus vaccine 23 years ago. After receiving patient spiked a fever 101 and cellulitis at the site. Reporter explained she is not 100 percent sure. She is not sure if the nurse used the DTap abbreviation and truly administered the Tetanus shot. Reporter indicated she is not sure which preparation patient got. Patient received the vaccine on 30Dec2020 and her arm was sore that day when went to bed. The next morning (31Dec2020) the site was tender. She then noticed a nickel size (as reported) red lump that had disappeared on 03Jan2021 (The next day she had tenderness and redness that went away after two days). Patient noticed the 50 cent size (as reported) lump on the side of her arm at injection site that was raised, warm, red, and tender at the injection site the morning of 31Dec2020, an exact time was not specified. On 07Jan2021 he had a 50 cent size lump on the side of her arm at injection site in arm received injection that was raised, warm, red, and tender at the injection site. On 07Jan2021 her axillary was tender and occasionally painful. On 08Jan2021 it returned to injection site at 1. That day at 6:30 PM on 08Jan2021 she had an area she had a 50 cent size area that was raised, red, and warm. She took Benadryl the next day. The morning of 09Jan2021 she woke up and had more redness tenderness in her arm, therefore, she called her doctor. Her doctor ordered an antibiotic. On 11Jan2021 they entered in the follow-up notes she had slow improvement even though the axillary area is still painful. Reporter explained it sounds like events are slowly improving, they are not completely resolved. Reporter stated it is so weird that the sore arm went away, disappeared, and then came back again. The final outcome of the events was recovering. The adverse events di not require a visit to the emergency room or physician office. The events were as assessed as non-serious by reporter. The causality of events was considered as related by reporter. Information on the Lot/Batch number has been requested.
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| 54 | 2021-01-25 | tingling, flushing |
Face became flushed after approx. 15 mins. Also had slight tingling in left arm (arm of the injecti...
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Face became flushed after approx. 15 mins. Also had slight tingling in left arm (arm of the injection). No flush or rash on the body. Symptoms subsided with a couple of hours
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| 54 | 2021-01-26 | weakness, flushing, tremor |
Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little we...
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Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
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| 54 | 2021-01-26 | feeling hot |
I had a red hot rash on my face that lasted about a week. During the night, I woke to my face cover...
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I had a red hot rash on my face that lasted about a week. During the night, I woke to my face covered all over after being clear at bedtime.
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| 54 | 2021-01-26 | feeling hot |
I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot....
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I had a bullseye rash about 7cm circular and 5 inches below the injection site that was red and hot. It was there for two days and went away. I had a 2.5cm hot spot on my chin and the left cheek saw red and hot.
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| 54 | 2021-01-26 | pain in extremity |
Shortly after injection my arm felt was sore as if I just had a flu vaccine. Approx 1930 my arm then...
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Shortly after injection my arm felt was sore as if I just had a flu vaccine. Approx 1930 my arm then felt as if I just had a tetanus booster then followed by chills, body aches, had 100.5-101 fever (on Friday). Chills on Friday resolved while taking Tylenol as well as body aches. continued with Tylenol 1000mg every 6 hrs. Saturday woke up with no fever, chills body aches resolved.
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| 54 | 2021-01-26 | cold extremities |
1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. ...
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1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. 1651: no symptoms BP 111/86, HR 54 1705: Hands colder than normal 1708: observed for 30 minutes; BP 127/68; HR 53; still cold hands. off balance, neck pain. 1717: continues to report feeling off and didn't wan tto leave. moved to chair for more observation and given crackers. 1726: Warming up, felt normal, felt okay to leave. Release home.
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| 54 | 2021-01-27 | migraine |
Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable ...
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Dizziness; Severe migraine; Nausea; Blurred vision; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3246, expiry: unknown), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included lupus SLE and known allergies with Stadyl. Concomitant medications included ascorbic acid (ESTER-C [ASCORBIC ACID]) and prednisone. The patient had no other vaccine in four weeks. The patient experienced severe migraine, blurred vision, dizziness and nausea on 12Jan2021 at 14:00. The patient was tested for Covid prior to vaccination but was not tested post vaccination. The events were not treated. The outcome of the events was recovering.
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| 54 | 2021-01-27 | pain in extremity |
She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty ly...
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She noticed redness, itchy swelling around the injection site, along with a sore arm and a shotty lymph node in the right axilla
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| 54 | 2021-01-28 | discomfort |
her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle sor...
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her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle soreness in left arm at injection area after receiving the second dose; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, expiration date: May2021), intramuscular on 12Jan2021 09:00 at 0.3 mL, single on left arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received her first dose of BNT162B2 on 22Dec2020 around 08:15am to 08:30 am, intramuscular injection in left arm. The dose she received was 0.1ml (lot number: EH9899). The patient received flu shot on Nov (no year reported). The patient experienced headache on 12Jan2021 and muscle soreness on 13Jan2021 in left arm at injection area after receiving the second dose. Her headache was not very strong. It was mild headache since she took Tylenol. She clarified it recovered completely as of yesterday (14Jan2021). When querying seriousness, she states it was a normal side effect so she did not think it is serious. She reported her body felt uncomfortable, and she cannot explain what it was happening, she did not have shortness of breath or diarrhea or anything. States it was like she got flu vaccine and had pain at injection site for a little bit. She received the flu vaccine in Nov (no year reported) and she does not know the name of the flu vaccine. The patient recovered from headache and muscle soreness/muscle soreness in left arm at injection area after receiving the second dose on 14Jan2021. Outcome of the rest of the events was unknown.
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| 54 | 2021-01-28 | feeling hot |
About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of ...
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About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of a panic attack. She tried to walk outside for fresh air, but had to sit down after about 20 feet of walking. She reported more nausea, feeling very hot, and had a hard time communicating. She was given a cool washcloth and fanned while being held up by a support person. Her blood pressure was initially high, and rose significantly over a period of about 5 minutes. Blood sugar was checked and was 475 mg/dL. 911 was called, and after about 10 minutes of supportive care paramedics transported her to the hospital. She was fairly limp at time of transport and had a hard time standing. The facility staff updated me several hours later that they had heard that she was doing well. It appeared to be a panic attack.
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| 54 | 2021-01-28 | feeling hot | Whole body hot, then general malaise, cephalgia and insomnia. |
| 54 | 2021-01-28 | flushing |
Patient felt anxious, flushed, and itchy. She reports hives over her chest and feeling lightheaded,...
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Patient felt anxious, flushed, and itchy. She reports hives over her chest and feeling lightheaded, though this was likely secondary to anxiety. Denies any other symptoms, SOB, throat swelling, abdominal pain, or nausea.
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| 54 | 2021-01-28 | pain in extremity |
pt states she has sore left arm around the injection site and looks like she had two injection marks...
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pt states she has sore left arm around the injection site and looks like she had two injection marks. Pt states she has had headaches and pain in the clavicle area with swelling in her lymph nodes on the left side.
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| 54 | 2021-01-28 | pain in extremity |
After I received my first dose around 8PM the pain in my right arm started. I could not move my arm,...
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After I received my first dose around 8PM the pain in my right arm started. I could not move my arm, the pain was unbearable, like someone had hit me several times with a baseball bat or something similar. I couldn't sleep due to the pain. It lasted for about 2 days. No other symptoms other than the awful excruciating pain.
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| 54 | 2021-01-29 | flushing, tingling |
20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing...
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20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing. Did not progress, waxed and waned. Had more flushing later, took benedryl. Went to Urgent care, advised benedryl to continue, but did not feel there was any cause for concern. Day after injection, mild flushing at times, and diffuse mild itching including scalp, face, particularly borders, and general arms, legs, torso. No rash, hives, and itching not aggressive, just mild. Persisted for about a week. Feel anxiety may have played role. Continued with benedryl. Had telehealth visits with PCP and with allergist. Resumed taking zyrtec daily with additional dose in pm- symptoms resolved. Not felt to be "serious" reaction by either MD, feel it is ok to have 2nd dose.
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| 54 | 2021-01-30 | migraine |
Severe headache (migraine) lasting 16 hours, nausea and vomiting, fever 101 for 6 hours, severe fati...
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Severe headache (migraine) lasting 16 hours, nausea and vomiting, fever 101 for 6 hours, severe fatigue, body aches, injection pain hot and very sore and hard.
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| 54 | 2021-01-31 | feeling cold |
Same symptoms as after 1st vaccine. starting about 12 hours post injection I developed chills, feve...
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Same symptoms as after 1st vaccine. starting about 12 hours post injection I developed chills, fever, could not get warm, joint pain-specifically low back, hips, shoulders, achy all over, headache, nausea. Slept poorly. Woke up the next morning with headache, achy. All symptoms passed about 18 hours post vaccine. of note I have never been tested for covid but my husband had a severe case in March. I tested positive for antibodies twice with the most recent time 12/14/20. I have never had symptoms of covid (until I got the vaccine)
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| 54 | 2021-01-31 | numbness, tingling, muscle spasms, weakness |
Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalanc...
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Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalance requiring hospitalization for More than 48 hours with repeated hematology follow up. Patient is a 54-year-old woman with history of Roux-en-Y gastric bypass surgery and some alcohol abuse who presented to the hospital with fatigue, headache, muscle cramps and weakness. She also had a slight fever that followed her 2nd dose of COVID-19 vaccine. She had basic lab work which revealed pancytopenia along with multiple electrolyte disturbances including hypokalemia, hypomagnesemia, hypocalcemia and hyponatremia. She admits that she had heavy alcohol use over the weekend with binge drinking of liquor. She otherwise does drink a couple of mixed drinks a night. She has also been trying to lose a lot of weight. She says that she lost about 60 lb in the last 6 months on purpose. She is doing this so that she can have a panniculectomy and tummy tuck. She recently had a breast reduction in November. She has not been following with a dietitian or having her vitamin levels checked. Despite having pancytopenia, her levels remained pretty stable during her stay. She had a peripheral smear sent which was pending at the time of discharge. She was also checked for vitamin deficiencies. She is given a dose of IM B12, IV iron, IV calcium and started on oral calcium vitamin-D supplements. She does take a daily multivitamin. Due to her reported history of heavy alcohol use she is also given thiamine and folate. After speaking with Hematology, recommendations were for her to have a follow-up appointment which is scheduled on February 10th. I also put in a referral for a dietitian to evaluate her for further recommend deficiencies in the setting of Roux-en-Y gastric bypass surgery with heavy weight loss. I prescribed her calcium vitamin-D along with folic acid. I recommended she continue her multivitamin. I also recommended that she abstain from alcohol use.
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| 54 | 2021-01-31 | nerve pain |
Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sens...
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Feel tired, chill, mild fever(100.9F), Whole body ache(muscle, bone, nerve pain) with headache, Sense of smell and taste lower down, tonsil swelling, Lymph node swelling and pain.
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| 54 | 2021-01-31 | pain in extremity |
I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with...
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I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with my RIGHT eye. I had a sore left arm and headache, which I attributed to the vaccine. By 12/27/20, I called the emergency number at my primary ophthalmologist as was seen. They thought I had a posterior vitreous detachment and asked me to see my primary eye doctor in a week. By 12/30/20 I could not see to work and called the eye doctor and they decided I should see my retinal specialist who deals with problems with my left eye. He could see nothing to explain my decreased acuity and told me to keep my follow up at the other office. I saw a Dr on 1/4/21, who takes care of my left eye cataract and glaucoma. He called in an associate. My vision had further declined and they thought I had ocular neuritis. I couldn't see the big E on the eye chart at all at my worst. I was scheduled for an MRI of the head, which showed ocular neuritis in my right eye. Dr assumed care and I started IV steroids on 1/13 for 3 days, followed by oral prednisone taper. I also was referred to a neurologist to rule out MS. I saw Dr. 1/28/21. After the steroids, my vision improved, but I still can't work or drive. Neurologist does not think I have MS and is ruling out NMO but doesn't think I have that either.
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| 54 | 2021-01-31 | pain in extremity |
body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; ...
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body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.
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| 54 | 2021-01-31 | pain in extremity |
fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She ha...
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fever, nausea, rash all over body, painful swollen knees and hands, and shortness of breath. She had an eppy-pin she used.
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| 54 | 2021-02-01 | weakness, pain in extremity |
kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Hea...
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kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation. Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications. Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning. She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning. She kind of fainted. She was walking from one room to the next and she just gave out. It has improved and she is not really dizzy any more. She is having a little fatigue though. Chills began at 06:30 and they come and go. She is going through menopause and it could have something to do with it. She was unable to answer outcome for this. She just wants the headache to stop. She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00. When she first got it, she did not feel it. As the day progressed, she could feel the pain. Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills 07:00-07:30. She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving. Information on the lot/batch number has been requested.
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| 54 | 2021-02-01 | tingling, numbness | tingling and numbness in right arm itching and rash around left wrist |
| 54 | 2021-02-01 | tingling |
This is a spontaneous report from a contactable other hcp (patient). A 54-year-old female patient r...
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This is a spontaneous report from a contactable other hcp (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via unspecified route of administration on 19Jan2021 14:00 at a single dose on left arm for covid-19 immunization. There was no medical history reported. Patient has no known allergies. Concomitant medication included Atenolol 25 mg, vitamin C 1000mg, vitamin D 5000mg; all on unspecified dates for unspecified indications. On 19Jan2021 at 14:15, the patient stated that "after the injection I went to the waiting area. I started to feel tingling on my left side of my face and then my nose and a little on the right cheek. I got the injection at 2 pm and now is 8:28 and I still have the tingling." Patient has not received any treatment. There were no other vaccine administered in four weeks. Patient has no COVID prior vaccination and has not tested post vaccination. The outcome of the event was not recovered. Information on the Batch/Lot number has been requested.
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| 54 | 2021-02-02 | feeling cold, muscle spasms |
On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinat...
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On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinate and began to have multiple bowel movement. I began to feel nauseated and very cold with shortness of breath and my heart racing. I cleaned up, washed my hands and proceeded to check my temperature it read 91.5, I continue to check it and it continue to read 91.5. I drank water and orange juice thinking it was my blood sugar. I began to feel dizzy but did not want to lay flat on my bed due to the shortness of breath. My heart rate was 120. I checked my blood pressure it was 180/120. I was fearful of shock. I continued to pace and warm up with blankets and a space heater. I took a warm bath and my temperature increased to 97.7. I continued to feel my pulse racing. I called Dr. office and got an appointment to see her 8:30 am 1/29/2021. She checked my vitals signs B/P - 143/87, P 80, T 98.1 O2Sat 99, heart and lungs. She did labs and urinalysis. She prescribed Clonidine 0.1mg TID take if BP greater 160/90 and Allergra 180 mg QD prn for itch and reaction. I will return to see her 2/5/2021.
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| 54 | 2021-02-02 | feeling of body temperature change |
Ten minutes after injection felt lightheaded/dizzy with brief periods of feeling alternately "hot an...
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Ten minutes after injection felt lightheaded/dizzy with brief periods of feeling alternately "hot and cold". Then felt some chest tightness with some difficulty breathing but no wheezing, She felt the tightness sensation on her chest. EpiPen administered once with transient improvement of symptoms but then recurred then administered EpiPen again. Thinks she saw some hives on her chest. Taken by ambulance and administered diphenhydramine 50mg Taken to the ER with no rash, upper/lower respiratory symptoms noted. EKG and cardiac workup negative. Patient discharged after 4 hours after improvement of symptoms with no other treatment given. Serum tryptase sent and 6.4mcg/mL.
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| 54 | 2021-02-02 | flushing |
Employee received Pfizer Covid19 vaccine on 2/3/2021 at 8:30 am and at 12:30 pm she began having in...
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Employee received Pfizer Covid19 vaccine on 2/3/2021 at 8:30 am and at 12:30 pm she began having intermittent palpitations and "flushed" feeling in her chest.
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| 54 | 2021-02-02 | numbness |
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre...
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swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 54 | 2021-02-03 | numbness, tingling |
1) Immediately noticed that I was light-headed or dizzy upon receiving shot. 2) My face started to ...
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1) Immediately noticed that I was light-headed or dizzy upon receiving shot. 2) My face started to feel numb on the left side (below the eye to the jawline and from below my left ear to my nose area. I was worried about a stroke, so I made sure that I was able to smile in my rear-view mirror. The numbness began to clear up around 8 hours later without any muscular drooping of eye or mouth. I still have tingling or a numb feeling in areas but it is not significant at this time. 3) fatigue, slight nausea, pain in right collar bone area has been present since Monday. All seem to be minor side effects.
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| 54 | 2021-02-03 | pain in extremity |
approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: ...
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approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: 112/78, HR 69, 16 RR,A/0x3, As time progressed c/o achiness when she turns head side to side. 7:12pm c/o head felt foggy, improved chest tightness, heaviness in abdomen, achiness in R) arm pitdenies SOB, BP:110/78, Hr 66, 7:25: felt HR flutter occasionally, heaviness in legs increased and cont. light headed. but ROM WNL, Denies numbness/tingling, denies SOB, no swallowing problems during entire time. Couldn't go back to work and went home with nursing instructions if heaviness were to increase or other symptoms worsen to call 911 or go to ER. Taken home by mother and brother. called next day and symptoms improved.
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| 54 | 2021-02-03 | tingling, difficulty speaking |
10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after i...
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10-15 minutes after injection splotchy redness forearms, palm of hands. Approximately 1 hour after injection splotchy redness both legs. Approximately 2 hours after injection tingling around neck, tingling in lips and swelling and tingling right side of face and voice change hoarseness.
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| 54 | 2021-02-03 | tingling, numbness |
Right sided facial numbness and tingling started 4 days post vaccination. Treatment: OTC Zyrtec with...
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Right sided facial numbness and tingling started 4 days post vaccination. Treatment: OTC Zyrtec with mild improvement Outcome: Does not interfere with ADLs.
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| 54 | 2021-02-03 | tingling |
Tingling in the face occurred after both doses of the shot. I didn't know it was an adverse effect a...
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Tingling in the face occurred after both doses of the shot. I didn't know it was an adverse effect after the first dose, but my daughter is in medical school and told me that it could be and I should report it
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| 54 | 2021-02-04 | feeling hot |
Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orall...
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Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orally administered with water, pt went by ambulance to the hospital
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| 54 | 2021-02-04 | numbness |
Numbness on the right side of my face after having spent 35 minutes after having the vaccine, the du...
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Numbness on the right side of my face after having spent 35 minutes after having the vaccine, the duration was 45 minutes after this time it was waking up little by little.
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| 54 | 2021-02-04 | numbness |
bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tight...
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bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer. She asked if shellfish is in the vaccine. Information about lot/batch number has been requested.
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| 54 | 2021-02-04 | migraine, pain in extremity |
Patient reports with 1st shot had arm pain described as mild and not interfering with daily activiti...
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Patient reports with 1st shot had arm pain described as mild and not interfering with daily activities. Patient reports with second shot, within 5 hours had arm pain, malaise, headache, and nausea. At 7 hours symptoms increased in severity limiting activity. Also had chills and body aches. Unable to sleep overnight, felt feverish. On day 2 had difficulty working due to migraine headache, unrelieved by migraine medication. On day 3 migraine remained present but was less severe, modifications needed to continue working. On day 4 had worse migraine and nausea, unable to work. Developed itchy blisters, at least 12 to inner thighs, also on belly and back. Took OTC allergy medication, no worsening or additional spread of blisters following this.
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| 54 | 2021-02-04 | pain in extremity |
she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; Th...
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she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient (weight: 150lb-160lb) received first dose of bnt162b2 (BNT162B2, lot number: EL0142), via an unspecified route of administration in left arm on 14Jan2021 15:40 at SINGLE DOSE for covid-19 immunisation. Medical history included none. No Prior Vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID), omeprazole, calcium. On 20Jan2021 weds: "bad diarrhea", vomiting, low grade fever, sore arm (only the day after) and bad stomach cramps. Caller says, "if that's going to happen after 2nd dose- I wont take it". Caller referred to HCP for treatment of post vaccination side effects. She notes that at work on Wednesday she didn't feel good on 20Jan2021 and yesterday she was useless on 21Jan2021. She does feel better today thank goodness. No AE(s) require a visit to Emergency Room or Physician Office. The outcome of the events didn't feel good, she was useless, sore arm was unknown and was recovering for the rest events. No follow-up attempts possible. No further information expected.
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| 54 | 2021-02-04 | pain in extremity |
HEADACHE, TEMPERATURE 101.4, DEEP MUSCLE ACHES, FATIGUE. AFTER DAY TWO AFTER INJECTION I STILL HAD A...
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HEADACHE, TEMPERATURE 101.4, DEEP MUSCLE ACHES, FATIGUE. AFTER DAY TWO AFTER INJECTION I STILL HAD A HEADACHE THAT I COULD'NT GET RELEIF FROM WITHOUT MIGRAINE MEDICATION. DAY 3 I HAD A VERY SORE AND SWOLLEN ARM BUT OTHER SYMPTOMS SUBSIDED. DAY 4 A LITTLE FATIGUE BUT FEELING GOOD.
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| 54 | 2021-02-04 | throat numbness |
PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING ...
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PATIENT INITIALLY COMPLAINED OF DRY MOUTH, METALLIC TASTE WHICH PROGRESSED TO NUMBNESS AND TINGLING IN MOUTH AND THROAT. PATIENT BEGAN TO FEEL DIZZY AND WAS PLACED INTO TRENDLENBERG POSITION FOR 20 MINUTES, AFTER WHICH SHE RETRUNED TO HIGH FOWLERS POSITION. SHE CONTINUED TO COMPLAIN OF NUMBNESS AND TINGLING IN MOUTH AND THROAT AND PATIENT REQUESTED EMS BE CALLED. PATIENT WAS NEVER IN ANY APPARENT RESPIRATORY DISTRESS, HR STRONG AND REGULAR, INITAL BLOOD PRESSURE MILDLY ELEVATED, SUBSEQUENT ONES WERE WNL.
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| 54 | 2021-02-05 | facial pain |
Woke up approximately around 1:30 a.m. with chills. Got up to get ready for work and felt slightly a...
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Woke up approximately around 1:30 a.m. with chills. Got up to get ready for work and felt slightly achy so I took my temp and it read 100.6. I ate a piece of toast and took one 500 mg tablet of a Tylenol and went to work but was sent home due to the fever after getting home my aches kept getting worse I developed a headache and my temp fluctuated all day between 99 3 and got as high as 101.7 bye the afternoon. When I went to bed around 10 p.m. my temp had dropped to 99 but my upper lip felt puffy and was slightly swollen. When I got up the next morning at approximately 6 a.m. my upper lip was still swollen and my right cheekbone very was very tender to the touch. Upon submitting this report it is approximately 1:15 Eastern Standard Time and my lips are mostly back to normal but around my mouth is very tender and to my right cheek bone is still very tender to the touch. Other than that headaches are gone fever is gone and I overall feel pretty good.
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| 54 | 2021-02-06 | feeling of body temperature change |
I felt lightheaded immediately after receiving vaccine on 2/01/2021 but it went away after 30 minute...
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I felt lightheaded immediately after receiving vaccine on 2/01/2021 but it went away after 30 minutes. On 2/07/2021 I started feeling tired with alternating cold/hot spells. After an hour I took my temperature and it was 99.5. I took 2 Tylenol and am waiting for relief.
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| 54 | 2021-02-06 | numbness | Numbness of lips, mouth, chin, upper area of neck |
| 54 | 2021-02-07 | numbness, muscle spasms, tingling |
both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles ...
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both of her legs seized. The muscles so tight that I was unable to walk (like a spasm); The muscles so tight that I was unable to walk/ just a muscular contraction that left me unable to walk properly (the left side seem to be the tightest side of by body); like a spasm; bilateral jaw pain; slight numbness on by left face; face still has a bit of muscle sensitivity (tingling sensation) near the mouth and jaw; redness on my left cheek; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 21Jan2021 09:15 at a single dose for COVID-19 immunization. Medical history included shellfish allergy. Concomitant medications included received within 2 weeks of vaccination but were not reported. The patient previously took codeine and experienced allergy. On 21Jan2021 11:30, both of her legs seized. The muscles so tight that she was unable to walk (like a spasm). There was no twitch just a muscular contraction that left her unable to walk properly (the left side seem to be the tightest side of by body). The patient also had bilateral jaw pain (not sure if it was because she was in so much pain in the legs that she was clenching my teeth). She also had slight numbness on by left face and by the evening she had redness on her left cheek but it went away. Her face still had a bit of muscle sensitivity (tingling sensation) near the mouth and jaw. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Events were reported as non-serious. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 54 | 2021-02-07 | numbness, tingling |
next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE...
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next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE numbness and tingling. Went to ED given hx of CVA. Testing all normal. Started to resolve 2 hours later. Continues to have pain at injection site (today is 2/8/2021)
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| 54 | 2021-02-07 | throat numbness, numbness |
numbness to right side of face from cheek to jaw line, to right side of lips, and also to the insid...
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numbness to right side of face from cheek to jaw line, to right side of lips, and also to the inside of the mouth on right side and inside right side of throat.
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| 54 | 2021-02-07 | tension headache |
Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep...
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Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep and mind was racing; her mind was racing; Soreness at the injection site; Tension headache with pressure; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on left arm on 20Jan2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient received the vaccine on Wednesday, 20Jan2021. This was her first dose. She had the vaccine at 12:30 PM. Right after the vaccine she waited her 15-20 minutes and was fine. These things did not start till later. She was not sick prior to getting the vaccine. 8 hours after, around 8:30 PM she had a tension headache with pressure that went all through the night and let up around 21Jan2021 10 AM. Around 12 AM Thursday morning on 21Jan2021, she had chills, fever, and a racing heart. She ached from head to toe/body soreness. It was a flu like feeling. Then they all got better around the same time 21Jan2021 evening. The racing heart was not enough to need 911. It worried her but was not enough. She also could not sleep and her mind was racing. She thinks it was because what was going on with her racing heart. It was making her head pound. She finally was able to sleep last night on 21Jan2021 around 8:30 PM and slept until 4:30 AM this morning on 22Jan2021. The doctors said if she was not better by tomorrow they would work her in to see her. But she is much better today. She also had soreness at the injection site on 20Jan2021. She knew that was normal though. She is still sore but overall is better. It felt like there was an invasion in her body. She is a little scared now for the second dose. She is unsure if she wants to get it. She asks, do you recommend getting the second dose after she had all of these side effects? It worries her. The heart is the main thing. That worried her the most. Outcome of the event tension headache with pressure, chills, fever, heart racing, ached from head to toe/body soreness, flu like feeling was recovered on 21Jan2021, outcome of the event could not sleep and mind was racing was recovered on 22Jan2021, outcome of the event soreness at the injection site was not recovered.
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| 54 | 2021-02-08 | pain in extremity | Extremely sore arm, chills with no fever, general body aches and tiredness that lasted 2 hours. |
| 54 | 2021-02-09 | breast pain, pain in extremity |
Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes unde...
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Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes under the right arm, and the right side of the neck; Tender lymph nodes under the right arm, and the right side of the neck; tender right breast; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3248) via an unspecified route of administration in right arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included HTN (hypertension) hereditary. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), verapamil hydrochloride (VERAPAMIL). The patient previously received the first dose of bnt162b2 (Lot number: EK5730) on 22Dec2020 11:00 in right arm for COVID-19 immunization. Events started from 12Jan2021 18:00 included very sore right arm, right underarm, and right breast pain onset the evening of the second dose, tender lymph nodes under the right arm, and the right side of the neck, also, tender right breast. All symptoms still present 13 days later, but better. The adverse event result in Doctor or other healthcare professional office/clinic visit. This is a non-serious report per reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
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| 54 | 2021-02-09 | numbness |
Adverse effect: numbness on the right side of body, facial numbness, oral mycosis numbness Treatmen...
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Adverse effect: numbness on the right side of body, facial numbness, oral mycosis numbness Treatment: Benadryl Outcome: Recovered in 2 hours
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| 54 | 2021-02-09 | pain in extremity |
achy for 3 days, stuffy headache, sore throat on and off, sore upper arm for 4 days I'm taking Ibup...
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achy for 3 days, stuffy headache, sore throat on and off, sore upper arm for 4 days I'm taking Ibuprofen.
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| 54 | 2021-02-11 | flushing |
15 minutes after receiving vaccine, felt flushed, about an hour later felt short of breathe and ches...
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15 minutes after receiving vaccine, felt flushed, about an hour later felt short of breathe and chest tightness
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| 54 | 2021-02-12 | pain in extremity |
Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion ...
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Cellulitic Sweet's syndrome of lower extremity. Significant LLE erythema and pain out of proportion to exam that has continued to progress despite broad-spectrum antibiotics, now s/p OR cut down x3 with no e/o necrotizing fasciitis. Initially most c/f infection/cellulitis, however in discussion with ID, rheum, and derm and given progression of rash in s/o broad spectrum Abx and negative tissue cultures, now most suspicious for cellulitic variant of Sweet's syndrome (SS). Pathology report w/neutrohpliic inflammation w/evidence of ischemia, w/o evidence of infection, c/w Sweets Syndrome. While this is a rare disorder, it primarily occurs in the setting of recent infection or malignancy. Currently working up potentially triggers. Infectious work up thus far negative. Hematologic malignancy most often linked with SS, given new and worsening pancytopenia, will consult heme for recommendations for additional work up. Other potential triggers include vaccinations (question about COVID vaccine recently) and often idiopathic. Maintain of treatment for SS is steroids, dermatology currently managing dosing.
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| 54 | 2021-02-14 | burning sensation |
A pressure/low burning sensation down the lateral rear side of my left leg. I have not felt this pai...
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A pressure/low burning sensation down the lateral rear side of my left leg. I have not felt this pain sensation there so intensely since before my back operation in October 2018. The intense sensation lasted from Sunday 07 FEB through Tuesday 09 FEB 2021, when it started to slowly wane. The inoculation site also had minimal pain. Emailed my PCP and my orthopedic surgeon.
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| 54 | 2021-02-14 | flushing |
flushing, racing heart and light headedness lasting about 2 minutes 25 minutes after the shot and a...
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flushing, racing heart and light headedness lasting about 2 minutes 25 minutes after the shot and again 2 hours later.
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| 54 | 2021-02-17 | numbness |
This is a spontaneous report from a contactable other health professional (patient). A 54-year-old f...
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This is a spontaneous report from a contactable other health professional (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via intramuscular route of administration on 25Jan2021 at 14:30 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular on 04Jan2021 at 11:30 am (age: 54-years) on the left arm for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 02Feb2021, the patient experienced numbness in arms, hands, legs and feet. The patient did not receive any treatment for the reported event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was not recovered.
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| 54 | 2021-02-18 | breast pain, pain in extremity |
swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast...
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swollen left arm down though elbow area, swollen underarm area, swollen and pain left side of breast up near under arm, could not lift left arm, painful down arm, up neck area, still having pain in arm. Pain is subsiding gradually daily, still noticeable.
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| 54 | 2021-02-21 | cold sweat |
At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108...
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At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108/68, 97.6, RR 16, o2 98% on RA, and HR 45. Pt AOx4. Pulses thready. Patient?s skin is moist and clammy. Called for a WC and took pt to exam room where she sat in a reclining chair. VS taken every 5 minutes. She kept mentation through her stay. She states she felt slightly nauseated but was able to hold down water. VS started to improve once she was reclined in exam room. Education provided about f/u with PCP as HR fluctuated between 57-85. Educated about monitoring for symptoms the rest of the day and when to go in for evaluation is symptoms reappear. Pt verbalizes understanding. At 1400, pt states she is feeling better and feels well enough to leave facility. She has no one in town to come get her. VS= 02 98% HR 60, T97.8, BP 120/74, RR 16. Time of leaving, pulses were strong and equal, cap refill WNL. Will call at 1700 for F/U call.
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| 54 | 2021-02-21 | feeling hot, pain in extremity |
Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the he...
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Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the head. Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6. I woke up on 02/20/2021 and my left eye was crusted over just like the first vaccine. My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back, one on chest, two on left leg, one on lower back and one on left buttock. Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired. My arm was much sorer with this injection.
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| 54 | 2021-02-21 | flushing |
Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one epi...
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Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis. Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.
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| 54 | 2021-02-21 | numbness |
Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Mov...
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Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Moved to tip of nose; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number Em9809), via an unspecified route of administration at single dose in the left arm on 04Feb2021 11:30 for covid-19 immunisation. Medical history included pituitary tumour. The patient had not been tested for COVID-19 prior and post the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included famotidine, paracetamol (TYLENOL), cabergoline, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). On 04Feb2021 12:15, the patient experienced numbness in chin, then lip area. Moved to tip of nose and then several hours later, left eyelid and area between my eyes was completely numb. No treatment required. The outcome of the events was recovered.
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| 54 | 2021-02-21 | pain in extremity |
This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I s...
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This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I stayed for 45 minutes after my vaccine due to my blood pressure was high. I also felt a little fuzzy. About an hour later I got nauseous, had chills and felt very fatigued. The next morning when I woke up, my left eye was crusted over. I did not think anything of it until I got the second vaccine and it crusted over with it as well. I was very fatigued for 2 1/2 days. Arm was a little sore.
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| 54 | 2021-02-22 | one side paralysis, tingling |
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin...
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Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
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| 54 | 2021-02-22 | pain in extremity |
ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense mala...
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ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense malaise for 24 hours followed by 2.5 days of fatigue
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| 54 | 2021-02-23 | feeling cold |
ABOUT AN HR AFTER RECEIVING MY 2ND DOSE OF THE PFIZER VACCINE I FELT COLD AND A SLIGHT HEADACHE AND ...
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ABOUT AN HR AFTER RECEIVING MY 2ND DOSE OF THE PFIZER VACCINE I FELT COLD AND A SLIGHT HEADACHE AND FATIGUED. LATER THAT EVENING AROUND 7PM THE SYMPTOMS I EXPERIENCED GOT WORSE, POUNDING HEADACHE, AND CHILLS, AND EXTREME MUSCLE ACHE,. INSOMNIA AS WELL. 7AM THE NEXT MORNING CHILLS WERE LESS BUT STILL THERE, BUT THE HEADACHE PERSISTED AND THE NAUSEA GOT WORSE. STILL UNABLE TO SLEEP. AROUND 3PM HEADACHE SLIGHT AND MILD NAUSEA. NO CHILLS. TODAY 2/24/2021 STILL HAVE SLIGHT NAUSEA AND HEADACHE. BUT MUCH BETTER.
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| 54 | 2021-02-23 | flushing |
0825 Feeling Shaky skin little red, Pfizer 2nd dose. 0835 Cheeks feeling flushed. Benadryl 50mg give...
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0825 Feeling Shaky skin little red, Pfizer 2nd dose. 0835 Cheeks feeling flushed. Benadryl 50mg given orally. 0842 Cheeks feeling better arms, still flushed NO SOB,NO CP NO NAUSEA 854am Reports no worsening symptoms 910 Feeling better released to go home.
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| 54 | 2021-02-23 | tension headache | 2/23 headache, and today nausea with tension headache |
| 54 | 2021-02-24 | tingling |
11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for furthe...
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11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for further assessment. Client also reports tingling in the fingers. Client was offered water which was taken and a seat by an open door for air. Client removed mask. Vitals taken: BP 185/100, Pulse 136. 11:59 Vitals taken: O Sat 99% Pulse 162. Client experiencing faintness and dizziness. EMT assessed Client further. 12:01 Client reports a slight tightness in her throat but reports the dizziness is lessening. Client reports no difficulty breathing. Vitals taken: O Sat 99% Pulse 142. 12:04 Vitals taken: BP 163/108, Pulse 128. 12:06 Vitals taken: O Sat 99%, Pulse 118. Client reports dizziness and tightness in the throat is lessening and feeling better. 12:08 Vitals taken: Pule 100, O Sat 98%. 12:11 Client reports no dizziness and the tightness in her throat is getting better. BP 157/99 Pulse 98. 12:15 Client reports that she feels well enough to leave. Client did decide to take a Benadryl due to a little tightness remaining. Client denied feeling any other previous issues or dizziness. Client given a 25mg (one tablet) of Benadryl. Education given regarding Benadryl taken. Client is here with her husband and daughter. Husband was present and Client felt well enough to leave. Client was able to ambulate to the car unassisted and her husband was able to drive her home
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| 54 | 2021-02-25 | facial paralysis, numbness, tingling, bell's palsy |
Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes aft...
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Throat felt like it was closing and had difficulty swallowing (that subsided quickly) 45 minutes after the shot, the right side of my face felt numb and tingly (Felt like when novocaine is wearing off.) Continued for 48 hours and worsened with slight drooping when smiling. Clearing my throat a lot and my right eye keeps tearing up. The doctor confirmed it was "Bell's Palsy" this morning and I have been put on Prednisone.
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| 54 | 2021-02-25 | flushing | Headache, nausea, facial flushing, refused transport by EMS |
| 54 | 2021-02-25 | tingling, feeling cold, discomfort |
After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressu...
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After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly. They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope). They transferred me to the ER for further monitoring. After a while, it stabilized more, but still continued to happen throughout the day.
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| 54 | 2021-02-26 | numbness |
Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vis...
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Left side of face ear area fullness numbness progressed later to numb lip on left side and poor vision in left eye , chest pain in center of chest and walking imbalance
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| 54 | 2021-02-28 | breast pain | pain above nipple, underarm lympnode is swollen |
| 54 | 2021-02-28 | feeling hot |
0900: Rec'd Covid vaccine 0931: Pt c/o dizzy/light-headed, sweaty in car 0937: BP 116/78 HR 60 RR 16...
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0900: Rec'd Covid vaccine 0931: Pt c/o dizzy/light-headed, sweaty in car 0937: BP 116/78 HR 60 RR 16 SpO2 98% Drinking water/juice; opened car windows/door; lying down in car 0942: Left arm from neck down feels hot inside; less light-headed/dizzy & sweaty 0956: Still feeling lightheaded, resting in car w/HOB down
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| 54 | 2021-02-28 | feeling jittery, feeling cold |
Patient began to feel "jittery" and cold all over as soon as she received the shot. There was no int...
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Patient began to feel "jittery" and cold all over as soon as she received the shot. There was no intervention patient was observed for the full 15 min wait time and stated they felt fine and wanted to leave.
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| 54 | 2021-02-28 | numbness |
Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and i...
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Within 5 minutes of vaccine I developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment. Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm. By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
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| 54 | 2021-02-28 | pain in extremity |
Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigu...
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Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigue; minor nausea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date unknown), via an unspecified route of administration on the right arm on 27Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included COVID-19; prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included Vitamin D NOS and Multi-Vitamin. The patient previously took injectable Iodine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced soreness in arm - inability to lift above head, fatigue and minor nausea on 27Jan2021 at 13:00 (01:00 PM). No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. The events were resolving.
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| 54 | 2021-03-01 | involuntary muscle movements |
I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very...
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I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very bad headache. I took and Advil. My husband was making breakfast. I came downstairs, ate, had a cup of coffee, then got a glass of water and an ice pack and sat on a recliner in the living room. I don't remember much of the rest. It was like a dream. My husband said I let out a yell, my arms flailed and my eyes were very strange. I lost muscle strength in my lift side mimicking a stroke. He called 911. I was taken to Emergency facility where I gained consciousness. I was then transferred to Hospital. So far every test has come back negative. I have an EEG scheduled for this Thursday.
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| 54 | 2021-03-01 | numbness, tingling | Tingley feeling in the whole R arm, numbness to the ring and pinky fingers, Lasted for about 4 days |
| 54 | 2021-03-01 | pain in extremity |
Headache first symptom, sore right arm, high fever 102 for 24 hours, chills, dizzy , achy all over ,...
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Headache first symptom, sore right arm, high fever 102 for 24 hours, chills, dizzy , achy all over , very tired. after 24 hours symptoms dissipated. Then just tired and sore arm next day.
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| 54 | 2021-03-01 | pain in extremity |
Friday, Feb 26th 2021-About a hour after shot I had joint pain in my elbow and wrist. I took Tyleno...
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Friday, Feb 26th 2021-About a hour after shot I had joint pain in my elbow and wrist. I took Tylenol 1 hour prior to the shot and 6 hours afterwards. No redness or pain Friday evening. I had insomnia Friday night and did not fall to sleep until 5am. Saturday, Feb 27th, 2021- I woke up with joint pain to my elbow and wrist. Arm was extremely sore. I did not eat until 4pm and I took Tylenol then, Once I started moving my arm felt better and the joint pain went away. Trouble sleeping Saturday night. Fell asleep around 4am. Sunday, Feb 28th- Work up and arm wasn't as sore. Noticed around 1pm I had a red spot under the vaccine spot where I was injected. It was red and painful, about the size of 2 nickels put together. I took more Tylenol that evening and was ok. Monday, March 1st- I noticed the red spot had gotten bigger. It wasn't as itchy and was not bothering me. Around 8pm, I noticed the spot was bigger and itchy. I toke a Tylenol and Benadryl and about midnight put an ice pack on the redness for 15 min intervals. I did this 3 times. I outlined the red spot, which is now as big as a orange to see if it was spreading. Tuesday, March 2nd - Noticed no spread at 8:30am. Site beginning to itch. At 12 noon, taking a Benadryl and Tylenol after eating lunch.
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| 54 | 2021-03-02 | flushing | light headed, Flushed. |
| 54 | 2021-03-02 | pain in extremity | Sore arm, tired |
| 54 | 2021-03-02 | pain in extremity |
Sore arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-...
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Sore arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 15:15, at a single dose, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication was not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 26Jan2021, at 04:00 AM, the patient experienced sore arm and body aches. The events were considered non-serious. The patient did not receive therapy for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination.
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| 54 | 2021-03-02 | tingling |
Pt states she recieved her first dose of the vaccine at 11:50 am.l Pt states after 40-50 minutes she...
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Pt states she recieved her first dose of the vaccine at 11:50 am.l Pt states after 40-50 minutes she started having tingling in her hands and face. Pt denies any rash, hives, or swelling. Crew determind the pt is having a panic attack and calmed her down. Pt's vitals are stable. Pt states she is feeling better and wants to leave. Pt didnt require transport to hospital.
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| 54 | 2021-03-02 | tremor |
Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells...
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Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells; motion; tired; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: T23248), intramuscular in the left arm on 29Jan2021 at 10:00 AM as a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. The patient did not have COVID prior to vaccination, had no other vaccine in four weeks and was not pregnant at the time of vaccination. Concomitant medications included multivitamins, ibuprofen, and paracetamol (TYLENOL). The patient received the first dose of BNT162B2 on 10Jan2021. On 29Jan2021 at 07:00 PM, the patient experienced uncontrollable chills, stabbing pain all over, headaches, body shakes, nausea, sensitivity to smells, "motion", and tired. The patient was not COVID tested after vaccination. The patient received no treatment for the events. Outcome of the events was recovering.
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| 54 | 2021-03-03 | flushing | lips numb, chest pressure, flushing, nausea. Evaluated by EMS-Cleared |
| 54 | 2021-03-03 | numbness, tingling |
The left side of my face and tongue got numb / tingly. It began to lessen after about an hour and co...
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The left side of my face and tongue got numb / tingly. It began to lessen after about an hour and continues to lessen as the day goes on. It is believed that my body may have just responded quickly. I was monitored for a few extra minutes, and then released.
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| 54 | 2021-03-03 | migraine | terrible migraine at 9:00 next morning |
| 54 | 2021-03-04 | weakness, pain in extremity |
Within a few hours of getting my first shot, I developed arthralgia and myalgia, including severe lo...
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Within a few hours of getting my first shot, I developed arthralgia and myalgia, including severe low back pain, right hip/groin pain), right ankle pain/weakness, mid/upper back pain, and severe fatigue. The low back pain, groin/hip pain, and fatigue lasted. 2.5 weeks. For those 2.5 weeks, I felt weak enough that I couldn't walk more than 30 minutes, when I had been walking 30-60+ minutes daily for the last year. Also, my low back/hip/groin felt "frozen," so it made it difficult for me to walk (I was limping). Within two hours of my second shot, I developed full-body arthralgia/myalgia, including thigh pain/weakness, low back/groin/hip pain, upper back pain, shoulder and neck pain, thumb and hand pain, and ankle weakness. Over the next 12 days, my right shoulder pain progressed to the point at which I had to get a cortisone injection in my right shoulder (for bursitis) today. Prior to the second Covid vaccine shot, I had not had shoulder bursitis symptoms since November 2020, when I had a cortisone injection. I am also still experiencing excessive fatigue from the second shot. I am reporting this information so it can be included in the post-marketing study.
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| 54 | 2021-03-04 | weakness, pain in extremity | Nausea, weakness, fever, bad stomach pain, sore arm, dizziness |
| 54 | 2021-03-04 | bell's palsy |
No adverse reactions other then pain in the injection site and being tired then last night 48 hours ...
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No adverse reactions other then pain in the injection site and being tired then last night 48 hours later my eye was twitching. Today it 72 hours later eye twitching again and then this afternoon my bottom lip began to tingle. Called the Urgent care they said come in and I did and the said it is bells palsy and gave me steroids and another drug to take
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| 54 | 2021-03-04 | numbness |
She received vaccine at 3:20PM right deltoid. She felt numbness on the right side of her neck, ligh...
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She received vaccine at 3:20PM right deltoid. She felt numbness on the right side of her neck, lightheadedness, and sweaty profusely. She reports feeling foggy and dizzy . Vaccine center called Rapid Response Team.
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| 54 | 2021-03-04 | night sweats |
Fatigue, body aches, night sweats (like menopause), painful under armpits (even on second day), head...
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Fatigue, body aches, night sweats (like menopause), painful under armpits (even on second day), headaches
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| 54 | 2021-03-05 | numbness, facial pain |
Within a few minutes after vaccination, while parked, she had onset of a severe pain on the right si...
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Within a few minutes after vaccination, while parked, she had onset of a severe pain on the right side of her face with numbness as if she just had dental work. She has history of severe migraines in past of similar severity, but usually on her head, not her face. The pain spread to her forehead. She denied weakness, shortness of breath, difficulty swallowing, face nor throat swelling. Her blood pressure was checked and was normal. Her face stayed symmetric. She had normal movement of all extremities. She took her migraine medication rizatriptan around 125pm. She repeated her dose 45min later. She was still in severe pain, but better enough where she could move and talk again. Her husband who was present, slowly helped her to the passenger seat and drove her home. I checked in 2 hours later and he reported that she was improving and resting. I advised multiple times to call us or 911 if having any new weakness. If she developed right face weakness, only we would likely start prednisone for bells palsy. Husband expressed understanding of plan. On 3/6 at 3pm, on follow-up call, pain has resolved. Still with numbness "as if I've been injected with novocaine", and tingling on her right side of face to touch. No weakness, no facial asymmetry.
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| 54 | 2021-03-05 | pain in extremity |
I received the shot Wed. afternoon. I had a sore arm right away, but that was all. Then Thur. I ate ...
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I received the shot Wed. afternoon. I had a sore arm right away, but that was all. Then Thur. I ate food that I normally eat (the doctor asked what foods I had) and went to bed. Fri 3am I work up and couldn't breath. I already have sinus issues, and it felt as if I was choking. I gargled, then looked at my throat in the mirror. My Uvula was swollen 3 times it's nomal size. I calle a family member to take me to the ER. I was diagnosed ith Uvulitis. givendiphenhydramine, dexamethasone, famotidine, and neck xray, and strep tests (which were negative) The doctor said it definitely was an allergic reaction. He asked me about foods (I hadn't eaten anything unusual) but couldn't conclusively say it was because of the vaccine.. None of the treatments worked, but they still released me, saying that it would eventually stop being swollen, and if it was still an issue in a week that I should contact my primary . Although my swelling came down after a day, my throat is still red and irritated as of Saturday.
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| 54 | 2021-03-06 | muscle twitching |
-Twitching mostly in my legs and stomach and ribs especially during the first week. It substantiall...
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-Twitching mostly in my legs and stomach and ribs especially during the first week. It substantially subsided during the second week but still occasionally happens in my leg and sometimes in my temple area beside my left eye. -On the first or second day after vaccination, my pulse was beating profusely (fast and furious) between my left thumb and index finger mid-way toward my wrist of my right hand. I am not sure what that was, since I had never seen that happen before and it was not happening on my left hand. I am scheduled to take my second vaccine on 3/15/2021 so I am trying to find out if you would recommend that I take the second vaccine or not take it. I am scheduled to tak
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| 54 | 2021-03-06 | tingling, flushing |
Flushing, tingling of extremities, increased heart rate. Initial BP 135/79 (pulse 125). F/u BP 138/8...
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Flushing, tingling of extremities, increased heart rate. Initial BP 135/79 (pulse 125). F/u BP 138/83 (pulse 106), 98% O2 sat.
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| 54 | 2021-03-07 | pain in extremity |
Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A...
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Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3246), via an unspecified route of administration on the right arm on 02Feb2021 08:15 at single dose for COVID-19 immunisation. Medical history allergies: pcn, latex, wheat/gluten, dairy, soy, corn. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (lot number: EL 3246) on 11Jan2021 06:30 PM on the right arm for covid-19 immunisation; epinephrine and experienced allergies. At 6:00 PM on 02Feb2021, patient developed fever 99.4 and steadily rose to 101.5 by 9:30 PM; sore arm all day and night, following day much less sore and easier to move. Fever stayed overnight, down to 100.5 morning on 03Feb2021. Nausea accompanied fever and still have slight nausea. The patient received no treatment. The outcome of the events was recovering.
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| 54 | 2021-03-08 | tingling, numbness |
Patient stated tingling and numbness. EMT transported the patient to hospital ER given Benadryl 50 m...
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Patient stated tingling and numbness. EMT transported the patient to hospital ER given Benadryl 50 mg.
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| 54 | 2021-03-08 | throat numbness |
Numbness of lips and throat commencing approximately one hour after receiving vaccine. Patient self-...
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Numbness of lips and throat commencing approximately one hour after receiving vaccine. Patient self-treated with benadryl and symptoms resolved after about 2 hours.
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| 54 | 2021-03-09 | numbness |
15 minutes after receiving the vaccine, my tongue, lips, inside of mouth (roof) and cheeks became nu...
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15 minutes after receiving the vaccine, my tongue, lips, inside of mouth (roof) and cheeks became numb. I administered benadryl 30 minutes after receiving the vaccine. The symptoms came and went throughout the next 4 hours. I administered a second dose of benadryl 4 hours after the vaccine and that seemed to reduce the symptoms greatly. My temperature was slightly elevated during this 4 hour period, as well. I took tylenol and that was effective. I had no further symptoms overnight or today. My concerns were about whether or not I should get second vaccine.
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| 54 | 2021-03-09 | pain in extremity, flushing |
sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days l...
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sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days later; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included Known allergies to Possible latex, Diabetes, sleep apnea, PTSD (Post-traumatic stress disorder)/anxiety, herpes, vitamin d deficiency, environmental allergies, asthma. Concomitant medication was unspecified medication in two weeks. On 16Jan2021 08:00, The patient experienced sore arm, slept for 17 straight hours, chills, upset stomach, upper body flushing for up to 4 days later. Treatment received for the events included OTC medications. The patient was not pregnant. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the events was recovered in 2021. information on the lot/batch number has been requested.
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| 54 | 2021-03-09 | pain in extremity |
hives all over the body 2 days after the vaccine, severe forearm pain bilateral from elbow down and ...
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hives all over the body 2 days after the vaccine, severe forearm pain bilateral from elbow down and was unable to write or lift anything for 3-4 days . pain has improved but still has hives very itchy
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| 54 | 2021-03-09 | tingling |
Lightheaded, facial tingling, weird sensation in left hand. BPs 166/102 (pulse 84), 160/97 (pulse 77...
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Lightheaded, facial tingling, weird sensation in left hand. BPs 166/102 (pulse 84), 160/97 (pulse 77), O2 sats 100%.
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| 54 | 2021-03-10 | weakness, night sweats |
Symptoms began about 12 hours after the 2nd shot. (The first one I just was lethargic for a couple o...
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Symptoms began about 12 hours after the 2nd shot. (The first one I just was lethargic for a couple of days and had a big knot at the injection site.). I had a terrible headache for about 36 hours and had zero energy for 2 days. I had night sweats the first night. Then I had a swollen, hot arm from left shoulder to elbow for 24 hours. It decreased some, but the knot remained for about 4 days. The symptoms were a lot less than the 2nd shingles shot I got in the fall. And certainly the symptoms were a lot better than the virus itself!
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| 54 | 2021-03-10 | weakness |
Severe headache, arm soreness at injection site, vomiting in first 24 hours, nausea, fever up to 102...
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Severe headache, arm soreness at injection site, vomiting in first 24 hours, nausea, fever up to 102 but consistently at 100 for approximately 48 hours, weakness and fatigue. Headache lasted to third day but less severe.
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| 54 | 2021-03-10 | weakness |
Lightheadedness on 3/5/21 Soreness at vaccine site Shortness of Breath Body Chills Fatigue Weakness...
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Lightheadedness on 3/5/21 Soreness at vaccine site Shortness of Breath Body Chills Fatigue Weakness Headache
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| 54 | 2021-03-10 | facial paralysis, bell's palsy |
Bell's Palsy, right sided moderate facial paralysis, acute onset Started on prednisone 80mg x 7 day...
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Bell's Palsy, right sided moderate facial paralysis, acute onset Started on prednisone 80mg x 7 days, valacyclovir 1g TID x 7 days, and acupuncture
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| 54 | 2021-03-10 | tremor, slurring |
Approximately 8 minutes after vaccination, while seated in monitoring area, experienced sudden onset...
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Approximately 8 minutes after vaccination, while seated in monitoring area, experienced sudden onset of dizziness, profuse sweating, shakiness, difficulty speaking, stammering, difficulty sitting or standing without assistance, increased blood pressure, headache in right temple through back of head on right side. Nursing support response included taking me by wheel chair to isolated area, removing face covering, providing drinking water, monitoring pulse and blood oxygen rates and blood pressure. Began to feel better after several minutes, then symptoms returned but not as severe. Cycles of improvement and return of symptoms but diminished in severity occurred over the next 30 minutes. Tired feeling for approximately 4 hours following vaccine and low grade headache. Took 2 Tylenol regular strength approximately 1 hour following vaccine and again 4 hours later. 20 hours following vaccine, still feeling episodes of dizziness, headache, fatigue, difficulty with speech (stammering), shakiness, difficulty focusing/concentrating.
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| 54 | 2021-03-11 | discomfort, tremor |
First I had chills and quite violent shaking. I then got a fever and felt muscle aches, joint pain a...
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First I had chills and quite violent shaking. I then got a fever and felt muscle aches, joint pain and my skin hurt. I also had a headache on and off. Sleep was almost impossible due to being uncomfortable, and I had thoughts racing through my head. I also had lack of appetite, but not nausea.
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| 54 | 2021-03-11 | numbness, tingling |
Around 5:55 I felt a numbing at the top of my leg while seated while waiting my 15 minute wait time....
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Around 5:55 I felt a numbing at the top of my leg while seated while waiting my 15 minute wait time. The numbing continued down the right side of my right leg. I didn't think much of it because I thought it was the way I was sitting. I didn't report it to anybody at that time. I got in my car and my three right toes started to numb. Then I felt it down my arm and the right three fingers. About 15 minutes later my jaw muscle, then up to my temple and across the fatty area of the eyebrow went numb. Several minutes later I noticed my nostril and right side of my tongue numb. It felt like my tongue and face were swollen but when looking in the mirror they were not and there was no drooping when I smiled and raised my eyebrows. It was a similar feeling that I have had when a shot has almost worn off from a dental procedure. The feeling and the movement is there but still tingly. The arm, leg, and toe numbness went away 2-3 hours later on the same day of the shot. I had no numbness on the left side. Two days later I still have the same numbness on my right two fingers, tongue, jaw, eyebrow area, and nostril.
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| 54 | 2021-03-11 | pain in extremity |
3/8: Sore arm on day of first injection 3/9: Approximately 4 pm- Fever, chills, lethargic - 100 degr...
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3/8: Sore arm on day of first injection 3/9: Approximately 4 pm- Fever, chills, lethargic - 100 degree temperature day 2
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| 54 | 2021-03-11 | pain in extremity |
Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cou...
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Cold sore, mouth sores, itchy burning eyes, abdominal rash, itchy skin head to toe, vertigo, dry cough, shortness of breath, traveling leg pain, development of ear infection, dizziness
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| 54 | 2021-03-12 | numbness |
patient sat down and started to feel numbness in the face swelling of throat and tightness in chest ...
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patient sat down and started to feel numbness in the face swelling of throat and tightness in chest patient was given an epipen and 911 was called she was taken to emergency room and monitored but currently feeling ok
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| 54 | 2021-03-13 | numbness, feeling hot, tingling |
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose ...
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pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
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| 54 | 2021-03-14 | weakness, inability to speak |
Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, troubl...
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Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, trouble swallowing, difficulty breathing, confusion, chills, difficulty speaking.
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| 54 | 2021-03-14 | numbness, sensory loss |
Following vaccination, began experiencing numbness and difficulty of grip in the left hand's ring an...
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Following vaccination, began experiencing numbness and difficulty of grip in the left hand's ring and pinkie finger- difficulty to feel strong sensation
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| 54 | 2021-03-14 | nerve pain, burning sensation |
About 5-6 days after the vaccine, neuralgia around my rib cage mirroring that of shingles (which I h...
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About 5-6 days after the vaccine, neuralgia around my rib cage mirroring that of shingles (which I have previously had in the same place) became active. No rash or outbreak, but the neuralgia was present, with burning and pain for a couple days. It subsided, then returned a week later and has remained painful for 4 days.
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| 54 | 2021-03-14 | pain in extremity, feeling cold | muscle pain, feeling cold, arm hurting |
| 54 | 2021-03-14 | pain in extremity, nerve pain |
Severe pain in entire body including joints and muscles along with severe nerve pain which is a seve...
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Severe pain in entire body including joints and muscles along with severe nerve pain which is a severe burning pain in all extremities (arms and legs)and including low back, both hips, hands and fingers and ankles and feet. It started the same day of the vaccine and it has been 2 and a half weeks and it is still very severe and debilitating. Also with muscle fatigue. I had experienced severe lethargy until I was put on medication. My doctor first put me on prescription dose of Ibuprofen (2400mg over 24 hours) after a week and a half of being on Tylenol with no relief. After four days of Ibuprofen and it tearing up my stomach and having to go on medication for my stomach (Pepsid 40mg with Mylanta) I was still having severe unrelenting pain. My doctor then put me Prednisone 40mg taper. I am on day four of Prednisone and still having severe pain.
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| 54 | 2021-03-14 | pain in extremity |
Fever, severe chills and fatigue, headache, body aches, pain in left arm, full body hot rash. Began...
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Fever, severe chills and fatigue, headache, body aches, pain in left arm, full body hot rash. Began on the afternoon 3/14/21, became severe in the evening, into 3/15/21. Symptoms have improved, but are still present, I have been in bed for 24 hours.
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| 54 | 2021-03-15 | weakness |
Soreness at injection site on the first day, around 24 hours later developed all over aches, lighthe...
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Soreness at injection site on the first day, around 24 hours later developed all over aches, lightheadedness, chills, and weakness to the point of not being able to ambulate. This lasted for two days, then started getting extremely swollen, sore lymph nodes under left arm to the point of not being able to tolerate wearing a bra along with dizziness and nausea. This has persisted for two days so far.
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| 54 | 2021-03-15 | pain in extremity | sore arm , joint pain and muscle more than normal and very sleepy. |
| 54 | 2021-03-15 | pain in extremity |
Initially, my arm was sore and I had extreme nausea. That lasted for about 2 weeks. My doctor told m...
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Initially, my arm was sore and I had extreme nausea. That lasted for about 2 weeks. My doctor told me to take Prilosec.
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| 54 | 2021-03-15 | pain in extremity |
I got the shot about 1 pm, and everything went well. About 7 pm, my arm started to hurt, like every ...
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I got the shot about 1 pm, and everything went well. About 7 pm, my arm started to hurt, like every sore muscle. The pain grew, and my arm and shoulder hurt badly with any movement, so that when I used my arm, I cried out in pain. This morning the pain is there, and I wince with any movement, and if I forget and reach up, I cry out in pain. I know this is no big deal, but this was a very overt pain that I've not to experience in the past with shots I've received.
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| 54 | 2021-03-16 | involuntary muscle movements |
On March 16, I was sitting in a chair next to my kitchen counter when I felt like my body was being ...
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On March 16, I was sitting in a chair next to my kitchen counter when I felt like my body was being thrown. My head was thrown forward and I hit the counter hard and sustained a large contusion above my left eye. The room was spinning and I was dizzy for the next few hours. I never lost consciousness but had no control of my body for the few seconds of the episode. The episode was sudden and violent and I was just sitting when it happened. I spoke with my physician who diagnosed me with having experienced a Tumarkin otolithic crisis. He has instructed me to wear a helmet and not to leave my home. He is also recommending that I have a labyrinthectomy to treat the symptoms. While I have a history of vertigo, I have not had any dizziness for more than a year. I now feel dizzy on and off most of the day.
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| 54 | 2021-03-17 | weakness | Weakness, Body aches, headache, sinus issues |
| 54 | 2021-03-17 | difficulty speaking |
Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My li...
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Received the vaccine and within a minute or two felt very dizzy and heart was beating so fast. My lips were tingling and my arms and legs felt suddenly so tired. They monitored me in the reaction tent for 45 minutes until I could sit up and walk. By the time I got home I had a burning rash on my neck and my voice was suddenly hoarse as if I was sick. Just rested and symptoms slowly subsided over the day. I must be hypersensitive to something because this is the third time I have had a reaction like this. The others were with the fly shot. Folks took good care of me.
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| 54 | 2021-03-17 | pain in extremity |
felt my left arm sour, heavy to lift; felt my left arm sour, heavy to lift; muscle ache on both shou...
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felt my left arm sour, heavy to lift; felt my left arm sour, heavy to lift; muscle ache on both shoulders; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247), via an unspecified route of administration on 17Feb2021 13:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of BNT162B2 on 27Jan2021 03:00 PM at left arm with lot number EL3247 for covid-19 immunization, also at age of 54 years old. Patient is not pregnant at the time of vaccination. The patient medical history was none, concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Two hours after the 2nd dose, patient felt headache and fatigue. She took 500mg of Tylenol at 6 pm on 17Feb2021. The headache went away during the night. The next morning, she felt left arm sour, heavy to lift. Some level of muscle ache on both shoulders. Patient took another 500 mg of Tylenol. The arm sourness was much less in the afternoon on 18Feb2021, and totally disappeared on 19Feb2021. The outcome of event headache was recovered on 17Feb2021, events fatigue and "heavy to lift" were recovered in Feb2021, the other events were recovered on 19Feb2021. The events were reported as non-serious.
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| 54 | 2021-03-17 | tingling |
approx. 5-6 hours after vaccine: rapid/racing/fluttering heartbeat, entire left side tingle sensati...
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approx. 5-6 hours after vaccine: rapid/racing/fluttering heartbeat, entire left side tingle sensation- restless ness
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| 54 | 2021-03-18 | weakness, tingling |
Mild adverse effects. Still experiencing. Low grade fever (102.4), headache, weakness, aching/tin...
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Mild adverse effects. Still experiencing. Low grade fever (102.4), headache, weakness, aching/tingling joints, lightheadedness, very sleepy
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| 54 | 2021-03-18 | cold sweat |
PATIENT OBTAINED 'SHOT.' ABOUT 10 MINUTES LATER (SHE) BEGAN TO FEEL CLAMMY PT STATED THAT SHE MAY ...
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PATIENT OBTAINED 'SHOT.' ABOUT 10 MINUTES LATER (SHE) BEGAN TO FEEL CLAMMY PT STATED THAT SHE MAY HAVE 'BLACKED OUT' A LITTLE - PT HAS A HISTORY OF FAINTING IN EMOTIONAL SITUATIONS
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| 54 | 2021-03-18 | feeling hot |
Approximately 10 minutes after receiving the Pfizer BioNtech COVID-19 vaccine, pharmacist was alert...
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Approximately 10 minutes after receiving the Pfizer BioNtech COVID-19 vaccine, pharmacist was alerted by the vaccine ambassador that a patient was sitting on the ground likely having a reaction to the vaccine. The pharmacist came to the patient to assess the situation. Patient described that she was experiencing "a warm sensation to going to her head" and was not feeling well. Patient was breathing, alert, and conscious. She did not state that she had any medical conditions that could be contributing to the reaction. A nurse who was shopping at the store also stopped to assist. Out of precaution, 911 was called and paramedics arrived on site. Blood pressure and heart rate were normal.
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| 54 | 2021-03-18 | migraine |
First dose - Got up with every joint aching in my body, as if I had the flu, along with terrible mig...
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First dose - Got up with every joint aching in my body, as if I had the flu, along with terrible migraine and extremely tired. Second dose - had the very same side effects as dose 1, slept many hours the next day.
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| 54 | 2021-03-18 | pain in extremity |
Left arm soreness on same day/night; This is a spontaneous report from a contactable consumer (patie...
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Left arm soreness on same day/night; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 54-year-old, via an unspecified route of administration, administered in left arm on 15Feb2021 13:00 (Batch/Lot Number: EN9581) as single dose for COVID-19 immunisation. Medical history included treated with high blood pressure. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient experienced left arm soreness on same day/night on 15Feb2021 19:30 with outcome of recovered. No treatment was given for the event.
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| 54 | 2021-03-18 | pain in extremity | sore arm |
| 54 | 2021-03-19 | night sweats | Fatigue, feverish, chills, night-sweats. |
| 54 | 2021-03-20 | feeling hot, cold sweat |
I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; ...
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I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; feeling hot and clamy; nausios; i could not breathe; It was like a really bad asthma attack; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EN6208), via an unspecified route of administration i as single dose in arm left on 10Mar2021 for COVID-19 immunisation. Medical history included known allergy to penicillin. The patient's concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 04:30 morning the patient experienced woke up with a headache, feeling hot and clamy, nausios. She took Iboprofin and was fine. On 12Mar2021 night she went to bed about 10 pm and woke up from a sound sleep about 12:30 am she could not breathe. It was like a really bad asthma attack which she have never had like that. It took a while to try to breath thru her nose but finally she was able to and took a nebulizer treatment with Abutero. She was very scary. She was wondering if she should take the 2nd dose. The events were considered life threatening. Therapeutic measures were taken as a result of events. Covid was not tested post vaccination. The outcome of events was not recovered.
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| 54 | 2021-03-20 | migraine | Migraine headache, chills and fatigue |
| 54 | 2021-03-21 | numbness |
Starting at 5 p.m. on March 18th (two days post-vaccine), pain began in the lymph node area of the l...
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Starting at 5 p.m. on March 18th (two days post-vaccine), pain began in the lymph node area of the left side of the neck. It became increasingly painful on March 19 in the evening (especially after dinner) and overnight (around 3 a.m.) and more painful in the evening on March 20th after dinner. On March 20th, I took 800 mg ibuprofen (4 tablets) at 6 p.m. to relieve the pain. My husband is an Emergency Physician and indicated that is the dose I should take given the pain. At 1:00 p.m. on Sunday the lymphnodes on the left side of the neck began hurting again (excruciating pain) and I again took 800 mg of ibuprofen to relieve the pain. This occurred after having lunch (a burger) at noon. However, at 1:30 p.m. the left side of my face began to feel numb. I had little control of the left side of my mouth and could not close my left eyelid properly. The numbness lasted for about 20 min and then subsided. After 40 min (2:10 p.m.) it felt better and I had a few potato chips left over from my lunch. The numbness started again about 10 min later and lasted about 20 min. The face went numb again the evening of March 22nd for 20 min despite remaining on ibuprofen 3 times a day.
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| 54 | 2021-03-21 | migraine | Migraine style headache and diarrhea |
| 54 | 2021-03-21 | tingling |
Tingling down right arm, vitals within limits, 134/78, P-68,R-18, O2 97%, client refused EMS transpo...
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Tingling down right arm, vitals within limits, 134/78, P-68,R-18, O2 97%, client refused EMS transport. client is waiting in her cr till she feels 100% and then she will go on her way home. Pt. reassessed multiple times to use EMT for transport, but pt. refused stating "I feel fine, I want to go home.
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| 54 | 2021-03-21 | tenderness |
When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left ...
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When I laid down for bed my tongue felt weird on my left side. I looked in the mirror and the left side of my face was swollen around the cheek. I have a little soreness around the jaw. My left are was sore to the touch and slight stiff where I cannot raise my arm all the way. I took 2 Benadryl tablets.
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| 54 | 2021-03-22 | inability to speak, slurring |
Approximate 20 hours after receiving dose #2 of vaccine, presented with symptoms of stroke: aphasia...
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Approximate 20 hours after receiving dose #2 of vaccine, presented with symptoms of stroke: aphasia, unable to process thoughts quickly, unable to write legibly, jarbled speech. I was working night shift at the hospital. I was immediately taken to the emergency department. Placed on monitor, labs drawn, neurochecks, EKG. Could not identify some simple pictures, could not recall my co-workers name ( worked with her for 25 years). CT done within 15 minutes of symptoms. MRI completed. Episode lasted approximately 45 minutes.
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| 54 | 2021-03-22 | weakness |
After only having the first dose (1 of 2): extreme light headed, nausea, weakness, no balance, pain...
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After only having the first dose (1 of 2): extreme light headed, nausea, weakness, no balance, pain in upper right side ribs below arm pit, Received shot for nausea and stayed in bed all day - mostly better the next day and normal the following day.
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| 54 | 2021-03-22 | weakness |
Arm and vaccination site not sore until this morning, but tolerable. Felt very sleepy starting at ar...
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Arm and vaccination site not sore until this morning, but tolerable. Felt very sleepy starting at around 5:30pm yesterday. Had a good night sleep but very tired and sleepy this morning. Low energy.
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| 54 | 2021-03-22 | burning sensation, migraine, weakness |
The night of the injection I had a headache and chills no fever. In the morning my headache was a m...
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The night of the injection I had a headache and chills no fever. In the morning my headache was a migraine no energy and a rash on forehead. My evening my head was on fire and blister formed on rash. My ear was ringing and hurt It was painful to swallow. Went to ER and was Dx with shingles was prescribed valtrex 1gram q8 hours and lotramin lotion
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| 54 | 2021-03-22 | migraine |
Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued na...
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Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued nausea & migraine. Tuesday 3/9 went to ER with same symptoms. Was admitted to hospital on 3/9 with acute kidney injury, nausea & Migraine. Was discharged from hospital on 3/14. Followe up with primary doctor on 3/17. Primary DR requested more bloodwork. Had low potassium. Ended up back in ER 3/17 with nausea and vomiting. They pushed more fluids and sent me home. Will have follow up blood work on 3/26 and next Dr appointment on 4/19. Returned to work for 1/2 day on 3/22. Absent 3/23 for extreme fatigue.
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| 54 | 2021-03-22 | migraine | Patient reports migraine day after covid shot. |
| 54 | 2021-03-22 | tingling |
Patient received first dose of Pfizer and started having tingling in her hands and feet. EMS respond...
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Patient received first dose of Pfizer and started having tingling in her hands and feet. EMS responded and took Vital Signs, BP 130/80, O2 sats 99, HR 105. Patient had taken her personal albuterol inhaler prior to EMS response she stated. Patient refused any further treatment and had recovered within few minutes.
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| 54 | 2021-03-23 | numbness |
Pt. reported feeling left sided cheek numbness 5 minutes. This RN performed Stroke Scale on pt and p...
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Pt. reported feeling left sided cheek numbness 5 minutes. This RN performed Stroke Scale on pt and pt had no neurological deficits. When asked pt about decreased sensation pt denies any difference in sensation but reported numbness. Stated all areas of body felt the same when checked. Pt had clear breath sounds, bilaterally, no swelling noted, able to swallow secretions. Pt was A&Ox4 with GCS of 15. Pt was able to ambulate under own power and steady gait. Pt denies any other issues. Pt requested to go to hospital and EMS was then notified.
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| 54 | 2021-03-23 | pain in extremity |
I received the vaccine at 7:45 am 3/23/21 and at 11:00am left arm was sore and is continuing to be s...
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I received the vaccine at 7:45 am 3/23/21 and at 11:00am left arm was sore and is continuing to be sore through 12:25pm 3/24/21. Arm is continuing to be sore Also around 9:30 am 3/24/21, I had an upset stomach which led to several loose bowel movements up through 12:45pm so far.
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| 54 | 2021-03-23 | pain in extremity | Body aches Chills Headache Sore arm |
| 54 | 2021-03-23 | pain in extremity |
The day after vaccine thigh pain, 5 days after vaccine, thighs start have Shingles Visit doctor on 3...
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The day after vaccine thigh pain, 5 days after vaccine, thighs start have Shingles Visit doctor on 3/22/21, doctor prescribes medicine ? Zovirax?
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| 54 | 2021-03-23 | pain in extremity | Chest pain, chest tightness, stomach upset, diarrhea , headache, arm soreness, brain fog |
| 54 | 2021-03-23 | tingling, pain in extremity |
Upon injection are immediately was tingly down the outer aspect across outer forearm down hand into ...
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Upon injection are immediately was tingly down the outer aspect across outer forearm down hand into fingers. Lasted about 30 minutes. About 4pm arm started to be sore. During the night started running a fever, 101.8 body hurt all over. Felt like I weighed 600 pounds and couldn?t move. Started in the top of my head, neck, shoulders, back, hips, thighs, knees, ankles, and feet. Very tired. No appetite. So much pain doctor ordered toroidal. Pain under left arm. Now about 36 hours later feeling much better. No fever, little more energy, pain is better but still taking toroidal so not sure.
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| 54 | 2021-03-24 | weakness, sensory loss |
The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomac...
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The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomach upset, vomiting. I had loss of sensitivity in my right thigh area that comes and goes. I also have brain fog, joint aches that overwhelming. Subsequently, I had Covid tests through my PCP which were negative but I had symptoms that mimicked Covid symptoms. My PCP recommended I go to the ER and I was admitted for two and a half days. They monitored my heart, did lab work, liver test. I continue with headaches that are more profound. I still have loss of strength in my right thigh, which is intermittent, comes and goes. I still have itchiness on my right thigh and leg with loss of sensation lasting from three to five hours. I will be seeing a neurologist next month.
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| 54 | 2021-03-24 | weakness |
delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills;...
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delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills; joint pain; pain at the injection site; lethargic; dry cough; severely nauseous; could not eat; serious fogginess; General malaise; fatigued; a debilitating headache; did not feel comfortable driving; weak; hurt in my chest; slept the whole day; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 13:30 (Batch/Lot Number: EN6202) at 54-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included hypertension, and acne from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included hydrochlorothiazide, olmesartan medoxomil (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; isotretinoin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone sodium) ANCEF, start and stop date were not reported, and experienced drug allergy. On 06Mar2021 at 04:00 (as reported), the patient experienced: delirious as if i was hungover (medically significant), felt on the brink of fainting (non-serious), chills (non-serious), joint pain (non-serious), pain at the injection site (non-serious), lethargic (non-serious), dry cough (non-serious), severely nauseous (non-serious), could not eat (non-serious), serious fogginess (non-serious), general malaise (non-serious), fatigued (non-serious), a debilitating headache (non-serious), did not feel comfortable driving (non-serious), weak (non-serious), hurt in my chest (non-serious), slept the whole day (non-serious); with no treatment received. The clinical course was reported as follows: The patient reported that on the first night (as reported) she had chills, joint pain and pain at the injection site. The next day (as reported) she was lethargic and was severely nauseous to the extent she could not eat. The patient also experienced serious fogginess, felt delirious as if she was hungover. The patient felt general malaise and a debilitating headache all day. The patient was fatigued to the extent she did not feel comfortable driving. The patient was so weak, that she felt on the brink of fainting. That evening, the patient slept the whole night through, except when she would awake with a dry cough that hurt in her chest. This cough was not as persistent and intense but was lasting even now. The patient slept the whole day and was just now beginning to feel as if she had recuperated from the vaccine four days later. The clinical outcome of the events was recovered with sequelae on an unspecified date (also reported as "recovered with lasting effects"). The patient was not tested for COVID post vaccination.
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| 54 | 2021-03-24 | flushing |
Pt developed a flushed feeling along with lightheadedness. She notes that it feels similar to prior ...
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Pt developed a flushed feeling along with lightheadedness. She notes that it feels similar to prior episodes of vertigo. Symptoms came on almost immediately after vaccination. BP 120/80, HR 73, SP02 98%. She ate a snack and felt slightly better and elected to go home with her husband driving. She declined EMS services and ER evaluation,
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| 54 | 2021-03-24 | pain in extremity |
Arm was sore as expected. Red spots developed on chest first. They do not itch or hurt. I didn?t ...
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Arm was sore as expected. Red spots developed on chest first. They do not itch or hurt. I didn?t notice that the spots were all over the torso - back, abdomen, breast, and I may have some on scalp. My allergy Dr described as fixed drug eruption and said the spots look like nummelar dermatitis - even though no itching. She prescribed Triamcinolone and I just started using. I first went to my internist and she had no clue what it was or how to help. I?ve never had anything like this ever - the only thing I?ve done differently in the last 3 weeks was getting vaccinated. No way I?m getting the second dose.
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| 54 | 2021-03-24 | tingling |
About 30 minutes after, arm and face became really hot. Then it turned into tingling, pins and needl...
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About 30 minutes after, arm and face became really hot. Then it turned into tingling, pins and needles along my whole left side. I am still having this as of today 3/25/21
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| 54 | 2021-03-24 | tingling | Feeling "light" and tingling in hands and lips |
| 54 | 2021-03-25 | feeling hot, flushing | hot/flushed. monitored in ER |
| 54 | 2021-03-25 | flushing |
Immediately after vaccination patient felt flushed and had "a funny taste in her mouth". She was eva...
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Immediately after vaccination patient felt flushed and had "a funny taste in her mouth". She was evaluated by an on-site EMT and symptoms resolved within 30 minutes. Patient has a history of panic attacks.
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| 54 | 2021-03-25 | numbness |
Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 min...
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Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 minutes of receiving shot, numb chest, neck, lower fac3 - and swelling of throat and lower face. The numbness and swelling lasted for approximately 3 hours.
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| 54 | 2021-03-25 | night sweats |
Dizziness, confusion, nausea, night sweats, lack of concentration & inability to think clearly. Ext...
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Dizziness, confusion, nausea, night sweats, lack of concentration & inability to think clearly. Extreme fatigue & quickly becoming short of breath from walking. Rapid/racing heartbeat. Started evening of the vaccination & continued through the entire day on 3/24, the day after the vaccine. Went to bed at 5:30pm on the 24th and felt much better on the morning of the 26th.
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| 54 | 2021-03-25 | pain in extremity, numbness |
Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for...
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Severe pain in left arm outside of injection, move down the whole arm to the bottom arm was numb for over 12 hours. Left side of the neck pain, left lymph node glands under the arm severely swollen, earache and left side, and extreme fatigue. Now 43 hours later after the injection I can move my arm but still cannot touch the site of the injection, left ear still hurts, left side of neck still painful but better. Can now lift arm above had but still feels very heavy. The lymph node glands under her left arm has reduced in size but still sore to the touch. I?ve been taking ibuprofen for the last two days to help with the discomfort.
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| 54 | 2021-03-25 | pain in extremity | Sore Arm, light swelling. |
| 54 | 2021-03-26 | pain in extremity |
Following day: vertigo, nausea, fatigue, chills, throbbing pain in both legs (all over), headache, ...
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Following day: vertigo, nausea, fatigue, chills, throbbing pain in both legs (all over), headache, sore arm, had to urinate every 15 minutes for approximately 12 hours. These symptoms lasted about 48 hours. Morning vertigo or just dizziness every morning since day of shot. Nausea every day since day of shot.
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| 54 | 2021-03-26 | tingling |
Throat tightness and dryness, facial tingling. After 10 minutes, persistent and worsening throat tig...
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Throat tightness and dryness, facial tingling. After 10 minutes, persistent and worsening throat tightness, facial tingling. Given Epipen and albuterol. Sent to ED.
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| 54 | 2021-03-27 | pain in extremity |
Mild sore arm x 2days , fatigue x2days and lymphadenopathy of bilateral axillae and swelling of righ...
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Mild sore arm x 2days , fatigue x2days and lymphadenopathy of bilateral axillae and swelling of right breast x5 days
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| 54 | 2021-03-28 | weakness, slurring |
heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immed...
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heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
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| 54 | 2021-03-28 | tingling, numbness |
This side effect randomly happens to me 2-3x/year, I wasn't overly concerned and just watched it. I ...
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This side effect randomly happens to me 2-3x/year, I wasn't overly concerned and just watched it. I have no idea what triggers it so it may not be vaccine-related Vaccine: 9am MT. About 25 minutes after the vaccine (9:25am) , my lips started tingling and went numb. Within 10 minutes or so, the tingle/numbness travelled to my entire face and inside my mouth and tongue. I waited 90 minutes then self-treated with two Benadryl tablets (11am). Tingle/numb were gone 1-1:30ish.
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| 54 | 2021-03-28 | tremor | Within 18 hours of dose 1, I woke with fever, chills, shaking, and body aches. |
| 54 | 2021-04-02 | weakness, discomfort, pain in extremity |
After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 ...
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After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 when developed a bad headache causing me to leave work. When I awoke on 2/11/21 I felt worse as the day went on until I had complete flu like symptoms. On Friday, 2/12, I went to my primary care doctor and they did a COVID-19 test which was negative. Hence, I just waited for the reaction to go away, I was not better and able to resume normal activity until 2/15/21. I did decide to get the second shot as I was not entirely sure it was a result of the vaccine. On 2/27/2021, I received the second vaccination. Again, the immediate side effect was only a sore arm. On the following Monday (3/1/2021) see cont.I began to have what I thought was muscle aches and pains around the mid section on my body but they were manageable. On Tuesday and Wednesday (3/3/2021) the pain and area of the pain spread and intensified. I was unable to sleep or find a comfortable position and was losing strength and knew I needed medical attention as I was afraid it was a heart issue. My husband took me to the ER (3/4/2021). The ER doctor ran a CT scan with contrast and the result was a blood clot in my right lung and pneumonia in my left lung along with pleurisy. I was then admitted to Clinic on 3/4/2021. I remained in the hospital until 3/7/2021. There I was treated with IV antibiotics, warfarin, Lovenox (80mg), and pain medication for the pleurisy. I was also on a full time heart monitor and my heart was checked several times. Since returning home, I finished a dose of two antibiotics and am using an inhaler to help with breathing. I have also just finished a long dose of steriods. My INR is still not regulated to the therapeutic level. Prior to this reaction, I was in the therapeutic range and had been checked. As of 4/3/2021 I am at 1.8 not in the 2-3 range and have increased my dose from before the reaction at 7.5 mg to 9.0 mg daily.
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| 54 | 2021-04-04 | numbness, facial paralysis | left side numbness and tingling throat 1/2 closed, right side lip |
| 54 | 2021-04-07 | cold sweat |
Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to...
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Dizziness; clammy kind of feeling; low grade fever; feels kind of sweaty; felt like she was going to pass out; blood pressure was up; This is a spontaneous report from a contactable consumer reported for herself that at the age of 54- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Mar2021 (at the age of 54-year-old), at a single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. Caller reports that since she received the vaccine on 15Mar2021, on the day of the vaccine, she felt like she was going to pass out and her blood pressure was quite high. Her blood pressure is usually about 120/70 something, but it was 160 or 155/96 on the day of the vaccine. The reporter stated, she has been experiencing a clammy kind of feeling, like she has a low-grade fever and she feels kind of sweaty on 16Mar2021. Caller make the comment that she is in her fifties and she knows what hot flashes feel like-your body gets hot, sweaty, and you get redness on your skin, and your temperature goes up. This feeling is different- she doesn't feel like herself and she doesn't feel right and she is not sure if this is related to the vaccine, but it started after she received the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 120/70 on an unspecified date and on 15Mar2021 reported as: 160 or 155/96 on 15Mar2021. The reported events were considered as non-serious by the health authority. The outcome of the events clammy kind of feeling, low grade fever and feels kind of sweaty were not recovered and unknown for other events. Information for lot/batch number has been requested.
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| 54 | 2021-04-09 | bell's palsy |
Bell's Palsy; This is a spontaneous report from a contactable other healthcare professional. A 54-ye...
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Bell's Palsy; This is a spontaneous report from a contactable other healthcare professional. A 54-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Feb2021 14:30 (Batch/Lot Number: EM9809) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine and sulfa drug allergy. Concomitant medications included hypericum perforatum (ST JOHNS WORT) taken for an unspecified indication, start and stop date were not reported; magnesium taken for an unspecified indication, start and stop date were not reported; and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient experienced bell's palsy on 20Mar2021. The outcome of events was not recovered. Therapeutic measures were taken as a result of bell's palsy.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event Bell's palsy due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-04-11 | facial paralysis, inability to speak |
Saturday March 13 Evening . Stroke symptoms, facial drooping, weakness in legs, difficulty walking, ...
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Saturday March 13 Evening . Stroke symptoms, facial drooping, weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. TPA administered. Situation resolved. Hospitalized 4 days. Note: My brother who resides in a different state suffered a stroke March 12. He also received the Pfizer vaccine date unknown.
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| 54 | 2021-04-12 | grand mal seizure |
neurological grand mal seizures; difficulty breathing; tight chest; sore achy bones, muscle; sore ac...
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neurological grand mal seizures; difficulty breathing; tight chest; sore achy bones, muscle; sore achy bones, muscle; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737), via an unspecified route of administration at the left arm on 27Mar2021 12:45 pm at single dose for COVID-19 immunization. The patient's medical history included juvenile rheumatoid arthritis, asthma, diabetic Type 2, neurological seizure disorder from traumatic brain injury. The patient had known allergies to penicillin, tetracycline, sulfonamide. Concomitant medications included methotrexate (withheld for 2 weeks 25mg injection). On 28Mar2021 1:15 AM, the patient experienced neurological grand mal seizures, sore achy bones, muscle, tight chest, and difficulty breathing. The patient was treated with nebulizer for difficulty breathing. It was reported that patient had no covid prior vaccination nor tested post vaccination. Outcome of events was reported as not recovered.
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| 54 | 2021-04-12 | pain in extremity |
Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm...
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Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm soreness; Extreme nausea; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 54 years, on 26Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Patient's medical history includes multiple sclerosis, hypothyroid, postconcussive syndrome and migraines from unspecified dates. The patient is not pregnant. Patient did not have other vaccine in four weeks. Patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. Patient previously took codeine for unspecified indication and had known allergies on an unspecified date, and other unspecified medications in two weeks. Patient historically took first dose of BNT162B2 (Product=COVID 19, Brand=Pfizer, administration time=05:00 PM, Vaccine location= Left arm) on 03Mar2021 at age 54 years for COVID-19 immunization. On 26Mar2021 20:00, 11 hours after vaccine administration, patient experienced fever, shaking chills, headache, hallucinations, body aches, flu-like symptoms, teeth chattering, arm soreness, extreme nausea. Therapeutic measures were taken as a result of these events which include paracetamol (TYLENOL). COVID was not tested post vaccination. Facility type of vaccine was at a public health clinic/veterans administration facility. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 54 | 2021-04-14 | tremor |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Addi...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Additional Details: temp within normal range, BP 149, 146, then 161. had a fast heartbeat so drink 2 small water bottle and shaking hands a liitle.\r\npharmay monitored her more than 1 hour and 30 minutes. she is ok to go home. (previous event happened on last december d/t epinephrine inj at dental office)
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| 54 | 2021-04-15 | tingling |
Client had 2nd dose of COVID vaccine, ten minutes later reported her fingers felt tingly. Vital sig...
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Client had 2nd dose of COVID vaccine, ten minutes later reported her fingers felt tingly. Vital signs stable, denies any other symptom. "Tingling sensation" resolved 15 minutes later, client able to go home.
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| 54 | 2021-04-16 | tingling, pain in extremity, numbness |
20 minutes after the vaccine my muscles started to become weak and painful. Throughout that day the ...
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20 minutes after the vaccine my muscles started to become weak and painful. Throughout that day the pain, muscle weakness, fatigue, lethargy increased then the next morning I was not able to function. This NEVER went away. The pain in every muscle and joint has been so severe and debilitating as well as the fatigue and lethargy. It has been 7 weeks and I am still suffering severely. I have been on high doses of Ibuprofen first(by my doctor) and then high doses of Prednisone by my doctor which I have not been able to come off of. The pain is in all four extremities, shoulders, low back, and hips and is a joint pain, muscle pain, and a severe burning pain. I continue to be lethargic and fatigued unable to get through my work day and needing to lie down often. I was a very fit, active person and now cannot do any activities due to the pain and lethargy. My joints will also give out when I walk including my hips, knees, and ankles. There is numbness and tingling in my extremities, but more in the right arm and right leg. It will feel like there is a tourniquet around them cutting off all circulation.
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| 54 | 2021-04-18 | facial paralysis, speech disorder |
Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of u...
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Stroke symptoms; Facial drooping; weakness in legs; difficulty walking; speech difficulty; loss of use of left arm; rash on hands; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 54 years, administered in the right arm on 10Mar2021 11:15 (Batch/Lot Number: EN6199) as single dose for COVID-19 immunization. Relevant medical history include Hashimoto's thyroiditis from an unspecified date, allergies to shellfish and tree nuts. Patient is not pregnant. Patient did not have COVID prior to vaccination. Concomitant medication include levothyroxine sodium (SYNTHROID). No other vaccines administered in four weeks. Patient previously took amoxicillin and cefalexin and experienced allergies. The patient historically took first dose of BNT162B2 (lot number: EM9810) at age 53 years on 17Feb2021 at 10:45 AM on the right arm for COVID-19 immunization. On 13Mar2021 at 19:45, evening, patient experienced stroke symptoms, facial drooping ,weakness in legs, difficulty walking, speech difficulty, loss of use of left arm, rash on hands. Treatment for the events was TPA. The patient was hospitalized for 4 days. COVID was not tested post-vaccination. Vaccination facility type was at a public health department. The outcome of the events was recovered on an unspecified date.
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| 54 | 2021-04-24 | weakness |
severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating ...
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severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating pain into the right arm and lymp nodes; blood pressure was through the rood; severe pain; cardiac issues; GI issues/GI malfunction of the pancreas and gallbladder; GI issues/GI malfunction of the pancreas and gallbladder; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 09:45 (Batch/Lot Number: Unknown reported as either EN6205 or EM6205) as SINGLE DOSE for COVID-19 immunization; azithromycin (ZITHROMAX), via an unspecified route of administration from 26Feb2021 until 02Mar2021, at unspecified dose and frequency for dental care; and corticosteroid (CORTICOSTEROID), via an unspecified route of administration from an unspecified date with last dose shot on 23Mar2021 at unknown dose, once or twice a year for a couple of years for knee pain and joint pain . Medical history included dental procedure on an unknown date. Concomitant medications were not reported. On 25Mar2021 (9 days later), she developed severe chest pain like severe heart burn attack radiating pain into the right arm and lymph nodes, blood pressure was through the roof and was in severe pain. She was unable to eat, was very weak and also cannot work or engage in daily activities noted in Mar2021. The patient required emergency room and physician office visit due the events (including cardiac issue and GI issues/malfunction of the pancreas and gallbladder). She was hospitalized on 03Apr2021 and was just released on 04Apr2021. During hospitalization, doctors have ruled out cardiac issue and GI issues/malfunction of the pancreas and gallbladder and they cannot find out the cause. The patient received famotidine (PEPCID), omeprazole (PRILOSEC), pantoprazole (PROTONIX), acetaminophen (TYLENOL) as treatment. While in the hospital they gave her dicycloverine (BENTYL) which she thought was for nausea noted in 2021.She stated a week after she got the vaccine she got a corticosteroid shot which she was wondering if it can impact one's immune system and cause an adverse reaction with the vaccine. She also stated that a month prior to vaccine she took an azithromycin. She also was wondering with the combination of all these three things being close together if it may have caused a disruption in her body organic system. The action taken in response with the adverse event for azithromycin was post therapy while unknown for corticosteroid shot. The patient did not recover from chest pain while outcome of the remaining events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021376222 Pfizer
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| 54 | 2021-04-24 | nerve pain, speech disorder |
passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; so...
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passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-04-24 | numbness and pain in extremities, sensory loss, pain in extremity |
Diagnosed radial nerve inflammation in the left arm.; radiating pain throughout the lower left arm; ...
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Diagnosed radial nerve inflammation in the left arm.; radiating pain throughout the lower left arm; some loss of sensation is also present in the index finger of the left arm; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 54 years, via an unspecified route of administration, administered in Arm Left on 10Feb2021 08:00 (Batch/Lot Number: EL9265; Expiration Date: May2021) as a single dose for covid-19 immunization. The patient's medical history included fibromyalgia like symptoms localized just to the right side of body. Concomitant medication included levocetirizine (LEVOCETIRIZINE) taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient experienced diagnosed radial nerve inflammation in the left arm, radiating pain throughout the lower left arm, some loss of sensation is also present in the index finger of the left arm on 01Mar2021. It was further reported that the patient was diagnosed with radial nerve inflammation in the left arm. Pain occurred two weeks after vaccination and continues up to today despite multiple medications (steroids and anti-inflammatory) tried over the last two months. In addition to radiating pain throughout the lower left arm, some loss of sensation was also present in the index finger of the left arm. The patient underwent lab tests and procedures which included nasal Swab on 24Mar2021 and 06Apr2021 which were both negative. Therapeutic measures were taken as a result of the events included Prednisone, Zorvolex and Tizanidine and Dexamethason. The outcome of the event was not recovered.
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| 54 | 2021-04-26 | numbness |
The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is...
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The left side of my body feels tingling and numbness; tingling on the left side of my mouth; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6200, Expiry Date: unknown) on 22Feb2021 15:00 via unspecified route of administration in the left arm on at single dose for COVID-19 immunization. The patient denied any medical history. She had no known allergies. The patients concomitant medications were not reported. Subsequently at the same time, after receiving the vaccine, the patient felt tingling and numbness in left side of her body. It started on her left calf, and she could mostly feel numbness and tingling on the left side of her mouth. The reporter assessed the events as non-serious. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. There were no relevant test. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-04-27 | breast pain |
Tenderness, burning and hurtful left breast; Tenderness, burning and hurtful left breast.; Really ru...
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Tenderness, burning and hurtful left breast; Tenderness, burning and hurtful left breast.; Really run down and tired as expected.; This is a spontaneous report from a contactable consumer, the patient. This 54-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via unspecified route in the left arm on 23Mar2021 at 15:15 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included overweight. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. On 24Mar2021 at 12:00 AM, the patient experienced tenderness, burning and hurtful left breast, especially around the of the breast almost as if touching a splinter on the breast. The patient also reported she was really run down and tired as expected. There was no treatment received for tenderness, burning and hurtful left breast, run down and tired. The clinical outcomes of tenderness, burning and hurtful left breast, run down and tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-04-27 | feeling hot |
Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn'...
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Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe; almost like she couldn't breathe/Difficulty Breathing; Felt funny in her chest, like a really weird, really warm and heavy feeling/ warm feeling in the chest; having an anaphylactic reaction from the vaccine; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Very sore right arm where she was given the injection; felt like she was punched several times in her arm; Injection site bruising; This is a spontaneous report from a contactable nurse(patient). The nurse reported similar events for herself and her husband. This is the first of two reports. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), dose 1 intramuscular, administered in arm right on 10Mar2021 16:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included severe asthma which started as a child and then it went away and then as an adult it got severe around 2010 and ongoing, she was an asthmatic and would panic and start feeling worse. She had ongoing chronic obstructive pulmonary disease (COPD), brain surgery in 2007, low immune system, allergies to cephalosporins, pulmonary and stomach issues; and bradycardia (as her BP usually runs 90/45 and she is bradycardic). Concomitant medications included tiotropium bromide (SPIRIVA RESPIMAT), salbutamol sulfate (PROAIR HFA), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol (VENTOLIN [SALBUTAMOL]), and montelukast (MONTELUKAST), all taken for asthma, chronic obstructive pulmonary disease from an unspecified start date and ongoing; clarithromycin (CLARITIN [CLARITHROMYCIN], omeprazole, phenytoin sodium, azelastine, ipratropium bromide, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and ipratropium bromide, salbutamol sulfate (DUONEB), all taken for an unspecified indication from an unspecified start date and ongoing; prednisone taken for an unspecified indication from 2021 and ongoing as she was on this steroid 2 weeks before the vaccine; and azithromycin which she takes prophylactically for her low immune system from an unspecified start date and ongoing. She was on a lot of medications period and most are for her pulmonary and stomach issues. The patient previously took propofol, Versed, Nitrous Oxide, and Percocet wherein the patient had drug hypersensitivity and anaphylactic shock with these; adhesive from nicotine patch made her arm to get red and swollen (Dermatitis contact). She previously took EpiPen for anaphylaxis. It was reported that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She got her vaccine at a hospital in their clinic and she was transferred from the vaccine clinic to the ER. Stated she was given a shot with an Epi-pen in her thigh at the clinic and transferred to the ER. In the ER, she was given Benadryl and watched for 4 hours. She would state this was medically significant because of airway, breathing, circulation and she felt like she couldn't breathe. She added that it was kind of weird and freaky. She mentioned that along with that, shortly before she was released from the ER, she experienced a very sore arm where she was given the injection. She heard that was very common so she dealt with it. However as the night progressed, it got increasingly worse, it almost felt like she was punched several times in her arm. It probably started between hour 3 and 4 after receiving the vaccine. She added that she had a very sore right arm where she was given the injection; felt like she was punched several times in her arm. It was not serious, just annoying and it was gone 3 days later. She had injection site bruising on 10Mar2021. She stated that she knows this because she was a nurse, but a lot of times, people experienced this reaction when they are given Dilaudid wherein they get a warm feeling in their chest, so they push it really slow and dilute it with saline so it doesn't have the respiratory factor. She stated that this was kind of what the feeling was like for her and it was scary because she didn't expect it. She stated that the ER team that assessed her said, because she wasn't used to that feeling, she may have had a panic attack and that may have made it worse. After she was treated, she spoke with her husband and he had the shot two minutes before her and he had the same feeling but he didn't freak out and didn't want to appear weak. Stated he told her he had the same feeling and it lasted 5 minutes and then it went away. Stated since she got scared, it made it worse. She doesn't know if she had a panic attack that made it worse. She stated that of course her husband didn't tell her that until she was out of the ER, that it does go away. That made her feel better because she wasn't the only one that experienced that. States he didn't say anything about it, because he was worried about her, he said it was a warm feeling in the chest and not being able to breathe but he didn't want to say anything because she was an asthmatic and would panic and start feeling worse. She mentioned that they weren't going to let her get the second dose, so she went to an allergy doctor and told them what happened and about her husband having the same reaction and because she was severely immunocompromised. Stated the hospital said they were not giving her the second dose unless an allergist says it is safe and sets a protocol and he had to write a letter to the hospital. Stated she was pre-medicated 24 hours before the vaccine with 50mg Benadryl, 50mg Benadryl the day of the shot and 50mg of Benadryl two days after the shot. Stated she will have full immunity on 14Apr2021. She added that she had a pulmonary doctor, brain cancer doctor, ENT doctor, stated they don't know if it was caused by the vaccine, but they are pretty sure she had a reaction but they can handle it with pre-medicating her. She received the second vaccine on 31Mar2021. She mentioned that she was happy to be able to get her second shot. She stated that at first they didn't want to give it to her because of her reaction but she kept calling. So she went to a hospital to saw an allergist and he had to sign off that it was safe to give her the second shot and under what circumstances. Stated she had the letter from the hospital that she was seen by them and she needed to be pre-medicated and it had to be given at a hospital that had the ability to intervene quickly and she needed to be watched for at least 30 minutes after the vaccine. She mentioned that to go through what she went though, and not be able to get would have been disappointing. Because of her immune system, it is important to get the shot and there was a way around the reaction which worked for her. She added that even having an anaphylactic reaction from the vaccine, she was able to recover quickly. Stated with having asthma, COPD and a low immune system, she may not recover from Covid. It makes sense they evaluated it and came up with a solution and a pre medication protocol and when and how long and she was still able to get the shot because it is important. Answers to follow up questions indicated that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She was given the shot and getting ready to get out of the chair and her husband was about to sit down for his shot. Stated she would say the time of the course of the reaction was within under 5 minutes of her injection. The patient required medical intervention with Epi-Pen, Benadryl, and Duo-Neb. The patient was not hospitalized because she was immunocompromised, it was better to watch herself at home and because she had an Epi Pen at home in case she has that sort of reaction returning over a 72 hour period. Stated they instructed her husband and told them if she felt any different to come back to ER. She was not admitted to the ICU. Organ involvement included: Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress. The event required initiation of new medication or other treatment or procedure including Epi-Pen, Benadryl, DuoNeb. Patient have a history of previous allergies: Medication Allergies to Cephalosporins, Anesthesia medications: Propofol, Versed, Nitrous Oxide, Percocet: Anaphylactic shock; Adhesive from nicotine patch, caused her arm to get red and swollen. She takes EpiPen as she had previous history of allergies and since she had multiple medication allergies and had a history of quickly going into anaphylaxis, stated her BP usually runs 90/45 and she was Bradycardic. She did not receive any recent vaccines for any other conditions prior to the events being reported. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. She has not received any other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient recovered from 'felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe', Difficulty breathing, and 'warm feeling in the chest' on 10Mar2021; while having an anaphylactic reaction from the vaccine, Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress were recovered on an unknown date; Vaccination site pain recovered on 13Mar2021 and Injection site bruising recovered on 18Mar2021. Therapeutic measures were taken as a result of all events except Vaccination site pain and Injection site bruising. Relatedness of drug to reactions/events: Reaction assessed for events "felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe", 'very sore right arm where she was given the injection; felt like she was punched several times in her arm.' and Injection site bruising: Method of assessment: Global Introspection: Drug result: Related. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered all serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological sequence. Current patient conditions of asthma, chronic obstructive pulmonary disease and allergic diathesis may have been considered as favoring factors in development of reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021406773 same reporter and drug, similar events, different patient
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| 54 | 2021-04-27 | pain in extremity |
a little bit of a headache; cough; typical sore arm; This is a spontaneous report from a contactable...
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a little bit of a headache; cough; typical sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) dose 1 via an unspecified route of administration on 29Jan2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 29Jan2021, the patient experienced typical sore arm, on an unspecified date, experienced a little bit of a headache and cough. She thought that cough was the oddest thing. She does not have her CDC vaccine record card with her. Sore arm started on 29Jan2021, that evening she could feel it; by really feel it 30Jan2021 but it did not hinder her in any way shape or form. Cough onset date unknown other than in middle of the night, probably about midnight. She kept coughing and coughing; it was a very peculiar cough. She does not think she has ever had that kind of cough before. It was like a dry cough and she just kept coughing. Finally, she got up and she had those pearls, she was not sure of the name of the pearls; but she had some of those pearls and took that and went back to sleep. She got up and had a slight headache, a little bit of a headache nothing big but a peculiar headache; not one she has ever had before. She went and fed the homeless, she felt the sore arm but it did not hinder her in any way shape or form. She was getting ready for bed and the cough started again. She took the pearls again, went to sleep, no problem. She woke up and her arm was fine, no coughing. She recovered completely from all of these events with Pfizer COVID-19 Vaccine. She is scheduled to get the second dose of Pfizer COVID-19 Vaccine on 17Feb2021. She had been hearing the consensus that it seems like the second one was the booger so she was hoping to have as mild symptoms this time with second dose as the first. Pearls were just something she had that probably expired or might be from the beginning of the year before COVID; you know how in spring things start so she probably still had it from last year but the pearls worked fine, she had no problem. Pearls: Lot, NDC, Expiry were unknown, she does not have product with her. Therapeutic measures were taken with pearls for event cough. The outcome of typical sore arm was recovered on an unspecified date in 2021, and headache and cough were recovered. Information on batch/lot number was requested.
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| 54 | 2021-04-29 | pain in extremity |
04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with i...
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04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with ice bag on head and use of tylenol. Drank soda and sat quietly. 04/20/2021 7:30 am. Headache gone with fever. Left arm is now very swollen. Hot to touch. Itchy. Achy. And about a 4? wide rash band on my left arm near crease/ elbow. 4-29/2021 rash is still slightly visible but fading. No heat emitting from it.
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| 54 | 2021-04-30 | discomfort, weakness, tremor |
high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; s...
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high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; shaking; very uncomfortable horrible feeling; very uncomfortable horrible feeling; faint; adrenaline rush; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 15Apr2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included low TSH and high blood pressure. Patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium; losartan potassium (LOSARTAN "AGP"); vitamin D3; cissus quadrangularis (CQL); all taken for unspecified indications, start and stop dates were not reported. On 15Apr2021, the patient had three times adrenaline rush at 16:10, 16:30 and 18:20. It came automatically at 16:15 (as reported) with high blood pressure, fast heart beat, fast blood stream, faint, weak, shaking, very uncomfortable horrible feeling. Usually, this feeling will come after something happen and impact the brain, but now it came just by itself. Patient has feeling that she might die. She wanted to know if this vaccine affected her nerve system and if she should take the second dose or not. No treatment received for the adverse events. The patient underwent lab tests and procedures which included on 08Jan2021, colonoscopy: none, nucleic: none and nasal swab: negative; on 08Apr2021, colonoscopy (received within 2 weeks of vaccination): unknown results; and on an unspecified date (since the vaccination, the patient been tested for COVID-19) nucleic acid test: unknown results. Outcome of events were recovered on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 54 | 2021-04-30 | one side paralysis |
Weakness on right side of body; Extreme visual disturbances in right eye that won't go away; Nausea;...
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Weakness on right side of body; Extreme visual disturbances in right eye that won't go away; Nausea; Chills so bad I was hyperventilating; Chills so bad I was hyperventilating; This is a spontaneous report from a contactable consumer reporting for herself. A 54-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 08:15 (Batch/Lot number was not reported) as single dose, Medical history included hypertension. The patient's concomitant medications were not reported. The Patient received the first dose of BNT162B2 vaccine on 23Mar2021. The patient experienced weakness on right side of body on 13Apr2021 19:00 with outcome of not recovered , extreme visual disturbances in right eye that won't go away on 13Apr2021 19:00 with outcome of not recovered , nausea on 13Apr2021 19:00 with outcome of not recovered , chills so bad I was hyperventilating on 13Apr2021 19:00 with outcome of not recovered. The events weakness on right side of body and extreme visual disturbances in right eye were considered Important Medical Events. The patient visited the ER because of the events and underwent CT scan, ultrasound, multiple medications. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 54 | 2021-05-02 | tremor |
5 minutes after I received my shot, I felt dizziness, heart palpitations, and had slight tremors. Th...
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5 minutes after I received my shot, I felt dizziness, heart palpitations, and had slight tremors. The back of my head felt heavy. I notified the nurse who measured my blood pressure which was at hypertension levels of 175/98 for 50 minutes and they called 911. They recommended that I go to the ER because my blood pressure kept rising at 45 minutes. After 1.5 hours, I measured my blood pressure at home and it was at 124/75. It took 5 hours for my blood pressure to be at 112/57. I have always been in the normal blood pressure range, so I believe the symptoms were due to the vaccine.
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| 54 | 2021-05-03 | pain in extremity |
feeling unwell, not healthy; headache; sore throat; chest cough; she tested positive for covid after...
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feeling unwell, not healthy; headache; sore throat; chest cough; she tested positive for covid after the first injection; she has had increased resting pulse rate from 90 to between 122-125/very high, elevated, resting pulse at 94 beats per minute/her pulse has been over 100 beats per minute continuously; arm hurt but not very much, arm was just tender; ran a fever of 101 to 104 for seven days/high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (Patient). A (Age: 54; Unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no. EP7534, expiry date not reported) via unspecified route in left arm on 26Mar2021 at 14:40 PM as single dose for COVID-19 immunization. Medical history included anxiety disorder (ongoing), bipolar disorder (ongoing) and bipolar with panic disorder. Concomitant medication included unspecified medication (When probing concomitant medications, she reports she'd been taking psychiatric medications since she was in her 20's. She'd been on all her current medication for at least 3 months or more). No other vaccine in four weeks. The patient experienced feeling unwell, not healthy, arm hurt but not very much, arm was just tender, headache, sore throat, chest cough on an unknown date, ran a fever of 101 to 104 for seven days/high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit, she has had increased resting pulse rate from 90 to between 122-125/very high, elevated, resting pulse at 94 beats per minute/her pulse has been over 100 beats per minute continuously on 26Mar2021 and she tested positive for covid after the first injection on 01Apr2021. Caller stated she caller to report an experience to the pfizer covid 19 vaccine. Caller stated she had the first dose of the Pfizer covid 19 vaccine on 26Mar2021. Caller stated she tested positive for covid after the first injection and ran a fever of 101 to 104 for seven days. Caller stated she has had increased resting pulse rate from 90 to between 122-125. Caller stated her pulse rate is usually in the 60's mostly 64. Caller stated she was feeling unwell, not healthy. Caller stated she was bipolar with panic disorder and is very scared at this point to get the second dose. Caller wanted to confirm that her increased resting pulse could be a severe allergic reaction. Caller wanted guidance about if or when to receive the second dose. Caller already reported to safety. Caller confirmed her concern was about the increased resting pulse. Caller asked since she had covid, was she protected for 90 days. She was calling about the Covid 19 vaccine. She had her first dose on 26Mar2021, and she immediately had a reaction to it. She had a very high, elevated, resting pulse, it was 94bpm. Since she had received the Covid 19 vaccine her pulse has been over 100 beats per minute continuously. The other thing that was peculiar was that she tested positive for the Covid 19 virus after receiving the Covid 19 vaccine. She had concerned that her pulse has not returned to normal. She has a question about when and if she should get the second Covid 19 vaccine. She was currently scheduled to receive her Covid 19 vaccine on 26Apr2021. She does suffer from an anxiety disorder and bipolar disorder so her pulse rate has been especially frightening for her. She is relieved because her husband has been reading and he's seen some stuff online that people have mental symptoms after the Covid 19 vaccine. She felt better knowing that her medication was still working. Meaning her medication for her anxiety disorder and bipolar disorder is still working. She has no further information on the people online. She reports her arm hurt but not very much. That started the same day that she received the vaccine. Her arm was just tender, she was aware of her arm. Her arm was only tender about 4-5 days. Her arm isn't bothering her now. She did suffer with a high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit starting on the day she received the Covid 19 vaccine. She's had no fever at all for the last 2 weeks. The only symptom that remains is her increased pulse. She got the Covid 19 virus test on 01Apr2021. She's not sure if was the rapid or the longer Covid 19 test. She received her results in about 24 hours. She also went to the emergency room on the night of 01Apr2021 because her fever was 104 degrees Fahrenheit even taking the Tylenol. When the Tylenol could no longer manage her fever, she went to the emergency room. She was on her second bottle of Tylenol. She reports the first bottle was the brand name of Tylenol, but she has discarded the bottle. It was the 4-hour kind. NDC/Lot/Expiry not known. The second bottle of Tylenol was the (Company name) Tylenol knock off brand of Acetaminophen. Each tablet was 650mg take 2 tablets every 8 hours as needed. Lot# unknown, NDC 0363-0336-01, Expiry Sep2022. She had to get her glasses to read the print on the (Company name) Tylenol knock off brand. She went to the emergency room because the Tylenol was no longer keeping her fever down and she got frightened. She did not have the Covid 19 test at the emergency room, she had the Covid 19 test. She was sent home from the emergency department. She was not admitted to the hospital. She reports the Covid 19 virus definitely moved through her body starting with a headache, sore throat, and a chest cough. She reports her symptoms lasted a bit longer than her fever. She reports the chest cough lasted the longest. She reports that some people think the Covid 19 vaccine would give you the Covid 19 virus. She believes she had the Covid 19 virus before she received the Covid 19 vaccine. She reports she might have remained asymptomatic until she received the Covid 19 vaccine. The event high fever, elevated heart rate resulted in emergency Room. The outcome of event Pulse rate increased was not recovered, Pain in arm was recovered, whereas unknown for all other events. Description of complaint: PC 1: Tested positive for the Covid 19 virus after receiving the Covid 19 vaccine. Received Covid 19 vaccine on 26Mar2021, tested positive on 01Apr2021. Lot# EP7534 in the left arm NDC/Expiry not known PC 2: She also went to the emergency room on the night of 01Apr2021 because her fever was 104 degrees Fahrenheit even taking the Tylenol. When the Tylenol could no longer manage her fever she went to the emergency room. She reports the first bottle was the brand name of Tylenol but she has discarded the bottle. It was the 4 hour kind. NDC/Lot/Expiry not known. The second bottle of Tylenol is the (Company name) Tylenol knock off brand. Acetaminophen. Each tablet is 650mg take 2 tablets every 8 hours as needed. Lot# unknown NDC 0363-0336-01, Expiry Sep2022 PC 3: She has to get her glasses to read the NDC/Expiry from the (Company name) Tylenol knock off brand. NDC 0363-0336-01 Expiry Sep2022, Lot # unknown No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-05-04 | pain in extremity |
I went back to the hospital and couple days later they told me that actually I have Deep vein thromb...
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I went back to the hospital and couple days later they told me that actually I have Deep vein thrombosis now in my legs; my Crohn's had caused really bad flare up/I have been in the hospital for 5 days now with the clot and Crohn's Flare; I also have superficial clot in that left leg that was the pain began on the edges/blood clot; the arm is much better now. You know that's not really sore; I just was too tired/extreme fatigue; really bad like pain; Shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 29Mar2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, ileostomy from an unknown date and unknown if ongoing, back surgery from an unknown date and unknown if ongoing, Crohn's disease from an unknown date and unknown if ongoing , blood clot in arm back from 2014 to an unknown date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 08Mar2021 and experienced terrible diarrhea and neuralgia. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; valaciclovir hydrochloride (VALTREX) taken for an unspecified indication, start and stop date were not reported; diazepam (DIAZEPAM) taken for an unspecified indication, start and stop date were not reported; (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; oxycodone (OXYCODONE) taken for an unspecified indication, start and stop date were not reported; lansoprazole (PREVACID) taken for an unspecified indication, start and stop date were not reported. After second dose on 29th (29Mar2021) immediately he was really bad like pain and had shortness of breath. The patient stated that she had a back surgery and so she always felt bad, so she didn't think anything of it. But then she ended up into ER after the second dose and discovered that her Crohn's had caused really bad flare up. She mentioned her foot was looking strange but she was just too tired and left the ER. She then went back to the hospital and couple days later they told her that she actually had deep vein thrombosis now in her legs. She also had superficial clot in that left leg where the pain began on the edges. The patient reported that the vaccine was basically started the Crohn's flare up. The patient also stated that "the arm was much better now and not really sore". The patient was hospitalized for DVT from unknown date and for Crohn's flare up for 5 days. The patient underwent lab tests and procedures which included endoscopy, sigmoidoscopy, ultrasound scan: all on unknown date with unknown result. The patient was treated with Entyvio and on blood thinners now for a blood clot. The outcome of pain in extremity was recovering while others was unknown.
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| 54 | 2021-05-06 | discomfort |
After receiving the first dose on 4/1/21 Lot# ER8733, I had light spotting for 2 days. Second dose ...
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After receiving the first dose on 4/1/21 Lot# ER8733, I had light spotting for 2 days. Second dose given 04/23/21 and by 04/28/2021 I started bleeding again And by the second day I was soaking through pads and huge clots were coming out. This has never happened to me before. After 7 days of bleeding heavily I woke up on May 5th at 4:00 a.m. with intense abdominal cramping The only way I can describe was labor. I felt back labor, pelvic pressure, frequent urination and intense pain. I reached out to my gynecologist And he immediately told me to remove my estrogen patch and later that morning he started me on progesterone treatment for 10 days to stop the bleeding. After 7 hours of pain on May 5th, I went to the emergency department and an ultrasound revealed a blood clot. From ultrasound results "there is a complex area in the area of the cervix measuring 5.7 x 3.6 x 2.6 cm." After several hours I was released from the emergency room taking toradol for pain. That evening I passed a huge blood clot! I'm very grateful it was where it was and I could expel it. But there's no doubt the second vaccine caused this issue that has never happened to me before. I still get my periods though irregular and very light. So this event was highly unusual and very painful
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| 54 | 2021-05-06 | flushing | Flushing/sweating, vitals wnl. C/o hypoglycemia. Given 3 cups juice, 2 graham crackers. |
| 54 | 2021-05-10 | bell's palsy, numbness |
Developed bell's palsy on the left side of my face; My mouth and side of my face started to feel num...
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Developed bell's palsy on the left side of my face; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; My mouth and side of my face started to feel numb within a half hour of receiving the vaccine; Within 24 hours the entire side of my face from my jaw to my eye was numb; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN0164 and expiry date was not provided), via an unspecified route of administration, in Arm Left, on 15Apr2021 at 10:00 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included bee venom (known allergies). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 15Apr2021 at 10:30 AM, she developed bell's palsy on the left side of her face. Her mouth and side of her face started to feel numb within a half hour of receiving the vaccine. Within 24 hours the entire side of her face from her jaw to her eye was numb. The patient received Medrol 4 mg dosepak and Valtrex - 7-day dose as treatment for the events. The events resulted in physician office visit. Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 55 | 2021-01-03 | flushing |
itching that started @injection site and then spread across body, facial flushing Administered 50 mg...
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itching that started @injection site and then spread across body, facial flushing Administered 50 mg of diphenhydramine orally and continued to observe Patient's husband was called and he took her home after approximately 30 mins.
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| 55 | 2021-01-03 | pain in extremity | Arm soreness Swelling Overall body feeling shaky |
| 55 | 2021-01-03 | pain in extremity |
Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radi...
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Dec. 29: she developed arm soreness and joint pain. Dec. 30: she developed pain in chest area radiating towards the back Jan. 01: she noticed a rash in the mid abdomen radiating towards the back. She has been experiencing pain in the affected area.
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| 55 | 2021-01-04 | feeling hot, flushing |
PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ...
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PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS. SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM: FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING. AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED. SYMPTOMS REPORTED IMPROVED FOLLOWING EPI. EMS ARRIVED 10:05AM. PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL. WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.
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| 55 | 2021-01-04 | pain in extremity |
I STARTED HAVING PAIN IN MY UPPER LEFT LEG AROUND 12/31 ..THE PAIN HAS WORSEN TODAY AND THE PAIN IS ...
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I STARTED HAVING PAIN IN MY UPPER LEFT LEG AROUND 12/31 ..THE PAIN HAS WORSEN TODAY AND THE PAIN IS CAUSING ME TO LOSE MY BALANCE. IT FEELS LIKE ITS GOING TO GIVE OUT WHILE WALKING. THE PAIN TRAVELS DOWN MY WHOLE LEG. IF I STAND STILL OR SIT FOR A WHILE ITS HARD FOR ME TO PUT WEIGHT ON MY LEG. I HAVE NEVER HAD PAIN IN MY LEG LIKE THIS BEFORE. I WAS TOLD TO LET VSAFE KNOW DURING MY CHECK IN AND WILL CALL THE NURSE ON DUTY TONIGHT. IT'S BECOMING UNBEARABLE. I AM DUE FOR MY 2ND DOSE ON THE 8TH .
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| 55 | 2021-01-04 | pain in extremity |
Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-conta...
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Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-contactable consumer (patient's Sister). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. On 27Dec2020 patient experienced an "intermittent stabbing headache" and her arm was very sore but much better the day of the report. Patient would not take paracetamol (TYLENOL) because she was still very functional. Outcome of the events was unknown. Information about lot/Batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-04 | tenderness | noted swollen lymph node left armpit area, slightly tender |
| 55 | 2021-01-05 | feeling cold |
Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure wa...
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Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure was high on taking 183/91. Patient reports History of "White Coat Hypertension". Symptoms resolved. MOnitored for at least 15 minutes and released to home. Recommended patient follow-up with PCP regarding potential underlying hypertension..
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| 55 | 2021-01-05 | muscle spasms, pain in extremity, weakness |
On 12/24/20 through Wed 12/30 daily while exercising; either back country skiing, resort/alpine ski...
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On 12/24/20 through Wed 12/30 daily while exercising; either back country skiing, resort/alpine skiing, Nordic/skate skiing or hiking uphill, I developed rapid onset, severe, debilitating, crippling 8/10 pain in my right fectus femoris thigh muscle. Duration of spasms 1-2 seconds, frequency every 10-15 minutes while exercising up to 6 hours/day. Self treatment included taking Ibuprofen 400 mg tabs po daily, OTC electrolytes po daily, application of topical diclofenac (Voltaren) gel, increase in hydration of non caffeinated/non alcoholic beverages; without any improvement.
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| 55 | 2021-01-05 | pain in extremity |
Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; ...
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Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; Shivering; Headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), intramuscular in the left arm, on 28Dec2020 at 16:30 (at the age of 55-years-old) at a single dose for COVID-19 immunization. Medical history included insomnia, gastrooesophageal reflux disease (GERD), anxiety, mitral valve replacement (MVR) on an unspecified date, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks prior to vaccination, included atenolol (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), eszopiclone (LUNESTA), krill oil (MANUFACTURER UNKNOWN), linum usitatissimum oil (FLAXSEED OIL; MANUFACTURER UNKNOWN); ascorbic acid (VITAMIN C; MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN). The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced allergy, nitrofurantoin (MACRODANTIN) and experienced allergy, and loracarbef (LORABED) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache on 29Dec2020 at 07:00. The events were reported as non-serious. The excruciating pain from left deltoid radiating downward to wrist woke the patient up from her sleep. Therapeutic measures were taken as a result of the events, which included treatment with hydrocodone bitartrate, paracetamol (VICODIN) and heat application. The clinical outcome of excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache was recovered with sequel in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 55 | 2021-01-06 | weakness, pain in extremity |
Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall ...
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Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.
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| 55 | 2021-01-06 | breast pain | INJECTION SITE PAIN, BREAST PAIN |
| 55 | 2021-01-06 | feeling hot |
Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot ...
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Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot and red with raised rash, my scalp became very itchy, my heart felt like it was beating out of my chest and I had pounding in both ears. My bilateral forearms began to itch and then developed hives. I notified my Supervisor that I was having a reaction. I was checked in to ER (where I am an RN). My blood pressure was elevated 180's systolic and my heart rate was 180BPM and short of breath. An IV was started and I was given Normal Saline Bolus, Solu-medrol 125MG and Benadryl 25MG IV. Prior to medications, my throat felt itchy and "tight" but resolved once medication given. The itching and hives continued to spread to my upper back, neck, bilateral feet and behind my bilateral knees. After approximately 1 1/2 hrs itching and hives continued then I was given Pepcid IV and Benadryl 25mg PO which after 40 minutes my itching and hives resolved. I was later discharged home with a prescription of Methylprednisolone 4MG dose pack. Symptoms resolved until approximately 1:30 am on 5/7/2021 when I awoke to pounding in my ears and the feeling once again my heart was beating out of my chest. My heart rate was 132BPM, I became hot and diaphoretic, short of breath. My scalp felt it was on fire and then I broke out in hives. I immediately took Prednisone, benadryl and pepcid. I took a cool shower, got dressed and drove to the hospital down the road and sat in the parking lot just in case my throat became itchy and tight (which it did not). The hives and itching began to resolve after an hour. My heart rate went back to 67BPM and shortness of breath resolved as well. I called Employee Health at hospital and made a report of symptoms.
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| 55 | 2021-01-06 | migraine | Migraine sore arm nausea body aches stiff elbows |
| 55 | 2021-01-06 | pain in extremity |
Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patien...
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Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patient managed symptoms with ice packs. Symptoms have resolved as of 1/6/2021
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| 55 | 2021-01-07 | weakness, night sweats, pain in extremity |
left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection si...
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left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
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| 55 | 2021-01-07 | weakness, tingling |
usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type ...
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usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type feeling in wrist
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| 55 | 2021-01-07 | feeling hot |
Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and ...
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Swelling, bleeding, and warmth immediately after administration. 1/7/21, she broke out in hives and had general body aches, which has continued into 1/8/21.
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| 55 | 2021-01-07 | flushing, tingling |
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,...
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Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
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| 55 | 2021-01-07 | flushing |
within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl ...
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within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl 25 mg , Pepcid , solu-medrol
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| 55 | 2021-01-07 | migraine |
VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea...
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VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea.
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| 55 | 2021-01-07 | migraine |
Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain...
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Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain; Headache; Severe muscle pain around the injection site; Severe muscle pain around the injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date, covid-19 from an unknown date. Concomitant medication included metformin. The patient stated the side effects were initially day one (30Dec2020) was this general aches, pains and headache. It almost started as if it was a Covid itself starting all over again because she had this disease already earlier this year and the headache and general ache and pains and pretty severe muscle pain around the injection site and also the general aches and pain. The second day (31Dec2020) was extreme fatigue, migraine that the never went away, body aching everywhere including joints and muscle everything. It almost felt like the Covid itself all over again. Patient took Motrin essentially around the clock something 6 (intent: 600mg) to 800 mg every 6 hours or so. The outcome of event migraine was not recovered, the other events was unknown.
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| 55 | 2021-01-07 | muscle twitching |
Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit o...
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Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown. No follow-up activities are needed. No further information is expected.
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| 55 | 2021-01-07 | pain in extremity, night sweats |
Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymph...
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Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymphadenopathy, fatigue, nausea-evaluation for symptoms- no prescribed treatment
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| 55 | 2021-01-07 | pain in extremity |
Recipient reported having chills overnight and reported to work today with left arm to left flank so...
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Recipient reported having chills overnight and reported to work today with left arm to left flank soreness. She took Motrin
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| 55 | 2021-01-07 | tingling, numbness |
Pfizer BioNTech: Complains of left foot numbness and tingling that progressed to left leg and then ...
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Pfizer BioNTech: Complains of left foot numbness and tingling that progressed to left leg and then to left hand and left arm. Benedryl PO 25mg given at 12:05pm. No changes after Benadryl given.
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| 55 | 2021-01-08 | muscle spasms | Diarrhea & NauseaVomiting Narrative: jaw pain, metallic taste, cramps |
| 55 | 2021-01-08 | pain in extremity |
Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills ...
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Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills and dizziness starting 10 hours post injection and persist entire next day.
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| 55 | 2021-01-08 | pain in extremity |
Myaglia left arm is painful Narrative: Employee reports onset of body aches on 12/29. She denies fe...
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Myaglia left arm is painful Narrative: Employee reports onset of body aches on 12/29. She denies fever. Her left arm is also very painful. 12/31 - symptoms resolved.
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| 55 | 2021-01-10 | weakness | Tiredness, queasy stomach, low energy, lethargic, headache, swelling and pain at injection site |
| 55 | 2021-01-10 | numbness |
Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased B...
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Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine. No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
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| 55 | 2021-01-10 | numbness | pt reported bilateral arm numbness and was diaphoretic at 0904 |
| 55 | 2021-01-10 | muscle spasms |
After both the initial and this second shot, I experienced cramps or tightness in muscles in arm. It...
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After both the initial and this second shot, I experienced cramps or tightness in muscles in arm. It was actually more pronounced with first dose. Started in right scapula, then moved to elbow, then to wrist. Symptoms gone after ~30-40 minutes.
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| 55 | 2021-01-10 | pain in extremity | localized redness at injection site, R arm/hand joint tenderness and pain, over 72 hr. period |
| 55 | 2021-01-10 | pain in extremity |
lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure du...
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lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure due to mask or injection) started with soreness/heat to site, joint pain, flu-like symptoms- body aches, tired and headaches. - January 9th. most joint pain gone except to fingers gone. soreness and heat to site of injection. - January 10th finger joints hurt still hurts, site of injection - redness swollen/ heat still - around site a "pinching" pain, which is a new today - Jan11th
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| 55 | 2021-01-10 | tingling |
1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2...
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1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2021 (thought due to wearing mask?) 1/9/21 soreness & heat to injection site - joint pain esp. hands, elbows and wrists; and flu-like symptoms - tired 1/10/21 little redness to site-swollen/soreness & heat still ; joint pain in fingers still not so much in main joints 1/11/21 finger joint pain - lot of redness/soreness/heat/swollen to site of injection ** new symptom sharp pinching pain around site
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| 55 | 2021-01-11 | pain in extremity |
began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; began having Covid ...
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began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; began having Covid symptoms on 24Dec and tested positive for Covid on Christmas; Arm was sore; This is a spontaneous report from a contactable physician reported for herself. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 vaccination. Medical history was not reported. There were no concomitant medications. Patient had arm sore on 18Dec2020. She started having COVID symptoms on 24Dec2020. She tested positive on Christmas, 25Dec2020. She was asking if she should get the second vaccine. When she got the vaccine she didn't pay attention to the paperwork. She was busy. Her arm was a little sore for a day that was the only reaction she had. She was hoping when she developed COVID symptoms that she was not sick. She was not hospitalized, and she is wondering if maybe the vaccine helped her not get as sick, and not end up in the hospital. It was the first dose she received. She has no other medical conditions. All the previous agent did was read off information to her. It sounds to her like she should go ahead and get the second dose. Outcome of event Arm was sore was recovered in 19Dec2020, of others was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be completely excluded for reported events.
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| 55 | 2021-01-11 | tingling, numbness |
Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later ...
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Approximately 1 - 2 hours after receiving I had numbess and soreness to my neck. A few days later started experiencing tingling, buzzing, weakness and heaviness to my right arm and leg. I reported this to my MS doctor who ordered an MRI of the brain and told me to report to you
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| 55 | 2021-01-12 | weakness |
After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weake...
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After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weakeness hit me and I had to sit on toilet. I was unable to move my arms or legs for 20 minutes, then was able to get up but walked VERY WOBBLY AND WEAK to my bed just a few feet away. I collapsed on my bed and turned my fan blowing on me directly. {Im NEVER hot, usually cold ALL the time}. I layed there so weak I could barely move for another 20 to 30 minutes. I thought I was having a stroke honestly and my thoughts were about my doors being locked so nobody could get in to help me and my phone was in the living room and for that time period I WAS TOTALLY UNABLE to go get it. THANKFULLY, after about 45 minutes total, all symptons went away and I returned to my baseline mobility. Im very grateful that this was not a stroke as I thought. but I do believe it may have been a reaction to the vaccine. I did not notify any physicians yet, and as of this writing Im perfectly fine, Thank the Lord.
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| 55 | 2021-01-12 | hot flush | ITCHY NOSE , BELTCHING, HOT FLADHES, TOUNGUE HAVINESS, TREATED WITH EPI AND BENADRLY |
| 55 | 2021-01-12 | numbness |
Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Loca...
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Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Location of numbness is in the area of the Right temple upper cheek bone easing toward ear. By 2:00 pm that day was experiencing a dull headache centering on my temple. I went home from work to lie down. The headache and numbness lasted into the next day. At the time of this report 8:57 pm on 1/13/21 the numbness is still there.
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| 55 | 2021-01-12 | migraine | migraine with mild vomiting resolved by morning with medications |
| 55 | 2021-01-12 | pain in extremity | Chills Very sore arm |
| 55 | 2021-01-12 | tingling, numbness |
to develop a rash yesterday. It started off as large red spots last night, and this morning they are...
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to develop a rash yesterday. It started off as large red spots last night, and this morning they are smaller red spots. She said the rash started in her feet and is moving upwards. This morning it is now on her arms. She also said she was having numbness and tingling from the waist down as well. Last night she did take Benadryl. She is not experiencing any other side effects. She did not have this reaction after the first dose. prednisone, benadryl given at urgent care, prescription for prednisone given at Urgent Care
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| 55 | 2021-01-12 | tingling, numbness |
The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injec...
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The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injection site and I noticed that the skin in my left flank, left back and Left abdomen felt numb. On Day 2 1/12/21, the numbness got progressively worse and it was noted that there was a marked difference while showering, my upper left hip and thigh were also beginning to get numb. I went into the ED where they took x-rays, gave me steroids (Decadron) and sent me home for follow up within the next 3-5 days. Today, Day 3-1/13/21,My skin still feels numb and less, and the tingling in my left thigh is no longer present. dx"paresthesia," no other concerns as it has not affected my movement or ability to work.
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| 55 | 2021-01-12 | tremor, breast pain, flushing, pain in extremity |
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck....
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12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
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| 55 | 2021-01-13 | burning sensation, feeling hot, flushing, tingling |
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d...
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I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
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| 55 | 2021-01-13 | burning sensation | Burning, itching, painful rash over back, stomach and groin. Rash and swelling in hands and ankles |
| 55 | 2021-01-13 | feeling hot |
During the early morning following my second Covid vaccination, I started having fever and chills, m...
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During the early morning following my second Covid vaccination, I started having fever and chills, muscle aches, and a headache. I woke up about 230 am and my stomach was hurting. I thought I would have to have a bm in a little while but was able to go back to sleep. About an hour and a half later, I again woke up with stomach pain, maybe some bloating. I decided to go into the bathroom and I sat on the floor beside the toilet and began vomiting. I vomited 5 times and had one dry heave. The vomitus was clear in color, thin with some small pieces of food. I had felt very hot before vomiting, but was unable to check my temperature due tp nausea and vomiting. I checked my temperature a little while later and it was 100.2 F. I was able to go back to sleep for a while and kept checking temperature during the day. It was between 99.1 and 99.8 for most of the day.
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| 55 | 2021-01-13 | pain in extremity |
I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full fron...
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I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday. I noticed a full front and back body rash that afternoon. It started spreading up my neck and onto my forehead. No other symptoms. I took 25mg of Benadryl that evening. Woke up the next day with improving rash but still visible.
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| 55 | 2021-01-13 | pain in extremity |
Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, requi...
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Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, required 10mg prednisone for 3 days to stop itching. Lasted 4 days. Also Left arm pain, 4 days. Fatigue and subjective fever.
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| 55 | 2021-01-13 | pain in extremity |
Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; mu...
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Egg sized lymphadenopathy under right arm 36 hours after 2D injection; flu symptoms; joint aches; muscle and joint aches; arm pain; arm pain and swelling; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; 1st dose of BNT162B2 on 17Dec2020 15:45/ 2nd dose on 06Jan2021 14:30; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 14:30 at single dose for COVID-19 immunisation. Medical history included mild hypertension and arthritis. The patient was not pregnant. No Covid prior vaccination, no Covid tested post vaccination. No known allergies. Concomitant medication included estradiol, norethisterone acetate (COMBIPATCH), meloxicam, propanol. The patient previously received 1st dose of BNT162B2 in left arm on 17Dec2020 15:45 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced egg sized lymphadenopathy under right arm 36 hours after 2D injection (08Jan2021 03:00), after flu symptoms of muscle and joint aches, arm pain and swelling at 20 hours (07Jan2021 12:00). No treatment received for the events. The outcome of events was not recovered. This case was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of lymphadenopathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-01-13 | tingling |
Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Mediu...
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Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Medium, Systemic: Headache-Mild, Systemic: upper body test rash, itchiness around eyes and mouth, she discribed a tingling sension in the back of her throat, verbilized her tongue was swelling; symptoms lasted 1 day
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| 55 | 2021-01-13 | tremor | Awakened severe shortness of breath, chills, muscle shakiness and pain, nausea, vomiting |
| 55 | 2021-01-14 | inability to speak, tingling |
Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am ...
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Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am 1/14, lasted until appx 12noon. On 1/15, appx 8am I awoke with nausea. Began to vomit and all my extremities began to tingle. At that point, my hands and feet became rigid. This spread throughout entire body, including my head. I was unable to move my hands or feet. My fingers were frozen so hard that my husband could not even close my hand for me. My tongue felt thick and I was having difficulty speaking. Husband picked me up off the floor and carried me to our bed. We were getting ready to call 911 when my feet began to wake up and the rigidity subsided for all areas. Epidsode lasted appx 15 mins.
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| 55 | 2021-01-14 | burning sensation |
Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a histor...
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Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a history of shingles in 2011. I received the 2 dose shingles vaccine in 2019. I received my second Pfizer dose on 1/11. Developed fatigue and muscle aches on 1/12, then slight headache, muscle weakness, myalgia's and arthralgia on 11/13. Morning of 11/14, woke up and noticed a sore spot/blister on my lower/mid back area. Slowly became more painful (burning sensation). No injury to area or any other reason for blister and pain. 11/15, realized it was shingles.
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| 55 | 2021-01-14 | cold sweat |
Within 1 and 1/2 hours headache, nausea, diarrhea, cold sweats. Lasted for about another hour and 1...
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Within 1 and 1/2 hours headache, nausea, diarrhea, cold sweats. Lasted for about another hour and 1/2. Now feel weak. All other symptoms are gone.
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| 55 | 2021-01-14 | pain in extremity |
Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, r...
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Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, rash on right arm. Lymph nodes sore on neck on Day 2.
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| 55 | 2021-01-14 | tingling |
About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by fee...
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About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by feeling dizzy and wobbly. Must hold onto something to walk. Has some trouble focusing, "like a fog".
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| 55 | 2021-01-14 | cold extremities |
Started to have horrible body aches and chills about 10 hours after shot. Felt very febrile with fro...
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Started to have horrible body aches and chills about 10 hours after shot. Felt very febrile with frozen finger tips. Could not warm them up. Continued fatigue and febrile and malaise.
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| 55 | 2021-01-15 | numbness |
The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feelin...
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The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time. Extreme, extreme fatigue- the worst lasted 48 hours post vaccination. Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only) right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination. Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing. More of a muscular pain/discomfort. Note: for 1st injection had some similar "side effects" but also some that were different.
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| 55 | 2021-01-15 | migraine |
Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatig...
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Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatigue, pain a swelling a injection site.
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| 55 | 2021-01-15 | unresponsive to stimuli, weakness |
Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At ...
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Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At around 2:30pm that day was complaining of chills and generalized malaise. Then at ~9:30pm when husband returned home from work found patient diaphoretic, confused (stating things like "not now, I want to go to lake"), and complaining of chills and weakness. Unable to provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to respond to verbal commands. Initial vitals notable for T102.6F (unclear other vitals). Patient is now AOx0 most concerning for encephalopathy.
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| 55 | 2021-01-16 | tingling |
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for se...
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I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes. My lips, tongue, lower jaw and teeth started to feel tingly and strange. This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
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| 55 | 2021-01-17 | weakness, feeling cold |
I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills o...
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I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills on 12/21/20. Mild body aches and soreness at site of injection and just feeling weird. This continued off and on 12/22, 12, 23 and etc. I thought it wasn?t a big deal as I had no respiratory symptoms and no fever. However, I just haven?t been well since then. I have ongoing nausea, head fog, severe weakness, very tired and just feeling unwell
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| 55 | 2021-01-17 | burning sensation, tingling, numbness, weakness |
Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection sid...
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Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection side that spread to top of head, and down to chest and right arm- sensation of face being scaled on right side Day 2- Brain Fog, Generalized Weakness, Generalized pain Right ear remains numb Day 3 1/13- felt like my entire body received a tetanus vaccine Day 4 unchanged Day5- woke up in head to toe hives- was sent to ED Have been having intermittent rashes ( like dermatitis) pop up all over my body and random numbness typically on head/ neck Continue with headache on day 7
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| 55 | 2021-01-17 | feeling cold |
12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle ac...
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12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle aches, dizziness, headache, disorientation. 20 hours after injection: swelling of lips. Continued body aches, headache, 32 hours after injection: chest pain, continued body aches, headache, swelling of lips.
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| 55 | 2021-01-17 | pain in extremity |
woke up the next day feeling nauseous, by 12 noon I had a fever 100.4 feeling very tired malaise and...
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woke up the next day feeling nauseous, by 12 noon I had a fever 100.4 feeling very tired malaise and headache. This feeling lasted for 24 hours. By Friday afternoon I was feeling better and by Saturday no reactions. Arm was sore for 24 hours
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| 55 | 2021-01-18 | weakness | Fever , joint pain, headache, weakness, nausea since 5 pm last night. |
| 55 | 2021-01-18 | weakness |
I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheade...
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I received the vaccine and approx 1min I developed chest pressure, head pressure, Dizzy + lightheaded - Had a hard time waking to gurney due to dizzy. BP +180s Back burning pain traveling mid back to lower back, joint pain, general weakness, throat scratchy, itichess on legs + Think I was monitored for 2 1/2 hrs and sent home after Benadry + Tylenol given. I have continued to have extreme fatigue. general weakness, lightheaded, dizzy and burning back pain lasted 11 days. Today is 12th day and still have lightheaded, dizzy intermittent and general weakness, fatigue, "no energy."
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| 55 | 2021-01-18 | flushing | Flush. SOB. Extremely nauseous. Rapid onset of fatigue |
| 55 | 2021-01-18 | pain in extremity |
This is a 55 year old female who presents with a history of right shoulder, upper arm and upper back...
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This is a 55 year old female who presents with a history of right shoulder, upper arm and upper back pain (mainly centering on the upper right scapula) that started on Saturday, Jan 16th. States that onset was sudden and limited her range of motion; when she turns her neck towards the left, the pain is exacerbated. She denies arm or hand weakness or sensory dysfunction (i.e. no tingling or numbness of the fingers). She does not note any fever or erythema of the shoulder. She has been treating with ibuprofen, which she states she has seen improvement of the pain. Two weeks ago, she received a COVID-19 vaccine in the right arm, although from the picture she took the vaccine appeared to be administered higher than the deltoid. Suspect this could represents shoulder injury related to vaccine injury. Other than synthroid she takes no other medications on a routine basis. She stated that she developed an iatrogenic hepatitis after taking either rifampin or INH, and was told not to take those medications; however, she reports no history of anaphylaxis to a drug or vaccine.
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| 55 | 2021-01-18 | pain in extremity | Reported sharp pain to the left arm, heart palpitations. Symptoms resolved. Will follow up with PCP. |
| 55 | 2021-01-18 | tingling |
Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15...
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Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15 mins. PT vitals returned to normal within 10 mins. Pt discharged home with friend.
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| 55 | 2021-01-18 | tingling | Tingling of body, chills, fatigue |
| 55 | 2021-01-19 | numbness | Transient numbness and tingling of left cheek lasting 7 minutes. No allergic signs or symptoms. |
| 55 | 2021-01-19 | tingling, numbness |
I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observ...
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I got the vaccine at 1:30pm at vaccine clinic and waited the mandatory 15 minutes in clinic's observation area. After release I went to my car and started to drive home. At the 25 minute mark post vaccine (1:55pm) I felt numbness and tingling of cheeks and lips (no swelling and no difficulty breathing). I drove the nearby adult hospital, parked on a side street to wait and see if anything got worse. After 10 minutes symptoms subsided and I continued home. At the 50 minute mark post vaccine (2:20) I felt numbness and tingling of my right arm which subsided after 10 minutes. No further side effects.
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| 55 | 2021-01-20 | facial pain, tingling, numbness |
After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after va...
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After injection immediately had odd taste on my tongue. Had elevated heart rate few minutes after vaccination and intermittently x 5 days after the vaccine. Following day had tingling to the right side of my upper lip and right side of face felt somewhat numb. Had pain to right side of face up to right ear.
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| 55 | 2021-01-20 | facial paralysis, pain in extremity, numbness, tingling |
HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONG...
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HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONGUE, TEETH, JAW, NECK WENT NUMB, I CAN FEEL IT NUMB AROUND MY LEFT EYE TO. ITS LIKE BELLS PALSY WHEN I TRY TO SMILE LEFT SIDE OF LIPS GO DOWN ANSLEFT SIDE OF LIPS ARE NUMB AND THELEFT SIDE OF FACE IS SWALLEN AND JAW IS TIGHT.CHEEK FEELS THICK, TINGALING IN ARM DOWN LEFT ARE TO PINKY FINGER. SORE ARM WHERE SHOT IS. TIGHTNESS IN SHOULDER. CALLED NURSE SAID TO WATCH IT STILL THE SAME AFTER ALL NIGIHT, STILL NUMB ANS SWALLEN BUT CAN EAT BREATH AND TALK.
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| 55 | 2021-01-20 | feeling cold |
About 13 hours after vaccine, fever to 100.4 F, shivering, chills, muscle aches, headache, nausea, f...
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About 13 hours after vaccine, fever to 100.4 F, shivering, chills, muscle aches, headache, nausea, fatigue, slight abdominal cramping. Throughout the day, fever continued despite Aleve and aspirin, but muscle aches began to subside with aspirin. Abdominal cramps lasted about an hour, and nausea went away after chicken soup and sleep. 24 hours after vaccine, fever coming down to 99.2F, muscle aches diminished, no nausea or fatigue, or abdominal cramping. The next morning, only a slight headache remained, no other symptoms.
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| 55 | 2021-01-20 | feeling hot | felt warm from head to toe. Instantly gone. |
| 55 | 2021-01-20 | numbness | I was walking to cross a street and both legs went numb and I fell. |
| 55 | 2021-01-20 | pain in extremity |
Went to dentist thinking i had a toothache on Monday from the pain. it was very painful was on m...
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Went to dentist thinking i had a toothache on Monday from the pain. it was very painful was on my whole left side of face did xray was referred to oral surgeon did exam and both confirmed it had to be a reaction to vaccine. was prescribed Flexural and Toradol Aleve. medication takes about an half hour to kick. been in bed for a week with ice on my face. Cant work at all.
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| 55 | 2021-01-20 | pain in extremity |
sore arm; This is a spontaneous report from a contactable Other HCP. A 55-year-old female patient re...
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sore arm; This is a spontaneous report from a contactable Other HCP. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EH9899, Intramuscular on 21Dec2020 06:00 at single dose on left arm for COVID-19 immunization. Medical history was none. The patient had no Allergies to medications, food, or other products. Concomitant medication included atorvastatin. The patient had sore arm after the fist dose of BNT162B2 on unknown date. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was resolved.
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| 55 | 2021-01-20 | pain in extremity |
pt currently has muscle pain at the injection site, chills, and has pain on upper left leg in betwee...
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pt currently has muscle pain at the injection site, chills, and has pain on upper left leg in between knee and groin area. Pt had 101.2 fever the night after the injection but it subsided by morning.
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| 55 | 2021-01-21 | weakness |
Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspot...
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Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspots: @ 12hrs temp 102.6 F: @ 15hrs Oxygen desaturation 89-90%, weakness, extreme fatigue Seen at ED aprox 6PM on 1/9/21: CBC, chem panel, CT abd, CXR Continued to have low sats and was admitted to hospital on 1/10/21 adverse reaction to vaccine, Reactive airway, asthma excerbation discharged on 1/12/21
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| 55 | 2021-01-21 | tremor |
High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shakin...
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High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shaking like a seizure. I was extremely confused I had a 8/10 headache. I had serve fatigue. This last about 24 hours then went away I finally got out of bed the next day about 4:30PM.
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| 55 | 2021-01-23 | weakness | Headaches,joints pain, weakness, temperature over 100 |
| 55 | 2021-01-24 | weakness | Extremely week, extreme muscle pain, temp over 100 degrees farenheit |
| 55 | 2021-01-24 | burning sensation |
The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Th...
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The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Thinking it was hives, I applied cortisone cream and took Zyrtec. This continued through following week. I went to my personal physician and was diagnosed with shingles though I never had any outward rash or blisters. Just skin sensitivity . I was prescribed triamcinolone acetonide cream 0.5% which I have been applying twice daily. I have not had an outbreak but have had minimal internal pain that feels like strained or pulled muscle in the same area.
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| 55 | 2021-01-24 | feeling hot, flushing |
Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the fac...
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Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the face and saying it was getting hot. Then, continued to cough and was using her prescribed inhaler ( unknown what type of inhaler it was ). Administered epi-pen immediately, and called 9-1-1. Had to administer second epi-pen 5 minutes later, and patient also took two 25 mg benadryls. A nurse at the facility was the one to administer her epi-pens. They were the patient's prescribed epi-pens
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| 55 | 2021-01-24 | pain in extremity |
On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. S...
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On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. Sever shivers, sweating, whole body aches, lethargic, nausea, loss of appetite, low grade fever, developed golf tennis ball size lump right axilla.
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| 55 | 2021-01-25 | feeling cold, tenderness |
Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; ...
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Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown. Information on Lot/Batch number has been requested.
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| 55 | 2021-01-25 | feeling of body temperature change | Body aches, hot and cold. |
| 55 | 2021-01-25 | numbness |
Right sided lips and facial numbness half hour post vaccination. Benadryl 25mg IVP Pepcid 20mg IVP S...
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Right sided lips and facial numbness half hour post vaccination. Benadryl 25mg IVP Pepcid 20mg IVP SOLU-Medrol 125mg IVPB
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| 55 | 2021-01-25 | numbness |
Right arm numbness; Right arm numbness and discomfort when raising at shoulder level and above; This...
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Right arm numbness; Right arm numbness and discomfort when raising at shoulder level and above; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), intramuscularly on 07Jan2021 08:15 at right arm, at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included omeprazole, potassium gluconate; oenothera biennis oil (EVENING PRIMROSE); ascorbic acid (VIT C); glucosamine; ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient previously took clarithromycin (MACROBID) and known allergies was Macrobid. The patient was not pregnant at the time of vaccination. The patient experienced right arm numbness and discomfort when raising at shoulder level and above on 12Jan2021. No treatment was received. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 55 | 2021-01-25 | pain in extremity |
I couldn?t lift my arm above shoulder height or laterally without extreme pain for the first few day...
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I couldn?t lift my arm above shoulder height or laterally without extreme pain for the first few days. The pain lessened for a day or two and then came back, but not as severe. It is uncomfortable to lift it even after applying heat and taking Extra strength Tylenol and Ibuprofen. It is keeping me awake at night and limiting movement in the upper right shoulder/bicep area.
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| 55 | 2021-01-25 | pain in extremity | DEVELOPED RIGHT ARM AND SHOULDER PAIN WITH DIFFICULTY RAISING ARM. PAI 7 OUT 10 ON PAIN SCALE |
| 55 | 2021-01-25 | tremor, weakness |
When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. aroun...
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When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. around 5 o'clock I started feeling ill and then i started about quarter to 6 I started getting cold and shaking bad but it wasn't like a seizure. So really severe chills. When i got home i got under heated blanket then I started getting itchy and noticed hives all over body. then I started getting blisters on palms of my hands and they were like water blisters. I was uncontrollably itchy. I started looking up online what to do and asked friends and family and started taking Benadryl. I had to take it for 4-4.5 days so then the hives finally went away but I was still itchy. I've just been very very exhausted and been having to push myself to get up. I had anxiety about getting the vaccine but I decided to get it. I still don't feel like myself, I don't have much of an appetite but not losing weight because I've been forcing myself to eat. I'm taking vitamins and praying I feel better but I just don't feel like myself. I don't have as much energy and exhaustion is the big thing. My joints started hurting really bad.
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| 55 | 2021-01-26 | burning sensation, pain in extremity |
mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soren...
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mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Workplace clinic. Medical history included obesity from an unknown date. Known allergies included sulfa and penicillin. Concomitant medication included metoprolol, vitamin d3, calcium, probiotics. Patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild metallic taste on 22Dec2020 11:30 with outcome of recovered, arm soreness on 21Dec2020 with outcome of recovered, poor administration tech on 21Dec2020 11:40 with outcome of recovered, extreme burning for 10 min following vax-i on 21Dec2020 11:40 with outcome of recovered. The verbatim as follow: 1st Vax: mild metallic taste and arm soreness (including extreme burning for 10 min following vax-I believe this was poor administration tech), slight metallic taste 24 hrs post vax, lasted a few hours. Patient didn't receive treatment for the adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Jan2021. The covid test type post vaccination was Nasal Swab. The covid test name post vaccination was PCR.
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| 55 | 2021-01-26 | pain in extremity, electric shock sensation |
1/26/21 at 6:30 am patient woke up and noticed that her left fifth digit felt like an electric shock...
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1/26/21 at 6:30 am patient woke up and noticed that her left fifth digit felt like an electric shock pain when making a fist. Pt. states that she took tylenol for the pain and did not get relief. Pt. states that her left fifth digit is still painful 8-9/10. Pt. states that she is currently working now, and she is trying to be cautious of her left fifth digit pain so that she does not trigger the pain.
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| 55 | 2021-01-26 | pain in extremity |
had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...w...
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had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...woke up at 5:00 this morning (day after shot) with horrible pain from shoulder all the way to finger tips....fell back asleep, woke again at 7:30 with the same symptoms got up and tried moving the arm (with pain) went ahead and used arm and read reactions and what to do...tried to use arm, after about 1 hour of trying to use arm the pain is just over the injection where there is a grapefruit size hard spot with intense pain. Will continue to try to move the arm and use cold compresses and drink water as the organization site suggested. Pain is not just in upper arm with majority of pain in that grapefruit size area.
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| 55 | 2021-01-26 | pain in extremity |
Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoul...
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Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoulders; fever of 99.6/low grade; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) from 06Jan2021 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), in the left upper arm with no issues. At first, she just had a sore arm on 08Jan2021. Then this morning, on 13Jan2021, she was having chills, enlarged lymph nodes, body aches in her back and shoulders, and a fever of 99.6. It is low grade but does not take much. She has been checking her temperature every 4 hours and it is not any different. She was taking paracetamol (TYLENOL) for a few days to ward anything off. Today (13Jan2021), she laid off the paracetamol to see if she really did have a fever. She did not want to mask it. So, she is taking paracetamol for that off and on. She talked to one person who said the symptoms should last 1-2 days. Then another person said they could last up to a week. She hopes that it is related to the vaccine. She will be mad if she gets COVID after doing all of this. Outcome of the sore arm was recovered on 09Jan2021 and of the remaining events was not recovered.
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| 55 | 2021-01-26 | tingling |
About 20 min after injection patient re-presented to clinic with complaint of R armpit tingling sens...
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About 20 min after injection patient re-presented to clinic with complaint of R armpit tingling sensation, as if it were 'asleep'. Sensation not relieved by anything, not worsened by anything. Patient said it was more a nuisance than anything. Advised by clinic staff that might be nerve issue related to the injection itself. She said she would not want to go to the ER but would follow up with her primary care doctor if issue persisted.
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| 55 | 2021-01-27 | flushing |
Pt. received shot at 1:47pm. Patient began feeling light headiness and flushed at 1:50-1:55pm and p...
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Pt. received shot at 1:47pm. Patient began feeling light headiness and flushed at 1:50-1:55pm and put head down between legs and tried to control breathing. At 2pm pt was given 50mg of Benadryl and BP was 120/40, pulse 102. Patient was then sitting upright with legs elevated and began sipping orange juice and water. Cold ice packs and/or wash cloths were applied to back of neck. At 2:12 patient feeling flushed again and put head back down between legs. EMS was contacted. At 2:17 pulse was 151/60. Pulse 74. Patient then was laid down with legs elevated. At 2:25 BP was 173/102. At 2:30 EMS arrived and then transported pt to ER.
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| 55 | 2021-01-27 | pain in extremity |
Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontane...
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Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 12Jan2021 at 16:00 at a single dose in the clinic for COVID-19 immunization. The patient received the first dose on 22Dec2020 at 16:00 on the left arm for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination and did not have COVID prior to vaccination. Concomitant medication included ibuprofen and tramadol. The patient experienced very painful lymphnode in arm of injection, pain radiating down arm into fingers on 13Jan2021 at 17:00. Outcome of the events was not recovered. Information of lot/batch number has been requested.
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| 55 | 2021-01-27 | tremor |
uncontrollable shaking; fever up to 103; This is a spontaneous report from a contactable Other HCP (...
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uncontrollable shaking; fever up to 103; This is a spontaneous report from a contactable Other HCP (patient). This 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284) intramuscularly on 11Jan2021 06:00 at SINGLE DOSE on left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included atorvastatin. The patient previously received first dose of BNT162B2 (lot number EH9899) intramuscularly on 21Dec2020 06:00 AM at SINGLE DOSE on left arm for covid-19 immunisation, and experienced sore arm. The patient experienced uncontrollable shaking, fever up to 103 on 12Jan2021. No treatment received for the adverse event. The outcome was recovered. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 55 | 2021-01-28 | weakness, pain in extremity | Soreness in left arm, fever, severe headache, nausea, weakness. |
| 55 | 2021-01-28 | flushing |
Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed f...
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Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed for 30 minutes without problems; patient reports she left after 30 minutes of observation and was on her way home when she started to feel itchy and scratched under her chin; around 10:15 AM she had more itching and redness to her skin and was flushed in her cheeks so she took a dose of over the counter Benadryl. by mouth; she continued to have itching throughout the day and reports she took another dose of Benadryl at 4:00 p.m. and again at around 2:00 a.m..
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| 55 | 2021-01-28 | hot flush, numbness, tingling |
Pt was waiting her 15 minutes post vaccine administration when pt began to feel hot & flushed, have ...
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Pt was waiting her 15 minutes post vaccine administration when pt began to feel hot & flushed, have difficulty swallowing ( constant need to clear throat), dry mouth, numbness & tingling in feet & legs. 2mL of dexamethasone 4mg/mL given IM to left deltoid by FNP. Epinephrine 0.3mg/0.3mL given IM to right upper thigh by FNP. Pt placed on 2LPM O2 via NC for comfort. Pt tolerated well. Pt recovered & left our clinic at 1635.
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| 55 | 2021-01-28 | migraine, weakness, discomfort |
Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighi...
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Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighing me down. I also had a migraine, nausea, joint discomfort mostly in my shoulders hips, lower back and base of head. I slept most of the day into the next day and felt better approximately 46-48 hours after the vaccine administration. Slight headache continued and swollen lymph nodes in the armpit noticed day 2 and continue to this day. Alternated Tylenol 1000mg PO w/ Advil 400ng PO.
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| 55 | 2021-01-28 | pain in extremity |
Little Mild Asthma when I exhale, have feeling I need to cough. when I breathe deep get sharp pain ...
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Little Mild Asthma when I exhale, have feeling I need to cough. when I breathe deep get sharp pain in back. Arm sore for a day.
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| 55 | 2021-01-29 | flushing |
Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst heada...
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Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst headache I've ever had, in addition to horrible neck stiffness. Slept most of the day. Felt awful. 28 hours after vaccine started vomiting. Vomited for almost 24 hours. Had stomach pain the night of the 15th. Had a low grade temp the next day 16th and on the 17th my heart rate was elevated as high as the 150's. The whole time I was tired. I was Covid tested the 14th because symptoms were so severe but it was negative. I was abnormally tired but finally felt normal by January 19th.
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| 55 | 2021-01-31 | weakness, tingling, numbness |
The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient rep...
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The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient reported driving and feeling lightheaded and heart started racing. The patient pulled over sat and walked around and felt better. Then got back in the car and kept driving, heart was racing again, couldn't move fingers, blood was pounding, fingers appeared white and numb. The patient called 911 and volunteer firefighter came, ambulance arrived and could move fingers again. Blood pressure was 136/104. For 10-15 minutes fingers felt numb and tingly, light headedness, and heart racing all stopped. The patient drove home and was not taken to the hospital and felt weak and shaky for about an hour.
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| 55 | 2021-01-31 | weakness |
Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (fel...
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Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (felt like all my internal organs are frozen cold); heartbeat sounded strong beats (can feel the pump); Body weakness; muscle weakness; It felt heavy and temporary unable to raise; This is a spontaneous report from a contactable consumer reported for herself. This 55-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 14Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced severe dizziness (BP normal at 120/80), nausea, body pain, while sideways lying down: unable to raise right foot or raise her foot. It felt heavy and temporary unable to raise for two days, severe chills (felt like all my internal organs are frozen cold), heartbeat sounded strong beats (can feel the pump) for at least 2 days, body weakness or muscle weakness.Start date for all events were 14Jan2021. Meclizine 25mg was received as treatment. The patient had no Covid tested post vaccination. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no known allergies. The patient had all normal from blood glucose of 109 and bp 120/80 on 14Jan2021, day of vaccine was a perfect day. Outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-31 | feeling hot |
Hot rash(almost like a sunburn) on my body. Mainly chest and arms., neck, shoulders. A little on bac...
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Hot rash(almost like a sunburn) on my body. Mainly chest and arms., neck, shoulders. A little on back stomach and legs. Started sat jan 30 and is still present. Also had bodyaches, headache and chills. Those are gone now.
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| 55 | 2021-01-31 | migraine | Migraine headache with floaters |
| 55 | 2021-01-31 | pain in extremity, tremor, weakness |
After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and ...
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After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and was awakened With: SEVERE CHILLS - teeth chattered in my head & legs shook -uncontrollably for over 9 hours FEVER- 103 Degrees -on & off for 8 hours BURNING - STINGING - in both hands and turned red 1-2 days LEFT ARM - sore- swollen 1 week [LEFT ARM - still has aches and stiffness] HEADACHE- -top of head for 2 days JOINT PAIN -all over for 3-4 days WEAKNESS- for over 72 hours
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| 55 | 2021-02-01 | feeling cold |
tired so slept; chills (freezing); chills (freezing); aches; fever 100 degree F; This is a spontaneo...
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tired so slept; chills (freezing); chills (freezing); aches; fever 100 degree F; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A 55-year-old female patient received second single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL1284, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 12Jan2021 07:30 for Covid-19 immunisation. Facility type vaccine: Hospital. Patient previously took first single dose of BNT162B2 (Pfizer, lot number: EJ1685) on 22Dec2020 06:15 (at 54-years-old), vaccine location: Left arm for Covid-19 immunisation. Facility type vaccine: Hospital. The patient was not pregnant. The patient had no known allergies. Patient had no other relevant history. There was no other vaccine given within four weeks. There were no concomitant medications. The patient did not have Covid prior vaccination. On 12Jan2021 22:00, also reported as 12 hours post second dose injection, the patient experienced chills (freezing), aches, and fever at 100 degrees F. The patient took paracetamol (TYLENOL). On 13Jan2021, also reported as in the middle of 1st night, she had 101.1 degrees F. On the same date, in the morning, the chills were gone, and fever was down to 99.9 F. On the second day (14Jan2021), she still had aches with temperature at 99.9 F and was tired, so she slept. The patient took paracetamol again. On the third day (15Jan2021) she had slight aches and no fever. On the Fourth day (16Jan2021) she was normal. No other treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from chills on 13Jan2021, fever recovered on 15Jan2021, while the other events recovered on 16Jan2021.
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| 55 | 2021-02-01 | feeling hot |
The first 15 minutes I got hot. 15 minutes after that which would be 30 min I started itching. I wor...
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The first 15 minutes I got hot. 15 minutes after that which would be 30 min I started itching. I worked my 12 hour shit. I woke up 300am and my body was hurting so bad, it felt like something was laying on my chest, shoulder arms and legs. I crawled out of the bed and took a Tylenol and that helped a little bit. at 600 am I took another 650 mg Tylenol. And my body has been hurting so bad and I've been itching. I took a bath yesterday about 6:00 and my body is on fire like I'm itching real bad. I don't think I should have took a bath, because that might have made the blood circulate more and my body aches like crazy, worse than before. The last time I took a Tylenol was 6:00.
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| 55 | 2021-02-01 | pain in extremity |
Severe headache, mild arm pain, extreme fatigue, and brain fog. The headache subsided with advil aft...
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Severe headache, mild arm pain, extreme fatigue, and brain fog. The headache subsided with advil after 12 hours. Arm pain was 2 days, brain fog lasted around 65 hours, fatigue lasted 3 days.
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| 55 | 2021-02-01 | pain in extremity |
headache/back of head, body aches, pain in right arm from elbow to shoulder and into neck, stiff nec...
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headache/back of head, body aches, pain in right arm from elbow to shoulder and into neck, stiff neck, fever 101, nausea
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| 55 | 2021-02-01 | tremor, burning sensation | Shaking , burning in arm, leg chest face, rapid heart rate |
| 55 | 2021-02-02 | weakness, migraine, hot flush |
36 hours after receiving the 1st dose of Pfizer vaccine I experienced extreme dizziness in the morni...
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36 hours after receiving the 1st dose of Pfizer vaccine I experienced extreme dizziness in the morning, nauseous, chills, hot flashes, racing heartbeat and was very weak. Had some lapses in thought process. I did not have a fever. These symptoms persisted for 5 days. On 2-2-21 I started to get a migraine, so took a prescription medication (Sumatriptan Succinate Tablet 50 mg) and this helped with the nauseousness. My symptoms seem to decrease around 3pm in the afternoon, but never completely go away. Each morning, the cycle repeats with dizziness, nauseousness and chills and some thought lapses. It's been one week since my first dose of the vaccine, and these symptoms are lessening but are still prevalent.
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| 55 | 2021-02-02 | feeling hot |
Systemic: Headache-Mild, Systemic: Other- Patient stated that she was feeling hot from her feet to h...
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Systemic: Headache-Mild, Systemic: Other- Patient stated that she was feeling hot from her feet to her head with sluggishness and headache 4/10 on pain scale.-Medium
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| 55 | 2021-02-02 | feeling jittery |
Received vaccine on 1/25/2021. Awoke on 1/27/2021 nauseated and took 1/2 promethazine 25mg tab, at 1...
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Received vaccine on 1/25/2021. Awoke on 1/27/2021 nauseated and took 1/2 promethazine 25mg tab, at 1630 that afternoon symptoms included vomiting, headache, aching and fever. These symptoms continued for 3 days. On third day patient started having diarrhea and feeling very "jittery". Took Excedrin for aches and headache. Pt did not seek medical treatment.
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| 55 | 2021-02-02 | pain in extremity, tenderness |
Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for...
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Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for 5 days was seen by doctor who did covid test came back negative. After 5 days flu like symptoms some what resolved but leg pain continued. Hard to walk and painful. Seen doctors 2 more times when they finally did bloodwork and sent her for admission to hospital. They have done Bloodwork, MRI's and they are all coming back normal but still have leg pain, cant bend toes or touch leg. Been out of work since.
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| 55 | 2021-02-03 | feeling cold |
Massive headache; Severe chills; Couldn't get warm all day even with multiple layers of clothing; Di...
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Massive headache; Severe chills; Couldn't get warm all day even with multiple layers of clothing; Dizziness/lightheaded; Feverish; Going from freezing cold to sweating profusely; Right arm is really itchy; Place on right arm started out as a red blotch the size of a nickel, but today is as big around as a grapefruit; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 16Jan2021 (17:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 30Dec2020 (when the patient was 55 years old) on the left arm for COVID-19 immunization. The patient had no issues with the first dose of vaccination. On 17Jan2021, the morning after the second dose of vaccination, the patient woke up with a massive headache; developed severe chills; could not get warm all day long even with multiple layers of clothing; was dizzy and lightheaded; feverish; was freezing cold one minute, and then sweating profusely the next; right arm was really itchy; and had red blotch that was as big as a nickel, then as big around as a grapefruit at the time of reporting. The outcome of the events was recovered on 19Jan2021 for 'massive headache', 'could not get warm all day long even with multiple layers of clothing' and 'dizziness/lightheaded'; was recovering for 'severe chills', 'feverish' and 'freezing cold one minute, and then sweating profusely the next'; was not recovered for 'right arm was really itchy' and 'red blotch that was as big as a nickel, then as big around as a grapefruit'.
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| 55 | 2021-02-03 | feeling hot, difficulty speaking |
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati...
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Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially.  Her symptoms mildly improved with the initial treatment.  Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered.  After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms.  1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes.  Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
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| 55 | 2021-02-03 | flushing |
Symptoms: c/o flushing, chills. Vitals stable. Intervention: rest, reassurance, used bathroom ? felt...
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Symptoms: c/o flushing, chills. Vitals stable. Intervention: rest, reassurance, used bathroom ? felt better.
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| 55 | 2021-02-03 | muscle spasms |
Patient received Pfizer #1 on 1/6/21 and developed muscle cramps and tinnitus and was evaluated by E...
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Patient received Pfizer #1 on 1/6/21 and developed muscle cramps and tinnitus and was evaluated by ENT, TMJ specialist,allergist and her PCP. Hearing test revealed mild hearing loss in high frequency. 1/27/21 received the second dose of the vaccine. The following day she developed flu-like symptoms, including fever, chills, headache and fatigue and worsening of Tinnitus. Received Dupixent two weeks prior to the vaccine.
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| 55 | 2021-02-03 | tremor, feeling cold |
Severe headache not responding to well to either Tylenol or ibuprofen, severe uncontrollable shaking...
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Severe headache not responding to well to either Tylenol or ibuprofen, severe uncontrollable shaking chills, oral temperature up to 102 F. Severe body aches, especially lower back, severe fatigue
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| 55 | 2021-02-04 | weakness, discomfort |
Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache an...
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Later that night after the vaccination I woke up hot, my body was achy all over, I had a headache and begin to cough. I took another dose of cough meds but it didnt work. That next morning I visited my PCP and my temp was 98.7 when I arrived but the temp elevated to 99.9 while there and another temp was taken shortly after and was 100.8 so I was advised to go back home. Once home I was so tired and weak I could barely make it to the couch. My temp then was 101 so I laid down. The couch was so bad it caused my throat to begin to hurt. I lost my taste and sense smell, my body ached so bad it was unbareable and I developed various bruises all over my body still while continue to cough presistantly. I was off work for about 3 days and those 3 days were the worse days of my life, I was so unconfortable and scared it was almost unbareable I thought I was going to die. And on Thursday the symptoms begin to diminish and by that night it was if nothing had ever happened.
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| 55 | 2021-02-04 | cold sweat, numbness, flushing | Tongue tingling /numbness Diaphoresis Clammy skin Lightheaded Facial flushing |
| 55 | 2021-02-04 | feeling of body temperature change, feeling hot |
Felt crummy; Felt funny and started to get hot and chills at the same time; Felt funny and started t...
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Felt crummy; Felt funny and started to get hot and chills at the same time; Felt funny and started to get hot and chills at the same time; Tired; Had increase temperature; Hot and flushed and bright red in face; Hot and flushed and bright red in face; immunocompromised; Slept 14 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248), intramuscularly in right arm on 15Jan2021 14:27 at single dose for covid-19 immunisation. Medical history included Lupus may make her immunocompromised which diagnosed in 2011, Raynaud's, hypertension which was completely managed, irritable bowel and reflux. All were diagnosed prior to the vaccine. Family medical history was none. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included hydroxychloroquine for Lupus for many years, tadalafil (CIALIS) took for years for secondary reynauds associated with lupus, amlodipine from Jan2019 for blood pressure abnormal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient only had the first vaccine and at the time she received it, she got hot and flushed and went bright red in the face. That lasted 2 hours. She was literally bright red on her face. She got it Friday at 2:27 pm on 15Jan2021. Friday night, she slept 14 hours, which was unusual. She only got out of bed to walk her dogs. Saturday (16Jan2021), she felt funny and she started to get hot and chills at the same time. She took her temperature and temperature started in mid 99 degrees Fahrenheit and popped up to 100 degrees Fahrenheit. Then same thing again Saturday night. She slept 14 hours, which was unusual. Sunday (17Jan2021), she felt crummy. Her temperature spikes to 100.3 on Sunday. She contacted her manager who advised her to contact Employee Health the next morning and employee health told her that if her temperature spiked again on Monday to get a COVID test. She said it never went above 99 degrees Fahrenheit. Today (21Jan2021) was the first day she did not feel crummy. The sleepiness improved but only because she had to go to work. She was still tired. Feeling funny lasted 2-3 days. Her temperature on Saturday (16Jan2021) was 100 degrees Fahrenheit and on Sunday (17Jan2021) was 100.3 degrees Fahrenheit. She never took her temperature on 15Jan2021. The temperature had improved, but it was still hanging out around 99.4 and 99.6. Feeling crummy persisted through yesterday (20Jan2021). Today (21Jan2021) was the first day she felt normal again. She felt crappy all week. She took a fair amount of medication and did not know if it was relevant or not. She had other medications and had been on them for a long time. No ER or physician's office required. She contacted with employee health but had not seen a provider. She planned to discuss with her provider because she wanted recommendation if she should receive vaccine 2. She realized it was a judgment call because she was only 50% covered after having the first dose. She was not sure if she will have a worse reaction with the second. Most people she talked to have no reaction but a significant reaction to the second one. She did not have any information on any of those that had a significant reaction. Details and time of onset provided as: Hot and flushed and bright red in face 14:28, Slept 14 hours 21:00-23:00, tired - she felt it the day before and said it started at 10:00 on Saturday morning, Felt funny and started to get hot and chills at the same time: 12:00, had increase temperature shortly after 12:00, because that was when she checked her temperature, felt crummy 10:00. The outcome of event hot and flushed and bright red in face, felt funny and started to get hot and chills at the same time, felt crummy was recovering. The outcome of event slept 14 hours, tired, increase temperature was not recovered.
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| 55 | 2021-02-04 | hot flush |
?Pfizer-BioNTech COVID-19 Vaccine EUA" (1st Dose) Muscle aches, severe head ache, hot flashes, rash...
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?Pfizer-BioNTech COVID-19 Vaccine EUA" (1st Dose) Muscle aches, severe head ache, hot flashes, rash and hives on scalp, back, stomach, arms, legs, face. Treated with topical prescription cream and allergy pills, ibuprophen
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| 55 | 2021-02-04 | tingling |
Patient received her Covid vaccine at 15:28 and at 15:50 started having prickly feelin gin her hands...
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Patient received her Covid vaccine at 15:28 and at 15:50 started having prickly feelin gin her hands, legs and lips. EMS assessed and treated with Diphenhydramine 25mg orally. She had no change in her symptoms so was sent by personal vehicle with a driver to local ER up the street. Report called and given to ER @16:05
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| 55 | 2021-02-04 | tingling |
nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; Th...
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nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 19Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included osteoarthritis, restless legs syndrome, rubber sensitivity (latex allergies), and COVID-19. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included ropinirole. On 19Jan2021 14:15, the patient experienced nausea, body aches, headache, fatigue, tingling in both hands (and fingers) and crushing depression. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 55 | 2021-02-05 | numbness | Headache, lightheaded, dizziness, bilat foot and arm numbness, chest pain, SOB |
| 55 | 2021-02-05 | pain in extremity |
Arm pain radiating to forearm, muscle pain in armpit area, swollen lymph armpit area left side of br...
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Arm pain radiating to forearm, muscle pain in armpit area, swollen lymph armpit area left side of breast
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| 55 | 2021-02-06 | pain in extremity, weakness, muscle spasms, tingling |
Chills, Fever, muscle pain, spasm, headache, stuffiness, dizziness, weakness, nausea, cramps, fatigu...
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Chills, Fever, muscle pain, spasm, headache, stuffiness, dizziness, weakness, nausea, cramps, fatigue, heaviness in legs, needle sticking sensation on hands and feet, sore left arm (limited mobility)
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| 55 | 2021-02-06 | tingling | Tingling in finger. Just one. Left hand |
| 55 | 2021-02-07 | weakness |
PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, C...
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PATIENT ACQUIRED COVID-19 ON 12/29/2020 AND SYMPTOMS WERE EXHAUSTION, SEVERE HEADACHE, BODY ACHES, COUGH, SOB, CHILLS, SWEATS, FEVER OF 103 DEGREES, RHINORRHEA, CHEST PAIN, FATIGUE, TIREDNESS, WEAKNESS, SUDDEN LOSS OF SENSE OF TASTE,, SUDDEN LOSS OF SENSE OF SMELL.
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| 55 | 2021-02-07 | discomfort, pain in extremity |
symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrib...
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symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrible diarrhea; constant headache; Gas; Bloating; Her arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL8982, unknown expiration), via injection once to right arm on 14Jan2021 at a single dose as she is eligible with first tier for vaccination. Medical history and concomitant medications reported as none. The patient reported that she received the first dose of COVID vaccine on 14Jan2021 (Thursday). The next day (15Jan2021), her arm was sore for 24 hours after the shot, and she didn't have any side effects over the weekend. On 19Jan2021, Tuesday, she started having constant headache, and was experiencing problems with gas and bloating, it is very rare for her to have this issue, and it was building the last of couple days, she was uncomfortable and was taking over the counter medication for relief. She was keeping the headaches at bay with generic ibuprofen (lot: S200378, expiry: Mar2023), but if she missed a dose or is feeling better and doesn't take, it is coming back, it is consistent. Gas and bloating are primarily after eating, on Wednesday, after 24 hours it was ridiculous. She got some generic Extra Strength Gas Relief one tablet after eating (lot: 75257, expiry: Jun2022), and it was giving her some relief until early this morning. Tuesday, Wednesday, and Thursday, the gas and bloating was worse. Last night, her entire chest, she wanted to burp so bad, but couldn't because it really hurt, and it took a while for the next tablet to kick in and give relief, she was like where is this coming from, she didn't know it could build up so much. On 22Jan2021, she had a terrible diarrhea. Diarrhea was painful and intense, she took generic Pepto Bismol 1-2 tablets, and she took 4, The first time she woke up at 04:30 AM and at 7 another wave hit her, so she took another two tablets. Right now, she is feeling okay, but the gas is building up, her chest is filling, she is uncomfortable. The patient asked if these are reported side effects. She works in a dental office, and the doctor is knowledgeable and sensitive to COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, are these side effects or may she have COVID, though she doesn't know who she could have gotten COVID from. Out of protection for patients at dental clinic, the HCP at clinic wants her to get the COVID test as he believes it could be COVID and not side effect of the vaccine. She doesn't want to quarantine for nothing if it is just side effects of the vaccine. She will be getting rapid diagnostic for COVID and not the antibody test. She thinks she should get tested, but there is no testing appointment available until tomorrow, and she does not want to self-quarantine needlessly, she will live through it, she is happy to get the test, but she doesn't want to lose 2 weeks of pay if others are reporting the same side effects. She was happy to get the vaccine. The patient recovered from the event arm sore on 16Jan2021; not yet recovered from events constant headache, gas, and bloating; while unknown outcome for the remaining events.
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| 55 | 2021-02-07 | feeling hot |
nauseous/sick to my stomach; Weird headache; slight ache in my hip; Slight dizziness; fogginess/didn...
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nauseous/sick to my stomach; Weird headache; slight ache in my hip; Slight dizziness; fogginess/didn't feel right; I got hot/got very over heated; This is a spontaneous report from a contactable other hcp (patient). A 55-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3246), intramuscular at left arm, on 20Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included possibly ibs occasionally from an unknown date. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No Known allergies. Approximately 20 hours after, on 21Jan2021 14:15, slight dizziness/ fogginess, she got hot, just didn't feel right lasted about 5 minutes. Around 1030 am on 22Jan. She got very nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated. Weird headache. No fever, slight ache in her hip. After about 10 minutes it passed and she feels fine. No treatment AE. No COVID tested post vaccination. The outcome of the events slight dizziness/ fogginess, she got hot, just didn't feel right on 21Jan2021 14:15 were recovered on 21Jan2021 14:20 (reported as lasted about 5 minutes), of events nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated, Weird headache, slight ache in her hip on 22Jan2021 10:30 were recovered on 22Jan2021 10:40 (reported as passes after about 10 minutes).
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| 55 | 2021-02-07 | flushing, tingling |
Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127...
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Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127/90 (usually 90/60); Had difficulty swallowing; Fingers started tingling; Chills (lasted 15-20 minutes); This is a spontaneous report from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 15Jan2021, after 2 minutes of the vaccine, patient heart rate went from normal (53-60) to 100 bpm; the patient felt flushing feeling and blood pressure went up to 127/90 (usually 90/60); patient had difficulty swallowing and fingers started tingling, followed by chills (lasted 15-20 minutes, as reported). The patient was ok 90 minutes after the shot. No treatment given. The final outcome of all the events was recovered in Jan2021.Information on the batch/lot number has been requested.
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| 55 | 2021-02-07 | night sweats |
Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus;...
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Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus; Bodyaches; fever; chills/Night chills; nausea; headache/mild headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 07Jan2021 at a SINGLE DOSE for COVID-19 immunization. Medical history included palpitations. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 on 18Dec2020 at 17:00 via intramuscular route of administration in the left arm for COVID-19 immunization. Concomitant medication included atenolol, vitamin b complex, colecalciferol (VITAMIN D), vitamins (MV), esomeprazole magnesium (NEXIUM), omeprazole (PROTON) and fish oil. The patient previously took morphine and experienced allergies. On 08Jan2021, 1 day post-vaccination after the second dose of vaccine, the patient experienced body aches, fever, chills, nausea, headache and muscle weakness. Then on 18Jan2021, she had night chills and sweating, HR (heart rate) of 130, and mild headache. She also noticed soreness and bumps to anus on 18Jan2021. On 19Jan2021, patient still had chills, HR was 120 and continue to feel muscle weakness Took 100mg atenolol to decrease HR. Usually prn 25 mg atenolol. The soreness and bump increase and was growing. Patient will consult with cardiologist regarding HR. The outcome of events body aches, fever, nausea, headache and was recovered on 13Jan2021. The outcome of event chills, muscle weakness, soreness and bumps to anus was not recovered. The outcome of the other events was unknown. Patient did not receive any treatment for the events body aches, fever, nausea, headache and muscle weakness. Whereas therapeutic measure was taken as a result of "HR of 130/HR was 120". No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 55 | 2021-02-07 | pain in extremity |
nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a s...
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nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. The patient took vaccine for work, and to get back to a normal life. The patient's medical history and concomitant medications were both reported as none. Shortly after her first dose of the vaccine, she developed nipple drainage. She didn't know if it was coincidental or what. She hadn't noticed it prior to the vaccine. She a work up with a mammogram and ultrasound. There were no masses or anything else. They showed no reason to have the drainage. She was unsure of her weight, but would get 140 or 150 lbs. With the first vaccine, she experienced a sore arm. It started the evening of the 30Dec2020 about 4-6 hours after the vaccine. That resolved, and she recovered completely. She also experienced a metallic taste in her mouth. It happened initially on 30Dec2020. She recovered completely. It only lasted a couple of hours. They were both not serious. She had noticed an increase in the itchy and watery eyes on an unknown date. It was ongoing and persisting. The patient underwent lab tests and procedures which included mammogram: normal, ultrasound breast: normal, weight: 140 or 150 lbs, all on an unknown date. The outcome of the nipple drainage was unknown, the outcome of the events sore arm and metallic taste was recovered on 30Dec2020, the outcome of the events increase in the itchy and watery eyes was not recovered.
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| 55 | 2021-02-07 | tingling, numbness, weakness |
I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it wa...
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I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it was nerves. No one asked how I felt after the vaccine and was passed along ( I told my daughter - who drove me - about my neck while at the vaccine site.) I noticed that my face was also going numb a few minutes later. As soon as we arrived at our meeting place, I told my daughter that my face(vaccine side) was also numb: "like when you get an injection for dental work." It is now ten hours after I received the vaccine, and the numbness has not seized. It is still there and with a strong tingle sensation. I also feel generally unwell with body aches and weakness.
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| 55 | 2021-02-07 | throat numbness |
Patient started by complaining of a metallic taste in their mouth shortly after administration. a fe...
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Patient started by complaining of a metallic taste in their mouth shortly after administration. a few minutes later it had evolved into numbness and tingling across the entire mouth and down the throat. Physical exam presented mild swelling
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| 55 | 2021-02-08 | feeling hot |
A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running co...
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A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running continuously, I got really congested in my face/nose and my throat felt thick, my heart was racing; it really scared me the nurse gave me Benadryl, I refused the epi-pen because I was starting to feel better and by 2 pm I was good to go
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| 55 | 2021-02-08 | flushing | Redness, flushing, rash |
| 55 | 2021-02-08 | tingling, numbness |
Few days after first shot/dose in left arm, my fingers started tingling and going numb few times a d...
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Few days after first shot/dose in left arm, my fingers started tingling and going numb few times a day everyday since and up until second shot/dose on Feb 5th 2021 , even did it on same day while in 15 min holding period. Informed nurses they had me wait another 30 mins. Today is Feb 9th 2021 and still have the tingling and numbness in left fingers , has been only left fingers .
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| 55 | 2021-02-08 | tingling |
Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset....
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Slight swelling and tingling of lips, cheeks, and tongue. Lasted about 20 - 30 minutes from onset. Consulted EMTs onsite but as no difficulty breathing and symptoms were reducing, nothing administered by EMTs.
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| 55 | 2021-02-09 | pain in extremity |
stress; not sleeping very well; sore arm; slight headache; This is a spontaneous report from a conta...
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stress; not sleeping very well; sore arm; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the first of three reports. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) via unspecified route of administration on 19Jan2021 at single dose in left arm for COVID-19 immunization. The patient's medical history included occupational exposure to COVID-19 (adult foster care, direct line caring for people). The patient's concomitant medications were reported as no. The patient experienced sore arm on 19Jan2021, slight headache on 19Jan2021. Sore arm went away between 20Jan2021 and 21Jan2021. She has recovered completely from sore arm. She is unsure if the headache was from the vaccine or stress, or several different things, such as not sleeping very well. Headache went away, she is not 100% positive, but maybe by the 22Jan2021, and she had recovered completely. The patient asked if she can take paracetamol (TYLENOL) or ibuprofen for side effects if have to. The outcome of sore arm and slight headache was resolved. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092693 same reporter/drug, different patient/ event;US-PFIZER INC-2021092694 same reporter/drug, different patient/ event
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| 55 | 2021-02-14 | pain in extremity |
Sore arm, body aches and chills approximately 13 hours after vaccine. Adverse effects resolved with...
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Sore arm, body aches and chills approximately 13 hours after vaccine. Adverse effects resolved within 36 hours or less.
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| 55 | 2021-02-14 | tingling, muscle twitching, numbness |
Sudden twitching of left foot, feeling idenical to electrical shock/tazer, numbness, tingling sensat...
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Sudden twitching of left foot, feeling idenical to electrical shock/tazer, numbness, tingling sensation from my feet going up my legs,lower back, spine, shoulders and neck .NEXT DAY severe aches all over same body parts, headaches,chills,dizziness, difficulty breathing, swollen left arm(injection site(
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| 55 | 2021-02-14 | tremor |
At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fev...
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At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fever of 102. Body aches and pains. Had to put on extra clothes and blankets. Went to work in am but had to leave early due to ongoing body pains and fever of 101. Also, inflamed lymph node in axilla of shot arm- very painful. Felt better by Sat late morning. Please note I am strawberry blonde as is coworker who had same response. Other individuals with us with very mild symptoms.
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| 55 | 2021-02-15 | weakness, tingling |
Pt developed weakness left leg with tingling . Similar occurred with Typhoid vaccine in past. Pt was...
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Pt developed weakness left leg with tingling . Similar occurred with Typhoid vaccine in past. Pt was taken to the ED by husband
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| 55 | 2021-02-15 | feeling jittery | First heat in upper arm, nausea, dizziness and jittery |
| 55 | 2021-02-15 | tremor, weakness | Felt week, trembling, felt like passing out, palpitations, bp 144/98, pulse 96 |
| 55 | 2021-02-16 | pain in extremity |
About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the compute...
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About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the computer could not remember what to do next as I searched for needed files. At the end of the day, I signed off my computer but needed to think about how to turn off the monitor. The next day was better, but by the 3rd day out I became very sensitive to sound. On the 4th morning the brain fog got much worse, my head hurt and I felt like I was moving through life in slow motion. This continued for two whole days and I could not sleep at night due to the intensity of my headache. All of this could have been a migraine which I had in the past, but never to this extent. Past migraines were visual in nature and only lasted about an hour. By the 5th day, I started to feel normal, with the occasional headache or wave of nausea.
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| 55 | 2021-02-18 | weakness |
About 48-hours after second COVID vax, I had serious body aches, headache, trouble focusing, feeling...
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About 48-hours after second COVID vax, I had serious body aches, headache, trouble focusing, feeling dizzy/ready to faint, unable to sleep, extreme exhaustion, general over all weakness lasting about 6-days.
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| 55 | 2021-02-18 | numbness |
Lip swelling on left side of face, also described numbness and tingling. "Felt like I went to the d...
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Lip swelling on left side of face, also described numbness and tingling. "Felt like I went to the dentist". Given 50 mg Benadryl. Numbness continued to spread through that side of face, EMS called, transported to ER.
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| 55 | 2021-02-21 | cold sweat |
Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little...
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Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little over 48 hours. Lymph nodes under left arm are still slightly swollen.
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| 55 | 2021-02-21 | tingling |
Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wr...
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Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wrist. The immediate reaction at the time of the shot was strong tingling in my left arm. The next day, I felt sore all over my body, as well as cold/flu like symptoms for 2 days. But the wrist pain has been getting worse, and consistent. I broke that wrist 10 yrs ago, and may have some slight work related carpel tunnel. With that in mind, I can say that the current issues and pain I?m dealing with have been acute and severe since I received the first dose of the vaccine. I just received the second dose 3 days ago, and still my wrist is hurting. I am careful to make sure I don?t put too much weight on it, and often wear a wrist brace. I am currently waiting to see my primary care doctor to seek medical attention.
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| 55 | 2021-02-21 | cold extremities, hot flush, pain in extremity |
FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO H...
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FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS.. IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM. CHILLS / NO FEVER . COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM. CHILLS/AND SLEPT MOST THE DAY. I DO NOT BELIEVE I EVER HAD A FEVER. SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE. MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE. I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS. OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.
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| 55 | 2021-02-21 | tremor | 2) "Stoned" From 8:15pm 2/5 thru 12:00 pm 2/7 1) Sporadic vibration of entire body 3) Constipation |
| 55 | 2021-02-22 | pain in extremity, feeling cold | Sore arm, headache, dizzy, tired, chill. a little fever, from 6 hrs to 40 hrs after dose. |
| 55 | 2021-02-23 | weakness, feeling cold |
At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time....
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At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time. Joint pain followed in ankles, knees, hips, elbows. Next day I had a severe headache with neck and mouth pain. Next day I was terribly weak.
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| 55 | 2021-02-23 | involuntary muscle movements |
I developed fever 102 comes down to 101, severe headache and today I began having dyskinesia for lac...
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I developed fever 102 comes down to 101, severe headache and today I began having dyskinesia for lack of better words, this has persisted for more than 3 hours. Don?t know what to do or who to call. Message in to new doctor but haven?t seen him yet.
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| 55 | 2021-02-23 | feeling hot |
3 days after vaccination I started to have intermittent localized "heat" sensation in right side o...
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3 days after vaccination I started to have intermittent localized "heat" sensation in right side of skull. It would only last for a short time, a minute or two, maybe a little longer and then disappear. It was an intense heat feeling but with no pain. I was sitting quietly doing a puzzle. Because of the weekend unable to contact Dr and on call Dr did not respond to my callback request. Monday 2/15/21 talked to Dr and he it's not a vaccine reaction and it'll go away. This continued occasionally for a few days until day 5 and 6 the heat sensation increased and duration of event was much longer, lasting most of the day with short time spans between episodes. Heat sensation moved from right side of skull to top of head and was very intense, having to use a icepack for some relief. Called Dr a second time and told me to wait it out and call him next week to report status. By day 7 there is a mild headache but intensity of the heat sensation in skull has decreased to milder and less frequent again. Day 13 symptoms were almost completely resolved but by 14/15 they have returned though milder than worst symptoms were. I called Dr's office on Friday 2/19 and they said to call back next week if symptoms do not get better will refer to nruology.
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| 55 | 2021-02-23 | flushing |
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
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| 55 | 2021-02-24 | feeling hot |
Patient complained of "Hot everywhere, chest and heart racing" Denies SOB Bp 139/78, hr 64, oxygen ...
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Patient complained of "Hot everywhere, chest and heart racing" Denies SOB Bp 139/78, hr 64, oxygen level 99% on room air. EMS at patient's side at clinic, evaluated and discussed symptoms with patient. No interventions needed at this time and patient monitored for an additional 15 mins. VS remain stable and at 1045a, BP was 142/76, oxygen level 100%, HR 58 with patient states feeling better and feels she can drive home. EMS released patient.
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| 55 | 2021-02-24 | hot flush, flushing |
Pt complains of flushing, light headedness, and hot flash. Pt provided apple juice, graham crackers...
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Pt complains of flushing, light headedness, and hot flash. Pt provided apple juice, graham crackers and allowed to rest while MD consulted. Event occurred at 11:19 am, Vaccine received at approx 10:55 Am
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| 55 | 2021-02-24 | pain in extremity | Arm pain, tiredness and headache |
| 55 | 2021-02-24 | pain in extremity |
Severe chills, back and neck ache, fever,- onset 10:00PM to 4:30AM, residual fever reduced after Tyl...
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Severe chills, back and neck ache, fever,- onset 10:00PM to 4:30AM, residual fever reduced after Tylenol taken at 6:00AM; localized soreness left arm- onset 1:00PM, reduced but still present today, 2/25 at 10:48AM
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| 55 | 2021-02-24 | tingling, cold sweat |
COVID-19 Vaccine Pt received her 1st dose of Covid-19 vaccination in her left deltiod at 1340. 12 m...
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COVID-19 Vaccine Pt received her 1st dose of Covid-19 vaccination in her left deltiod at 1340. 12 min later, pt stuck her head out of the doorway of her room to notify LPN that she was feeling lightheaded. LPN went to pt's room to assess. Patient laid back in exam chair. Patient mask removed. Color palor. Skin clammy, Vitals obtained, patient reports tingling in arms, legs, and feet. Patient vitals 96/67. Provider at door for eval and advised EMS notification. Patient vitals monitored. 20G IV placed at 1358 left forearm by RN x1 NSL. Color begins to return. Patient tilted back up in chair, vitals obtained and WNL. At 1423 patient stood up with stand by assistance, placed mask on herself and reports does not feel can stand at this time. Patient A&O x4. Reports lightheadedness and dizziness. Patient asks what she is to do about her second vaccine and was advised that she needs to consult with her PCP. Pt states will take Benadryl. Pt again advised to check with her PCP before having second dose or taking Benadryl with second dose. Patient advised per EMS to bring second person with for transport if cleared to receive second dose. At 1428 reports no lightheadedness or dizziness with standing. At 1429 patient ate three PB crackers with water. At 1432 patient ambulatory in halls with Medic staff by side. At 1434 back to room, reports 95% better with head, tinglining in feet and hands 90% improvement. At 1445 vitals WNL patient A&O x4. At 1449 IV pulled by RN. At 1452 patient discharged to home per self.
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| 55 | 2021-02-24 | tremor | Shaky, felt closed in, patient believes it was anxiety, waited 15 minutes, cleared by EMS. |
| 55 | 2021-02-25 | feeling cold, feeling hot |
Reaction to 2nd Dose Pfizer covid19 vaccine I had second dose of the experimental Pfizer vacine Feb...
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Reaction to 2nd Dose Pfizer covid19 vaccine I had second dose of the experimental Pfizer vacine February 17, 2021. 1st dose was on January 27, 2021 I had reactions both times. I already reported on this site, on my 1/27/2021 reaction Received through a pharmacy clinic set up at my work. Lot#. EL9263 Received dose #2 about 10:30am on Wednesday 2/17/2021 during my work hours. (7-4pm) Paid closer attention to how I felt during the day, I could feel, I was going to be foggy in my head again. I was getting tried quickly. My left arm was not sore this time. Got home about 4pm (left a little early). Very tired, went to bed by 5:30pm. Slept, woke up to heat soup and eat. 7pm: Back to sleep. Very exhausted, my eyes were hurting (a sign I have a fever) I did not care enough to take my temp. Seemed to hard to try and find the thermometer. 7:30pm: Back to bed. Sleep. I'm very warm in my bed, sweating under arms and chest, I don't care, I can sleep thru that. Smells funny (sweat has a distinct oder) 11pm: wake up. I want to go pee, but I'm too cold to leave my warm covers. as soon as I uncover to get up, I have violent chills. I don't have chills if I stay covered. This was the exact same symtom I had on May 11, 2021 when I had the covid19 and came home sick from work. Violent chills, barely able to stand and walk alone. After midnight: I wait for someone to come upstairs to help me get up, with a blanket ready to throw over me and help me to toilet. I was too weak to call for him or to care, I just slept and waited for him to check on me. someone helped me to to tiolet, chills are under control if I have a blanket on me. The house is not cold, someone has the wood stove cranking that night, it's 70 in my bedroom. I sleep all night Wednesday. 6:30am: Thursday My eyes still hurt, I'm still hot. I don't care what my temp is. No more chills. I'm smelly from sweating all night. I'm motivated to shower, I think maybe I can do stuff today, I try to plan some things for the day. I shower and eat some oatmeal. I'm exhausted from doing those two things. My lower back/hips and neck are and shoulders are tight and sore, aches all over, especially neck. It's hard to think, brain fog, finding the right words. The injection site is not really sore though (last time it was). I have to just go back to bed. I sleep all day Thursday. Get up late afternoon to eat a little bit (soup and crackers) I try to watch TV. I can't focus on the show. I go back to bed by 5:30pm. I look at dumb funny videos on FB. Asleep by 6pm on Thursday evening. Sleep all night and wake up Friday 5am. I'm able to function and do most of my usual activities on Friday, but not very motivated to exercise or go for with dogs like I normally would do. Still stiff muscles. I do play in snow Friday night with dogs. By Saturday most of the stiffness is much better, I'm moving, walking dogs outside, moving furniture, doing my usual activities. I care about things again.
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| 55 | 2021-02-25 | feeling cold |
Patient reported feeling cold in the chest, and palpitations. Has history of anxiety. After observat...
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Patient reported feeling cold in the chest, and palpitations. Has history of anxiety. After observation, reported feeling better.
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| 55 | 2021-02-25 | numbness | Numbness in left upper extremity, especially hand. BP 142/83, pulse 59. |
| 55 | 2021-02-25 | pain in extremity |
one day after my first vaccine, I started to feel muscular pain in my legs, it felt as if they were ...
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one day after my first vaccine, I started to feel muscular pain in my legs, it felt as if they were extremely sore. At first I though t it was due to a personal training session but then it would not go away (also I have been swimming for 7 month almost every day, so I should not get sore. Then about a day before the second vaccine everything went back to normal, now after the second vaccine I had the same symptoms (2/3/21 was the second dose) and they are still persisting. If I take Aleve Muscular Pain, they symptoms go away completely but come back as soom as the medication wears off. It feels like I am constantly sore, if I am active it is fine but once I sit or lay for extended periods of time I have a problem getting up.
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| 55 | 2021-02-26 | burning sensation | Swollen lymph node (R axillary) burning sensation in armpit/radiating down arm, fatigue, joint pain. |
| 55 | 2021-02-26 | pain in extremity |
The very next day and for the next three days I had over 103 fever bodyaches nauseous fatigue for ov...
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The very next day and for the next three days I had over 103 fever bodyaches nauseous fatigue for over a week and the arm I get the shot and did not feel better until a week later.
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| 55 | 2021-02-28 | pain in extremity |
sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour l...
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sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.
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| 55 | 2021-02-28 | pain in extremity | severe pain and swelling in left lower leg. Diagnosed with 2 DVTs 3 days later in emergency room. |
| 55 | 2021-02-28 | pain in extremity |
Headache Throwing up Stomach upset, only ate toast Sore arm Overall feeling lousy Could not go to...
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Headache Throwing up Stomach upset, only ate toast Sore arm Overall feeling lousy Could not go to work
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| 55 | 2021-03-01 | facial paralysis, slurring |
Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness...
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Per patient's report: She received her first dose of Pfizer COVID-19 vaccine and developed soreness at localized injection site and felt sleepy, otherwise no adverse reaction signs or symptoms patient reported. On 2-19-21 at 2:30 PM she received her second dose of the Pfizer COVID-19 vaccine at a mall. She reports the lot number of the vaccine was EL9269. She was monitored for 15 minutes after receiving the second dose. She and her husband left and took the car to a car wash where she fell asleep on her way home and her husband woke her up when they got home. At about 320 or 3:25 PM, she noticed that her face felt puffy and she had a sensation that her face was sliding down, she developed tongue swelling, blurry vision, dizziness, and she reports that she was talking funny/slurring her words. Her husband got a flashlight and looked in her throat and said that her throat was swelling. She felt like falling asleep. Her husband used her EpiPen on her. The EpiPen worked right away to improve the symptoms. She took no other treatments at home. Her husband drove her to the hospital where she slept the entire way. She never developed rash, flushing, skin itching, wheezing, coughing, chest tightness, shortness of breath, nausea, vomiting, diarrhea, fevers, chills, or joint pains. She does not know if she passed out, she states it was hard to stay awake. She reports having some abdominal cramping and churning for the following 2 to 3 days afterwards. She was discharged from the hospital ED where she was never admitted. They gave her an albuterol inhaler to use every 4 hours for 6 days after she left the ED. She went home at about 10:00 PM and went to bed about 10:30 PM. She woke up at 3:00 AM crying and then fell back asleep and woke up again around 7:30 AM. She did not develop any local injection site reactions on her arm this time.
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| 55 | 2021-03-01 | feeling jittery | shaky, jittery. Waited 15 mins extra. Evaluated by EMS-Cleared |
| 55 | 2021-03-01 | pain in extremity |
Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm p...
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Severe Muscle pain throughout my entire left side and severe joint pain left side only. Severe arm pain at the site of injection. This pain was severe visceral pain and lasted for over 6+ weeks. Only on my left side. The pain was present when simply sitting as well as during activity. There are still days when the pain returns for no reason at all. The pain is deep inside my left thigh and lower leg. I need to take ibuprophen to decrease the discomfort.
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| 55 | 2021-03-02 | weakness |
Patient received vaccination. Approximately 12 minutes following vaccination, patient complained of ...
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Patient received vaccination. Approximately 12 minutes following vaccination, patient complained of shortness of breath, chest pain, and weakness. Had some burning in the left, upper chest. Vital signs were stable throughout episode. EMS onsite. Baseline EKG normal. Patient requested transport to ED. Transported via EMS.
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| 55 | 2021-03-02 | feeling jittery | Spiked blood pressure 187/157. Rapid pounding heart heaviness in chest nausea jittery dizziness |
| 55 | 2021-03-04 | migraine |
March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, na...
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March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes. March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine
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| 55 | 2021-03-04 | pain in extremity | None. Just sore arm. |
| 55 | 2021-03-04 | tingling |
I have called and reported this, I was told to do this by Vaers after reporting it. My first shot...
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I have called and reported this, I was told to do this by Vaers after reporting it. My first shot was on 12/22/20 -was nauseous and sick with cold chills, body ache and pain, slight fever at night, next day felt like a truck hit me, total body aches, some restless leg syndrome, fatigue and joint pain lasting almost 2 weeks second shot was 1/11/21. I told them that I had a reaction to the shot, was feeling better that day, and was told it would be ok to get second shot. so I did, I am under doctors care, severe restless leg syndrome, joint pain, fatigue, pain shooting down legs and arms. at times feels like pins inside me. blood work every 2 weeks some in between. low WBC. Has gone up. on steroids and anti antiflamitory meds that are not helping. stay awake from pain that wakes me up. problems are not getting better.
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| 55 | 2021-03-05 | pain in extremity, tremor |
Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congesti...
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Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congestion, headache, earache
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| 55 | 2021-03-05 | pain in extremity |
Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Inc...
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Extreme pain in right arm, worst in arm pit. Lymph nodes area. Started 25hrs after injection. Including fever. Fever gone in 12 hours. Lymph node pain and swelling continues including bruising under right arm. Left arm swelling very minimal but right nodes continue to get worse 3 days in. Today
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| 55 | 2021-03-06 | numbness, tingling | Feet and leg hands arms back. Pins and needles numb |
| 55 | 2021-03-07 | inability to speak |
Immediately after IM injection, patient stated she had a funny taste and reported lips felt like the...
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Immediately after IM injection, patient stated she had a funny taste and reported lips felt like they were tingling. Patient then began having difficulty breathing with throat swelling. Patient was unable to swallow and had difficulty speaking. Epinephrine was administered and EMS was notified. Patient improved after epinephrine administration and was transported by EMS to hospital.
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| 55 | 2021-03-07 | numbness, tingling |
C/o tingling left arm/shoulder 15 minutes after injection. Then increased tightening left side neck ...
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C/o tingling left arm/shoulder 15 minutes after injection. Then increased tightening left side neck and numbness of neck and jaw with extension from her ear to nose. Felt some tightening of chest on 3/4/21 at noon. took benadryl. Majority of numbness subsided on Friday 3/5 however still having numbness at hairline on opposite side of face.
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| 55 | 2021-03-08 | flushing |
headache/nausea/flushing/chest tightness/paroxysmal breathing within 5 minutes of vaccine administra...
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headache/nausea/flushing/chest tightness/paroxysmal breathing within 5 minutes of vaccine administration
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| 55 | 2021-03-08 | numbness, tingling |
Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseate...
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Thirty hours in, I had joint aches in my spine (mainly neck and low back); low grade fever; nauseated; headache. I felt like everything was it was swollen and tight - I couldn't wear my watch on my wrist. Almost like lymph system - nothing tight in my arm pits; felt like my pants were too tight in my groin - my body was swollen by my lymph nodes. Developed all kinds of gas in my stomach. I was having chest pains - 3 or 4 times a month before the vaccine - after the vaccine - I'm having the chest pains daily. That lasted for about 12 hours. Next day, 22nd, I developed diarrhea for 24 hours. 9 days later - I got numbness and tingling started radiating down my wrist into my fingers; lower calf to my feet and I had to go see my orthopedic surgeon - it was radiating down into my feet. He sent me to a podiatrist and he doesn't know. Those symptoms still haven't resolved. When I wake up - it's a low level and by night time my feet would get so numb and tingly it drove me crazy and then it went into my hands. Went to my doctor on March 2nd - my doctor thought I was having a histamine response in my body. I took an antihistamine - and half my symptoms went away. My esophagus is going into spasms - and I am trying to see a GI specialist. I was taking Benadryl last week but I got too tired. So I take 2 Benadryl at night now and I'm taking a Zyrtec (generic) at the day - it takes the edge off but doesn't resolve the symptoms entirely. Eleven day - I developed a floaty in my right eye - a black spot. I went to my eye doctor - it looks like my eye is healthy -but floaty is not going away. So talking on the phone, My throat is starting to swell up and feels like something back there and the more I talk pretty soon I start losing my voice (happening now on the phone). They added to my meds: Pepsid, Viscus lidocaine; Mylanta after every meal; Pantoprazole; Sucralfate; gave me another one but I haven't taken it yet: Hyoscyamine - for really bad spasms and I haven't had another really bad one since I went to ER (besides taking the antihistamines). I have seen 5 specialists all together.
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| 55 | 2021-03-08 | tenderness | Quarter size lump, redness , rash. Inflammation, painful if pressure placed on area. |
| 55 | 2021-03-09 | pain in extremity, tingling |
Shot was given approximately at 4:50. I left the store after being watched at 5:15. Went to pick u...
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Shot was given approximately at 4:50. I left the store after being watched at 5:15. Went to pick up food for supper. While waiting for the food, I was seeing spots (like when you have a photo taken with a flash). This lasted for about 20 minutes. This went away so I continued on my way home. As I was driving I notice that my face was tingling and my eyes seemed to be really dry. Both lasted about 30 minutes. Then I had the headache, arm soreness and light headedness that are "normal" side effects.
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| 55 | 2021-03-09 | pain in extremity |
Soreness of arm, low-grade fever, chills, body aches, sore throat started around 8 AM the day after ...
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Soreness of arm, low-grade fever, chills, body aches, sore throat started around 8 AM the day after the vaccine. Felt progressively worse throughout the day. Took ibuprofen, slept and after a several hours started feeling better. Day #2 felt fine; asymptomatic Day #3 felt tired, slight headache Day #4 normal
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| 55 | 2021-03-09 | pain in extremity |
1st injection (1/7/21)-12 hours later ( approx 3 a.m.) felt achy, fever up to 102.7degrees, sore arm...
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1st injection (1/7/21)-12 hours later ( approx 3 a.m.) felt achy, fever up to 102.7degrees, sore arm, fatigue and headache. Took tylenol several time through the day and fever resolved approx 7pm on 1/8/21. Approx 11:00pm that day I woke up dizzy and felt chest heaviness, but went back to sleep. Woke up again after midnight and sat up in bed and felt like I was falling out of the bed (extremely dizzy) and decided to check my oxygen level due to me having prn shortness of breath since contacting covid in July 2020 and noticed that my heart rate was 186 bpm. Went to ER and MD was told that I had a covid shot the she wasn't sure if that what caused the SVT and could not tell me if I should or shouldn't take injection #2. Injection #2-(1/29/21) 4 hours after taking this injection started with low grade temp, sore arm and achy all over and noticed my heartrate was in the 120's. Woke up next morning temp was 103.0. Took tylenol troughout day and that day. Heart rate was in the upper 150's. I did not go to the ER. The next day heart rate continues 140-150.
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| 55 | 2021-03-09 | pain in extremity |
rash/Rash is about 6 " below injection site; Large hot itchy welts; Large hot itchy welts; Large hot...
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rash/Rash is about 6 " below injection site; Large hot itchy welts; Large hot itchy welts; Large hot itchy welts/warmth; injection site has small bruise; arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 55-years-oldnon-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL9263, via an unspecified route of administration from 06Feb2021 12:00 (at the age of 55 years old) as a SINGLE DOSE in the left arm for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing, supraventricular tachycardia (SVT) from an unknown date and unknown if ongoing. The patient did not have allergies. Concomitant medication included metoprolol, ibuprofen, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]). The patient did not receive other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 12:00, the patient experienced large hot itchy welts. Turned into one large spot. Approximately 4 inches around. Rash began appearing about 2 hours after injection (06Feb2021 14:00). Rash is about 6 " below injection site. Actual injection site has small bruise from 06Feb2021 12:00, and arm is very sore from 06Feb2021 12:00. Rash and warmth still present after 24 hours. No treatment was received for the events. Outcome of large hot itchy welts, injection site has small bruise, Large hot itchy welts/warmth, arm is very sore, rash/Rash is about 6 " below injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 55 | 2021-03-09 | tingling |
I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started ...
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I received the shot in the left arm. Sat for 15 minutes with staff and felt perfectly fine. Started to drive home and in 5 minutes began to feel tingling in mouth, tongue, lips face and itching in throat. Kept checking lips and tongue to see if they were swelling, (which they were not). Event lasted about 15-20 minutes and then subsided after 40 minutes. Itching in throat lasted 24 hours. Whole body felt itchy the next few days.
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| 55 | 2021-03-10 | weakness |
extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chil...
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extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-03-10 | pain in extremity, migraine |
Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, h...
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Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, had chills , and malaise , 2nd dose had more chills fatigue , GI upset , nausea , swelling at site of injection , arm pain couple of small hives on arm no lip swelling with second dose and migranous headache . Was not as bad as prior reactions to flu vaccine but enough to not feel well enough to go in to work Monday . Was able to go to work Tues though after Sat appt .
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| 55 | 2021-03-10 | pain in extremity | I had a severe headache, sore arm, fatigue and overall malaise for two days. |
| 55 | 2021-03-10 | pain in extremity |
Second morning after vaccination I had an 8 cm round, red, warm, rash at the injection site on my r...
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Second morning after vaccination I had an 8 cm round, red, warm, rash at the injection site on my right arm with pain which slowly resolved over a period of days. I also had fatigue and chills without fever for approximately 24 hours. Now, two months later, I have significant atrophy of the soft tissues/muscle of my arm at the injection site directly beneath the area of the red rash. I have not seen this atrophy in any discussion of delayed reactions. No other symptoms. I have photos of the arm from January 7 and March 11, 2021.
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| 55 | 2021-03-10 | tingling, numbness |
Having tingling on the left side of my face and left leg. Feels like my leg is asleep. My face feel...
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Having tingling on the left side of my face and left leg. Feels like my leg is asleep. My face feels like after you go to the dentist and the numbing is going away. It has gotten better but still having some numbness under my left eye and inside my left nostril.
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| 55 | 2021-03-11 | weakness, pain in extremity |
Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt...
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Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt like the Flu, and would not describe as mild. Symtoms began the evening after the shot. Fever gone but still unusually tired as of 3/12/2021 at 4:00 pm. Missed 3 days of work.
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| 55 | 2021-03-11 | migraine |
After my second dose vaccine, I experienced headaches along with nausea. No vomiting. Headaches beca...
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After my second dose vaccine, I experienced headaches along with nausea. No vomiting. Headaches became migraines and I went to my doctor's office because my headaches were getting worse and I had started to throw up. I also had body aches, nausea and vomiting which lasted three das. My doctor prescribe anti nausea medications, prescribe Zofran, gave me sleeping medicine as well as a Toradol medication. I also received my first dose injection, lot#: EH9899 on 12-18-2020 at 8am. I developed headaches for two hours, little bit of nausea for 45 min and had a sore arm.
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| 55 | 2021-03-11 | pain in extremity |
arm was sore & headache right away, half hour later felt very tired, 3 hours later my heart starti...
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arm was sore & headache right away, half hour later felt very tired, 3 hours later my heart starting racing & my throat felt swollen I didn't seek medical treatment because I have an epi pen in my house ( i have a granddaughter allergic to peanuts) I went to bed, woke up around 4am heart racing & swollen throat were gone
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| 55 | 2021-03-12 | numbness |
Patient received their first Pfizer Covid vaccine in the left arm and she reported numbness in her...
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Patient received their first Pfizer Covid vaccine in the left arm and she reported numbness in her face and left side. Patient was advised to go into urgent care or the ER.
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| 55 | 2021-03-13 | muscle spasms, feeling hot |
Patient reported sudden onset of muscle spasms to her left neck and trapezius. Reports neck feels ho...
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Patient reported sudden onset of muscle spasms to her left neck and trapezius. Reports neck feels hot. Reported feeling lightheaded.
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| 55 | 2021-03-14 | burning sensation |
About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness...
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About 5 minutes after injection I had stiffness in right hand and neck and shoulders. The stiffness started to go away at 20 minutes later. 15 minutes after I left test site (35 minutes after injections, my tongue, lips, and face started swelling and had trouble swallowing an hour later). I ate a frozen popsicle and the swelling in tongue and lips started to go down. Hours later I took my blood pressure medicine (Lisinopril) I started to have tightness in face and jaw area, burning sensations in ears, jaws and back of my head and headaches. I contacted health care provider after hours number. They scheduled a video appointment with doctor. The doctor advised me not to take blood pressure and any other medications for another day and to put warm compressor on shoulders to relieve some of the tightness in jaws. I was also advised to call 911 or immediately come to healthcare facility if swelling re-occurred. A follow up appointment with primary care provider is scheduled on 3/17/21. I do not have any symptoms at the time of this report, March 15, 2021 at 1:23 pm.
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| 55 | 2021-03-14 | feeling cold, weakness |
Feeling weak and tired/achy about 12 hours after shot; woke up in the morning and went to work but c...
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Feeling weak and tired/achy about 12 hours after shot; woke up in the morning and went to work but couldn't get warm - cold & chilled all day, headache, muscle & joint achiness; took Tylenol for achiness and headache, felt better about 48 hours after shot, but still feel a bit "off" 4 days after shot
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| 55 | 2021-03-14 | grand mal seizure |
tonic-clonic seizure Patient has a history of seizure disorders, dissociative convulsions, and head ...
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tonic-clonic seizure Patient has a history of seizure disorders, dissociative convulsions, and head trauma.
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| 55 | 2021-03-14 | pain in extremity |
Left arm pain day after injection followed by left arm pit swelling of gland with pain, low grade fe...
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Left arm pain day after injection followed by left arm pit swelling of gland with pain, low grade fever,headache.
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| 55 | 2021-03-14 | tingling | Tingling stinging in hands after second shot Trouble breathing since second dose |
| 55 | 2021-03-15 | facial pain, tenderness |
Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore ...
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Day 1 and 2- very tired Day 3- bruised, very tender, slightly painful feeling in left temple. Sore when biting down on anything, slightly throbbing otherwise. Day 4- soreness in temple subsiding
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| 55 | 2021-03-15 | feeling hot, discomfort |
Shortly after leaving, the patient said that she began to feel very warm; she also said that her thr...
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Shortly after leaving, the patient said that she began to feel very warm; she also said that her throat felt itchy. She went to the store to buy some medication, but then noticed that she was diaphoretic, and she had pressure in her upper chest and neck. She presented to the ER with these symptoms.
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| 55 | 2021-03-15 | numbness, burning sensation, discomfort |
Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on t...
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Shortly after being vaccinated, I felt a burning sensation down my left arm, heaviness and pain on the back of my neck and head, and numbness in my face around my checks, nose, and mouth area. These side effects continued for the next 24 hours along with headache, body aches, tiredness, dizziness, and nausea. I took Tylenol and rested for the first 24 hours, which helped and the side effects subsided. After 24 hours, I still felt tiredness, dizziness, nausea, and tingling/numbness on my left side of my mouth.
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| 55 | 2021-03-15 | numbness | Numbness in arm, fainting, nausea for a thirty minute period. Treated in emergency room for nausea |
| 55 | 2021-03-15 | muscle spasms |
Sleeping 1 full day after vaccine tiredness, Back Pain and spasms for 4 days, Headache for 1 day, ...
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Sleeping 1 full day after vaccine tiredness, Back Pain and spasms for 4 days, Headache for 1 day, Vivid Dreams, feeling out of it, increased pulse 110, increased blood pressure 160/80 not a hypertensive patient, dizziness and light headedness. Increase vitals day 2 Back pain started late in the 2nd day and ended on 3/16.
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| 55 | 2021-03-16 | feeling hot, flushing |
After sitting for the required 15 minutes, stood up and felt light headed and fuzzy. Waited for it t...
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After sitting for the required 15 minutes, stood up and felt light headed and fuzzy. Waited for it to pass and walked to car. Sat in car for a few minutes, drank some water and had a few bites of a protein bar. Felt hot, flushed, broke out in an all over sweat. Waited about 5 minutes, continued to sip water and nibble on protein bar. It eventually passed. On and off headache for next couple of hours. Only some injection sight tenderness since then.
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| 55 | 2021-03-16 | flushing |
Three days after receiving vaccination I became extremely nauseous, had facial flushing and spikes i...
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Three days after receiving vaccination I became extremely nauseous, had facial flushing and spikes in blood pressure. This has continued for four additional days. Visited doctors office on third day of sickness. Was given promethazine for nausea.
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| 55 | 2021-03-16 | numbness | redness of the face and numbness of her face for couple of mins |
| 55 | 2021-03-16 | pain in extremity |
I?m suffering from right arm pain that began a week after my first injection. I?m currently in a lot...
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I?m suffering from right arm pain that began a week after my first injection. I?m currently in a lot of pain, unable to use my arm. I?m taking Aleve and Tylenol intermittently.
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| 55 | 2021-03-17 | hot flush |
Pt reported palpitations and feeling flushed , as well as vertigo. Symptoms resolved within 5-10 m...
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Pt reported palpitations and feeling flushed , as well as vertigo. Symptoms resolved within 5-10 minutes with rest. No uticaria, dyspnea, weakness. Pt departed after 15 additional minutes
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| 55 | 2021-03-17 | night sweats |
pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain inte...
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pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe/lower lumbar pain; dull headaches; Some night sweats; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265) on left arm intramuscularly from 28Jan2021 15:00 (03:00 PM) at single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), allergies to trees, pollen, grasses and latex. Concomitant medication included omeprazole (PRILOSEC), sucralfate (CARAFATE), sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , minerals nos/ vitamins nos (OPTISOURCE CHEWABLE VITAMIN & MINERAL SUPPLEMENT). There was no other vaccine in four weeks. The patient historical vaccine included bnt162b2 (lot number: EL1284) for first dose on 04Jan2021, 03:00 PM, Intramuscularly, left arm, for covid-19 immunisation. The patient previously took metoclopramide (REGLAN), pethidine hydrochloride (DEMEROL) and hydrochlorothiazide (HCTZ) and all had allergies. On 29Jan2021, 02:00 AM, 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe it caused me to pass out. In Jan 2021, 20 hours to 48 hours post injection continued to have dull headaches and lower lumbar pain achy at this point. Some night sweats. The vaccination facility type is hospital. There was no covid prior vaccination and covid tested post vaccination. There was no treatment for the events. The events were not result in emergency room visit or physician office visit. The outcome the events recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the event back pain and loss of consciousness are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-03-17 | pain in extremity |
Swelling and painful/stinging lips. No immediate reaction, sore arm and a little fluish the next d...
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Swelling and painful/stinging lips. No immediate reaction, sore arm and a little fluish the next day
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| 55 | 2021-03-17 | tingling, numbness, pain in extremity |
right arm felt like needles and sensitive to the touch; all joints hurt more than usual; difficult t...
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right arm felt like needles and sensitive to the touch; all joints hurt more than usual; difficult to concentrate; The right arm felt a little dormant with a little tiredness and pain; The right arm felt a little dormant with a little tiredness and pain; This is a spontaneous report from a contactable female consumer reported for herself. A 55-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EN5318) in left arm 14:15 on 17Feb2021 for Covid-19 immunization. The patient had her first injection (lot number EN5318) in left arm 2:15PM on 27Jan2021. The patient had a history of some age related arthritis and had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had not received other medications within 2 weeks of vaccination. The vaccine was applied in the left arm, close to shoulder. About one hour later, the right arm felt a little dormant with a little tiredness and pain. 18 hours later the right arm felt like needles and sensitive to the touch. Additionally, all joints hurt more than usual and it was difficult to concentrate. No headache nor fever. After 48 hours patient felt normal. No Tylenol was taken. No treatment was received for the events. The patient had recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered all events were non-serious.
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| 55 | 2021-03-18 | flushing |
Pt received vaccine and reported feeling flush and shaky. Pt was escorted via wheelchair from a vacc...
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Pt received vaccine and reported feeling flush and shaky. Pt was escorted via wheelchair from a vaccination pod to an observation unit where she was observed and monitored for +30 minutes. Vitals were 114/74, O2 94%, HR 80. Pt reported using albuterol as a rescue inhaler and G Breo regularly. Pt verified symptoms had subsided and was escorted via wheelchair from the premise.
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| 55 | 2021-03-18 | pain in extremity, migraine |
Migraine headaches, fever of 100.8, severe body aches, severe body chills, left upper arm swollen an...
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Migraine headaches, fever of 100.8, severe body aches, severe body chills, left upper arm swollen and major pain in whole arm, sneezing and severe running nose and nauseated really bad
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| 55 | 2021-03-18 | tingling, pain in extremity, numbness |
Just after the dose was injected, my face become numbing and I felt tingling sensation. Right after...
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Just after the dose was injected, my face become numbing and I felt tingling sensation. Right after this it was very hard to swallow and breath. This last around 25 minutes. Then my muscles in my legs got numb. Pain in the left arm. After 22 hours my face is still partially numb.
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| 55 | 2021-03-18 | tingling | Lightheadedness, dizziness, tingling in toes and fingers, and headache. |
| 55 | 2021-03-19 | night sweats |
With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pai...
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With 24 hours pain at site of injection that traveled through shoulders and neck. Severe neck pain/swollen glands/- 2 days later pain traveled to mouth and throat- on day 5 in the evening starting run a fever with severe night sweats/Chills/no appetite/fatigue . I have never experienced this feeling before --- the amount of sweat coming out of my body was like a demon was being released. I felt these severe symptoms for about 4 days . One week later from onset of night sweats/c hills/ fatigue I still have these symptoms but not as severe.
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| 55 | 2021-03-20 | burning sensation, flushing |
A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in...
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A metallic taste and burning sensation in mouth was noted; A metallic taste and burning sensation in mouth was noted; intense flushing and burning sensation from my waist up, mostly in the chest, developed; intense flushing and burning sensation from my waist up, mostly in the chest, developed; increase in heart rate, but no tachycardia; elevation of blood pressure; This is a spontaneous report from a contactable 55-year-old female physician reported for herself. A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,Lot number: FM 9809) on her right arm intramuscularly on 09Feb2021 (at the age of 55-years-old ) at single dose for covid-19 immunisation.Medical history included HBP, RA, Hyperlipidemia. Allergies to medications included NSAID'S. Other medications which patient received within 2 weeks of vaccination included Irbesartan 150mg, Toprol 100mg XL, Plaquenil 200mg, Simvastatin 10mg, Folic Acid 1mg, Methotrexate 15mg sq weekly. On 09Feb2021 14.15 it was reported that less than one minute after receiving the vaccine, a metallic taste and burning sensation in mouth was noted , and then an intense flushing and burning sensation from her waist up, mostly in the chest, developed. There was some increase in heart rate, but no tachycardia, no skin and/or respiratory manifestations. There was mild elevation of blood pressure. The symptoms resolved without any medication and lasted about 10 -15 minutes. No more symptoms or complaints thereafter. The events were considered as non-serious by reporter. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.No treatment received for events. The outcome of the events was reovered.
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| 55 | 2021-03-20 | tremor |
pt got light headed and took a tumble after the 15 minute weight, stated she felt light headed and d...
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pt got light headed and took a tumble after the 15 minute weight, stated she felt light headed and dizzy. after recovering from the light headedness she stood up and complained of chest tightness and difficulty breathing, ems stated blood pressure increased and heart rate as well. she complained of a shakey feeling. she was sent on ambulance to the hospital after 45 minutes in EMS tent.
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| 55 | 2021-03-21 | weakness, pain in extremity |
Friday afternoon: left arm started getting sore. by Friday evening developed pounding headache, comp...
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Friday afternoon: left arm started getting sore. by Friday evening developed pounding headache, complete body aches, fever through out the night. took Tylenol around 3 am Saturday morning. Saturday: chills, headache, feverish, and weakness. By Midnight was feeling better. Sunday 3/21/2021 back to normal self
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| 55 | 2021-03-21 | pain in extremity, hot flush |
On 3/21/21 - 30 minutes after the shot I developed a bad headache. Took Tylenol. 3/22/21 - At 1:...
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On 3/21/21 - 30 minutes after the shot I developed a bad headache. Took Tylenol. 3/22/21 - At 1:30 AM body aches, legs and feet throbbing. Left-arm very painful. Intense headache. 4:00 AM chills and severe pain in my limbs. Limbs felt heavy. 12:00PM soaked feet in Epsom Salt for pain relief. 1:15 PM felt queasy then had diarrhea. Afterwards, nn my way upstairs legs felt heavy, flash of heat in my head and almost fainted. Been in bed and symptoms have not subsided. Still taking Tylenol.
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| 55 | 2021-03-21 | tingling |
1615- complained of feeling nauseated, tingling fingers, BP-176/135, p-91, O2 sat- 98%, patient wi...
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1615- complained of feeling nauseated, tingling fingers, BP-176/135, p-91, O2 sat- 98%, patient with small amount clear emesis given Zofran 4 mg SL 1626- BP- 173/95, p-84, O2 sat- 96% 1644- p-77, BP-164/94, O 2 sat- 97% Feeling better, no further nausea, no further dizziness Home with family members with instructions to seek immediate care if any shortness of breath, trouble swallowing, swelling of lips, tongue or mouth
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| 55 | 2021-03-22 | breast pain | Sharp pains in left armpit/upper breast and now sore and painful especially to the touch. |
| 55 | 2021-03-22 | difficulty speaking, flushing |
- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors ...
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- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors and ID team discussed risks of COVID vaccine and determined low risk due to no similar components between flu vaccine and COVID vaccine - Pt received first dose of COVID vaccine today (3/22/21) around 1230 - Within 10 minutes of injection, pt felt nauseous and was flush. She was given a drink and snack, monitored for 30 minutes, and felt better ? went back to work upstairs - 4 hours post injection (~1630) pt came to ED - itchy throat, hoarseness, urge to clear her throat, chest heaviness - In ED, pt has received methylprednisolone 125 mg, famotidine 20 mg, diphenhydramine 25 mg, duonebs, epinephrine 0.3 mg IM, and fluids with improvement. - Pt is being admitted for further monitoring
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| 55 | 2021-03-22 | flushing |
Patient received vaccine at CVS. With in 5 min developed flushing. Patient given Benadryl and epi at...
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Patient received vaccine at CVS. With in 5 min developed flushing. Patient given Benadryl and epi at CVS, transported to ER. Patient develops difficulty swallowing and a rash, monitored and Evaluated. D/C home with PO prednisone.
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| 55 | 2021-03-22 | numbness |
After about 40 minutes post-vaccination in my left arm, I experienced some numbness on left side of ...
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After about 40 minutes post-vaccination in my left arm, I experienced some numbness on left side of my chin/cheek and general nausea. The numbness proceeded up the left side of my face w/no visible drooping, and also included my left arm, left leg and left side of my tongue. Numbness level was like what it feels like as dental novocaine wears off. Went to ER and had CT scan, bloodwork, and an MRI which ruled out any stroke concerns. Monday, day after vaccine, I was tired (understandably since in the ER until 4 AM Monday) and had some residual numbness, mostly on my face, some on my arm/leg. Nausea went away after an hour or so on Sunday afternoon and I ate variety of food w/no issues on Sunday and forward. Still have some of the numbness sensations as of Tuesday, mostly feel it in my face. Overall, it feels like half my body got the vaccine and the other half wasn't impacted.
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| 55 | 2021-03-22 | pain in extremity | face swelling, rash on cheeks, eyes,nose, sore arm, |
| 55 | 2021-03-22 | tremor | shaking. Evaluated by EMS-Cleared |
| 55 | 2021-03-23 | numbness | Numbness and swelling in left cheek and under chin, feeling faint. |
| 55 | 2021-03-23 | migraine |
I started feeling extremely tired about 5 hours after the 1st does of Pfizer vaccine (have not had a...
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I started feeling extremely tired about 5 hours after the 1st does of Pfizer vaccine (have not had any soreness at injection site at all). Other symptoms presented themselves much later: Headache/Migraine onset at approximately 4:30am (15 hrs post vaccination) that lasted for about 6 hours, treated with Advil and strong coffee. Chills set in at approximately 9:30am (20 hrs post vaccination) and lasted for about 3 hours then dissipated. As of 1:30pm on 24 March (24 hrs post vaccination) all symptoms are no longer present.
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| 55 | 2021-03-23 | tenderness, breast pain |
3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around...
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3/22/21: Pain and swelling at injection site around 4p. Chills, nausea and extreme exhaustion around 5p. Just got in the bed to sleep off the symptoms about 6:15p. 3/23/21: Pain and swelling at injection site persisted. Also had pain under left arm that radiated to left breast, down left side, up the neck and upper left back as day progressed. Went to take a shower around 4:30p and noticed the lump/swelling under left arm, beside left breast. Area of the lump was tender to the touch. Went to Patient first to get checked out and was prescribed steroids to reduce the pain, swelling and inflammation.
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| 55 | 2021-03-24 | burning sensation, weakness |
Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensat...
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Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensation all over body, especially breast area. Patient has also blue spots on upper Thigh. Patient also complaining of weakness, body aches, and abdominal pain sometimes. Patient also today is complaining about head ache and feeling confused.
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| 55 | 2021-03-24 | cold sweat |
Patient developed headache, nausea, dizziness and clammy skin about 15 minutes after vaccination. Sh...
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Patient developed headache, nausea, dizziness and clammy skin about 15 minutes after vaccination. She was assessed by the RN; pulse was 85-95 bpm, and O2 saturation was 93% on room air (normal per patient). Patient reported increased headache pain to 8/10 and increased dizziness; she was taken to the emergency department.
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| 55 | 2021-03-24 | feeling hot |
Hotness in chest area and stomach, nausea, and headache, and anxiety feeling. Which lasted about 2 ...
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Hotness in chest area and stomach, nausea, and headache, and anxiety feeling. Which lasted about 2 hours but headache lasted until next day.
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| 55 | 2021-03-24 | flushing |
Patient has a recent history of breast cancer on chemo and radiation. After 1st dose had allergic re...
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Patient has a recent history of breast cancer on chemo and radiation. After 1st dose had allergic reaction was given epi and transported to ED. Patient pre medicated prior to arrival today, 40mg PO prednisone yesterday then 40mg PO prednisone & 50mg PO Benadryl today. Approx 7 mins after injection #2 tonight patient complained of shortness of breath, coughing with laryngeal spasm, flushed face. Vitals Bp 239/129 HR 126 Sats 96 RR26 MD on site requested to administer 0.3mg Epi IM and transfer to ED. Patient took own albuterol. At approximately 1721, administered IM EPI 0.3mg. Patient transported to ED at 1735.
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| 55 | 2021-03-24 | numbness, tingling |
Pt c/o numbness/tingling in arm. Assessment showed speech not slurred, equal grip bilaterally. Hig...
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Pt c/o numbness/tingling in arm. Assessment showed speech not slurred, equal grip bilaterally. High BP is abnormal for patient, but pt stated anxiety due to shot. Pt refused transport, advised to contact PCP if HTN, symptoms occurs
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| 55 | 2021-03-24 | muscle spasms |
After receiving 1st injection on 3/19/21, I develeoped severe back pain on 3/20/21. Pain started in...
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After receiving 1st injection on 3/19/21, I develeoped severe back pain on 3/20/21. Pain started in lower back and progressed to mid/upper back, sides and under front ribcage over the next 6 days. Muscle spasms accompanied back pain. I had a fever of 99.9 as well. Fever broke on 3/25/21 and pain has started to lessen somewhat on this date. This is by far the worst back pain I've ever experienced and was very strange in that it moved from lower to mid back over the course of 5 days. I've never had back spasms before.
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| 55 | 2021-03-24 | pain in extremity, numbness, tingling |
After receiving her vaccine client states she has tingling, numbness and pain in the arm she was vac...
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After receiving her vaccine client states she has tingling, numbness and pain in the arm she was vaccinated in. Vital signs obtained by EMS. BP 114/78, HR 88, 98% O2 sat. Client stated she feels better. Client discharged home.
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| 55 | 2021-03-25 | muscle spasms, migraine |
Joint pain swelling abdominal pain severe constipation, temporary obstipation, joint heat, chest pai...
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Joint pain swelling abdominal pain severe constipation, temporary obstipation, joint heat, chest pain, peripheral vascular prominence fatigue unilateral muscle cramp.back pain exacerbation and return of migraine headaches resolved after hysterectomy.
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| 55 | 2021-03-25 | pain in extremity |
Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach a...
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Having all kinds of trouble in walking; sick on my stomach and was throwing up; sick on my stomach and was throwing up; Pain; sick on my stomach and was throwing up; Headache; Hips, legs and neck is a little swelled; my hip down were pain; arm was very sore; could not move arm; arm was very sore; could not move arm; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received second dose of BNT162B2 (pfizer-biontech covid-19 vaccine, Formulation: solution for injection, lot number: EL3246; Expiration Date: 30Apr2021) via intramuscularly on right arm as single dose on 14Jan2021 for covid-19 immunisation. The patient received first dose on 24Dec2020 and she didn't have any reaction, no nothing. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient work at the hospital in the kitchen and don't have any health issues before, none. Laboratory data included, Multiple blood work, 3 MRIs, Chest X-ray, EKG, EMG. On 15Jan2021, after receiving second dose patient stated, it's been almost a month, she had all kinds of trouble, in walking, hips, legs and neck is a little swelled. she had a major headache the last four days, her arm was very sore, she was sick on her stomach, she was throwing up. The next day she could hardly walk. She used a walker. She was out of work and did physical therapy, from her hip down were pain and was hard to walk and it spend like that for a month now and it's now 17Feb2021. Patient hospitalized cause she couldn't walk. She spent six days in a hospital (28Jan2021 to 3Feb2021), they are not sure if it is related to that. They are not even sure what's going on. They can't tell what's wrong. Patient started the treatment with "Gabapentin-300 mg, twice a day, still taking, start date: Consumer stated, " she don't remember. Acetaminophen-codeine 3-1 tab every 6 hours as needed, still taking, start date: Consumer stated, "Last week, I don't know." She was just wondering why she had all these side effects. The outcome of the event she was sick on her stomach was unknown and all of the event was not recovered.
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| 55 | 2021-03-25 | pain in extremity | very sore arm for four days and fever, headache and body aches on second night |
| 55 | 2021-03-25 | pain in extremity |
muscle pain; joint pain; I could barely walk; Temperature increased slightly; sweating; soreness in ...
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muscle pain; joint pain; I could barely walk; Temperature increased slightly; sweating; soreness in the arm; Headache; Tiredness; chills; This is a spontaneous report from a contactable consumer. A 55-year-old female patient (non-pregnant) received first dose of BNT162B2 (lot number El9267), via an unspecified route of administration on left arm on 14Feb2021 at 13:00 at the age of 55 year old at a single dose for COVID-19 immunisation at hospital. Medical history included thyroid problems and hypertension. No Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (LEVOXYL) and lisinopril. The patient received other medications within 2 weeks of vaccination. On 07Feb2021 at 16:00, the patient experienced soreness in the arm, headache, tiredness, chills, on 08Feb2021, the next morning with severe soreness in the arm, very severe muscle and joint pain and could barely walk. On 08Feb2021, temperature increased slightly. Chills and sweating. It felt worse than the flu! This morning feeling better, still weak but better. Patient did take Alene to help with the muscle pain, soreness and could barely walk. Seriousness of all the events was reported as non-serious. No treatment was received in response to the adverse events temperature increased slightly, headache, tiredness, chills, joint pain and sweating. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from all the events.
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| 55 | 2021-03-25 | pain in extremity |
I woke up with extreme pain and swelling at the base of my left big toe and the ball of my left foot...
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I woke up with extreme pain and swelling at the base of my left big toe and the ball of my left foot. I suspect it was a gout attack. I've had attacks like this before, followed by bloodwork which did NOT show elevated uric acid levels, so I've been told it's arthritis, not gout. I still think it's arthritis. The swelling/pain has made it difficult to walk, but it's decreasing in intensity as the days pass. I've been taking ibuprofen regularly since the onset of symptoms and discontinued use of HCTZ and potassium supplements..
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| 55 | 2021-03-25 | speech disorder, difficulty speaking, tingling |
pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started...
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pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started feeling a little prickly and she developed rash on her extremities and upper chest. She started having trouble speaking, her voice got hoarse and she started coughing. She had an intense headache, fatigue and could barely speak. She was taken to the UrgentCare . She was given EPI pen and steroids injections. Paramedics were called and she was taken to a hospital, where she was monitored after getting those injections and given Pepcid and IV fluids. She was diagnosed w/ Anaphylaxis from adverse reaction to vaccine. She discharged and sent home to FU w/PCP. Her appt w/ her PCP on 3/25/2021 she was taken next door by wheelchair to all allergist Dr. She noticed that her respiratory symptoms were improving while she was there as her Pepcid medication was wearing off. Pt is convinced that she is allergic to the ingredient Polyethylene Glycol. She is still taking prednisone medication and continuing to improve.
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| 55 | 2021-03-26 | inability to speak |
POSSIBLE ANAPHYLAXIS, DIFFICULTY SWALLOWING, BREATHING, THEN SPEAKING. 911 CALLED. TRANSPORTED VIA E...
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POSSIBLE ANAPHYLAXIS, DIFFICULTY SWALLOWING, BREATHING, THEN SPEAKING. 911 CALLED. TRANSPORTED VIA EMS
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| 55 | 2021-03-26 | difficulty speaking |
Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal...
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Hoarseness, trouble swollowing. Sudden hypertension about 35 minutes after vaccine. Immediate metal taste at time of vaccine.
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| 55 | 2021-03-26 | flushing |
0810- C/O FAST HEART RATE, FLUSHING, FEELING, LAST 3-5 MIN. 0815 S/S EXCEPT A HEADACHE IN TH BACK O...
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0810- C/O FAST HEART RATE, FLUSHING, FEELING, LAST 3-5 MIN. 0815 S/S EXCEPT A HEADACHE IN TH BACK OF THE HEAD. PT STATED A HISTORY OF GETTING H/A. MONITORING V.S. WATER OFFERED REFUSED HAD BREAKFAST. 0810-02 SAT 99% 0812 HR 68 0815 BP 142/82-SAT 99% RR 20 HR 65 0824 99% RR 20 HR 67 0825 BP- 112/78 RR 16 Patient felt well enough to leave
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| 55 | 2021-03-27 | migraine, muscle spasms |
3/27 Awoke at 1 am with muscle ache & cramps in legs. Shoulder was stiff., could not sleep due to p...
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3/27 Awoke at 1 am with muscle ache & cramps in legs. Shoulder was stiff., could not sleep due to pain. Around 5 am 101 fever, body aches, sick to stomach, migraine headache. 3/28 fever is gone , muscle pain gone, migraine more like a bad headache now..
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| 55 | 2021-03-27 | muscle spasms |
My reaction to the vaccine is the same way I felt when I had Covid back in December but with a new s...
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My reaction to the vaccine is the same way I felt when I had Covid back in December but with a new symptom. I am experiencing bad head aches, severe body aches, fever, nauseous,. This time with the vaccine I'm having severe spasms on my leg, arms and back to the point that I can't even touch it . I feel worse than I did when I was going through Covid. This is my 2nd day and I'm still feeling terrible.
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| 55 | 2021-03-29 | tingling, muscle twitching |
feeling dizzy; tingling sensation and twitching sensation that comes and goes; tingling sensation an...
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feeling dizzy; tingling sensation and twitching sensation that comes and goes; tingling sensation and twitching sensation that comes and goes; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, lot number and Expiration date were not provided) on 04Mar2021 (also reported as 16 days ago) via unspecified route of administration at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021 (also reported as last night) the patient experienced feeling dizzy and a tingling sensation and twitching sensation that comes and goes. There was side effect mentioned. There was no PQC present. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
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| 55 | 2021-03-30 | facial pain |
Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/...
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Significant pain following the trigeminal (CN5) nerve on right side (injection side); Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; Jaw/tooth/gum/cheek pain; sensitive to pressure/heat/cold both upper and lower jaw; This is a spontaneous report from a 55-Year-Old non- pregnant female contactable Other Health Professional reported for herself that she received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 EUA, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 28Jan2021 (age at vaccination: 55 years) at 17:45 at single dose in right arm for covid-19 immunization. The patient's medical history included high cholesterol, Obesity, high blood pressure and known allergies: contrast dye. Concomitant medications included Simvastatin, Lisinopril, Aspirin 81, and Fish oil. On 28Jan2021 at 22:00, the patient experienced significant pain following the trigeminal (CN5) nerve on right side (injection side), Jaw/tooth/gum/cheek pain and sensitive to pressure/heat/cold both upper and lower jaw. The patient did not take any treatment for the events. The outcome of the events was not recovered Information on Lot/Batch number has been requested.
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| 55 | 2021-03-30 | pain in extremity, numbness, nerve pain, hot flush |
Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe nec...
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Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
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| 55 | 2021-03-30 | pain in extremity |
Head ache; arm pain; This is a spontaneous report from a contactable consumer or other non hcp (pati...
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Head ache; arm pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL92962, expiration date not reported), via an unspecified route of administration, administered on the left arm on 27Jan2021 12:15 (at the age of 55-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine (manufacturer unknown) taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Health Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced head ache and arm pain on 27Jan2021 16:45. Events were assessed as non-serious. Treatment was not received for the events.The outcome of events was recovering.
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| 55 | 2021-03-30 | tenderness |
I developed headaches; swelling of thyroid gland; tenderness; pain on swallowing; elevated TSH; low ...
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I developed headaches; swelling of thyroid gland; tenderness; pain on swallowing; elevated TSH; low T3,T4 levels; low T3,T4 levels; subacute thyroiditis; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142), via intramuscular route of administration on 23Dec2020 (age at vaccination: 55-years) at a single dose in the left arm for COVID-19 immunization. Medical history included Diabetes mellitus (DM) and Hypertension (HTN). Concomitant medications were not specified. The patient previously took codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 27Dec2020, the patient developed headaches, swelling of thyroid gland, tenderness, pain on swallowing, elevated TSH, low T3,T4 levels. Patient thought to have subacute thyroiditis. The events resulted to physician office visit. The patient did not receive any treatment for the reported events. The patient underwent nasal swab test on an unspecified date and showed negative result. The outcome of the events was recovered on an unspecified date.
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| 55 | 2021-04-01 | tingling, numbness, facial paralysis |
her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; al...
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her stomach was bothering her; her daughter told her the right side of her tongue looked swollen; allergic reaction to the COVID-19 Vaccine; heaviness with her headache; stroke; Facial droop; Numbness / left half of her face was numb /numbness in her left hand/numbness and tingling all over her body; Tingling; Tiredness; Pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old adult female received the first dose of BNT162b2 (solution for injection; Lot EN6202 and expiry information not provided) via unspecified route in the left arm on 03Mar2021 between 17:10 and 17:30 (at 55-years-old) for COVID-19 immunisation. Relevant medical history included Frozen shoulder (2020-2020), and severe migraines (especially in the past ten years). The patient further stated that she has always had migraines. She said sometimes when her migraines escalate, her blood pressure goes up, and her left side tingles. She said several times in the past, she thought her migraine symptoms may have been a stroke. She said she her doctor is checking her for any kind of things like rheumatoid arthritis, mast cells, constant (chronic) fatigue, and fibromyalgia. She said right before the COVID-19 Virus pandemic she had passed out unexpectedly. She said she doesn't know what caused her to pass out. She said she needs another neurological test done. She said she had a neurological test that maybe showed that veins were dying in her brain, but she wasn't sure. She said her doctor had been doing heart tests too, but because of the pandemic, it was taking longer to have the tests done. The patient also mentioned that her last blood work was probably in/around Nov2020. There were no concomitant medications or past drug history reported. The patient denied receiving any other vaccination within the four weeks prior to the vaccination. The patient also denied receiving any other vaccination on the same date as the vaccination. The patient reported that on 04Mar2021, approximately seventeen hours after she received the COVID-19 vaccine, she had what she thought was a kind of severe reaction. She said she had an inside numbness and tingling all over her body. She said the left side of her body, especially, had a very strong numbness and tingling, like a stroke. She said the numbness was in her left hand, and outside left shoulder. She said the left half of her face was numb. She said at the time she felt weird. She said she was speaking to her friend on a video call and did not want her friend to think she was a cry baby. She said then her friend told her there was something happening with her face. She said the right side of her face had dropped. She said her right eye and the right side of her mouth were drooping. She said she told her friend she thought she had an allergic reaction to the COVID-19 Vaccine. She said it took about three hours for her symptoms to pass. She said afterward she was so tired, had pain, and a headache. She said it was strange for her to have a headache because she was used to migraines. She said she still had a headache today (08Mar2021). She said she had a heaviness with her headache. She said if she had a migraine, she would not be able to do anything, but with the headache she had, she was able to go about her everyday things. She said her stomach was bothering her too, but she was not worried about how her stomach felt. The events did not require any visits to a physician's office nor the emergency room. Treatment for the events included drinking a lot of water and moving around. The outcome of the events, inside numbness and tingling all over her body, very strong numbness and tingling, like a stroke¸ numbness was in her left hand, and outside left shoulder, half of her face was numb, right side of her face had dropped, and tongue looked swollen, and allergic reaction to the COVID-19 Vaccine was recovered on 04Mar2021 after about three hours duration. The outcome of the events so tired, and pain was recovered on an unspecified date in Mar2021. The outcome of the events, headache, and heaviness with her headache was not recovered.
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| 55 | 2021-04-06 | nerve pain, tingling, numbness | Tingling, rapid fire sharp nerve pain, numbness through out body. |
| 55 | 2021-04-06 | pain in extremity |
could hardly breathe; Dizzy; Throat started to close; Headache; allergic reaction; pain in thighs; T...
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could hardly breathe; Dizzy; Throat started to close; Headache; allergic reaction; pain in thighs; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EP6955, expiry date: Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in Arm Left on 19Mar2021 09:00 AM (received at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included hypertension from Jan2015. Concomitant medication included ascorbic acid (VIT C, 1000 mg tablet) for immunity (help with the immune system to help fight against cold and those things), from Apr2020; fish oil (OMEGA 3 FISH OILS, 500 mg Capsule) for heart health, from 2019; vitamin d nos (VITAMIN D NOS, Gel) for immunity (help with the immune system to help fight against cold and those things), from Apr2020; tocopherol, ubidecarenone (COQ-10 ST, 200 mg Gel) taken to help with energy and cardiovascular health, from Apr2020; amlodipine (AMLODIPINE, 5 mg) taken for hypertension, from 2016; hydrochlorothiazide (HYDROCHLORZIDE, 12.5 mg) taken for hypertension, from 2017. The patient experienced could hardly breathe, dizzy, throat started to close, headache, allergic reaction on 19Mar2021. The patient stated that she took Pfizer covid vaccine first dose last Friday (19Mar2021) and ended up in the hospital. After taking the COVID Vaccine, she immediately had symptoms that started with being dizzy and her throat stated to close. She ended up with a headache. She also had to appoint because it was pretty consistent and pretty high, so she ended up at an ER. She added that her throat was closing, she could hardly breathe. She was able to walk and talk fine before the vaccine, she stated after the vaccine she ended up in the ER (emergency room). The patient did not stay in the ER overnight; alternatively, it was reported that patient was hospitalized for 5 hours (from 19Mar2021 to 19Mar2021). They checked all of her vitals as well as blood work and everything (19Mar2021). They only thing they came up with was that she had allergic reaction. She said she is doing better now. As corrective treatment, she took Benadryl 25 mg. The patient said she also noticed pain her thighs (Mar2021). Outcome of the event pain in thighs was unknown, while the outcome of the remaining events was recovering. She wanted to know about any program to investigate it or to assist with hospital bill.
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| 55 | 2021-04-06 | pain in extremity |
I began developing pain in my left leg Friday, March 19th - two days after receiving my second injec...
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I began developing pain in my left leg Friday, March 19th - two days after receiving my second injection. My early Monday morning I was in so much pain that I went to the ER. I was diagnosed with acute DVT in my entire left leg from the Iliac vein in my abdomen down to the ankle. The entire leg was occluded.
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| 55 | 2021-04-07 | burning sensation, tingling |
Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started a...
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Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started about 24 hours after receiving the vaccine. These symptoms resolved by day three. However, she started developing parasthesias in her feet and pain in left hip. Patient came to hospital on 4/5 after symptoms worsened. In hospital, patient received an LP and GBS was ruled out and was discharged with patient still complaining of burning of her feet and hands.
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| 55 | 2021-04-07 | tingling, numbness, tremor |
Patient had shaking chills and fevers for the a few days after getting her 2nd shot. The patient co...
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Patient had shaking chills and fevers for the a few days after getting her 2nd shot. The patient complained uncomfortable numbness tingling in her arms and legs on 4/3. Was admitted to medical center on 4/5.
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| 55 | 2021-04-09 | speech disorder, difficulty speaking, tingling |
in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightne...
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in respiratory distress; Mild lightheaded; itchy; rash; severe headache; tightening in chest/tightness chest; voice increasing hoarse/decreased voice volume and able to say 2 words max; coughing; shortness of breath; very effortful to talk; Eyes droopy; tingling jaw, neck; stressful; Unable to do anything seconda; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534), via an unspecified route of administration at Arm Left on 24Mar2021 08:30 (at age of 55 years old) at single dose for COVID-19 immunization. Medical history included Type1 diabetes, allergies, Shellfish allergy. Concomitant medication included insulin lispro (HUMALOG); pravastatin sodium (PRAVASTATIN +PHARMA); cetirizine hydrochloride (ZYRTEC ALLERGY). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:30 AM, the patient experienced mild lightheaded first 1/2, by 90mins post skin itchy with rash just under skin, severe headache, tightening in chest, voice increasing hoarse, coughing, shortness of breath, decreased voice volume and able to say 2 words max, no observed swelling but in respiratory distress. Went to AMC Umergent care, epipen + benedryl +steroids administered, transferred to AMC hospital via ambulance. Monitored, IV fluids+ Pepcid, stabilized d/c home on 50mg prednisone + Pepcid. Symptoms (milder)reoccur in Wednesday pm, Thursday AM, Thursday PM following Pepcid. Friday Mild coughing during the day, but overall good energy, activity level, almost back to normal. 1/2 hour prior to prednisone 4:30 pm starting experiencing respiratory symptoms again. Vitals all stable, but very effortful to talk, exhale (coughing). Eyes droopy, tingling jaw, neck, tightness chest. Overall took 1.5 hours post prednisone for symptoms to improve and voice to return to almost normal. Very stressful. Unable to do anything seconda. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (EPINEPHRINE, BENEDRYL, PEPCID, PREDNISONE) received for AE. The outcome of the events was unknown. Information on the lot/batch number has been provided. Other information has been requested.
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| 55 | 2021-04-11 | flushing |
Flushing/sweating, dizziness. BP 106/64, HR64, RR 16, given juice and monitored, patient left in sta...
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Flushing/sweating, dizziness. BP 106/64, HR64, RR 16, given juice and monitored, patient left in stable condition
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| 55 | 2021-04-12 | bell's palsy, slurring |
All was fine till day 9 evening when my right eye kept watering, and I brushed my teeth water shot o...
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All was fine till day 9 evening when my right eye kept watering, and I brushed my teeth water shot out right side. Next day same thing with blurred speech. I went to hospital, had CT n MRI. No blood clot determined its bells palsy. I have been healthy accept for mild seasonal allergies
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| 55 | 2021-04-12 | pain in extremity, seizure like phenomena |
When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoul...
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When she was able to fall asleep she woke biting my tongue like a seizure; Severe left arm and shoulder pain; Severe left arm and shoulder pain; Fever that gradually went higher to 103.7; Severe headache; Jaw pain; Blurred vision; Tired; Sweaty; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:00 as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Sulfa's and sulfurs, Unknown blood clotting disorder, Arnold chiari malformation syndrome, sinusitis. Concomitant medication included apixaban (ELIQUIS) taken for Unknown blood clotting disorder. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6199) on 06Mar2021, 04:00AM on left arm for covid-19 immunisation (55 years old). On 28Mar2021, 04:00, the patient stated that she had severe left arm and shoulder pain, fever that gradually went higher to 103.7 then a day later the fever went down. Severe headache with jaw pain, blurred vision. When she was able to fall asleep she woke biting my tongue like a seizure. Currently she is tired and sweaty, fever has gone, arm pain gone within a day and a half. Therapeutic measures were taken as a result of all the events included At home pain and fever medicine. The patient was not pregnant. Outcome of the events pain in arm and fever was recovered on an unspecified date while outcome of the remaining events was recovering.
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| 55 | 2021-04-13 | inability to speak, facial paralysis |
The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her ri...
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The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her right eye that never went away. Then on Wednesday morning, March 31st (two weeks after receiving the first dose), she was found in bed by my mother, unable to walk or talk, her face was drooping, she was very sweaty, and had defecated on herself. My mother called the ambulance. She was transported to Hospital where it was determined she had suffered a massive hemorrhagic stroke. She was immediately transported by ambulance to another Hospital. She spent one day in ICU and then was put on palliative care. She died around 12/N on Friday, April 2nd, two days after the stroke.
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| 55 | 2021-04-13 | slurring |
That evening after getting 2nd shot I was rushed to ER because I has slurred speech- I went to ER an...
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That evening after getting 2nd shot I was rushed to ER because I has slurred speech- I went to ER and they initially thought I had bells palsy, but after a CT to confirm they found a brain bleed and I was rushed to hospital and put in the ICU and after two MRI's they also found a stroke - I had several tests and stayed in ICU for 5 days they could never determine the cause of the brain bleed or stroke - all tests were negative for autoimmune diseases.
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| 55 | 2021-04-15 | tingling |
fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial ...
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fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial tingling/bilateral hand and foot tingling; double vision; disorientation; joint pain; orthostatic hypotension; chills; photophobic/photophobia; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left deltoid on 26Jan2021 15:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The first dose was received on 05Jan2021 15:00 (lot number: EL1284) on the left arm. Medical history included herpes simplex virus (HSV), Superior Oblique Myokymia, and Lyme Disease; from an unspecified date and unknown if ongoing. Patient was not pregnant. Concomitant medications included calcium citrate, magnesium citrate (CAL/MAG CITRATE), ergocalciferol (VIT D), fish oil (OMEGA 3), and paracetamol (TYLENOL). The patient previously took VICODIN and flu vaccine as a child, and experienced allergies. The patient experienced headache, nausea, dizziness, facial tingling, double vision, disorientation, joint pain, orthostatic hypotension, chills, photophobic from 27Jan2021 05:00. On 02Feb2021, she experienced dizziness, headache, nausea, photophobia, facial tingling, bilateral hand and foot tingling, GFR 47 all other CBC, cmp normal. There was headache, nausea, photophobia, facial tingling on 07Feb2021 and on 10Feb2021, tingling and fatigue from waist to feet posteriorly and bilaterally. She had lab test drawn and blood work done when she was sick and her GFR came back as 47, so everything else was normal, and her GFR was 47 which was out of range. On 03Feb2021 was the first test and it was 2 weeks that she had to repeat test just to make sure it was back in normal range which it was. Thee patient was still experiencing the events but 'not as bad', and stated she can still function. Her side effects were improving but she still have a daily headache and paresthesia. The events resulted in physician/ healthcare professional visit. Patient was recovering from the events. ZOFRAN was given as treatment for the events. Patient stated she takes Tylenol but her doctor want her not to take medication for a while but she had to take Tylenol. Patient had no covid prior to vaccination and has been tested (nasal swab) post vaccination on 29Jan2021 with negative results.
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| 55 | 2021-04-17 | numbness |
My Ulcerative Colitis flared up 2 weeks after I got my second dose of the vaccine on January 29th, 2...
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My Ulcerative Colitis flared up 2 weeks after I got my second dose of the vaccine on January 29th, 2021. And I have had to re-start on medication after being in remission for 2 years. Then since April 12th, I have began to have daily spells of dizziness, numbness, tiredness and feeling like I'm having a stroke. I would feel better after I take a couple of aspirins and Tylenols two or three times day. I am getting ready to go to the ER after I turn in this report because I do not know if i will get better.
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| 55 | 2021-04-17 | pain in extremity |
Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden...
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Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden vaginal bleeding during menopause; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Lot Number: EW 0150) at single dose for covid-19 immunization. Medical history included chronic pain from old injury. No known allergies. The patient didn't have Covid prior vaccination. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; hydromorphone 2 mg taken for an unspecified indication, start and stop date were not reported; tramadol ER 200 mg taken for an unspecified indication, start and stop date were not reported. No other vaccines in four weeks. The patient previously received the first dose of bnt162b2 (Lot number: EN6207) in left arm on 12Mar2021 at 55 years old for covid-19 immunization. The patient experienced very sore arm, tiredness, sudden vaginal bleeding during menopause on 01Apr2021 05:00 PM. No treatment was received for the events. Covid was not tested post vaccination. The outcome of the events was unknown.
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| 55 | 2021-04-18 | breast pain, pain in extremity |
I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt ...
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I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt a lot of fatigue; a lot of arm pain; I felt some mild dizziness later in the day; irritable bowels throughout the day as well as a loss of appetite./My appetite is very much diminished; irritable bowels throughout the day as well as a loss of appetite.; I also started experiencing an odd ribcage/breast pain on the side of the injection (left side).; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration in the left arm on 02Apr2021 (age at time of vaccination: 55-years-old) at a single dose for COVID-19 immunization. Medical history included asthma, allergies to medications, food, or other products as Tree Nuts and NSAIDS. Concomitant medication patient received within 2 weeks of vaccination included zyrtec, vitamins C, Vitamin D, Vitamin E, Probiotic and Tylenol. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced about 90 mins after 1 vaccine dose on 02Apr2021 at 04:00 PM, she developed a strong headache. The patient then felt very fatigued and came down with fever that night. The next day (yesterday), the headache was improved still present but she felt a lot of fatigue and a lot of arm pain. She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. On 02Apr2021, a day after 2 vaccine dose, she again felt fatigued with mild headache. her appetite was very much diminished with still irritable bowels. She also started experiencing an odd ribcage or breast pain on the side of the injection, it was felt like deep shooting pains. There was no pain or redness or swelling. she not breast issues to date (last mammography was clear-Fall 2018). Facility where the most recent COVID-19 vaccine was administered was Clinic. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal swab was unknown on 02Apr2021. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 55 | 2021-04-22 | speech disorder |
Presented to ED with a chief complaint of throat swelling, difficulty speaking. Patient reports sign...
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Presented to ED with a chief complaint of throat swelling, difficulty speaking. Patient reports significant history of anaphylaxis. Intramuscular epinephrine, IV fluids, IV Benadryl, IV Pepcid ordered. In addition, p.o. prednisone ordered. Discharged in improved condition.
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| 55 | 2021-04-26 | feeling hot, burning sensation |
this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burn...
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this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs. The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events. Information on the lot/batch number has been requested.
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| 55 | 2021-04-28 | pain in extremity |
weakness in her left arm; pain is increasing; Total hysterectomy; pain is up to her shoulder and dow...
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weakness in her left arm; pain is increasing; Total hysterectomy; pain is up to her shoulder and down to her elbow; waking her up at night; soreness in her left arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No. EL3246; Expiration Date: unknown) via an unspecified route of administration in left arm on 30-DEC-2020 09:15 at single dose (age at vaccination: 55-year-old) for COVID-19 immunization and patient had second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No. EL9251; Expiration Date: unknown) via an unspecified route of administration in left arm on 20Jan2021 1:30 PM at single dose for COVID-19 immunization. The patient medical history included high blood pressure (From: Unspecified To: Ongoing). The patient concomitant medications included losartan: (Start: Unspecified Stop: Ongoing), taken for 7 years, amlodipine: (Start: Unspecified Stop: Ongoing) taken for 7 years. It was reported that, she has had both vaccines. First vaccine on 30Dec2020 and the second vaccine on 20Jan2021 and she is having pain. She wasn't having pain, just soreness in her left arm. But that soreness has gotten worse now. She also reports that when she got her first Covid 19 vaccine, the person who gave the injection went straight into her arm with the needle and when she got the second vaccine the person who gave the injection went more towards the back of her arm with the needle. The first injection where the needle went straight on has bothered her since 30Dec2020. She also has weakness in that left arm and it's waking her up at night. She is an administrator and was in the first phase of people who received the Covid 19 vaccine. she did tell the attendant giving her the second Covid 19 vaccine that she was still having soreness in her left arm. That person told her soreness in her arm was normal. She reports she had a total hysterectomy on 18Feb2021 and had preop labs done at that time. Her primary care doctor has not ordered any labs related to her issue with her left arm. On an unknown date in Apr2021, the pain is increasing, and the arm is getting weak. The attendant giving her second vaccine did ask her if she wanted the injection in the right arm, her other arm and she said no. She is right hand dominant, and she needed one working arm. On an unknown date 2021, that soreness, that pain is up to her shoulder and down to her elbow. She reports her doctor did reflex testing and asked the caller to squeeze the doctor's hands and push down on her hands like a strength test to see if there was equal strength. The doctor told her she had less strength in her left arm than her right arm. She had gone to the doctor for a blood pressure check and while she was there, she mentioned to her doctor the problem with her arm. She had gone to the doctor for a blood pressure check and while she was there, she mentioned to her doctor the problem with her arm. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event hysterectomy was unknown, for rest of the events it is not recovered. No follow-up attempts possible. No further information expected.
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| 55 | 2021-04-29 | flushing, numbness |
Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 1...
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Flushing/sweating, dizziness, numbness on arm/lips. Rested and had water. BPs 158/100 (pulse 125), 171/105.
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| 55 | 2021-04-30 | muscle twitching, facial paralysis |
both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my d...
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both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE)), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:30 (Batch/Lot Number: EP7533) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation . Medical history included high blood pressure (HBP) from an unknown date and unknown if ongoing , supraventricular tachycardia (PAT) from an unknown date and unknown if ongoing, had Bell's palsy from 2001 to an unknown date. No known allergies. Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; enalapril taken for an unspecified indication, start and stop date were not reported. The patient did not have any vaccines in four weeks and did not have covid prior to vaccination. In 2001, the patient had Bell s palsy (Medical history). Her left side paralysis never fully went away. Now, both of her doses of vaccine led to facial tightening, twitching, and slightly more paralysis on 23Mar2021 11:30 with outcome of unknown. She did not regret taking the vaccine and would do it again. Her mainly reason for reporting this was that she wanted to know if the vaccine was still effective. No treatment was received. No covid test post vaccination.
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| 55 | 2021-05-04 | pain in extremity |
Muscle aches; Extreme fatigue; sore arm; This is a spontaneous report received from a contactable (r...
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Muscle aches; Extreme fatigue; sore arm; This is a spontaneous report received from a contactable (reporting on herself) via Pfizer Sponsored Program. A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 29Jan2021 14:15 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: (diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was Animal dander, Pollen and Asthmatic from 1966 to an unknown date. Family Medical History includes: Father Asthmatic and Mother Allergies. The patient's concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 on 08Jan2021 and patient experience sore arm. It was reported that on 29Jan2021patient got the vaccine shot (yesterday) and said that she got a sore arm. On 30Jan2021 at 12:00 Extreme fatigue and at 15:00 Muscle aches. Patient took Advil on 29Jan2021 and stop on 31Jan2021. The outcome of the events recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 55 | 2021-05-07 | bell's palsy |
Bell's palsy; This is a spontaneous report from a contactable physician and consumer (receptionist)....
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Bell's palsy; This is a spontaneous report from a contactable physician and consumer (receptionist). A 55-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines received on four weeks. Patient was not pregnant. The patient experienced bell's palsy on Apr2021 which caused hospitalization. Prednisone was given as treatment. Outcome of the event was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Bell's palsy due to temporal relationship and current known drug safety profile. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 55 | 2021-05-10 | muscle spasms, pain in extremity |
Heart racing, heart was skipping beats for up to two weeks 3-4 times a day and about once every othe...
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Heart racing, heart was skipping beats for up to two weeks 3-4 times a day and about once every other day the 3rd week. Pains in legs.
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| 56 | 2020-12-31 | pain in extremity |
Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then m...
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Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then mild headache for 24 hrs. No symptoms after 24 hrs except sore arm for 2 days.
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| 56 | 2021-01-03 | weakness |
Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. ...
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Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
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| 56 | 2021-01-03 | facial pain |
After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was...
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After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was not to bad and I tought is a normal symptom but the pain and swelling an my face is increasing every day, even my teeth hurts and I'm taking Gabapentin 100MG 3 times a day. I am not sure if the vaccine components triggered my Trigeminal Neuralgia and if it's okay to get the second dose, I will see my Dr. tomorrow 01/05/21
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| 56 | 2021-01-03 | pain in extremity |
Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appe...
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Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appetite I had a hard time sleeping. I just took Tylenol.
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| 56 | 2021-01-03 | tingling |
Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling ,...
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Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling , headache
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| 56 | 2021-01-04 | weakness |
Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and abou...
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Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and about 3 minutes later, experienced nausea, dizziness and weakness. Patient was brought to ED to be evaluated @ 07:35 am. Ondansetron 4mg inj was given at 8:29am and NS 1000 mL was given over 2 hrs at 8:30am. Patient felt better and tolerating oral at 09:19 am and discharged at 9:25am.
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| 56 | 2021-01-04 | flushing |
About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I...
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About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I was taken to the ED where I was given non drowsy antihistamine and observed. At home I experienced severe fatigue, muscle aches and chills. At about 30 hours the symptoms went away
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| 56 | 2021-01-04 | numbness, tingling |
Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had he...
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Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had her blood pressure taken. It was 171/105. Stated that she had not taken her morning blood pressure medications (lisinopril 10mg and atenolol 50mg). The nurse at the facility gave her a dose of lisinopril 10mg. Patient then stated prickly, numb feeling and foggy-headed. The facility then gave her 2 doses of diphenhydramine 25mg. At approximately 11am, patient was still not improving and felt like she was getting worse. The facility then called for an ambulance to take her to the ER for assessment.
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| 56 | 2021-01-04 | pain in extremity |
Sore left arm 2-3 days after vaccinated; This is a spontaneous report from a contactable consumer. A...
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Sore left arm 2-3 days after vaccinated; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK5730, via an unspecified route of administration, in the left arm, from 22Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included allergies to penicillin, gluten, chicken eggs (whites & yolks) and cow's milk. Patient was not pregnant. The patient's concomitant medications were not reported. on 23Dec2020 09:00, after being vaccinated, the patient experienced sore left arm for 2-3 days. The patient underwent lab tests and procedure on unspecified date which included Nasal Swab test/COVID test, yielding negative result. The outcome of event was recovered on Dec2020. Follow-up attempts are completed. Information on the batch/lot number has been obtained.
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| 56 | 2021-01-04 | pain in extremity |
soreness in arm when using arm or to touch; This is a spontaneous report from a contactable nurse. ...
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soreness in arm when using arm or to touch; This is a spontaneous report from a contactable nurse. A 56-year-old female nurse received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 28Dec2020 at 12:30 PM at single dose for COVID-19 immunization on right arm.Relevant medical history included ongoing osteoarthritis and high cholesterol. Concomitant medications included atorvastatin calcium (LIPITOR ORIFARM), escitalopram oxalate (LEXAPRO) and pantoprazole. On 28Dec2020 at 07:00 PM patient started experiencing soreness in arm when using arm or to touch. At the time of the reporting the patient was recovering from the event.
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| 56 | 2021-01-05 | facial paralysis |
Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left ...
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Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left upper lip 2-3 hours after vaccine, but noted facial droop 3 days later. Numbness is improving at this time. Some fatigue.
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| 56 | 2021-01-05 | feeling cold |
"Received vaccine around 9:30am without any initial reaction. Around 9:30pm developed rigors felt co...
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"Received vaccine around 9:30am without any initial reaction. Around 9:30pm developed rigors felt cold no fever went to bed and rigors subsided after 20 minutes. Body did ache overnight and headache developed. Took Tylenol with some relief. In am aches and rigors remained absent but still had dull headache. Took headache medicine and otherwise felt fine. I have a history of feeling like this in the past after receiving my flu shot."
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| 56 | 2021-01-05 | pain in extremity |
Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Rig...
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Extreme pain in Right shoulder approximately 4 hours post injection and later difficulty lifting Right arm. Shoulder pain moved into and included the axilla approximately 9 hours post vaccination. During the night, approximately 16 hours after vaccination, I began to have radiating, shooting pain up both sides of my neck up into the ears. This neck pain lasted approximately 72 hours. The arm pain had resolved at approximately 30 hours. The neck pain lessened and resolved with repeat applications of heat and Ibuprofen.
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| 56 | 2021-01-06 | weakness |
Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/...
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Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
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| 56 | 2021-01-06 | feeling hot, hot flush |
In less than 24 hours following the immunization, feeling of "flush" and "warm inside" without fever...
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In less than 24 hours following the immunization, feeling of "flush" and "warm inside" without fever. Probably 6-8 times per day lasting greater than 30 min. This "warmth" or "flush" feeling continues to this day. I am peri-menopausal, but have not had "hot flashes" prior to the administration of the COVID immunization.
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| 56 | 2021-01-06 | feeling hot | "Hot, Blotchy" given Benadryl 25mg liquid, po x1 dose. Resolved |
| 56 | 2021-01-06 | flushing, feeling hot |
Started feeling hot and flushed less than 24 hours after injection. No fever. Have been having 4-5 e...
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Started feeling hot and flushed less than 24 hours after injection. No fever. Have been having 4-5 episodes throughout the day since. No treatment needed. I just wanted to report just in case .
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| 56 | 2021-01-06 | flushing | Rash, itching, facial flushing/redness |
| 56 | 2021-01-06 | numbness, weakness, pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
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| 56 | 2021-01-06 | pain in extremity | Pain on injection site, turned red, swollen & hard. |
| 56 | 2021-01-06 | pain in extremity | Arm hurts and woke up with headache fever and body aches 12 hrs after vaccine was administered. |
| 56 | 2021-01-06 | pain in extremity |
C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest tw...
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C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest twinge". Radial pulse measured 88- pulse felt weak. Brought over to EMS for evaluation, monitor shows HR 87, BP 185/98 (160/88 manual), O2 99% on RA. HR came down to 79, BP 142/80. Around 0910 c/o nausea and dizziness. 0915 called daughter to drive her home, refused to transfer with EMT to hospital.
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| 56 | 2021-01-06 | pain in extremity | arm soreness from 12/31/20 to 1/5/21. fatigue 12/31/20 to 1/4/21. |
| 56 | 2021-01-06 | pain in extremity |
2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; ...
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2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; 3-4 hours later took 3 ibuprofen due to the headache. Feeling light headedness. Next morning, sore arm was heavy, headache, body aches, temp 99, and nausea; felt unwell; took 3 ibuprofen. Time off from work to just lay flat and rest for the day.
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| 56 | 2021-01-06 | tingling, hot flush |
Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites...
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Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites" all over body
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| 56 | 2021-01-06 | tingling, hot flush | Headache, chills, hot flashes, rash on face, feeling like "mosquito bites" all over the body |
| 56 | 2021-01-06 | tingling, hot flush | headaches, hot flashes, chills, rash on face, feeling like "mosquito bites" all over body |
| 56 | 2021-01-06 | throat numbness |
Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk ...
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Patient received COVID-19 vaccine and waited 15 mins prior to leaving clinic. Patient begin to walk back to work area and started to feel numbness and tingling in tongue and throat, face as itching and cheeks red. Patient taking in observation room and emergency response team called for precaution. Patient remained alert. Team arrived taking taking blood pressure which was 185/108, Benadryl given, patient monitored. Team and patient agreed no emergency department care needed. Patient monitored for another 30 mins, blood pressure rechecked 158/95 . Patient allowed to return to unit. Had no signs of distress, denies shortness of breath or any throat discomfort. Patient was stable when leaving unit.
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| 56 | 2021-01-07 | weakness |
Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27...
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Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27, patient started having pressure in her head and sinuses, weakness. Then she developed nonproductive cough and progressive shortness of breath. She was seen at urgent care and tested positive for COVID-19 on December 29. She had low oxygen saturation on home oximeter and severe shortness of breath. Patient's husband is also ill with COVID-19 at home. Patient was sent to the ED and admitted to the hospital.
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| 56 | 2021-01-07 | feeling hot |
Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/...
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Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/P 126/86 HR 76 Sat 96% Patient did elect to call her husband to pick her up
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| 56 | 2021-01-07 | pain in extremity |
After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I bec...
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After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I became sick.
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| 56 | 2021-01-07 | pain in extremity | Headache Fatigue, sore arm |
| 56 | 2021-01-07 | pain in extremity |
The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went t...
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The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went to ER high BP and got tested for Covid results negative. On that Saturday my BP was still high and left calf pain. Since I'm usually hypotensive I monitored my BP however it has continued to elevate.
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| 56 | 2021-01-07 | pain in extremity | swollen uvula, throat lymph edema, arm soreness. has history of anaphylaxis |
| 56 | 2021-01-07 | tenderness | Left shoulder pain and tenderness |
| 56 | 2021-01-08 | flushing |
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ...
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Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
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| 56 | 2021-01-08 | numbness |
Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, l...
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Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
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| 56 | 2021-01-09 | feeling hot, weakness |
Mild pain/soreness at injection site starting later the day of injection and next day. Approximately...
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Mild pain/soreness at injection site starting later the day of injection and next day. Approximately 2 pm the day after injection, began feeling overly hot and nauseated. That was followed by pressure type headache, muscle/bodyaches, and overall feeling of no energy progressing as the afternoon and evening continued. Spent that evening sleeping on/off. The following day spent in bed with continued headache, body/muscle aches, feeling overall drained/ no energy. Nausea improved some; was able to stomach some soup later in the day. So far today, feeling some improvement with bodyaches, but overall drained of energy. Headache has lightened some as well.
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| 56 | 2021-01-09 | migraine, pain in extremity |
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, ...
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1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
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| 56 | 2021-01-09 | tingling, pain in extremity | Sore arm and tingling in fingers |
| 56 | 2021-01-10 | weakness |
Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the P...
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Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the Pfizer vaccine (COVID-10) that she had had disturbing nightmares. Pt reports that she had two night-mares after the 1st dose, but said the second dose she started having nightmares this morning. Pt declined evaluation at the clinic after reporting of the events. Other S/S she had experienced are headache, nausea, chills, weakness, feeling tired but symptoms have improved.
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| 56 | 2021-01-10 | weakness |
Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports...
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Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports on 01/11/2021 to this RN that she had a couple nightmares after the first injection. Pt reports that she had two nightmares after the first dose. Since her second dose was received on January 8, 2021 she reports having disturbing night mares and requested reporting of the events. Pt declined evaluation at the clinic after notification of the event. Pt voiced she will follow-up with her PCP if the nightmares continue. Other side effects she reported with the second dose is nausea, tiredness, fatigue, headache, chills and some weakness. Those symptoms have since improved.
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| 56 | 2021-01-10 | bell's palsy | Numbing of tongue, possibly mild Bell's Palsy, and occurred about 7 minutes after vaccination |
| 56 | 2021-01-10 | feeling hot, pain in extremity |
01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completel...
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01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.
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| 56 | 2021-01-10 | flushing |
feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta ...
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feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
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| 56 | 2021-01-10 | pain in extremity |
STARTED WITH ACUTE LEFT ARM PAIN WITH DIFFULTY RAISING LIMB, PAIN EXTENDED TO LEFT SHOULDER AND ELBO...
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STARTED WITH ACUTE LEFT ARM PAIN WITH DIFFULTY RAISING LIMB, PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, FEVER, GENERALIZED JOINT PAIN, FATIGUE. TOOK PERCOGESIC AND ACETAMINOPHEN
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| 56 | 2021-01-10 | pain in extremity |
3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, l...
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3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, less than flu shot pain. lasted 3 days. 6 hours post vaccine- bad headace-lasted 29 hours 8 hours post vaccine-mild chills. Lasted 5 minutes 10 hours post vaccine- another episode of chills-lasted 10 minutes 12 hours post vaccine-moderate tiredness. Lasted 24 hours 12 hours post vaccine-generalized achiness-lasted 24 hours
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| 56 | 2021-01-10 | pain in extremity | Fever, chills, arm ache, mouth ache, body aches, sore throat, dry cough, rash and exhaustion |
| 56 | 2021-01-10 | pain in extremity |
10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotic...
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10 days post vaccination presented to ED with LUE swelling redness and pain. Treated with antibiotics and f/u w Allergy to determine whether to have second dose
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| 56 | 2021-01-10 | pain in extremity |
After 7hrs of the vaccine I was feeling very tired I had muscle ache almost a week later I went to t...
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After 7hrs of the vaccine I was feeling very tired I had muscle ache almost a week later I went to the ER because I had a lot of pain on my legs mainly on my right one I thought I had a blood clot but in the ER they told me it was just a reaction the the vaccine.
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| 56 | 2021-01-10 | pain in extremity |
SEVERE LEFT ARM PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, GENERALIZED JOINT PAIN, FEVER, MALAISE AN...
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SEVERE LEFT ARM PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, GENERALIZED JOINT PAIN, FEVER, MALAISE AND FATIGUE STATED ON 1/9/2021, TOOK PERCOGESIC ALTERNATED WITH ACETAMINOPHEN
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| 56 | 2021-01-10 | pain in extremity |
Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 a...
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Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 at 10 am. Took Advil with relief. Sunday afternoon low grade temperature of 99 at 3 pm. Reports arm soreness bilateral.
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| 56 | 2021-01-10 | tenderness, tremor |
Shaking chills on 12/8/21 and low grade temp of 99.7 headache and body aches on 12/9/21 body aches a...
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Shaking chills on 12/8/21 and low grade temp of 99.7 headache and body aches on 12/9/21 body aches and fatigue on 12/10/21 local arm tenderness that started on 12/9/21
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| 56 | 2021-01-11 | facial paralysis, numbness, tingling |
Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight ...
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Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed.
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| 56 | 2021-01-11 | feeling hot, tingling |
I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha...
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I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
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| 56 | 2021-01-11 | migraine |
Patient said they experienced a migraine after being vaccinated and also reported they are prone to ...
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Patient said they experienced a migraine after being vaccinated and also reported they are prone to migraines
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| 56 | 2021-01-11 | muscle spasms |
Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tirednes...
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Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills. Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol. Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol, now returning (noon). occasionally feels like I need to take a deep breath. I believe its mostly muscular pain gets a little worse with deep breathing. Sent home from work day of vaccine, worked partial days next 2 days
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| 56 | 2021-01-11 | pain in extremity | Sore Arm Can't lift arm |
| 56 | 2021-01-11 | pain in extremity | Shivers. Chills. Body aches , fever 101.2 tympanic Sore left arm |
| 56 | 2021-01-11 | pain in extremity | chills, elevated heart rate, headache, Sore Arm |
| 56 | 2021-01-11 | tingling, numbness |
Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hou...
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Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hours after injection. 5 days after injection; chills and major lower back pain.
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| 56 | 2021-01-11 | tingling, numbness |
Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling wit...
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Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling within 10 hours after injection. 5 days after injection resulted in massive lower back pain and chills.
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| 56 | 2021-01-12 | feeling cold | Body aches, fever, chills, headache, nausea, sore throat, left ear pain, COVID exposure w/in 14 days |
| 56 | 2021-01-12 | pain in extremity, discomfort |
Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drai...
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Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drainage and pressure. Headache. Very congested. Medicated with Mucinex and Advil Sinus. A couple days later went to my chest. Got medical care from Telemed visit - Z-Pac - took for five days - 250 mg and a liquid decongestant: Guaifenesin - 100 mg/5 mm once every six hours for 10 days as needed. I took it for six or 7 days. Resolved.
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| 56 | 2021-01-12 | pain in extremity, tension headache |
Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of adminis...
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Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of administration patient developed intermittent chills, fever 101.4 to 102.2 F , moderate to severe tension headache, mild muscle ache/joint pain, insomnia, severe fatigue, and mild nauseau. Fever lasted for approximately 48 hours. Other signs and symptoms resolved by 72 hours following vaccination. Patient also noticed mild fatigue as well as slight disorientation and slight loss of balance until 1/11/21. Patient was normal by 1/12/21. No specific treatments administered.
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| 56 | 2021-01-12 | pain in extremity |
Arm was very sore. Lasted 2 days. On 24th Dec. woke up with very heavy nasal drainage; continued for...
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Arm was very sore. Lasted 2 days. On 24th Dec. woke up with very heavy nasal drainage; continued for several days and it went to my chest. I Medicated with: Mucinex and Advil sinus - but wasn't working. Telehealth call to DR. and He prescribed C-Pac - 250 mg - 5 day dose and decongestant: Guaifenesin 100 mg - 5 mg liquid - 10 ml every six hours by mouth as needed for 10 days and I took that decongestant for 6 days. Felt better at this point. Never had had this before.
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| 56 | 2021-01-12 | cold extremities, cold extremities |
16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and p...
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16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and pains in joints, chills-cold hands,feet, lethargy, slight nausea, diarrhea. Symptoms subsided over the following 24 hours. Joint aches continue
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| 56 | 2021-01-13 | weakness, tingling |
56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine....
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56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine. She reports feeling weakness and dizziness. She states she fellt sensation to her neck immediately after she got the vaccine. Pt appears very anxious. Provided cold pack behind her neck and vital signs taken 152/90 with HR 98 O2 SAT 98%. Pt then taken to the gurney to lay down. Pt continued to feel weak with short of breath, tingling finger tips. 100% NR mask provided, Dr notified and arrived immediately. vital signs taken every 5-10 min with b/p trending down within 20 minutes. Pt states felt better around 1150. Attempted to sit up but states felt weak again. Pt felt anxious and wanted to speak to her husband, Medic, called husband and was able to speak to him. Pt continues to feel weak. Continue to monitor and comfort provided. Discussed with medical team that patient need to be sent to the ER for further observation. 911 called at 1215 and arrived within few minutes, report given to EMS. Patient transferred to ER at 1230 via gurney. 1117: 152/90,HR 103, O2 sat 98% 1121: 144/72, HR 89, O2 SAT 99%-applied O2 100% non rebreather mask 1126: 153/88, HR 80 1142: 160/92, HR 85, O2 SAT 100% 1147: 147/85, HR 77, O2 SAT 100% 1152: 136/85, HR 70, 02 SAT 100% 1202: 133/81, HR 68, 02 SAT 99%
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| 56 | 2021-01-13 | weakness |
approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to fee...
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approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to feel weaker and getting confused. C/O legs weighing 500 pounds and leg weakness with difficulty walking. Intermittent chills.
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| 56 | 2021-01-13 | flushing | Had flushing and warm BP elevated to 158/98 pulse 68 for 30 min and resolved on own |
| 56 | 2021-01-13 | pain in extremity |
left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; ...
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left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 07Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, allergic to certain types of chocolates. Concomitant medication included Levothyroxine and vitamins. The patient was also allergic to Quinine, tramadol, Dilaudid, Msg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left arm/shoulder soreness, headache, light headedness, fatigue and aches on 07Jan2021 11:45 AM. The patient received Tylenol and bed rest as treatment. Events outcome was not recovered. Information about lot/batch number has been requested.
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| 56 | 2021-01-13 | pain in extremity |
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck ...
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Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
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| 56 | 2021-01-13 | pain in extremity |
Felt sore arm (deltoid), developed headache (20 hours after vaccine), body aches, chills (developed ...
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Felt sore arm (deltoid), developed headache (20 hours after vaccine), body aches, chills (developed 30 hours after vaccine). Temp 100.1, (approx 32 hours after vaccine). All resolved 43 hours after vaccine.
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| 56 | 2021-01-13 | pain in extremity |
itching/itching at the site and on her chest going all the way to her groin; rashes/She does have th...
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itching/itching at the site and on her chest going all the way to her groin; rashes/She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin; itching at the site; soreness on her arm; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 56-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), by injection via an unspecified route of administration on Arm Left on 06Jan2021 12:00 noon at single dose for covid-19 immunisation (front line health care worker). Medical history included Hot flashes, Hashimoto's disease, Osteoporosis and Allergy. Concomitant medications included ongoing estrogens conjugated/medroxyprogesterone acetate (PREMPRO) at 0.45mg; take once daily by mouth for Hot flashes from 2017, ongoing Levothyroxine at 50mcg; take once daily by mouth for Hashimoto's disease from 2014, ongoing alendronate sodium (FOSAMAX) at 70mg; take once weekly by mouth for Osteoporosis from 2017, montelukast sodium (SINGULAIR) at 10mg; take once daily by mouth for allergy from 2018, ongoing Azelastine at one spray per nostril daily for Allergy from 2019, ongoing Fluticasone at 50mg; one spray each nostril daily for Allergy from 2019, ongoing Hydroxyzine at 10mg; once daily by mouth for Allergy from 2019. The patient had the COVID-19 vaccine yesterday (06Jan2021) and today (07Jan2021) 16:00 experienced itching and rashes. She also had soreness on her arm. She is concerned whether this is expected of the COVID-19 vaccine and will it happen again because she has heard that the side effects may worsen on the second dose of the vaccine. What would happen if I don't get the second dose of the vaccine? Itching was reported as worsened. Rash was reported as worsened. Occupational Therapist calling regarding the Pfizer COVID 19 vaccine. States she had the vaccine yesterday and just started itching and can't get up with her primary care provider. Asking if this is a normal side effect? Will it happen again? Reports she received the first dose of the COIVID 19 vaccine 06Jan2021 at 12:00 noon in the left arm. Today 07Jan2021 within the last the hour, 16:00, she started itching at the site and on her chest going all the way to her groin. Adds she has a lot of allergies and that is how it always starts. She knows she will wake up with a red bathing suit rash. She does have the rash some already but she expects it to get worse. The rash starts at the armpits and goes down to the groin. Reporter is Occupational Therapist reporting on herself She is unsure if she will take the second dose of the vaccine. Vaccination Facility Type was nursing home. No vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Physician Office or ER.Prior Vaccinations (within 4 weeks) was none. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The outcome of the events Itching and rash was not recovered. The outcome of the other events was unknown.
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| 56 | 2021-01-13 | tremor |
The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling ...
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The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling like her heart was racing and short of breath. She was diaphoretic, had a notable tremor and reported anxiety as well. Patient was transported to the Emergency Department where the patient was monitored. Ultimately, patient felt better, with a normal EKG. Patients states this reaction felt similar to anxiety attacks she has had in the past. ED Physician felt this was likely an anxiety attack. Patient remained stable throughout ED course and was discharged from the ED in stable condition.
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| 56 | 2021-01-14 | bell's palsy, facial paralysis, tingling, tremor |
Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left...
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Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left side of face. On exam, she had left facial droop consistent with Bell's palsy. She was monitored for about an hour with no further progress, and some visible improvement. She had tremor of right hand. By next day, patient reported complete resolution of symptoms. Of note, patient has multiple sclerosis and will have similar symptoms when she has a flare. Jen Silvey spoke with patient on 1/6/2021 @ 2051: "Her face - no droop to left side of her face and lips- back to normal. But her tongue is still tingling."
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| 56 | 2021-01-14 | one side paralysis, numbness, pain in extremity |
Left leg pain, increasing in intensity over 2 1/2 weeks requiring treatment. Sharp pain down leg, w...
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Left leg pain, increasing in intensity over 2 1/2 weeks requiring treatment. Sharp pain down leg, with an achiness in bones of entire leg, numbness in toes at times, with increasing weakness. Received Doppler scan, X-rays, and MRI with no know problems seen. Required treatment of prednisone, anti-inflammatory meds, Percocet, gabapentin, as well as epidural.
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| 56 | 2021-01-14 | pain in extremity | Fever chills fatigue arm pain upset stomach bradycardia |
| 56 | 2021-01-14 | tremor | Mental confusion,shakes, foggy brain , things did not make sense to me, driving confusion |
| 56 | 2021-01-16 | pain in extremity |
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lighthead...
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I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips. Went back to bed. Later Sunday felt better.
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| 56 | 2021-01-17 | weakness, unresponsive to stimuli |
Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the ob...
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Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the observation area. Her husband and I walked her over to the cot and medical treatment area. Her pulse felt thready and weak while walking and her gait was unsteady. As soon as she sat, then lay on the cot she lost consciousness and did not respond to verbal or noxious stimuli over the next few minutes. I gave her one dose of an epi-pen into her left mid outer thigh but she still did not regain consciousness so we called a "Rapid Response code" for transport to the E.R. for further treatment and stabilization.
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| 56 | 2021-01-17 | weakness |
Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reporte...
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Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reported for herself, a 56-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Dec2020 at a single dose with lot number: EJ1685, and the second dose via an unspecified route of administration on 10Jan2021 at a single dose with lot number: EL3248, for COVID-19 immunization. The patient had no medical history nor concomitant medications. When patient had the first vaccine on 20Dec2020, she experienced dizziness, weakness and tiredness which lasted for 4 days. The outcome of the events was recovered with sequelae, patient received the second dose of the Covid-19 vaccine on 10Jan2021, she was also having dizziness, weakness and tiredness which were ongoing at the time of report.
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| 56 | 2021-01-17 | difficulty speaking |
I sat for 15 minutes and felt fine but when I was leaving I had to climb up a set of stairs, after d...
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I sat for 15 minutes and felt fine but when I was leaving I had to climb up a set of stairs, after doing that I felt light headed and out of breath. That continued for about 15-20 minutes. At 30 minutes after the injection my voice went hoarse. About an hour after I had a serve bullet like headache in one point in my head, I took Tylenol and lasted for about 5 hours. I started taking Benadryl (25mg), the headed improved, but when I woke up in the morning the next day I had all over swelling to the the point where I couldn't make a fist and had facial swelling . The facial swelling lasted for 5 days. My co worker took my vitals signs but everything was normal. For the next 5 days I had facial swelling that increased, hands got better. I continued to Benadryl . After the 5th day things finally started to get better. I did go back to have my second dose. I contacted my PCP but he was out of town .
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| 56 | 2021-01-17 | tremor |
Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the follow...
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Symptoms began approximately 7 hours after receiving the vaccine and continued throughout the following day. The first symptoms were ear and sinus pressure. Then malaise/fatigue, headache, mild stomach upset. Fever occurred in the middle of the night and got up to 101.1. Also developed shakes/tremors and severe back and body aches. My arm was sore at site of injection.
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| 56 | 2021-01-18 | weakness, feeling of body temperature change |
Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side ...
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Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 56 | 2021-01-18 | weakness |
1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes ma...
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1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes mark which subsequently resolved spontaneously at 30 mins (closely monitored by MD, NP) 2nd vaccine: spontaneous tachycardia, and elevated BP (160/100) at 10 minutes mark (monitored by MD and NP), normalized after 1 hour of observation. On 1/8/2020 I developed severe fatigue, fever, numbness on lower lip, bitter taste in my mouth, fever, chills, headache until Sunday 1/10/2021. Went to work on 1/11/2021 with worsening symptoms. Ended up in ER on 1/12/2021 due to weakness, high BP, numbness on lower lip, difficulty focusing. BP is normalizing as of 1/19/2021 but still have weakness, equilibrium is off and difficulty in focusing
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| 56 | 2021-01-18 | migraine |
Dose1 start time 28Dec2020, dose 2 start time 11Jan2021; Red, inflamed, hot to touch injection site;...
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Dose1 start time 28Dec2020, dose 2 start time 11Jan2021; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Red, inflamed, hot to touch injection site; Chills; fever- 99.8; severe headache (migraine); This is a spontaneous report from a contactable nurse (patient) reported for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number=Ek9231) intramuscularly at left arm on 11Jan2021 at 01:30 PM at a single dose (dose number:2) for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM) and known allergies to latex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included metformin, atorvastatin, lisinopril, exenatide (BYDUREON) and bimatoprost (LUMIGAN). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand=Pfizer, lot number= Ek5730) intramuscularly at left arm on 28Dec2020 at 02:30 PM at a single dose (dose number:1) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included "red, inflamed, hot to touch injection site", chills, fever- 99.8, and severe headache (migraine); all with start dates on 11Jan2021 at 08:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 56 | 2021-01-18 | night sweats, feeling cold, feeling hot |
10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour...
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10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour went away and came back later in the day. 13 hours after the vaccine injection I developed extreme rigors lasting atleast 60 minutes followed by very hot body temperature to touch unable to sleep body not comfortable cold then hot and very bad headache. Next day rested all day terrible headache, body aches and chills on and off. The next night did sleep for 5 hours then woke up soaked hair night garments had to change still had headache and just felt achy and tired all day mild headache arm was sore warm at inj site and very itchy. Third day headache was gone just felt extreme fatigue and today tired but feel more like myself.
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| 56 | 2021-01-18 | pain in extremity | Patient describes Arm soreness, repiritory (congestion) Fever and chills. |
| 56 | 2021-01-18 | pain in extremity | sore arm chest pains began on friday December 25th |
| 56 | 2021-01-18 | tingling |
Received vaccine at 10:30am, completed 15 minute post monitoring without adverse event. Upon driving...
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Received vaccine at 10:30am, completed 15 minute post monitoring without adverse event. Upon driving home within 5 minutes of leaving started feeling tingling in face and nose. Felt roof of mouth tingling and tongue and eyes felt swollen and felt flushed. Face was notably red. EMS assessed patient established IV. 0.3mg epinephrine given IM and 50 mg Benadryl administered IVP. Patient agreed to go to ED and transported by EMS without issue. Vital signs remained stable and wnl throughout reaction monitoring.
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| 56 | 2021-01-18 | tingling | tingling tip of tongue and upper extremities |
| 56 | 2021-01-18 | tenderness |
Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and ten...
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Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine.
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| 56 | 2021-01-19 | weakness |
At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling naus...
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At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling nauseated almost threw up, also felt drunk (balance, lack of clear thinking, a little weak, etc). That lasted from about 8 hours after the shot (when it started) to 20 hours after the shot was administered.
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| 56 | 2021-01-19 | numbness, facial paralysis |
Patient developed right facial numbness and facial droop on 1/7/21. She came to the TMH ED and was a...
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Patient developed right facial numbness and facial droop on 1/7/21. She came to the TMH ED and was admitted. She was afebrile; neurologic exam was consistent with a peripheral facial palsy on the right.
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| 56 | 2021-01-19 | numbness |
Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination....
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Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination. Patient said she felt like she couldn't breathe. Taken to ED for further evaluation.
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| 56 | 2021-01-19 | pain in extremity, tremor |
acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7...
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acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7 minutes then stopped - 30 minutes after injection given blurry vision - 30 minutes after injection given mild shaking - following morning lasting for about 2 hours extreme fatigue - lasting for 48 hours - Sunday evening through Tuesday evening
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| 56 | 2021-01-19 | pain in extremity |
From the evening of the day I have received the vaccination, my left arm started to feel dull contin...
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From the evening of the day I have received the vaccination, my left arm started to feel dull continuous pressure pain, progressed stronger and stronger as the time goes. No treatment given. Following day, the pain was worse and stayed same. The IM insertion site was also painful to touch or pressure. Then afternoon of the same day, I started nausea, light headache, dizziness, and occasionally chills as well as occasional dry cough accompanied by itchy throat or without itchy throat. At this point, I took Advil 200mg 1 tab around 3pm. The muscle pain on my left arm and headache is eased but other symptoms stayed same at this time, 4:30pm.
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| 56 | 2021-01-19 | pain in extremity | sore arm, gastric upset, tirednessn/a |
| 56 | 2021-01-19 | tingling | PATIENT REPORTS TINGLING IN HANDS, NAUSEA, AND SWEATING WITH THE FIRST DOSE |
| 56 | 2021-01-19 | tingling |
Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", ...
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Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", tingling in legs. Patient was monitored for approximate one hour total in the clinic. Patient vital signs were stable at the beginning and continued to be stable. No other signs or symptoms of an allergic reaction.
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| 56 | 2021-01-19 | tingling | Patient reports tingling in hands, nausea, and sweating with the first dose. |
| 56 | 2021-01-19 | tingling | had itching and tingling the next day. with in 2 days hives all over chest and arms. |
| 56 | 2021-01-20 | flushing |
Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mil...
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Site: Redness at Injection Site-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Fainting-Mild, Systemic: Patient felt faint then had an overall body flushing sensation, quickly went away shortly after vaccination-Mild
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| 56 | 2021-01-20 | muscle spasms | Hives Charlie horse in right leg, front calf |
| 56 | 2021-01-20 | pain in extremity, numbness |
On the day of vaccination (1/6/2021), I had arm pain and chills which continued into the next day. I...
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On the day of vaccination (1/6/2021), I had arm pain and chills which continued into the next day. I felt fine on 1/8/2021. On 1/13/2021 I began to have arm pain and shoulder weakness. The arm pain has resolved but I have transient numbness and the shoulder weakness is getting more and more painful.
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| 56 | 2021-01-20 | pain in extremity |
Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a sp...
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Body ache; Headache; Light fever; Sore arm; neck pain; It's swollen under my right arm; This is a spontaneous report from a contactable (patient). A 56-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm, on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included hydrochlorothiazide for hypertension. Patient reported that on Friday (Jan2021), she took her first dose of vaccine. She didn't have any reaction right away but after like 8 to 9 hours in Jan2021 she had body ache and headache, light fever. She knew this sore arm would be, it always will be there, she knew it's now under her arm, it's swollen under her right arm that she took the vaccine, was swollen. Patient took ibuprofen (MOTRIN, Expiry Date: Jun2023) 200 mg orally two times a day for treatment. Her body does not as hurt as it used to after taking it, but she still has neck pain and her arms still hurting and right now under her right arm that she took the shot that was swollen, patient said she still has 'this band' (not clarified further) in her neck right now. Patient works in the healthcare. She does cut skin. She took it at her work. Patient did blood test three months ago (Oct2020) at her doctor's office. Outcome of sore arm was not recovered, outcome of body ache was recovering, outcome of other events was unknown. Information on lot number/batch number was requested.
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| 56 | 2021-01-20 | pain in extremity | chills, sore arm, heart racing loss of appetite |
| 56 | 2021-01-20 | pain in extremity |
moderate tiredness; generalized achiness; mild chills/another episode of chills; Bad headache; sever...
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moderate tiredness; generalized achiness; mild chills/another episode of chills; Bad headache; severe nausea; Left arm pain-mild, less than flu shot pain; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received bnt162b2 (COVID 19, Pfizer, lot number: EL3246), via an unspecified route of administration on the left arm on 08Jan2021 16:45 at a single dose for an COVID-19 immunisation. Medical history included impaired gastroparesis, pancreatitis, hashimoto's thyroiditis, allergies: sulfa and adhesives. The patient's concomitant medications were not reported. The patient has known allergies with pethidine hydrochloride (DEMEROL). The patient is not pregnant. The patient has no COVID prior vaccination and was not COVID tested post vaccination. On 08Jan2021 at 19:45 (3 hours post vaccine), the patient experienced severe nausea that lasted for 29 hours; and left arm pain-mild, less than flu shot pain that lasted 3 days. At 22:45 (6 hours post vaccine), the patient had a bad headache that lasted 29 hours. On 09Jan2021 at 00:45 (8 hours post vaccine), the patient experienced mild chills that lasted 5 minutes, then 02:45 (10 hours post vaccine) another episode of chills that lasted 10 minutes. On 09Jan2021 at 04:45 (12 hours post vaccine), the patient experienced moderate tiredness and generalized achiness that lasted 24 hours. The patient recovered from severe nausea on 10Jan2021 00:45 and bad headache on 10Jan2021 03:45, recovered from left arm pain-mild, less than flu shot pain on 11Jan2021, recovered from chills on 09Jan2021 00:50, and recovered from moderate tiredness and generalized achiness on 10Jan2021 04:45.
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| 56 | 2021-01-20 | tremor |
3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. S...
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3 hours post innoculation, sore throat with swollen glands, chills, shaking and a mild headache. Shortly thereafter, started experiencing uncontrolled itching and my skin was bright red (flushed) from above pubic bone and up to top of my head. (nothing on lower extremities). No fever (98.1) and no visible rash. The itching became so uncontrollable, I took 25mg Benadryl and remained taking it every 4 hours until 1/21/21. A very fine, red rash appeared on 1/20/21 in the early morning. The rash was, mainly at my fatty areas, breasts, abdomen and hips, but the Benadryl helped to control the itching. The Benadryl did not take away the itching entirely. As of this morning, the rash has faded, but i'm still itching, mildly, in my abdomen and out edges of my breasts. I am going to try to stop the Benadryl this morning and see how I do. If not better, will go see my PCP.
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| 56 | 2021-01-21 | flushing | Flushing, dizziness, throat tightening, difficulty swallowing |
| 56 | 2021-01-21 | numbness | Systemic: numb from the neck up |
| 56 | 2021-01-21 | tremor | Chills, couldn?t get warm! Whole body couldn?t stop shaking, Pounding headache, Fever, & Vomiting. |
| 56 | 2021-01-22 | flushing |
At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was e...
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At the clinic today had who suffered an adverse reaction. When she came in for the vaccine she was extremely nervous due to a hatred for needles. She got the vaccine and within 5 minutes she turned red and her blood pressure sky rocketed to 203/104. She had no difficulty breathing, no rash, just flushed skin and high blood pressure. Her pulse was also elevated to 103. Due to, the ambulance was called. She expressed her wish to not go to the hospital multiple times due to being afraid of missing work and hating the hospitals. By the time the ambulance came her blood pressure was 203/104 with a pulse of 104. Her pulse ox remained at 98 on room air. From the minute she felt ill to the minute they left made sure she was breathing ok and showed no signs of anaphylactic shock. She had a history of panic attacks and GERD, with no blood pressure problems. She did also report an allergy to latex and penicillin prior to the vaccination. All products again were double checked to show her they were latex free. Patients blood pressure decreased at the hospital and was discharged with directions to follow up with her primary. They stated they aren't sure why her blood pressure increased so high.
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| 56 | 2021-01-24 | discomfort | Muscular pain and discomfort went to the doctor |
| 56 | 2021-01-24 | facial pain |
face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on ...
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face swelling and pain where I had dermal fillers put in in August 2020. Started with upper lip on 1/22/21 and then my eyes were swollen, bruised and painful upon waking 1/23/21 and lasted until early morning of 1/25/21. My whole face was sore to touch during this time. I also had fatigue and headache starting 1/21/21 which lasted a few days along with fever, chills, body aches and sore left armpit which started early morning 1/22/21. I had expected these last symptoms so was not alarmed. I was not warned about the facial swelling and that was a bit scary.
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| 56 | 2021-01-24 | tremor, flushing, hot flush, tenderness, tingling, pain in extremity |
significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness;...
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significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness; muscle weakness/lower leg feel shaky and weak and tingly; depersonalization; shakey/lower leg feel shaky and weak and tingly; mild nausea; arm pain; The caller would touch her hand but couldn't feel her hands, it was like they weren't hers; lower leg feel shaky and weak and tingly; hand on that same side was painful, but not unbearable, just uncomfortable; emotional; tearful; felt completely overwhelmed; This is a spontaneous report from a contactable consumer. A 56-Year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 12Jan2021 about 9:15am at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history and concomitant drugs were not reported. Weight: 175-180 lbs. No additional vaccines administered on same date of the Pfizer suspect vaccine. No prior vaccinations within 4 weeks. Past drug included rivaroxaban (XARELTO) been using the product more than 10 years and never had a problem with it, she didn't think that was related to her experience. Patient received first vaccine yesterday 12Jan2021. 45 minutes after receiving vaccine (12Jan2021 10 AM), she developed hot flashes in sternum (flushing sensation in her sternum or upper chest area. It was like when she had a dye injected), anxiety, dizziness/ light headedness, muscle weakness, significant dissociation, depersonalization, shakey, mild nausea, arm pain. The patient explained that this was why she was in the MRI scanner (Jan2021). This came a couple of times yesterday and had not been experienced this today (13Jan2021). It (dizziness) was ongoing and sporadic and had happened couple times yesterday and today. There were a few hours yesterday 12Jan2021 where she felt like herself but then it all started again last night. The patient reported feeling disassociated from her body, this was within about 20 minutes of the flushing and went in and out of being more or less alarming. She stated she felt disconnecting from where she was and space she was in, mentally. She knew where she was but could feel no connection to where she was or her body. The patient would touch her hand but couldn't feel her hands, it was like they weren't hers. This was during the half hour of the events occurring. She had mild nausea, this started not long after the flushing and it came and went a little bit but it was not too troublesome. The patient felt disconnect from her body and had shakiness like her lower leg feel shaky and weak and tingly. This happened on and off since the episodes started. The patient reported she slept great and had a few hours yesterday where she felt good. Her arm was tender, this might have been yesterday but she thought it was this morning and was only tender to touch. The hand on that same side was painful, but not unbearable, just uncomfortable. The patient apologized for being emotional and tearful. She felt completely overwhelmed. She couldn't believe that she put herself in this position and she was perfectly fine before the shot. She did contact her doctor. No AE required a visit to emergency room/ physician office. There had been no treatment, she didn't know what to do. She remarked she was not going back for the second dose. Outcome of event dizziness was not recovered, and the rest of events was unknown.
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| 56 | 2021-01-25 | flushing |
The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted ...
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The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted 4 3-4 days. I did seek medical attention at the emergency room day 3 and was hospitalized 1 day. I was found to have unexplained and unregulated hypoglycemia. The second shot I had body aches, headache, fever. I was able to manage my symptoms with Tylenol and Advil.
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| 56 | 2021-01-25 | hot flush | s/p 1st dose vaccine c/o feeling flushed with palpitations and dizziness |
| 56 | 2021-01-25 | pain in extremity |
Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all o...
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Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all over, can hardly move; This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via unspecified route of administration on 12Jan2021 between 13:30 and 14:00 at single dose in left arm for COVID-19 immunization. Patient worked in EVS. The patient medical history included rheumatoid, asthma, artery disease, gastroparesis. There is no family medical history. The patient concomitant mediations not provided. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 22Dec2020 at single dose in left arm for COVID-19 immunization. The patient had a headache with the first dose of bnt162b2 and a little bit of chest pain (stated she had heart troubles) (AER 2021050910). The patient experienced severe headache, nausea, and pain all over, can hardly move from 12Jan2021. Pain all over, can hardly move started at the night of 12Jan2021. It hurts so bad. The patient also experienced runny nose and left arm is hurting from unspecified date. There is no relevant tests. The outcome of events severe headache, nausea, and pain all over, can hardly move was not resolved. Nausea and pain all over, can hardly move was reported as worsened. The outcome of others event was not reported. Information about lot/batch number has been requested.
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| 56 | 2021-01-26 | pain in extremity, numbness, feeling hot |
Had a hot spot in my right palm that lasted 24-48 hours I think pretty soon after for sure on my ...
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Had a hot spot in my right palm that lasted 24-48 hours I think pretty soon after for sure on my drive home from work I noticed Right side of face felt funny then numb on cheek, whole side of right head top of scalp to jar and over to right ear x 8-10 days Sore arm, tiredness and fatigue x10 days and some numbness in hand x5 days
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| 56 | 2021-01-27 | weakness | Chills, joint pain overall felling tired and weak |
| 56 | 2021-01-27 | burning sensation |
Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and i...
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Swollen, Large Red whelp with hard knot inside arm. Burning and itching sensation. Ibuprofen and ice packs did not improve area.
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| 56 | 2021-01-27 | feeling hot |
Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After app...
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Experienced warm feeling, nausea and itching of lips within 10 minutes of administration. After approximately 40 minutes noted itching in throat. Returned to vaccination area approximately 60 minutes after injection for guidance and instructed to ED. Noticed lip swelling and facial swelling later in ED, had mask on entire duration, did not note when first occurred. Lip itching, throat itching relieved with Benadryl, prednisone and pepcid all given po, released to home after 4 hours observation. Throat itching persists on day 2, some relief with benadryl Q 4 hours.
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| 56 | 2021-01-27 | feeling hot |
Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizzines...
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Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizziness and I went out for help from a physician in hallway. Next thing I remember I was on an exam table and I had not strength in my limbs and core. I had a rash on neck and chest. They monitored my vitals and decided I needed to go to urgent care or ER. Since the urgent care was on the way to the ER they took me there. They moved me from wheel chair to ecam table. Gave me epi and Benadryl injections, prednisone by mouth and started an IV. They monitored my vitals and said if I worsened are didn't respond then they would send me to ER. They gave me some Pepcid and eventually over the 3 hours I was able to stand on my own and they decided to discharge me around 14:00, making sure that I had someone who could stay with me at home.
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| 56 | 2021-01-27 | flushing, pain in extremity, weakness |
metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chil...
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metal taste, flushing, palpitations, dizziness, nausea, headache 9pm arm sorness, severe aches, chills weakness, fatigue the next day aches, weakness and fatigue headache continued for 5 days fatigue and headache continues daily
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| 56 | 2021-01-27 | flushing |
started yawning 5 minutes, yawning multiple times a minute, could not even speak without yawning. S...
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started yawning 5 minutes, yawning multiple times a minute, could not even speak without yawning. Stopped yawning at 2pm then broke out in rash on trunk, neck, arms, face, flushed. Took 2 benadrdyl, monitored x 1 hr, rash subsiding, then started itching at 5pm all over, at 8pm left arm got blood red, throbbed x 30 min, took more benadryl. She has itched all over since day of vaccination and cannot get a deep breath.
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| 56 | 2021-01-27 | migraine |
On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw ...
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On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw my PCC provider. Woke up 1/17 with blurry vision and continued eye pain. Talked to my Rheumatologist 1/19. I saw my PCC in person 1/20. Got sent to ER got admitted. Had an MRI and a lumbar puncture. I was diagnosed with optic neuritis by the neurologist. I continued to do 5 days of out pt iv steroids.
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| 56 | 2021-01-27 | pain in extremity |
Sore arm after dose 1 (mild, ,resolved); Mild-Moderate side effects after dose 2 (headache, fatigue,...
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Sore arm after dose 1 (mild, ,resolved); Mild-Moderate side effects after dose 2 (headache, fatigue, muscle aches, dizziness, chills, sleeplessness) persisting past 48 hours and ongoing but fluctuating; At 72 hours: Injection site is red, with raised welt around 2 inches in diameter, with itching and warm to touch; ongoing.
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| 56 | 2021-01-27 | tenderness |
Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg ...
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Tenderness under arm, - lymph node association, mid to lower back, site swelling Ibuprofen 400 mg relieved symptoms
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| 56 | 2021-01-27 | tenderness | Body aches, Tenderness under right arm - lymph node association, mid to lower back pain, |
| 56 | 2021-01-28 | numbness, facial pain, tingling |
I feel ok during the observation period, after I left I felt pain on my face and numbness and tingli...
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I feel ok during the observation period, after I left I felt pain on my face and numbness and tingling. My face was swollen on the left side and my head on the left side hurt. I took some tylenol and went to bed. I had body aches. The body aches went away after the third day. Only my face hurt and it was kinda swollen. I called my doctor on the 5th day and he prescribed Gabapentin. The pain increased more and more each day.
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| 56 | 2021-01-28 | pain in extremity |
Body aches, Temp 100, left arm soreness treated with tylenol and ibuprofen. fever and body aches sub...
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Body aches, Temp 100, left arm soreness treated with tylenol and ibuprofen. fever and body aches subsided after 15 hours
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| 56 | 2021-01-28 | tingling, feeling hot |
close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken ...
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close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient). A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO). Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination. No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt "heat waves" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal. Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "close to passing out". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-28 | tingling |
CC: "Tingly hands & arms" After receiving her first series of her COVID-19 vaccine. Pt denies any di...
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CC: "Tingly hands & arms" After receiving her first series of her COVID-19 vaccine. Pt denies any difficulty breathing or any rashes/hives. Pt felt better after 30 mins and was cleared to RTW.
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| 56 | 2021-01-28 | unresponsive to stimuli |
She became acute short of breath. Called EMS. On their arrival she was nearly unresponsive. Bagge...
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She became acute short of breath. Called EMS. On their arrival she was nearly unresponsive. Bagged. NOT hypotensive. HYPERCARBIC. Difficult intubation. Transferred to our facility on VENT with bilateral pulmonary infiltrates, wheezy with size 6 ETT from outside facility.
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| 56 | 2021-01-29 | numbness, tingling |
Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands fa...
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Numbness tingling in bilateral hands and feet at 4 1/2 hours post vaccine then swelling of hands face lips and tongue. At 6 hrs post vaccine. Core temperature below 95. Severe headache , lightheaded dizziness at 4 1/2 post vaccine Severe muscle weakness and pain start at 8 hrs post vaccine . All symptoms last 48 hrs post vaccine Took aspirin, ibuprofen and Benadryl
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| 56 | 2021-01-29 | cold extremities |
18 hours after the second shot, I started feeling feverish with uncontrollable chills. My extremiti...
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18 hours after the second shot, I started feeling feverish with uncontrollable chills. My extremities were ice cold and for about an hour I couldn't feel my right thumb. I experienced waves of fever and chills for about 6 more hours with extreme body aches, headache, joint pain, and a foggy head. I was able to go to sleep that night but woke often. I was unable to work the next day due to extreme fatigue and slept most of the day. On the 13th, I was back to normal.
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| 56 | 2021-01-30 | numbness, weakness |
Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling an...
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Uncontrollable shivering for 3 hours, headache, numbness and tingling in hands and feet, swelling and redness at injection site, swollen armpit, chest pain, extreme tiredness and slept for 22 hours, weakness.
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| 56 | 2021-01-30 | numbness |
Distal third thumb numbness. Numbness in soft palate, tingling of the lips. Resolved after given Be...
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Distal third thumb numbness. Numbness in soft palate, tingling of the lips. Resolved after given Benadryl P.O. Discharged home with husband driving, advise to continue Bendaryl every 4-6 hours and to follow up with PCP.
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| 56 | 2021-01-31 | weakness |
Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest p...
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Generalized weakness; Numbness in lower lip; Prolonged malaise; Headaches; Poor equilibrium; Chest pain; Persistent increase in blood pressure; Intermittent tachycardia; This is a spontaneous report from a contactable nurse. This nurse reported for herself that the 56-year-old female patient who received econd dose of bnt162b2 (BNT162B2, COVID 19 Pfizer) via Intramuscular on 07Jan2021 04:00 PM on Left Arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included Known allergies: Taxotere and Breast cancer. Concomitant medications included Tamoxifen. The patient previously took first dose of bnt162b2 at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced Generalized weakness Numbness in lower lip Prolonged malaise Headaches Poor equilibrium Chest pain Persistent increase in blood pressure Intermittent tachycardia from 08Jan2021 3:00 PM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was unknown. No treatment received. No COVID prior vaccination. COVID tested post vaccination included Covid test post vaccination: Nasal Swab, PCR panel on 12Jan2021 with covid test result: Negative. Information Requested on Lot/ batch number.
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| 56 | 2021-01-31 | numbness, tingling | after second dose feel like mild flu and body aches, light headache and little nusia |
| 56 | 2021-01-31 | migraine |
Shortness of breath,chills,hot sweating. Later that night legs aching like a toothache all night sha...
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Shortness of breath,chills,hot sweating. Later that night legs aching like a toothache all night sharp shooting pain in left shoulder couldn't sleep. Next day chills nausea aching legs migraine. Couldn't eat. Still having problems with legs.
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| 56 | 2021-02-01 | weakness, feeling hot |
sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; se...
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sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-01 | breast pain |
fever, headache, muscle aches, diarrhea, nausea, breast on injection site painful, sore throat, righ...
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fever, headache, muscle aches, diarrhea, nausea, breast on injection site painful, sore throat, right ear ache, malaise
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| 56 | 2021-02-01 | flushing |
Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Pa...
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Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.
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| 56 | 2021-02-01 | hypersensitivity of all senses |
left armpit and under arm became swollen and tender to the touch; left armpit and under arm became s...
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left armpit and under arm became swollen and tender to the touch; left armpit and under arm became swollen and tender to the touch; arm remained somewhat sensitive to the touch; Patient was also extremely tired; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL1284, on 06Jan2021 09:30 Intramuscular at single dose in left arm for COVID-19 immunization. Medical history included Anxiety and depression, Chronic pain in right foot, tendinopathy of right foot since 2015, Derangement of medial meniscus, Environmental allergies, Fatty liver H/O, hypothyroidism since 25Jan2013, Health care maintenance, Hyperlipidemia since May2016, thyroid nodule since 25Jan2013, Obesity, Prediabetes. Concomitant medications included salbutamol (ALBUTEROL), levothyroxine and omeprazole. The patient previously received first dose of BNT162B2 lot number=EH9899 on 16Dec2020 11:00 AM via Intramuscular at left arm at 56-year-old. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch on 07Jan2021 08:00. Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve. Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch. Patient was also extremely tired for 2 days after the vaccine but otherwise fine. No treatment was received for all events. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The outcome of all events was resolved.
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| 56 | 2021-02-01 | pain in extremity, weakness |
Shot given on January 25. Legs sore most of week. Saturday evening, January 30 started having extre...
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Shot given on January 25. Legs sore most of week. Saturday evening, January 30 started having extreme soreness and weakness in hips. Extreme pain while standing and difficulty walking. Persisted and went to see regular doctor on 2/2/2021. No fever or other symptoms. Gave Toradol shot in hip. No relief. Soreness and difficulty walking continues
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| 56 | 2021-02-01 | pain in extremity, weakness |
General weakness; nausea; stomach cramps; high blood pressure; aches all over the body especially in...
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General weakness; nausea; stomach cramps; high blood pressure; aches all over the body especially in lower extremities; aches all over the body especially in lower extremities; severe headaches; This is a spontaneous report from a contactable nurse reported for self. This 56-year-old female patient the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) via an unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunisation. The patient is not pregnant. The patient had no other medical history. The patient had no known allergies. The patient concomitant medication was none. The patient previously received first dose of BNT162B2 (Lot number EL0140) at 22Dec2020 09:00 AM at single dose in left arm for COVID-19 immunisation. The patient experienced general weakness, nausea, stomach cramps, high blood pressure, aches all over the body especially in lower extremities, severe headaches on 17Jan2021. These events resulted in emergency room/department or urgent care. The patient received amlodipine besilate (NOVARSC) 5mg, hydroxyzine (ATARAX) for treatment. The patient had no COVID prior and post vaccination. The patient was recovering from the events.
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| 56 | 2021-02-01 | pain in extremity, weakness | finger joints pain and weakness |
| 56 | 2021-02-01 | pain in extremity |
After dose #1- sore left deltoid lasting for 1 week and severe fatigue lasting for 48 hrs. After do...
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After dose #1- sore left deltoid lasting for 1 week and severe fatigue lasting for 48 hrs. After dose #2-12 hours post injection, myalgias, chills and cough set in. Took to bed and became febrile @100.4, noted a metallic taste in mouth a/w headache. Lasting 48 hours.
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| 56 | 2021-02-01 | unresponsive to stimuli | Employee was found unresponsive in floor at her home. EMS arrived and person had expired. |
| 56 | 2021-02-02 | weakness, inability to speak |
syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck througho...
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syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-03 | weakness, cold sweat |
severe stomach pains; bad headache; dizzy; Didn't have any energy and strength; Cold sweats; Nauseou...
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severe stomach pains; bad headache; dizzy; Didn't have any energy and strength; Cold sweats; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 20Jan2021 at 02:45 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history included chronic lyme disease. Concomitant medications were not provided. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 23Jan2021 at 12:00 AM patient had severe stomach pains with a bad headache. Shortly after she got dizzy, did not have any energy and strength. She had cold sweats. Patient tried sips of water, but it made her nauseous. This all happened all at once and it hit patient hard in the middle of her work. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events.
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| 56 | 2021-02-03 | discomfort |
In the beginning I didn't have any issues, I was fine. I went to bed and woke up at 2am and started ...
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In the beginning I didn't have any issues, I was fine. I went to bed and woke up at 2am and started vomiting like I never before and had diarrhea , a fever of 101.3. My fever dropped in three hours back to normal which was weird. It was strange. The diarrhea lasted for days, it was uncontrollable . The vomiting lasted for three days, it was non-stop. I had this headache that was unbelievable . Since having Covid I get headaches daily. I had Covid in March 2020. I lost 4lbs in three days and I called my Dr. He said You need to go the ER right now. I went to the ER and had to wait three hours, I had aches and pain like the flu, I was totally out of it. They did a Cat scan, and blood work was normal. They gave me IV fluids, IV Tylenol and Tramadol. They did a Covid and flu test, both were negative. Then they gave me a shot of Fetanal , that took away my headache for 30 minutes. At this point I didn't have any more vomiting or diarrhea . I stayed about 8 hours in the ER and went home. I was told by my Dr. not to get the next shot.
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| 56 | 2021-02-03 | face paralysis, tingling |
56 year old female presents with complaint of tingling and numbness that she noticed to her lower le...
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56 year old female presents with complaint of tingling and numbness that she noticed to her lower left jaw. It occurred yesterday around 3 PM after she received her Covid vaccination. She states that then started to move up to her left cheek but has now gone back down just to the lower left jaw. It is in a specific region of that area. She states also that she is having a fever today and generalized body aches that are moderate in nature. She also notes some urinary frequency without dysuria or hematuria. Patient took Tylenol this morning around 6 AM. She initially tried to swallow the pill and felt like she was going to choke on it and spit the pill up. She then sat down for a few minutes and was then able to take the pill. She denies any actual stridor or wheezing. No focal weakness or numbness of one arm or leg. No change in speech. Differential diagnoses include but are not limited to: CVA, TIA, anxiety reaction, paresthesia, metabolic process, bleed, vaccine reaction. 56-year-old female with paresthesia to the left chin. Otherwise normal neurologic examination. The TPA window given symptoms started yesterday. I will get a head CT but I do not feel the patient needs an MRI. Given the fact the patient does have autoimmune disorder, blood cultures and lactic acid obtained. I suspect that her fever is in response to her Covid vaccine yesterday. Covid test negative. Urinalysis no evidence of UTI. Chest x-ray is clear. Head CT negative. On reevaluation after Motrin patient feels much improved. At this time I think she is stable for discharge to home. I do not think this is Bell's I am finding no facial weakness on my examination. Follow-up and return precautions discussed patient understood
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| 56 | 2021-02-04 | discomfort, tingling, numbness |
Woke up suddenly at 1am on 2/5/2021 with increasing neurological symptoms similar to a migraine aura...
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Woke up suddenly at 1am on 2/5/2021 with increasing neurological symptoms similar to a migraine aura. There was a no obvious pain, but a sense of deep heaviness/pressure/sinking/dizziness in my head and body. Bilateral tingling/numbness, but still was able to move legs and arms. Did not lose consciousness. My first thought was seizure or stroke. I later spoke to an infectious disease doctor that thought it may be brain vessel spasm due to inflammatory response from vaccine. I had no side effects from first COVID shot other than arm pain.
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| 56 | 2021-02-04 | hot flush |
After vaccines I get hotflashes all day and night. My temperature has remained normal; This is a spo...
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After vaccines I get hotflashes all day and night. My temperature has remained normal; This is a spontaneous report from a Non-contactable Other-HCP (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EH9899, via an unspecified route of administration from 21Dec2020 16:00 to 21Dec2020 16:00 (at the age of 56-years-old) as a single dose in the right arm, for COVID-19 vaccination. The patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from 11Jan2021 as a single dose in the right arm lot number EK9231, for COVID-19 vaccination. Medical history included autoimmune illnesses from an unknown date and unknown if ongoing , many allergies from an unknown date and unknown if ongoing , occasional hot flashes (before vaccines I got only occasional hot flashes) from an unknown date and unknown if ongoing Before vaccines I got only occasional hot flashes. There were no concomitant medications. The patient was administered the vaccine in hospital. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced before vaccines she got only occasional hot flashes. After vaccines she got hot flashes all day and night on 22Dec2020. Her temperature has remained normal. No treatment was received for the event. The patient underwent lab tests and procedures which included temperature: remained normal on 22Dec2020. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-02-04 | pain in extremity |
Arm aching/arm started aching on 20Jan2021, little by little and was worsen on 21Jan2021; arm aching...
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Arm aching/arm started aching on 20Jan2021, little by little and was worsen on 21Jan2021; arm aching, it is just like when got a flu shot three months ago, arm hurts happened; Got the COVID Vaccine on 20Jan2021. second dose will be on 17Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL929), via an unspecified route of administration at site of left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing Type 2 diabetes (diagnosed about 10 years ago) and ongoing high cholesterol (diagnosed about 10 years ago). Concomitant medications included ongoing unspecified blood pressure medication to protect her organs. She did not have any issues with her blood pressure. The only thing she was experiencing is her arm aching. But it was just like when she got a flu shot, her arm hurts happened. She got the flu shot on Oct2020 (about 3 months ago), along with the shingles shot and the pneumonia shot. Her second dose will be on 17Feb2021. Her arm started aching on 20Jan2021 little by little and was worsen on 21Jan2021. No treatment received for adverse events. She did not like to take medication and pain pills. The outcome of events was not recovered.
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| 56 | 2021-02-04 | tremor | chills, shakes, body aches, 100.8-103.9 fever, fatigue |
| 56 | 2021-02-05 | weakness |
56-year-old female presents via video visit today for symptoms that started after her second Covid v...
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56-year-old female presents via video visit today for symptoms that started after her second Covid vaccine on January 29. Patient states that she started developing headache 1 week ago now with extreme fatigue, chills, body weakness and nausea. Patient has no congestion, cough, fever, soreness, vomiting or diarrhea. She was doing fine the first few days after the vaccine but today symptoms worsen with new onset of nausea, weakness. She has been drinking turmeric tea. Has not been taking any NSAIDs. She feels "winded" even doing a load of laundry. She also reacted to the first dose of vaccine with a prolonged headache.
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| 56 | 2021-02-05 | difficulty speaking |
56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her secon...
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56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her second dose of the Pfizer COVID-19 mRNA vaccine and subsequently developed generalized pruritis five minutes after. She developed similar symptoms 6 hours after receiving the first dose, but this time was more severe. She arrived to the emergency department and after 15 minutes began to develop a cough, increased work of breathing, and voice changes. She received 0.3 mg epinephrine subcutaneously and albuterol nebulizers. Over her three hours in the department she received famotidine, 125mg methylprednisolone, diphenhydramine, an additional dose of epinephrine and 4x albuterol nebs. However, he dyspnea continued to return, and she was admitted. Improved overnight and was discharged HD2. widespread pruritis initially 5min post-Pfizer vaccination (2nd dose). Progressed to severe coughing, dyspnea requiring repeated doses of epinephrine and albuterol. Admitted to intermediate unit for further cares. Noted to have had mild delayed pruritis prior to first dose of pfizer vaccine.
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| 56 | 2021-02-05 | pain in extremity |
Received dose #2. That evening, developed headache and dizziness, arm pain. 1/7-arm pain radiating d...
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Received dose #2. That evening, developed headache and dizziness, arm pain. 1/7-arm pain radiating down the ribs, extreme fatigue, body aches, dull headaches. 1/8- chest tightness, temp 99.8, body aches, fatigue, dull headache. Only able to dose with Tylenol. 1/12-follow up: states doing well and all symptoms subsided.
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| 56 | 2021-02-05 | pain in extremity |
Right Arm ache and Head Pressure and Headache. Used icepack for right arm and used cool compress fo...
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Right Arm ache and Head Pressure and Headache. Used icepack for right arm and used cool compress for headache.
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| 56 | 2021-02-06 | flushing | "feeling flushed and tight neck" |
| 56 | 2021-02-07 | feeling hot |
Headache 1 hour after vaccine. Chills the next morning at 6:00am, followed by headache and periods o...
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Headache 1 hour after vaccine. Chills the next morning at 6:00am, followed by headache and periods of being hot after taking Advil
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| 56 | 2021-02-07 | night sweats |
Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - w...
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Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - went home & went to bed, slept through night and had sweats on and off. Post vaccine day 2- Fatigue, abdominal discomfort and pressure, constipated. Nausea and vomiting developed, with dehydration. Constipated, symptoms consistent with Crohn's flare. Went to ER but due to long wait was not seen by physician. Gradually improved, saw GI specialist day 4, felt much better by day 6. Bowels not quite back to normal 2 weeks later
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| 56 | 2021-02-07 | throat numbness, numbness, weakness, tingling |
within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next da...
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within 5 minutes of receiving the vaccine, my left arm became numb & weak & resolved by the next day; 1-2 hours later my legs/feet from the knees down became numb/tingling with tightening muscles; 2 hours later left side entire face became numb with puffy left eye lid which lasted for 8 days; by the 8th day my symptoms began to resolve only to return with 4 days with left face/throat numbness & left side numbness/tingling with tightening forearm muscles both hands/fingers/arms from elbows down & numbness/tingling/muscle tightening in both legs/feet/toes from the knees down along with pain in both knees which lasted another 2 days; I continue to have some residual symptoms of numbness on the left side of my face that comes and goes as well as the same symptoms of numbness/muscle tightening and tingling in both legs/feet that comes & goes.
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| 56 | 2021-02-07 | tenderness |
This was my first vaccine. I had Covid last March. As of Jan 2021 i still had some antibodies in my ...
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This was my first vaccine. I had Covid last March. As of Jan 2021 i still had some antibodies in my body. After 12 hours i began to get chills and my skin was very achey. I took advil because when i was very sick with covid and too tylenol every 6 hours it didn't lower my temperature or take away any of my pain. two hours later, i had a stomach ache. While having a bowel movement i fainted onto the floor and ended up with a black eye. i do not pass out from having bowel moments otherwise. My cheekbone was sore to the touch for a week.
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| 56 | 2021-02-09 | pain in extremity |
Face and scalp itching, headache, fever, pain to soles of feet, extreme fatigue, body and joint pain...
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Face and scalp itching, headache, fever, pain to soles of feet, extreme fatigue, body and joint pain. Started approx 3 hours after injection and is continuing on day 3, but symptoms are lessening some. Tylenol and Motrin and rest treatment. Contacted my physician for further advice or treatment needed.
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| 56 | 2021-02-10 | cold sweat, pain in extremity, feeling hot |
While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating,...
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While waiting the 15 minutes after vaccine, after 8 minutes, my body got very hot, clammy, sweating, and about to pass out. Nurse took my oxygen levels and heart rate, below 40. Blood pressure very low. Called 911. Put oxygen on me, gave me Epipen, and checked sugar levels. Next heart rate, a few minutes after first one, 40 heart beats and blood pressure coming back up. Gave me water and orange juice. Next check, heart rate up to 88 and blood pressure they said was getting back to normal but don't remember numbers. I was still trying to feel back to myself after a half hour to 45 minutes. My doctor says not to get 2nd dose in which I'm due on 2/21/2021. I started to feel back to myself around an hour later. I did not go to hospital due to me feeling better. After shot, regular symptoms, sore arm, fatigued, lymph nodes felt swollen, and sniffles and sneezing. No fever. I called my physician on 2-1-2021 to let her know what happened.
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| 56 | 2021-02-14 | feeling cold, tingling |
1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels res...
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1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels rested or wants/needs to sleep, a lot. Noticed abdominal pain, but did not connect the two. 2/11/2021- 2nd dose- Two hours later (approx) moderate pain at site, my head/mind felt "off", out of sync like one side of brain slower, affected balance. It was strange, and unpleasant. 2/12/2021- Groggy, face/eyes swollen, did not feel well, but not so bad I could not go to work. It was a 50 mile drive, and as I drove the same feeling of not thinking straight did not want to drive. The feeling of being unwell escalated quickly. Congestion, muscle aches throughout, sore throat, chills, and a need to catch my breath caused dizziness. I pulled over, called work, and made my way home where I went directly to bed. My head ached, abdominal (sharp) pains, especially after ingesting fluids. or food similar to gall bladder pain, but not close to its worse intensity still, continues. 2/15/2021- Update- Nearly 96 hrs. passed: What remains is: Feeling exhausted, need to sleep, more frequent and intensifying abdominal pains, headaches, pain in left lung/easily winded, and site pain expansion. Injection arm (left) pins & needles, and fingers ice cold, neck pain (stiffness).
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| 56 | 2021-02-14 | hot flush |
After first dose severe headache for two days with some dizziness. After second dose sleepless that...
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After first dose severe headache for two days with some dizziness. After second dose sleepless that night then around 4AM chills and hot flashes with sweating, got up to walk around and had shortness of breath, teeth chattering, slept most of Friday had aches, headache, nausea.. had to concentrate on not vomiting, heightened sense of smell, had 101.7. Saturday initially felt ok the terrible headache and nausea, achey and still 101.7 temp. Sunday initially felt good and then with the headache, nausea, shortness of breath, achey, 101.7 temp. Monday felt ok all day until around 5pm and then chest hurt and shortness of breath.
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| 56 | 2021-02-14 | pain in extremity | My arm is hard and feels like I have a knot in my arm. The area where I got the injection is warm |
| 56 | 2021-02-14 | tingling | Numbness lower face; swelling lower face and tongue; lump in throat (throat closing); extreme thirst |
| 56 | 2021-02-15 | bell's palsy | left-sided bells palsey |
| 56 | 2021-02-15 | feeling jittery, tremor |
patient reported to observers feelings of anxiety, jitteriness, shaky hands, and chest itchiness. As...
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patient reported to observers feelings of anxiety, jitteriness, shaky hands, and chest itchiness. Assessment performed respirations counted and were within normal limits, clear respiratory sounds. had patient sit near the door for cooler air, symptoms continued and Benadryl was given. Paramedics arrived and further assessment was completed and she refused to received further treatment in the ambulance and was allowed to go home. LVN and RN assessed further and patient stated symptoms no longer present 20 minutes after Benadryl was given.
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| 56 | 2021-02-15 | numbness |
2/4 Headache, dizziness, neck and shoulder aches, left hand and foot numbness which continued into 2...
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2/4 Headache, dizziness, neck and shoulder aches, left hand and foot numbness which continued into 2/5.
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| 56 | 2021-02-15 | pain in extremity, flushing |
1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt...
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1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt went to work and felt out of it, overall unwell feeling, went to walk in clinic, blood pressure was high even after meds, EKG showed tachycardia but normal rhythm, pt went home went to bed at 2 PM slept until next morning, 1/9/21 fatigue, swollen lymph node under left arm, small lymph node in neck also swollen, headaches, flushed/grey looking, as of 2/16/21 pt is feeling much better
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| 56 | 2021-02-16 | weakness | Vomiting, fevers up to 102, dizziness, weakness, body aches. |
| 56 | 2021-02-16 | pain in extremity, feeling cold, burning sensation |
massive headache, 11 hours post vaccination at midnight. Extreme arm pain, throbbing, burning, join...
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massive headache, 11 hours post vaccination at midnight. Extreme arm pain, throbbing, burning, joints felt swollen, extreme abdominal pain (like someone wrenching my intestines and organs), aching neck, body pains and felt like I was freezing btwn midnight and 3 am. Had lay still in a fetal position for it to calm down at 3am.
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| 56 | 2021-02-18 | pain in extremity |
Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and ...
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Arm pain but it was tolerable, but extreme joint pain, as well as extreme muscle pain, fatigue, and eye pain. Tinnitus and dizziness. Also had chills. Remained pretty consistent for a day and half.
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| 56 | 2021-02-18 | tingling | Tingling of the feet, fever, chills and body pains |
| 56 | 2021-02-21 | pain in extremity, weakness |
Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness ...
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Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness to her left arm followed by general myalgias to her body and weakness. She states she sx have not resolved and has only been taking ASA. Rx Voltaren gel and Tizanidine refill given.
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| 56 | 2021-02-21 | tremor, muscle twitching, flushing |
Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was cal...
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Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM 56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started "twitching everywhere" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies. No evidence of anaphylaxis or airway compromise. Discussed rebound potential; feel home observation reasonable. Instructed on antigen avoidence. Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved. Patient feels better by 1pm and goes home.
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| 56 | 2021-02-22 | hot flush, flushing |
Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes...
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Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3302) via intramuscular, on right arm on 02Feb2021, 10.30 at single dose for COVID-19 immunization. The medical history included allergies to bees and nickel, GERD (Gastro-oesophageal reflux disease). The concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on an unknown date in 2021. The patient previously received historical vaccine, first dose of bnt162b2 (Brand: Pfizer, Lot number: EL0140) via intramuscularly on left arm at 9.30 on 12Jan2021 for COVID-19 immunization. It was reported that at 10.45 on 02Feb2021, the patient experienced chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes. The patient was not pregnant at the time of vaccination. The patient received most recent COVID-19 vaccine at nursing home/senior living facility. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received Tylenol Pm within 2 weeks of vaccination. The patient visited emergency room for the events. Therapeutic measures were taken because of events via oral and subcutaneous. The patient had not diagnosed with COVID-19 prior to the vaccination and since the vaccination. The outcome of the events was recovered on an unknown date in 2021.; Sender's Comments: The association between the events chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes with BNT162B2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-22 | tingling |
Since the vaccine, I have had intermittent tingling of the tips of my fingers. It is all day, includ...
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Since the vaccine, I have had intermittent tingling of the tips of my fingers. It is all day, including during the night but it comes and goes. Both hands have the tingling finger tips.
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| 56 | 2021-02-23 | weakness, pain in extremity | I had chills, weakness and then fever; weakness; sore arm and soreness under armpit |
| 56 | 2021-02-23 | flushing |
Approx 10 minutes after the immunization the patient started showing s/s of difficulty breathing and...
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Approx 10 minutes after the immunization the patient started showing s/s of difficulty breathing and c/o itching. The patient was very flushed. Mouthed "I can't breathe". Wasn't able to speak a full sentence. Staff at the clinic first administered IM Benadryl out of the emergency bag, with Epinephrine on stand-by. About 2 minutes after the Benadryl was given, she started showing signs of breathing easier, and was starting to speak to staff. She said her doctor's office was across the street and he told her to go to his office if there was any reaction. She was able to walk out on her own, accompanied by her friend who was able to take her to her doctor's office.
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| 56 | 2021-02-24 | flushing |
Patient 56 years old presenting after adverse reaction to the COVID-19 vaccine. Patient reports fee...
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Patient 56 years old presenting after adverse reaction to the COVID-19 vaccine. Patient reports feeling very flushed and had itchy throat. Patient reports it went away after few minutes and then came right back. Patient denies any shortness of breath or difficulty swallowing. Patient denies any lip, tongue swelling. Patient did not take anything prior to arrival. Patient has had anaphylactic reaction to chemo before but never any vaccine.
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| 56 | 2021-02-24 | pain in extremity |
Shoulder soreness, day after shot. Arm soreness and painful for over two weeks with severe pain and ...
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Shoulder soreness, day after shot. Arm soreness and painful for over two weeks with severe pain and arm mobility pain began after three and diagnosis of SIRVA, shoulder injury related to vaccination administration four weeks after vaccination.
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| 56 | 2021-02-24 | tingling, cold sweat | Chest pain, difficulty breathing, tingles in the face, tongue swelling, cold sweats |
| 56 | 2021-02-25 | inability to speak, one side paralysis, facial paralysis |
15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport ...
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15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport to ER, Left side weakness, loss of speech. Er evaluated for sudden onset left sided weakness, facial droop.Code stroke was called CT angiography was unremarkable and patient admitted for bp control. Bp normalized with Clonidine , neurological exam is stable. Md felt that thus was a combination adverse reaction to vaccine in combination with Wellbutrin. Discharge after 24 hours
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| 56 | 2021-02-25 | facial paralysis |
To whom it May concern: I want to report that after the first dose of Pfizer's COVID-19 vaccine I su...
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To whom it May concern: I want to report that after the first dose of Pfizer's COVID-19 vaccine I suffered from peripheral facial paralysis and it affected my mouth. My right upper lip does not rise and I have trouble eating, drinking, and washing my mouth. This is the first time something like this has happened to me. Thanks for your attention.
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| 56 | 2021-02-25 | numbness |
Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As...
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Woke up the next morning and she felt numbness in her ear. She could hear, but it felt muffled. As the day went on she realized that her ear was ringing. It started as a buzzing and now a high pitched ringing that she still has in her left ear. She also had a nose bleed that occurred twice on her right nostril. She has had nose bleeds in the past, but none recently. She was sitting working and her nose just started bleeding. The vaccine site itself was sore, minor and not unbearable. It's just the humming and buzzing in her ear that will not go away.
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| 56 | 2021-02-26 | pain in extremity |
Delayed reaction to both shots. 11-12 days after, low grade fever ( continues) Lower leg pain, mild...
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Delayed reaction to both shots. 11-12 days after, low grade fever ( continues) Lower leg pain, mild chills each evening.. last shot 2/11
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| 56 | 2021-02-27 | numbness, tingling |
Almost immediate left shoulder tingle. Tingle progressed up to shoulder, collarbone area, left side...
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Almost immediate left shoulder tingle. Tingle progressed up to shoulder, collarbone area, left side of neck, underside of chin. Some numbness accompanied the tingling. Left cheek and left ear felt hot (internally). These symptoms never worsened. Subsided approximately 2-3 hours after vaccination. About 6 hours later, my left calf was incredibly itchy. I took a Benadryl and went to bed. Felt normal the next day.
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| 56 | 2021-02-28 | cold sweat, feeling hot |
almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very ...
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almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very low; kept taking my Blood Pressure and pulse ox. Both very, very low; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: reported as 96.8), via an unspecified route of administration in the left arm on 31Jan2021 14:15 at a single dose for covid-19 immunization. The patient's medical history included Lupus, Fibro, Hyperthyroidism, Hashimoto's, IBS all from an unknown date. Patient has no known allergies. Concomitant medication included pantoprazole, xylometazoline hydrochloride (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]), vitamin c [ascorbic acid], vitamin d3 and calcium (CALCIUM). 15 minutes after the shot while waiting, 8 minutes into it the patient felt dizzy, clammy, hot, and almost passed out. Nurse gave patient oj, oxygen, Epipen, checked sugar, and kept taking her blood pressure and pulse ox. Both very, very low until it came back up within 20 minutes. The patient declined hospital due to feeling better. Called the doctor next day to discuss what happened. She recommended no 2nd shot. The outcome of the events was recovered. The patient has not had Covid prior to vaccination and patient has not tested post vaccination.
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| 56 | 2021-02-28 | difficulty speaking | Since the vaccine I have noticed an increase in throat irritation--I cannot talk or sing well. |
| 56 | 2021-02-28 | hot flush, feeling hot |
At 10:45 AM pt c/o feeling "hot" states gas "hot flashes" Offered water to drink, with resolution o...
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At 10:45 AM pt c/o feeling "hot" states gas "hot flashes" Offered water to drink, with resolution of symptoms. No nausea or itching. BP 110/72, HR 66, SO2 93
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| 56 | 2021-02-28 | muscle spasms, pain in extremity |
legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing mo...
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legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 09Jan2021, at single dose, for COVID Prevention/COVID-19 immunization. Medical history included heart palpitations. Concomitant medication included unspecified medication for heart palpitations. The patient did not receive any other vaccines on the same day as BNT162B2. On 09Jan2021 (the same day as the patient received the vaccine), she developed sore arm which went on about for three days. The patient reported she put rubbing alcohol on it and that helped. On 12Jan2021 (day three after the vaccine), the patient experienced leg cramps and stomachache which went on about for 24 hours. The patient reported that she has a history of heart palpitations, but when she got the vaccine, on 12Jan2021 (day three after the vaccine), she felt her heart started rushing more, she had rapid heartbeat, but then she got it under control. She reported she has some pills for that, so she took an extra dose of her pills and that helped out with the palpitation. The patient recovered from the event sore arm on 12Jan2021; from leg cramps and stomachaches on 13Jan2021; and from "has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat" on an unspecified date.
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| 56 | 2021-03-01 | tingling, burning sensation |
On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke o...
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On Tuesday morning after receiving 2nd vaccination the previous Friday afternoon, I suddenly broke out in hives on both arms and across upper torso that alternated between itching and burning like fire. It quickly spread over entire body. I called my PCP to speak to a nurse and while on the phone, I begin experiencing tingling around nose and mouth, nose stuffed up making breathing difficult, and tongue became numb. PCP office told me to hang up and go to the nearest emergency room.
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| 56 | 2021-03-02 | numbness |
After getting the vaccine and driving home, one side of my face started to feel like it was getting ...
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After getting the vaccine and driving home, one side of my face started to feel like it was getting a little numb. It has stayed the same all day and has not gotten worse. There has been no facial drooping. Also, I have had a metal taste in my mouth.
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| 56 | 2021-03-02 | numbness |
VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CL...
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VOMITING for two days after shot and ondansetron prescribed, SWOLLEN GLANDS ON LEFT SIDE NECK AND CLAVICAL AREA, NUMBNESS IN HANDS AND FINGERS, RAISED BLOOD PRESSURE, 103F FEVER on DAY AFTER SHOT
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| 56 | 2021-03-02 | pain in extremity |
12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R s...
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12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination Later that evening, I had tightness on R side chest. Rapid HR. Pulse 144. Lasted 3-4 minutes. Called 911. HR had gone back down to 78, normal BP, normal EKG. Tachycardia 1/11 lymph nodes swollen under armpit on R side. Sore arm. Had another episode 2 days later; Tachycardia. Went to Dr 1/13/2021. Full work up. Started on BP medicine.
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| 56 | 2021-03-02 | tremor |
tremors of hands, feeling like shaking inside all over, difficulty texting, typing, and signing my n...
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tremors of hands, feeling like shaking inside all over, difficulty texting, typing, and signing my name
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| 56 | 2021-03-03 | weakness |
Onset of symptoms was about 15 hrs following injection: Severe reflux and gastric distress (nausea);...
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Onset of symptoms was about 15 hrs following injection: Severe reflux and gastric distress (nausea); chills; fever to 100.8; muscle, bone and joint aches; severe fatigue; weakness; slight headache, no appetite. Alleviated somewhat with naproxyn sodium and benadryl. I also felt like I had cardiac arrhythmias. Slept most of day on 2/27. Felt improved morning of 2/28 and back to "normal" Monday 3/1.
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| 56 | 2021-03-03 | bell's palsy, muscle twitching |
Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one...
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Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiry date not reported), via an unspecified route of administration at the right arm on 20Feb2021 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EL9265, expiry date: not reported) in the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization but experienced face numbness and swelling throat/ear canal on right side. It was reported that the second dose was even worse than the first time and involved continued eye twitching and significant dizziness. The patient had not sought medical attention yet, but if it continued to get worse, she would call her doctor or (helpline number). The patient reported that it almost feels like Bell's Palsy on an unspecified date. It was unknown if treatment was received for Bell's palsy. Clinical outcome of Bell's palsy was not recovered, while for eye twitching and dizziness was unknown.
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| 56 | 2021-03-03 | numbness |
swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbnes...
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swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration at the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 30Jan2021 10:45, both times the patient had right face numbness (felt like Novocaine) that started in her right cheek and spread to her lips and up into her eye and ultimately radiating throughout her head, and also swelling throat/ear canal on right side. It was unknown if treatment was received for the events. Clinical outcome of the events was not recovered.
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| 56 | 2021-03-03 | pain in extremity |
Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nau...
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Extreme Body aches, extreme headaches, extreme chills, fever 105.2, pain in the arm, dizziness, nausea, fainted at 6 pm on 02/27/21,, no response or movement. Blood pressure dipped down to 60/42 ...Ambulance came. EMT measured the blood pressure... 60/42 Was taking Tylenol 2 tablets of 500 mg. (max out) Fever will go down for an hour but would be back with extreme chills. Symptoms Fever, chills, body aches persisted for 30+ hours.
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| 56 | 2021-03-04 | bell's palsy |
4 days post vaccine I got Bells Palsy. Went to hospital for diagnosis on 5th day. Put on predniso...
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4 days post vaccine I got Bells Palsy. Went to hospital for diagnosis on 5th day. Put on prednisone and valtrex. Total paralysis on left side of face. Currently under the care of a neurologist, opthalmologist, acupuncture, massage and general practiioner. I tested COVID positive on 1/7 and 1/21. Tested negative on 1/28. Received vaccine 25 days after negative test.
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| 56 | 2021-03-04 | feeling hot | Warmth in body |
| 56 | 2021-03-04 | pain in extremity | Sore upper arm |
| 56 | 2021-03-05 | muscle spasms, muscle twitching | Muscle Spasms, twitches around mouth, muscles feel tight |
| 56 | 2021-03-06 | breast pain |
Right breast tenderness/mild pain, starting approximately 18 hrs after vaccine, lasting approximat...
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Right breast tenderness/mild pain, starting approximately 18 hrs after vaccine, lasting approximately 48 hrs. Fatigue beginning approximately 3 hrs post vaccine, lasting approximately 48-72 hrs.
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| 56 | 2021-03-06 | feeling hot |
Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute wa...
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Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute waiting zone as she has had anaphylactic reactions in the past. At 2008 patient stated she felt hot. She had a rash developing on her neck, noted a dry mouth and thickening tongue. EMS brought in for evaluation. Blood pressure 204/102, pulse 65, oxygen 100% on 2L nasal cannula. 50 mg benadryl administered IM left deltoid 2011. 20g PIV started left antecubital, 125 mg administered. Ambulance on site. Patient able to speak clearly, verbalized the need to void her bladder. Patient accompanied by 2 RNs to the restroom. She was stable on her feet, escorted back to EMS stretcher. She was taken to hospital. VAERS submitted.
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| 56 | 2021-03-06 | tingling, numbness | Tingling, numbness to right cheek and chin. Cleared by medics. |
| 56 | 2021-03-07 | feeling hot |
patient received first Covid 19 vaccine, placed in observation after 15 minutes patient complained o...
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patient received first Covid 19 vaccine, placed in observation after 15 minutes patient complained of feeling dizzy and felt hot. Vital signs taken, BP- 118/70, HR- 88, Sats 99%, offered water accepted and consuming , patient observed for another 15 mins for total of 30 mins, voices that she feels better with dizziness and feeling hot now gone.
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| 56 | 2021-03-07 | feeling hot |
Extreme hot, sweating, rash and itching all over chest, neck, back, red and horrible itch on face a...
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Extreme hot, sweating, rash and itching all over chest, neck, back, red and horrible itch on face and head, out of breath, fast heartbeat, dizzy
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| 56 | 2021-03-07 | numbness, facial paralysis |
Possible throat swelling, facial numbness/droop to the rights side. Vaccine administered in right ar...
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Possible throat swelling, facial numbness/droop to the rights side. Vaccine administered in right arm. Benadryl 50 mg administered to left arm IM, transport recommended but the family stated she would seek medical care and declined transportation.
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| 56 | 2021-03-07 | migraine | Migraine that lasted 36 hours, 101.7 fever (not sure how long), chills, muscle and joint ache |
| 56 | 2021-03-07 | pain in extremity |
Headache; Tired; Arm soreness; This is a spontaneous report from a contactable consumer, the patient...
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Headache; Tired; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3247), dose 1, single dose via an unspecified route of administration in the left arm on 14Jan2021 at 20:30 for COVID-19 vaccination. There was no relevant medical history. There were no known drug allergies. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D), estradiol (VIVELLE) patch .05 estrogen only and famotidine (PEPCID). On 04Feb2021 at 12:00, the patient had headache, tired and arm soreness. No treatment was received for headache, tired and arm soreness. The clinical outcome of headache, tired and arm soreness was recovered.
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| 56 | 2021-03-07 | pain in extremity |
Immediately following injection felt fine with only minor soreness in arm. 24 hours post injection, ...
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Immediately following injection felt fine with only minor soreness in arm. 24 hours post injection, chills, fatigue, headache, neckache, backache, nausea, throbbing pain in arm. Symptoms persisted 5:00 PM through 3:00 PM following day. Symptoms kept me in bed unable to function.
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| 56 | 2021-03-08 | pain in extremity |
On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm...
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On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm my left eyes was bloodshot. Really, really red. I put some over the counter eye drops in both eyes on Tuesday night and Wed every 4 hours. Redness subsided 24 hours later, but eyes were still itchy. They Thursday night my left gland started swelling. On Friday it was very swollen. I could cup my hand around the swelling from check to neck. It hurt to swallow. I took my temperature every few hours and it was never elevated. It was always normal . I took an ibuprofen, 800 mg and just relaxed around 5:00 pm. Still swollen on Saturday, but going down, Took another 800. mg of ibuprofen Saturday night around 8:00 pm and swelling continues to go down, but still swollen as of Tuesday, March 9, my birthday. I did receive my Tetanus shot, preventative on February 15, 2021.
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| 56 | 2021-03-08 | throat numbness |
I had a headache and sudden lethargy. I ended up sleeping for 3 hours. Throughout that time, I wok...
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I had a headache and sudden lethargy. I ended up sleeping for 3 hours. Throughout that time, I woke up several times with 'cotton mouth' and a strange feeling that the back of my mouth, roof of my mouth and maybe a bit of my throat had a numb and tingly feeling. I drank quite a bit of water, but kept falling back to sleep. I can only compare it to when you receive novacane at the dentist but the sensation starts to goes beyond your mouth and a bit into your throat. This feeling stayed about the same for 3 hours and then over the next 3 hours started to dissipate. After that I just hand a mild lingering headache and general feeling of tiredness. By the next morning I just had a slight headache and physical feeling of tiredness.
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| 56 | 2021-03-08 | tenderness |
Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigu...
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Pain and swelling at injection site. Nausea Muscle aches Earaches Joint pain Chills Tiredness Fatigue
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| 56 | 2021-03-09 | discomfort |
Fatigued, heaviness to vaccination site, chills, low grade fever, chest pain, heaviness, pressure an...
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Fatigued, heaviness to vaccination site, chills, low grade fever, chest pain, heaviness, pressure and left upper arm pain that is still on as I am reporting this side effect today.
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| 56 | 2021-03-09 | flushing | Pt had flushing and some sensation of throat closing. |
| 56 | 2021-03-09 | numbness | NUMBNESS IN LEG, DIZZINESS |
| 56 | 2021-03-09 | muscle spasms |
5 hours after first shot I began to feel the pain at the injection site but I also began to feel pai...
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5 hours after first shot I began to feel the pain at the injection site but I also began to feel pain in my lower back at the trunk of my spine. By the next day, March 4th I was in agony and could barely move. But Saturday morning the pain had not dissipated even with rounds of ADVIL and TYLENOL heat and ice packs. I went to the ER as given Tramadol, Naxoproxin, Cyclobenazprine and Lidocaine patches. I use these all weekend but I discontinued everything but the Lidocaine patches because I need to drive and function at work. The pain is still there as a constant ache but travels up my spine in the forms of spasms. I feel it is definitely at the trunk but more pain to the right side. I have an appoint with a Spinal Pain doctor for next week.
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| 56 | 2021-03-09 | tingling, numbness, tremor |
begin with numbness and tingling to thumb ,pointer and middle finger then numbness and tingle to bil...
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begin with numbness and tingling to thumb ,pointer and middle finger then numbness and tingle to bilateral body sides from cheeks to ankles, became dizzy though I would pass out, begin shaking then had some nausea, heart was racing. It felt like the tingling was surging through my body. made it to couch to lie down took 12.5 mg Benadrly ODT. some relief then after about 5 min begin again 911 called ambulance to Hospital
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| 56 | 2021-03-09 | tremor |
Immediately after vaccine administration, patient became dizzy and started to shake, become sweaty a...
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Immediately after vaccine administration, patient became dizzy and started to shake, become sweaty and short of breath.
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| 56 | 2021-03-10 | burning sensation |
Severe facial burning , neck redness, 2 red spots around injection site that happened 30 minutes aft...
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Severe facial burning , neck redness, 2 red spots around injection site that happened 30 minutes after she left facility
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| 56 | 2021-03-10 | one side paralysis, weakness |
The patient received her vaccination and waited the 15 minutes and the post vaccinating associate wa...
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The patient received her vaccination and waited the 15 minutes and the post vaccinating associate was asked to sit with her as she was feeling weak and had a bad day. She felt better and went to leave and had difficulty walking due to weakness in her legs. We helped her to a chair, checked her BP and it was 194/106 pulse 96. No meds were given. She explained that her mother was set to the hospital today and was just upset. Her BP did not improve so we called paramedics. Paramedics reviewed her situation She refused to go to the hospital and was taken away by her father who was with her.
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| 56 | 2021-03-10 | migraine |
The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxie...
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The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxiety and then relief of receiving the vaccination causing that effect. I had dry mouth and I was thirsty. The second vaccine EN 6201 I had a headache the next day. Throbbing headache. I read not to take Advil or anything right after. February 09= vaccine February 10=headache February 11= headache didn't go away. I took Advil in the evening. February 12=headache worsened. I took Advil in the afternoon. February 13=I woke up and couldn't see out of my left eye. There was a fog in central vision. About an hour later there was a strange aura. A tornado like tunnel in the central vision started and then shot out from the corner of my left eye. The aura lasted seconds and then the foggy center dissipated throughout the day. The headache throbbed and throbbed. I took Advil around the clock every four hours instead of just one a day. February 14= Full head-ache was gone but sinus throbbed above both eyes. February 16= Eye doctor visit. Know clue if the vaccine caused the ocular migraine or not. I've never had one before and it is super scary. My vision hasn't been clear since then and my dry stable MD turned into wet which I don't think has anything to do with the vaccine. Maybe the headache and the Ocular Migraine was caused by the vaccine. Who knows. I just thought I would report it in case other people have the same. Collecting data is a good thing.
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| 56 | 2021-03-10 | pain in extremity |
Sore arm 3/6/21 Bad headache, nausea, chills 3/8/21 Headache, body sore all over, slight fever , w...
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Sore arm 3/6/21 Bad headache, nausea, chills 3/8/21 Headache, body sore all over, slight fever , worn out. 3/9/21 Slight headache, worn out. 3/10/21
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| 56 | 2021-03-10 | tingling, tremor |
Progress NotesFamily Medicine Cosigned/8/2021 10:39 AM COVID VACCINE CLINIC a 56 y.o. female wh...
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Progress NotesFamily Medicine Cosigned/8/2021 10:39 AM COVID VACCINE CLINIC a 56 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience tingling/shaking, short of breath. She denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and respiratory distress. PMH: depression, takes Abilify and Cymbalta. GERD on Protonix. Lipitor for cholesterol. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills ("shaky") and shortness of breath Patient denies fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches, joint pain, dizziness and headaches tingling in hands.: Previous Reactions: none Objective Vitals Vitals: 03/08/21 0833 03/08/21 0851 BP: 133/78 123/71 BP Location: Left arm Patient Position: Sitting Pulse: 95 81 SpO2: 99% 98% Blood Sugar 117 collected at 0839 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: intially hyperventilating but improved after removal of mask. Eupnea at discharge. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Comments: Hyperventilating upon arrival to bay. Mask taken off to assist with this along with instructions on deep breathing. Assessment/Plan Treatment included: water, snacks and pepcid Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Pt observed in the bay for approx. 15 minutes. Pt greatly improved with treatments above. Pt encouraged to eat 30 minutes prior to next vaccine. She reports that she is appreciative of her care today. F/up with pcp as needed.
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| 56 | 2021-03-11 | pain in extremity, hot flush, flushing, numbness, tremor |
45 minutes after receiving the vaccine I felt like I was helping by getting my vaccine. After 45 min...
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45 minutes after receiving the vaccine I felt like I was helping by getting my vaccine. After 45 minutes I started to get weird symptoms. I started to have a hot flushing sensation in my left chest and became mentally dissociated from the situation. I felt separated from the conversation and tried to touch my hands together and couldn't feel them it was like a part of me. I was still trying to function for days and the feeling of being unable to think continued. I remember muscle weakness and dizziness. It was hard to focus. I had body tremors and some nausea and fatigue, headaches, body aches. The dissociation came and went and I felt really wobbly. I tried driving on day four and was unable to function in traffic. I started having abdominal pain which has lasted for five weeks. The flushing was still there in my chest and started to move up into my neck. Extreme dizziness on day 6 and I slept for much of the day, brain fog. I reached out to many doctors for help but no one had advice. I felt really scared and overwhelmed. Day 8 I had severe nausea and abdominal pain muscle pain in legs and dizziness. I thought I wasn't going to wake up after sleeping on many days. My muscles hurt so bad that I thought it wouldn't end. I had many days of day long headaches and the flushing sensation with shortness of breath. All of my symptoms continued with different levels of severity for five weeks. On the fifth week I had a few days that I thought I was not going to live. I had a band of pain and abdominal fluid that felt hard to touch. I had no appetite and I still had severe muscle pain. I was still disoriented and dizzy. Over this time I reached out through telehealth and several medical professional that had no advice. My symptoms seemed to lessen from the five week point with more periods of feeling more normal. I have only felt a little normal for three weeks.
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| 56 | 2021-03-11 | pain in extremity | Sore arm for 3-4 days |
| 56 | 2021-03-11 | tingling, weakness |
Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I h...
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Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I had chills. Moved to the clinic area. While under observation, symptoms increased. Tongue was reported to be swelling on right side. In retrospect, believe this was lymph nodes.Administered 2 doses together of Benadryl. Oxygen level and blood pressure remained strong. Hands turned bright red and itched. Left at 2:30. Took Benadryl and Tylenol at 3:00. Rashes and itchy throat continued for 48 hours as well as chills and aches. Overall outcome, positive health returned. Lack of energy. Bit of brain fog still remain.
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| 56 | 2021-03-12 | weakness | Nausea, weakness, severe body aches, very painful injection site |
| 56 | 2021-03-12 | discomfort, burning sensation |
I got my second Covid-19 dose on Thursday morning 3/11/2021 at 9:35 am. I was feeling uncomfortable ...
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I got my second Covid-19 dose on Thursday morning 3/11/2021 at 9:35 am. I was feeling uncomfortable in my left armpit since Friday 3/12/21 noon, but I only realized it was swollen when I went to take a shower around 8:00 pm. I'm feeling it swollen, burning and mild pain.
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| 56 | 2021-03-12 | discomfort, difficulty speaking | Discomfort, soreness and pain in neck area, as well as change in voice. Internal sore throat. |
| 56 | 2021-03-12 | pain in extremity, weakness |
About 2 hours after receiving the vaccine, I became very nauseated. I than begin vomiting. I vomit...
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About 2 hours after receiving the vaccine, I became very nauseated. I than begin vomiting. I vomited probably around 7-8 times (maybe more), and the last 2 times there was nothing left in my stomach to come up and I was just heaving. I also had moderately severe lower abdomen cramps (just above my pelvic bone). It felt like my insides were twisting at times, and the pain was constant cramping with moments of pretty severe twisting doubling over pain. I had chills just before the vomiting started, and felt like I had a slight fever, but because of the constant nausea/vomiting I did not take my temperature (all I have is an oral thermometer). To get the pain to stop, I had to lay down on a bed and put pressure on my stomach sides to ease the cramping. I tried taking Pepto-bismol to stop the nausea and vomiting, but immediately vomited that up too. The vomiting finally stopped after 2 times of dry heaving and nothing left to come up. The severe lower abdomen stomach cramping calmed down around 1 or 2 am. Today I feel weak, my right arm is very sore and slightly swollen, and as of the time of this report at 2:30pm I have only eaten some saltine crackers today. My stomach still feels weak, even though the nausea, cramping, and vomiting have gone away now.
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| 56 | 2021-03-12 | pain in extremity |
Low grade fever, exhaustion, arm pain started approximately 20 hours post administration Mild ches...
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Low grade fever, exhaustion, arm pain started approximately 20 hours post administration Mild chest pains 10 min post injection
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| 56 | 2021-03-12 | tingling, numbness |
Site: Pain at Injection Site-Medium, Additional Details: pins and needles numbness/ tingling that is...
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Site: Pain at Injection Site-Medium, Additional Details: pins and needles numbness/ tingling that is spreading up her arm
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| 56 | 2021-03-13 | muscle spasms |
started out as feeling kind of like I was getting sick. It progressed to feeling achy, low grade fe...
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started out as feeling kind of like I was getting sick. It progressed to feeling achy, low grade fever and overall feeling bad. As the evening progressed so did the intensity and I began to have chills and my whole body hurt. I would have almost like a spasm throughout my body that happened a few times. I could not move without it hurting or feeling awful. The chills and fever finally broke early the morning of 03/14/2021. I had a confirmed case COVID in December of 2020. I never felt like this when I actually had COVID.
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| 56 | 2021-03-13 | pain in extremity | Left Under arm swollen and pain, some pain in arm |
| 56 | 2021-03-13 | paralysis, pain in extremity, burning sensation |
Pain and paralysis in all 4 extremities. Burning and stabbing sensation, bulging veins in hand. W...
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Pain and paralysis in all 4 extremities. Burning and stabbing sensation, bulging veins in hand. Was hospitalized from 2/28 until 3/5. Left hospital with no diagnosis and no real relief
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| 56 | 2021-03-14 | feeling hot, feeling jittery |
PATIENT RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE. AT APPROXIMATELY MINUTE 15 POST VACCINATION ...
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PATIENT RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE. AT APPROXIMATELY MINUTE 15 POST VACCINATION PATIENT STATED THAT SHE WAS HOT AND FELT JITTERY. PATIENT WAS GIVEN WATER AND A BANANA AND HAD SEVERAL COUGHING SPELLS, SAID THAT SHE FELT A LOT OF MUCUS IN HER THROAT AND THAT SHE WAS ASTHMATIC. PATIENT HAD RESCUE INHALER WITH HER BUT NEVER USED IT. PATIENT REPORTED FEELINGS OF ITCHINESS AND WAS OFFERED BENADRYL BY RPH. PATIENT TOOK BENADRYL FROM EMERGENCY SUPPLY KIT. AFTER MINUTE 45 PATIENT WAS FEELING BETTER AND WAS RELEASED FROM OUR CARE.
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| 56 | 2021-03-14 | muscle spasms | After being in menopause since 2013 trigger menstrual cycle. Cramps and bleeding |
| 56 | 2021-03-14 | pain in extremity, tingling |
having pain and tingling in my right thigh; having pain and tingling in my right thigh; pain in my b...
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having pain and tingling in my right thigh; having pain and tingling in my right thigh; pain in my back; I can barely walk.; leg is weak; her arm was hurting; pinched nerve; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL9267) on 19Feb2021 10:00 at single dose for COVID-19 immunisation. Medical history included pain, tingling in right thigh, pain in back, patient can barely walk (she had this problem 10 years prior and haven't had these symptoms until she got the covid vaccine). Concomitant medications were none. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247) on 25Jan2021 for COVID-19 immunisation (Her first dose 25Jan2021. She sees UA-DOD. It has a little piece of paper on top that has lot number EL3247 for the first dose). Patient reported that she got the second Pfizer covid vaccine last Friday at 10am (19Feb2021 10:00). On Sunday (21Feb2021) she started having pain and tingling in her right thigh (21Feb2021), and patient experienced pain in her back (Feb2021). She can barely walk (Feb2021). She worked in a school. Everyone here had their second shot and everyone was fine except her. She had this problem 10 years prior and haven't had these symptoms until she got the covid vaccine. She spoke with the nurse here at the school and she said that this couldn't be related to the vaccine. Patient asked if this could be associated with the vaccine. In addition, patient reported that she got the shot, the second vaccine and she was doing fine the first day and Saturday and then Sunday (21Feb2021) she went walking, hiking and the only thing she had as far as reaction was her arm was hurting (Feb2021). On Sunday she started having a lot of pain in her right leg and it was tingling (21Feb2021), she thought the next morning she thought her body was having a reaction, it was weird she couldn't walk, her leg is weak and it bothers her, her thigh is hurting. She didn't have this problem before she got the vaccine, she does not know if it has to do with it. She is at work and every time she tells people about what is happening, she does not know if they have had a reaction but she knows that they told her you can have headaches, body ache, fever, that is what they told her but all she got is that tingling in the right thigh and it is bothering her, she can't walk and she is at work and can't even walk. She doesn't know what to do if she should see a doctor, she does not know if it has to do with the vaccine. She is confused she feels like she is crazy because she kept telling what is going on and people say it is everything else like stress but she did not have this before how come it is happening now. She asks does she need to go see her doctor now. She got the second dose Friday at 10 am, she confirms 19Feb. Sunday night she felt tingling and hurting and it was bothering her and she didn't think it was the vaccine but it got worse the next day and right now she is in a lot of pain she doesn't know if it is related. She confirms it started Sunday 21Feb2021 and it is ongoing. She says it has not gotten better she would say it has stayed about the same overall. She says she had this problem with something with her back. She thinks it had to do with her back about 10 years ago and it has come back. She is really surprised that it came back she got the vaccine and it came back 3 days after she got the vaccine. She does not know if this was a reaction but this pain thing and back thing she thinks she has a pinched nerve but she didn't have it for 10 years vaccine and now she has had a reaction. She does not know if that has to do with it or not. She has been fine all this time, no problems and now her back and the side of her thigh are hurting. The outcome of events having pain and tingling in my right thigh was not recovered. The outcome of other events was unknown.
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| 56 | 2021-03-14 | unresponsive to stimuli, hot flush |
annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonre...
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annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient) A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318 at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic. Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020. There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows: On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020. She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped. She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100 on 20Feb2021 , blood pressure measurement: 167/102 on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
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| 56 | 2021-03-15 | flushing |
flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and g...
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flushing on upper torso and face, hives on lips, tingling of tongue, throat itching , bloating and gas approximately 35 to 40 minutes after injection. Self dosed with Benadryl, alerted my physician
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| 56 | 2021-03-15 | muscle spasms, muscle twitching |
Pain, muscle ache and spasm down entire left arm. All day. Continued into 2nd day (3/16). Forearm & ...
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Pain, muscle ache and spasm down entire left arm. All day. Continued into 2nd day (3/16). Forearm & fingers twitching nonstop.
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| 56 | 2021-03-15 | numbness and pain in extremities, tingling, pain in extremity |
Ulnar neuropathy - pain and tingling in left elbow to pinky and ring finger Prednisone Ortho appoi...
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Ulnar neuropathy - pain and tingling in left elbow to pinky and ring finger Prednisone Ortho appointment scheduled
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| 56 | 2021-03-15 | pain in extremity |
Sharp pain in upper arm that feels like I am being stabbed. It radiates from my shoulder to my elbow...
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Sharp pain in upper arm that feels like I am being stabbed. It radiates from my shoulder to my elbow. I do not have a complete range of motion moving my arm at the shoulder and cannot reach my arm behind my back. Ice has been applied 3x per day since the injection and ibuprofen does not help.
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| 56 | 2021-03-15 | pain in extremity | Sore arm, Sluggish and fatigue for about 30 hours |
| 56 | 2021-03-15 | pain in extremity |
3-11-21 9AM HAD 'CHEST PAIN, SOB, SORE ARM, MUSCLE ACHES AND FEVER'. 'LUNGS ALSO HURT/PAINFUL TO BR...
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3-11-21 9AM HAD 'CHEST PAIN, SOB, SORE ARM, MUSCLE ACHES AND FEVER'. 'LUNGS ALSO HURT/PAINFUL TO BREATHE IN'. 3-15-21 11:20AM PT STATES 'FEELS BETTER NOW'. ADVISED TO CALL HEART DR R/T DOSE#2.
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| 56 | 2021-03-15 | pain in extremity |
Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progresse...
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Itching started in feet immediately after shot. Weird pain in lower middle back. Itching progressed to entire body after about an hour. Took 12.5 mg Benadryl, then took 12.5 mg two hours later. Next day arm was swollen and aching, itching continued. Took 625 mg Tylenol Arthritis, 25 mg. Hydroxyzine every 8 hours for two days.
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| 56 | 2021-03-15 | pain in extremity | pain in R arm/bicep swollen lymph nodes over right clavicle, with redness and pain on palpation |
| 56 | 2021-03-15 | pain in extremity |
Moderate fatigue, metallic taste in mouth, burning sensation in nose, muscle aches, bilateral ankle ...
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Moderate fatigue, metallic taste in mouth, burning sensation in nose, muscle aches, bilateral ankle and knee soreness, headache, very sore left arm, flu-like -ache in nipples Arm soreness declined over two weeks, ankle and knee soreness currently persist, fatigue lasted one week, other symptoms stopped after third or fourth day Treatment was acetaminophen, increased water intake and rest
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| 56 | 2021-03-15 | cold extremities, pain in extremity, weakness |
2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximate...
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2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximately 4 days. Within 4 hours: severe headache, took 2 500mg Tylenol about 3-4 times over the course of 48 hours. Headache subsided on 3rd day. 3/15/2021 2nd Dose: Within 1 hour: weakness, pain from neck thru fingertips in L arm, throat swelling, came home took 2 Tylenol 500mg gel caps at 4:00pm. Napped until 7:00pm. Temperature was 97.5. Thought I was feeling better. Went to bed at 11:00pm. By 2:30am I was awaking, restless sleep, pain all over body, every joint. Finally got out of bed at 11:30am today. Nerves and joints feel as tho on fire. Both arms and hands very swollen. Toes swollen. Nauseous. No appetite. Hurts to move, sit or lay down. Have rested all day. 6:40pm temperature is 99.8. Feel awful. Shooting pain like electricity down both arms into hands extremely sensitive to cold - feels like fire.
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| 56 | 2021-03-15 | tenderness |
Severe lower abdominal/pelvic pain located in the center and left side. Very tender. Pain came and w...
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Severe lower abdominal/pelvic pain located in the center and left side. Very tender. Pain came and went for several days. Went to the emergency room Thursday (3/10/21) due to increasing pain. Tried Tylenol, tums and Gas-X during this time without and alleviating of symptoms. Pain & tenderness slowly decreased over the course of a week.
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| 56 | 2021-03-16 | breast pain |
Never been pregnant I received the injection in my right arm. On the next day around 12 pm, I began ...
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Never been pregnant I received the injection in my right arm. On the next day around 12 pm, I began to feel a dull ache in the left breast. The pain grew sharper and deeper to the point where I could not lift my left arm, it was that painful making it hard to sleep. The next day the pain started diminishing. On the 3rd day after the vaccine, the pain had mostly resolved.
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| 56 | 2021-03-16 | pain in extremity | Fatigue and very sore arm the following day |
| 56 | 2021-03-17 | breast pain |
Chills and tiredness on 3/14/2021. Injection site pain from 3/14-3/17. Sore breasts from 3/15-3/17. ...
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Chills and tiredness on 3/14/2021. Injection site pain from 3/14-3/17. Sore breasts from 3/15-3/17. No treatment. Outcome - resolved.
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| 56 | 2021-03-17 | discomfort |
Chills began 11 hours after shot and continued for 4 hours. Mild fever ( 99.5) began 11 hours after ...
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Chills began 11 hours after shot and continued for 4 hours. Mild fever ( 99.5) began 11 hours after shot and continued on and off until 60 hours after the shot. All over body aches and skin sensitivity began 11 hours after the shot and continued for 36 hours and then resolved. Swollen lymph node at left armpit began 11 hours after the shot and was/is uncomfortable and at times painful. Initially the swelling was very pronounced and interfered with arm movement. The swelling has diminished a bit now (75 hours after the shot), but there is still some swelling and occasional pain.
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| 56 | 2021-03-17 | facial paralysis, numbness | Fevers x 24 hours, Aches x24 hours, Wheezing X 24 hours Drooped face and numbness x few days. |
| 56 | 2021-03-17 | pain in extremity | Very sleepy, as if i had anesthesia. My arm hurts, I can't touch it, and it hurts to move it. |
| 56 | 2021-03-17 | pain in extremity |
Sore arm day of vaccine: vaccine at 10:15, sore arm starting at 8 pm and still is sore at 11 pm the...
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Sore arm day of vaccine: vaccine at 10:15, sore arm starting at 8 pm and still is sore at 11 pm the next day: headache upon waking the day after vaccine: only lasted a few hours. Runny nose the evening after the vaccine on the 18th.
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| 56 | 2021-03-17 | tingling, numbness |
About 3 days after the vaccine I started feeling arm pain (right below the shoulder, not exactly at ...
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About 3 days after the vaccine I started feeling arm pain (right below the shoulder, not exactly at the injection site, a little back), in the evening, around suppertime. In the morning it got much worse. I had a little trip the next morning (3 hours each way) and when I returned home the pain was really severe. Used Ibuprofen at home and it solved the problem at first (for the weekend), it would take off that edge. But by Tuesday, I noticed that it was not getting any better just would ease off while taking Tylenol and Ibuprofen. Decided to go see my PCP. Initially PCP thought it was a case of tendinitis and was treated with Voltaren and Tramadol for night time in case it was too hard to sleep. Took Voltaren for a couple of days but did not see any real improvement so decided to go back to the Ibuprofen. The next Monday or Tuesday (about a week later) it was really really bad, and PCP gave me a shot of cortisone into that shoulder because at that time I was feelings numbness on my fingers and horrible pain in the shoulder. About 48/72hrs after the shot the pain subsided but the numbness and the tingling on my pointer finger and thumb were still present. The pain went away in about a week. Then PCP decided to refer me to see a neurologist. By the time I had my appt the numbness and tingling were much better and I had some tests done and they came back normal. Never lost strength in my arm. Neurologist said the numbness and tingling should go away on its own. Now, 2 months later he numbness and tingling are really mild, I am a stomach sleeper and I can't because if I do it will make my arm tingling again. Nowadays I feel it maybe once or twice a day an not extreme.
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| 56 | 2021-03-18 | difficulty speaking | Throat tightness, hoarseness, cough shortly after administration |
| 56 | 2021-03-18 | flushing, muscle spasms |
Within 5 minutes, burning and swelling in throat, cramps and diarrhea, flushing and hot neck and fac...
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Within 5 minutes, burning and swelling in throat, cramps and diarrhea, flushing and hot neck and face, rash on chin and face. Responded to Benadryl and Ventolin.
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| 56 | 2021-03-18 | flushing |
30 minutes after receiving the COVID 19 vaccine, the patient experienced an allergic reaction with f...
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30 minutes after receiving the COVID 19 vaccine, the patient experienced an allergic reaction with facial and tongue swelling and difficulty swallowing. A rapid response was called and the patient was taken to the emergency department where she had an IV placed and received IV famotidine, IV diphenhydramine, IV methylprednisone, a NS bolus, and epinephrine. Patient was then monitored in the ED. Patient has plans to discharge from the ED to home. COVID vaccine was placed as an allergy in the patient chart.
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| 56 | 2021-03-18 | pain in extremity |
It's only pain in my arm. Quite severe in the beginning. Right now it is easing. Just thought it wou...
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It's only pain in my arm. Quite severe in the beginning. Right now it is easing. Just thought it would be good for you to know for statistics.
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| 56 | 2021-03-18 | pain in extremity |
The first day about 4 hours after shot my arm started hurting and steadily got so i could not lift i...
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The first day about 4 hours after shot my arm started hurting and steadily got so i could not lift it more than 1/3 up. My neck hurt. by Tuesday my neck and back hurt so bad I had a hard time talking and raising my head all the way. I had to take more of my prescribed pain med and prednisone to control the pain. The pain/burning is now all the way down my neck/spine around my right rib and into my arms and mostly right leg. I called my doctors and she called in a medrol dose pack which i will pick up today. I also started having a bad headache Thursday. I may have to go to urgent care if I can't control the pain.
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| 56 | 2021-03-19 | discomfort, weakness |
Extreme dizziness with weakness and nausea started about an hour after I got home. I felt so ill I d...
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Extreme dizziness with weakness and nausea started about an hour after I got home. I felt so ill I did not think to call the doctor or go to the doctor's office since I was home alone. I laid down on the floor for awhile before managing to get to the bedroom. I stayed in bed for several hours before attempting to get up; the symptoms were not as severe but still felt weak and dizzy when standing. Today symptoms have improved but still feel uncomfortable.
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| 56 | 2021-03-19 | pain in extremity |
Fever chills pain in arm severe headache body aches slight nausea fatigue. Almost 48 hours and stil...
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Fever chills pain in arm severe headache body aches slight nausea fatigue. Almost 48 hours and still have headache arm pain nausea. I believe after 36 hours the fever left.
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| 56 | 2021-03-19 | pain in extremity |
5 minutes after the shot my heart began to beat very hard and very fast. It lasted about 5 minutes. ...
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5 minutes after the shot my heart began to beat very hard and very fast. It lasted about 5 minutes. For the remainder of the day into the evening I had heart palpitations. The following day I felt tired and nauseous until around 11am. My arm is sore and itchy.
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| 56 | 2021-03-20 | feeling hot |
Three days after injection, there was a sudden onset of hives over much of my body, accompanied by a...
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Three days after injection, there was a sudden onset of hives over much of my body, accompanied by an intense feeling of heat. Affected areas were face, neck, arms, hands, and knees. I took one Benadryl and went to bed. The next morning, most visible signs of the rash are gone, with a slight itchiness remaining.
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| 56 | 2021-03-20 | numbness | Swollen tongue, diarrhea, throat closing, numb tongue, numbness on left cheek on face. |
| 56 | 2021-03-20 | pain in extremity |
I had my first shot around 10 am and my left arm was very sore and got progressively worse. I playe...
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I had my first shot around 10 am and my left arm was very sore and got progressively worse. I played golf the next day (Tuesday) and I woke up in the middle of the night with nagging shoulder and chest pain. I was concerned it was heart related. It continued for 2 weeks off and on but fairly intense at times. Not sure if I slept on it funny. When to my primary care dr and had an X-ray and ekg. Both came back negative. I am still having chest pain so I am calling again 3/22 to discuss with dr.
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| 56 | 2021-03-20 | pain in extremity | Sore arm, Body aches, chills |
| 56 | 2021-03-20 | tingling |
Pins and needles feeling in my feet, legs, hands and arms. Started out off and on, but is now almost...
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Pins and needles feeling in my feet, legs, hands and arms. Started out off and on, but is now almost constant. It's been 13 days since I was vaccinated and is not going away yet. Very prevalent shaky, buzzy type feeling. I am concerned about getting the second vaccine. Do I still get it? It is scheduled for Apr 1st. Hopefully this will have subsided by then. If not, and I don't get the second dose, am I still protected against Covid?
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| 56 | 2021-03-21 | flushing, tremor |
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mil...
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Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
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| 56 | 2021-03-21 | throat numbness |
on 3/4 went to ED w/ numbness in throat and rib cage pain. Treated with prednisone, hydroxyzine/ at...
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on 3/4 went to ED w/ numbness in throat and rib cage pain. Treated with prednisone, hydroxyzine/ atarax and discharged home
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| 56 | 2021-03-22 | burning sensation |
Two days after vaccine - I break out in a rash on my arms, legs, back, neck. It is a allergic react...
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Two days after vaccine - I break out in a rash on my arms, legs, back, neck. It is a allergic reaction rash. It has lasted four days and still going. Very itchy and burning. Red welts. Have been taking Bendryl and Zytrtec
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| 56 | 2021-03-22 | feeling hot, numbness, tremor |
About 15-17 minutes after the shot I was driving home and all of a sudden felt hot, my heart started...
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About 15-17 minutes after the shot I was driving home and all of a sudden felt hot, my heart started racing, my hands started shaking, and I felt dizzy and lightheaded and my hands also felt numb. The worst of it probaby only lasted 5 minutes. I felt well enough to drive home but was still lighthead and shaky for about 45 minutes. An hour later, I feel ok except for a little lightheadedness.
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| 56 | 2021-03-22 | flushing | Pt felt flush after Covid shot. |
| 56 | 2021-03-22 | pain in extremity, tenderness |
As soon as I received the second dose of the vaccine my left arm started to hurt a lot. The pain was...
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As soon as I received the second dose of the vaccine my left arm started to hurt a lot. The pain was increasing to a point where I was not able to hold anything with my left arm. It felt like someone was punching me in the arm, or a had a needle in there, throbbing in the left shoulder. The pain and tenderness in the front of my arms continue. This pain continues,. I went to see an specialist on 03/22/2021, and he said a have Impingement syndrome of left shoulder from the covid vaccine. On 03/23/2021 Md prescribed me DEPO-MEDROL INJ 40 mg and Physical Therapy
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| 56 | 2021-03-23 | weakness |
3/22/2021 at 12:00 p.m. Intense headache relieved somewhat with Tylenol. Ended around midnight on 3...
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3/22/2021 at 12:00 p.m. Intense headache relieved somewhat with Tylenol. Ended around midnight on 3/23/2021. 3/22/2021 at 1:00 p.m. mild diarrhea which lasted until 3/23/2021 7:00 a.m. 3/23/2021 1:00 p.m. overall weakness and fatigue. Resolved 3/24/201 at 7:00 a.m. 3/22/20221 7:00 p.m. left arm pain at injection site. Almost completely resolved 3/24/2021 at 7:00 a.m.
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| 56 | 2021-03-23 | difficulty speaking, slurring |
Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue s...
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Pt received 2nd covid-19 pfizer shot at 3/6/21, pt had anaphylactic reaction within 30min - tongue swollen, slurred speech, dysphonia. Was given benadryl, epipen and decadron transferred to ER where she was given additional benadryl and solumedrol and observed. Pt discharged from ER after period of observation.
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| 56 | 2021-03-23 | feeling hot |
Progress Notes Healthcare Provider Cosign Needed Expand AllCollapse All Subjective Patient is...
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Progress Notes Healthcare Provider Cosign Needed Expand AllCollapse All Subjective Patient is a 56 y.o. female who was seen at healthcare facility today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience dizziness and hot. Patient has a history of multiple sclerosis and complained of a weakness in her legs that she experiences during her flares. She does mention having to be on 2L oxygen at times when she has a flare. O2 is 100% at rest today. She denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. This provider was notified of patient reaction and she was then assessed. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and increased weakness. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing and headaches Previous Reactions: Denies reactions to prior vaccines Objective Vitals Vitals: 03/24/21 1202 03/24/21 1219 03/24/21 1232 BP: (!) 155/92 (!) 145/78 136/76 Pulse: 86 79 80 SpO2: 100% 100% 100% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling of lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Water and lying patient in trendelenburg position. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash)
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| 56 | 2021-03-23 | numbness |
Patient experienced numbness in lower right side of face about 12:15PM after receiving second Covid ...
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Patient experienced numbness in lower right side of face about 12:15PM after receiving second Covid vaccine dose 3/24/21. Patient went to MD and doctor determined patient had no motor deficits.
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| 56 | 2021-03-23 | pain in extremity |
Swollen & sore arm for 4 days. Gas for 18-20 hrs. Nausea for 2 wks. Headache on left side is still o...
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Swollen & sore arm for 4 days. Gas for 18-20 hrs. Nausea for 2 wks. Headache on left side is still occurring.
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| 56 | 2021-03-23 | pain in extremity | Sore arm Headache Drowsiness Upset stomach Body aches |
| 56 | 2021-03-23 | tingling, feeling cold |
Within 5-7 minutes of getting the vaccine, I felt a cold sensation in my brain followed by a tingly ...
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Within 5-7 minutes of getting the vaccine, I felt a cold sensation in my brain followed by a tingly sensation in my face, sick on my stomach, dizziness and feeling faint. My husband told me to lean by in my chair, and I did. For a minute or two I felt slightly better, but then it started again; my stomach hurt, I felt dizzy and felt like I was going to faint. My husband got out of the car and went to get the paramedics. When they arrived, they asked me if I could walk to the tent. I knew I had to because I knew I was in trouble. When I got to the tent, I sat down and told the paramedics I was going to faint, and I did. When I regained consciousness, I threw up twice. The paramedics put a heart monitor on me, (from what my husband told me) they took my blood sugar, (I heard the paramedic say the result, and I told him I was not a diabetic). They put an IV in me, and gave me fluids, (from what my husband told me). They sent me by ambulance to ER. In the ED, I told the doctor what happened. She said what happened were not the side effects of the vaccine. After lying supine for sometime, I started to feel the same symptoms again; sick on my stomach, dizziness and feeling like I'm going to faint. I called out for someone. When the doctor came in, I told her I was starting feel the same way as before. She said my labs were great, and they were ready to discharge me; but I could stay if I wasn't ready to go. I told her I trusted her judgement, and was discharged. Throughout the day, I had the same symptoms, but did not faint again.
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| 56 | 2021-03-23 | tingling |
Uticaria rash to left arm and face which occurred 9 days after vaccine. Itching and picking discomf...
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Uticaria rash to left arm and face which occurred 9 days after vaccine. Itching and picking discomfort to rash . On antihistamine twice a day, hydrocortisone cream to face and triamcinolone cream to arm. Hydroxyzine for itching. At this time the rash continues . Note my father (different home) had the same reaction with biopsy of rash to confirm and 2 months later is still battling the rash.
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| 56 | 2021-03-23 | tremor |
about a minute after injection, started shaking, sweating, got very light headed with the feeling I ...
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about a minute after injection, started shaking, sweating, got very light headed with the feeling I might pass out. Chest got very tight and breathing was strained. Waited with a pharmacy tech, drank water, called husband to come pick me up. Blood pressure went to 178/110, heart rate up to 154 before it subsided. Was able to leave after 45 minutes. Took Benadryl for the next 48 hours to stop reaction. Had waves of the same symptoms several times a day for 4 days after injection.
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| 56 | 2021-03-23 | tremor |
Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of ...
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Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of incident: vaccine hub triage area Pertinent patient history: History of severe anaphylactic reaction to gabapentin in 2018. Patient had discussed with PCP and allergist who agreed that patient should receive her COVID-19 vaccine. Description of incident: Patient was brought back to the triage area for vaccinator to administer the vaccine near emergency equipment and patient had her own epi pen with her (this was not used). Patient agreed and consented to receive the COVID-19 vaccine. Patient received the COVID-19 vaccine at 1013. At 1023 patient started feeling "off" BP was 177/105, pulse 96 and oxygen 97% Dr. was notified and was present in the triage area and 1st dose of epinephrine was administered in patients right thigh. Patient was coughing and feeling like her throat was closing. Patients BP at 10:25 was 197/109 and 10:26 pulse ox 95% and pulse 64. Patient continued to cough and experience shakiness and unable to catch her breath oxygen was applied at 6 L/minute per VORB from Dr. Patient received 2nd dose of epinephrine at 1026 per VORB from Dr. Patient received 125 mg of IM solumedrol in left deltoid VORB from Dr. at 1032. No benadryl was given due to allergies. EMS arrived at 1035 and administered a 3rd dose of epinephrine. IV started by EMS. EMS transported patient to ED. Patients wife was present during event and drove to meet patient at ED. Orders initiated per RN protocol: EpiPen administered per protocol Additional verbal order for 6 L oxygen by nasal cannula, 2nd dose of epinephrine & 125 mg of solumedrol given by Dr. - read back by RN Patient outcome: Transported via EMS to ED Patient left vaccine clinic via Patient Transport: Ambulance: EMS Called at 1023 arrived at approximately 1033. Other notes: Other RN's involved in this event were RN, RN, RN, Dr., and Dr. RN .................... 3/24/2021 11:04 AM
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| 56 | 2021-03-24 | flushing |
Flushing/itching. BP 147/104 (pulse 85), 97% O2 sat. Final BP 133/96 (pulse 78), 96% O2 sat. Benadry...
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Flushing/itching. BP 147/104 (pulse 85), 97% O2 sat. Final BP 133/96 (pulse 78), 96% O2 sat. Benadryl 25 mg PO given.
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| 56 | 2021-03-24 | pain in extremity, feeling hot, burning sensation |
Very sharp shooting pain from left clavicle to left TMJ, tachycardia, left ear hot, burning sensatio...
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Very sharp shooting pain from left clavicle to left TMJ, tachycardia, left ear hot, burning sensation, chest tightness, pain radiating into left arm and left leg. Tx: diphenhydramine 50 mg orally every 10 min until symptoms lessened/resolved. Aprox 300 mg over 30 min All symptoms resolved within 60 min
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| 56 | 2021-03-24 | pain in extremity, muscle spasms |
Woke up at 3am with shooting pains in my arm back and neck. Had a bad headache and was nauseous. I ...
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Woke up at 3am with shooting pains in my arm back and neck. Had a bad headache and was nauseous. I got up and took a Tylenol, went back to bed and woke up 2 hrs. later with the same side effects. I could not eat, tried to drink as much as possible and continued to have extreme cramping all over my body as well as chills, sweats, nausea and light headedness. I did not run a fever, but was unable to get off the couch and do normal activities until the next morning. I continued to take Tylenol for 3 days but had a low grade headache and backache for a number of days. I have not been this sick for years. Glad the severity only lasted a day and a half. Im still struggling with back pain 3 days later.
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| 56 | 2021-03-24 | pain in extremity |
At time of the shot, just a sore arm for about a day. Then fine for a week. One week later the inj...
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At time of the shot, just a sore arm for about a day. Then fine for a week. One week later the injection site started to itch. By the 8th day, there was a red itchy rash at injection site.
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| 56 | 2021-03-24 | tingling, pain in extremity, numbness |
Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingli...
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Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingling like it had fallen asleep but I was not laying on it. I moved it around until it finally stopped. Pain continued all not. On 3/24/21 was very tired and foggy. On 3/25/21 have a headache and slight nausea. I had an ophthalmic event where I saw lighting flashes in my right eye so it could be this causing instead of the vaccine. I am fine just thought I should report these occurred. Thanks!
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| 56 | 2021-03-24 | tingling |
Patient stated they experienced left arm tingling following receiving the vaccine. Client was evalu...
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Patient stated they experienced left arm tingling following receiving the vaccine. Client was evaluated by onsite Fire Rescue. Client was released to go home at 12:33 pm . Per Fire Rescue no additional evaluation needed.
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| 56 | 2021-03-24 | tingling |
03/19/2021 1055, 5-6 min she started having pain, tingling in her face then pass out. When she wok...
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03/19/2021 1055, 5-6 min she started having pain, tingling in her face then pass out. When she woke she was c/o upset stomach and vomited twice. Was brought to hospital and stayed for 3 h0ours. Headache is still
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| 56 | 2021-03-24 | seizure |
Pt received 2nd dose vaccine, waited her 15 minutes and upon leaving was witnessed by PD to have slu...
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Pt received 2nd dose vaccine, waited her 15 minutes and upon leaving was witnessed by PD to have slumped on the floor, without trauma and began to seize. EMS called to scene and medical OIC called. Upon arrival, 911 called, SpO2 placed. VSS and respirations adequate. Negative for emesis. After 2 seizures, the patient regained consciousness and was able to communicate that her husband was outside, his name was in a blue vehicle. She confirmed she had a history of seizures. Her husband informed us she has a history of these seizures and brain CA. EMS arrived and took control of patient and transported to hospital.
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| 56 | 2021-03-24 | tenderness |
1. Mild headache 2. Moderate itchiness all over (I am on my 4th round of antihistamine) 3. On the l...
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1. Mild headache 2. Moderate itchiness all over (I am on my 4th round of antihistamine) 3. On the location of the shot (left upper arm) muscles are very tender. It hurts when I put pressure. Unable to sleeping on my left side. 4. Mild stomach pain - typical feeling when I am having an allergic reaction.
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| 56 | 2021-03-24 | tremor |
dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a litt...
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dehydrated; shaking; bowel movement that was loose but not like it was, not diarrhea; she had a little bit of something in her bladder, in her urine; she had a little bit of something in her bladder, in her urine; woke up completely drenched; Blood pressure dropped; Vomiting; nauseated and couldn't eat; nauseated and couldn't eat; high fever/ It got to over 103; Diarrhea is like a greenish color; diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 56-years-old, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6204; Expiration Date: 30Jun2021) as single dose for COVID-19 immunization. Medical history included kidney and pancreas transplant patient since 01Apr2014 (On 01Apr2021, will be seven years since her transplant), Gastroparesis from 2005, Small intestinal bacterial overgrowth from 2019 (hasn't had any issues with that in over a year), Diabetic macular edema (Doesn't think Diabetic macular edema pertains to anything with the COVID Vaccine), pacemaker in her stomach (Procedure for pacemaker for stomach performed first time in 2006. Stomach pacemakers only last eight to ten years. Had the battery replaced in 2017), she had previously had C-Diff, high blood pressure (Doesn't have high blood pressure anymore), immunosuppressed. The patient's concomitant medications were not reported. Patient states about a week ago, she talked to someone at clinic, reporting after she got the first dose of the Pfizer COVID 19 vaccine. She had reported she had diarrhea. Clarifies she got her vaccine on 03Mar2021 at 15:00PM in the right arm. She previously reported she started having diarrhea in the night, Thursday (04Mar2021), and had it for ten days. At that time, when she had reported, she only had diarrhea. Diarrhea is like a greenish color. Has been trying not to eat heavy things, but diarrhea is still a greenish color. She contacted her stomach doctor and he wanted her to do a COVID 19 test, which was negative; and a whole stool work up because she had previously had C-Diff. She did all that and turned it in Friday. Adds she did have the chills a little on the day of the vaccine but they went away. Reporting new events today including on 13Mar2021 she started having a fever. It got to over 103; she was so nauseated she couldn't eat (13Mar2021); with chills (03Mar2021) and shaking (unspecified date). She treated the fever with Tylenol and got some relief but then her fever would go back up. She thinks she was getting dehydrated (Mar2021) from all the diarrhea and then she started to throw up on Tuesday (16Mar2021). That day she was admitted to the hospital, 16Mar2021. At the hospital they did another COVID 19 test that was negative; blood tests; urine test; US kidney; CAT Scan whole stomach; and they could not find anything that could cause her symptoms. Adds they did say she had a little bit of something in her bladder, in her urine (unspecified date). While hospitalized she was treated with IV antibiotics; Phenergan and Zofran which controlled the nausea and vomiting. Her fever went down to 99 by Friday. Adds she did have one episode on Friday of low blood pressure (19Mar2021) and they were watching it. She was discharged on Saturday and has not had a fever since she came home. Adds she did have a bowel movement that was loose but not like it was, not diarrhea (unspecified date). Mentions for the last two nights she woke up completely drenched (20Mar2021) but she did not have a fever. Adds she felt a little chill last night, but she just covered up with her blanket. She feels her dehydration is improving. Therapeutic measures were taken as a result of dehydrated, high fever/ it got to over 103 (pyrexia), vomiting, nauseated and couldn't eat. The outcome of dehydrated was recovering, diarrhea and diarrhea is like a greenish color was recovered on 18Mar2021, high fever/ it got to over 103 was recovered on 19Mar2021, chills was not recovered, vomiting recovered on 17Mar2021, nauseated and couldn't eat recovered on 18Mar2021, blood pressure dropped recovered on 19Mar2021, woke up completely drenched was not recovered, and all other events was unknown. The patient was hospitalized for dehydrated from 16Mar2021 to 20Mar2021.
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| 56 | 2021-03-25 | slurring, tingling |
About 20 minutes after vaccination when I was released and in my car headed home, my lower lip, left...
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About 20 minutes after vaccination when I was released and in my car headed home, my lower lip, left side only, started tingling. My tongue felt fat but didn?t appear fat. However, I slurred about six words. Then one tip of finger started tingling. I had no other symptoms. I immediately took one child Benadryl pill (half an adult dose). I had an epi-pen ready but didn?t need it (I?ve never had anaphylactic reaction before, but my throat has tightened from malic acid before, so I wanted to be prepared). I went home and slept rest of afternoon, probably because of the Benadryl. I had no respiratory issues; no hives; throat did not swell. Just lip tingling, ?fat? feeling tongue, and finger tip tingling.
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| 56 | 2021-03-25 | numbness |
Patient reports numbing of arm the day after injection. She is also reporting shortness of breath (s...
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Patient reports numbing of arm the day after injection. She is also reporting shortness of breath (she has COPD and has not used her rescue inhaler) and a rapid heart rate.
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| 56 | 2021-03-26 | numbness and pain in extremities, pain in extremity |
March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the ch...
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March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the chest and palpitations. I was given anti-nausea medication. I found the longer that I spoke the tighter and more sore my throat felt. Symptoms of lightheadedness, headaches, brain fog, pain in throat, ear pressure, nausea, diarrhea, body aches and pain, chills, fever of 102 at 6am on March 27th, neuropathy was exacerbated, palpitations and sore left arm. I feel a sharp pain in my right arm, deltoid muscle, when I try to lift it, I can barely move it. It feels as if I had the shot there but I know it was in the left arm for both doses. March 27th all symptoms continue and my temp is fluctuating between 99.5 and 100.5 so far today. March 5th 2021- Dose 1 Within 10 minutes I started to feel the vaccine. I felt a few pangs, brain fog, and exhaustion. The first night I had terrible nightmares. The first three days I experienced dizziness, light headed and off-balance, headaches, brain fog, pain in throat, ear pain, tinnitus and pressure, nausea, diarrhea, body aches and pain, difficulty breathing, chills, fever of 99.5, neuropathy was exacerbated, heart racing and palpitations and sore arm. On the fourth day, I felt normal but was very tired. On the fifth day (March 9th) I again felt exhaustion, brain fog, throat and ear pain, loose stools, body aches and pain, sharp chest pain and neuropathy.
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| 56 | 2021-03-26 | tremor | Fever, chills, shaking, body aches, and underarm lymph nodes swelled more |
| 56 | 2021-03-27 | muscle spasms |
Pfizer-BioNTech COVID-19 Vaccune EUA Headache, alternating chills/sweating throughout the day, Lowe...
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Pfizer-BioNTech COVID-19 Vaccune EUA Headache, alternating chills/sweating throughout the day, Lower intestinal distress including cramps and minor diarrhea, general muscle aches between shoulders. Occurring on Day after injection (3/12/21), 3 days after injection (3/14/21), 5 days after injection (3/16/21), 7 days after injection (3/18/21), and continuing every other day to every 3rd day through today (3/28/21).
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| 56 | 2021-03-27 | pain in extremity |
Swollen under arm swelling and painful Same arm as the injection site began 24 hours after receiving...
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Swollen under arm swelling and painful Same arm as the injection site began 24 hours after receiving vaccination (3/21/21) stopped (3/23/2021)
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| 56 | 2021-03-27 | tremor | Lightheaded, chills and shaking, fever, diarrhea |
| 56 | 2021-03-28 | muscle spasms, pain in extremity |
Extreme tiredness two hours post vaccine. Eleven hours post vaccine, extreme nausea, headache, body ...
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Extreme tiredness two hours post vaccine. Eleven hours post vaccine, extreme nausea, headache, body aches, chills, fever, pain at vaccination site. 24 hours post vaccine: Extreme nausea and vomiting, diarrhea, fever, body pain, difficulty remaining awake, extreme aversion to light and sound, headache. Currently 96 hours post second dose of Pfizer vaccine and still have leg aches, cramps, severe tiredness and diarrhea.
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| 56 | 2021-03-29 | tingling, feeling hot |
The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vac...
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The vaccine site was Community Center being done by Paramedics and Fire Fighters. I received the vaccine and sat down in the chairs to wait the required 15 minutes. Within 2-3 minutes my face got very hot. I could feel the heat under my mask. Another minute or two, just below my knees to my toes started tingling. Another two minutes or so, I felt like my eyes were swelling. I took my glasses off and looked at my husband and asked if my eyes are swelling, he said, they sure are and called over one of the paramedics that were there. They directed me to a more private are and put me on a monitor and monitored my vital signs. My blood pressure which is well controlled on my meds (which I did take that morning) climbed and climbed to 200s/100s. My chest was tight and uncomfortable and getting more difficult to breath. They put and 02 mask on and gave me Benadryl IM. By that time the squad was there and took me to the local hospital ER. In the squad my tongue started to swell. At the hospital they gave me Solumedrol IV which took care of it all. The swelling quickly went away in my tongue and face, the chest pressure went away, and all the other little annoyances like the tingling. The hospital did a chest x-ray and bloodwork. I went home after 3-4 hours with a prescription for Prednisone 50 mg daily for 5 days. No further reactions after that.
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| 56 | 2021-03-29 | tingling, numbness and pain in extremities |
tingling in face and fingertips; heightened neuropathy in feet; Headache; fatigue; This is a spontan...
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tingling in face and fingertips; heightened neuropathy in feet; Headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6703) via an unspecified route of administration, administered into the left arm on 09Mar2021 17:00 as a single dose for COVID-19 immunisation. Medical history included guillain-barre syndrome survivor and breast cancer survivor. Patient was not pregnant. Concomitant medications included levothyroxine sodium (LEVOXYL), hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN+HCTZ/MYLAN) and letrozole (LETROZOLE). On 09Mar2021, patient experienced headache and fatigue. On 10Mar2021, she had heightened neuropathy in feet. On 12Mar2021, she experienced tingling in face and fingertips. The patient did not receive treatment for the events reported. Outcome of events was not recovered.
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| 56 | 2021-03-29 | tenderness, pain in extremity |
A rash developed; Within three hours of receiving the Pfizer vaccine my right thigh became painful; ...
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A rash developed; Within three hours of receiving the Pfizer vaccine my right thigh became painful; started itching; area of the rash is tender when pressure is applied; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Left arm on 16Feb2021 16:00 as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. If Other vaccine in four weeks: No. Facility type Vaccine: Doctor's office/urgent care. if Covid prior vaccination: No, if covid tested post vaccination: No. known allergies: n/a. The patient experienced a rash developed (non-serious) on 16Feb2021 18:30, within three hours of receiving the pfizer vaccine my right thigh became painful (non-serious) on 16Feb2021 18:30, started itching (non-serious) on 16Feb2021 18:30, area of the rash is tender when pressure is applied (non-serious) on 16Feb2021 18:30. if treatment AE: No. Within three hours of receiving the Pfizer vaccine my right thigh became painful and started itching. A rash developed, about 5" wide and 6" long. The itching lasted about two to three hours. Twenty-four hours after the vaccine, the rash remains and the area of the rash is tender when pressure is applied. For event rash developed, area of the rash is tender when pressure is applied, outcome was not recovered and for started itching, outcome was recovered on unspecified date in 2021, for other remaining, outcome was recovering.
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| 56 | 2021-03-30 | weakness |
Shortly after vaccine administration, the pt honked her car horn for help and was noted to be minim...
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Shortly after vaccine administration, the pt honked her car horn for help and was noted to be minimally responsive. Initial BP was noted to be 60/palp. She was promptly given a dose of epi (epipen) at appx. 0830. She did not improve immediately and required a second dose of epi. Prior to transport by EMS, she improved slightly and denied any respiratory symptoms or skin involvement. She complained of feeling weak and tired only. SP02 was 89% and HR was in the 70s and regular. 02 was administered by EMS and she was given a dose of Benadryl, 25mg as well. While EMS was still on scene with the pt, BP improved to 130 systolic and she was noted to be significantly improved. She had a significant period of hypotension for appx. 20 minutes however (prior to improvement). Unclear if she had a prolonged vasovagal response or possibly anaphylaxis. She did not have clear mucosal, respiratory or GI involvement to suggest a definite diagnosis of anaphylaxis. She was transported to local ER by EMS in improved condition.
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| 56 | 2021-04-03 | speech disorder, pain in extremity |
Very sore arm for several days after shot. On day 9 I started to get a low grade fever, body aches,...
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Very sore arm for several days after shot. On day 9 I started to get a low grade fever, body aches, headache, upset stomach and extreme fatigue. Day 10 I was having severe memory issues. I struggled with putting words together and forgetting things like passwords and even how to turn off my computer. My husband was very alarmed and thought I was having a stroke. He took me to the ER.
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| 56 | 2021-04-08 | pain in extremity |
I have continued stiffness and pain in my left arm. I have limited range of motion. I can't lift m...
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I have continued stiffness and pain in my left arm. I have limited range of motion. I can't lift my arm or put it behind my back without considerable pain.
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| 56 | 2021-04-10 | pain in extremity |
sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe...
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sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe headache; blood sugar spikes of 200 fasting; Increased tahcycardiaI suffer from that) but it was more frequent and severe; chest pains; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 56-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM6199) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 at a single dose for covid-19 immunisation. Medical history included had covid from 30Jun2020. Concomitant medication patient received within 2 weeks of vaccination included Metoprolol ER 25 mg cyclic, Armour Thyroid 30 mg cyclic. The patient previously took fluoroquinolones and experienced known allergies. The patient reported that on 13Mar2021 on Day 3 of vaccine BP starts to go up. My average is 100/50. By day 4 BP is spiking to 165/100 with a mile fever and sore arm, and a sinking sense of doom-death). Severe headache and continued blood pressure spikes throughout week along with blood sugar spikes of 200 fasting. I'm not diabetic. Increased tahcycardiaI suffer from that) but it was more frequent and severe. Blood pressure spiked to 187/167, I took extra BP meds (which was low dose more for my tachycardia)to help with insane BP. Went to hospital and stayed for 2 days. No heart attack, Just insane BP with chest pains and high heart rate. Day 18 after shot and BP is going down and so is blood sugar. Every once in a while, it will spike to 160/100--last for about 1 hour and then drop to my normal BP before the shot. The events were considered serious with seriousness criteria hospitalization and medically significant. The patient was hospitalized for 2 days. Adverse events resulted in Emergency room/department or urgent care, Hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Mar2021. The patient was recovering from all the events. Follow up needed, further information has been requested.
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| 56 | 2021-04-12 | pain in extremity |
allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closi...
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allergic reaction/Allergic anaphylactic reaction; lungs were filling up with fluid; throat was closing; Main trouble is breathing and is out of breath; legs sore; Throat sore; Cough; hard for her to walk; tired; trying to swallow a tablet and digest it and it gets stuck; trying to swallow a tablet and digest it and it gets stuck; breathing was heavy; choking; trying to swallow a tablet and digest it and it gets stuck; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 24Mar2021 (Lot Number: ER2613) as a single dose for to prevent COVID (covid-19 immunisation). Medical history included having blood clot from 2019 to Mar2021 which the patient stated a couple of weeks ago (Mar2021), she had an ultrascan in her leg and the blood clot was not there, but she is on medication. The patient has recovered completely from blood clot (not ongoing). Concomitant medication included warfarin (WARFARIN) to prevent from having blood clot ongoing since Jun2019. The patient previously took gabapentin for pain but had throat started closing, allergic reaction, coughing and was intubated until she was released from hospital; and albuterol [salbutamol] for dyspnoea but had nebulizer to open up her airways and prevent closing and did not work (drug ineffective). The reporter mentioned that the patient ended up in the ICU because of the COVID vaccine. As soon as the vaccine was administered within seconds, the patient experienced a reaction and was given an epi pen, another epi pen even an epinephrine drip and was sedated and intubated. The reporter mentioned that they gave the patient the first shot of epi pen and it did not work, and she was given a second one and a third one plus steroids. By the time the ambulance people arrived, they hooked the patient up to an IV and gave her additional epinephrine and administered another epinephrine. The ambulance guy told her; she does not need to keep up with them because they needed to go to the hospital ASAP because the patient is not getting better but getting worse. Once the patient got to hospital, she was intubated because her throat was closing. The reporter stated that the patient has allergies to begin with and this was worse than the first time she had to be intubated. The epi pens did not work, the patient was intubated and then had to be sedated. The patient was on Propofol in order to sedate her and later on in the evening was given Fentanyl to relax her then the epinephrine drip was removed at 6 pm on 24Mar2021. The epinephrine drip was started in the emergency room and the patient could not be moved to the intensive care unit until she was somewhat stable. The patient was moved to the intensive care unit and was there overnight and by the time next morning she was able to be extubated where they removed the tube from her around 9:30 to 10:00 25Mar2021. Of course, the patient was taken off Propofol, but she went through a lot and her legs are sore, throat is sore, and is coughing on 25Mar2021 because of the side effects from being intubated and that she went through a lot. The intensive care unit doctor said that the patient can no longer have the vaccine and she would only be 70% protected till whenever they are not sure how long the vaccine will last. The adverse events almost took the patient's life which made the reporter angry at that. The reporter is not sure what the contents in the vaccine that it in the other drugs and vaccines since there is something that is contained in all of them and the patient was not allowed to have any whether it is the Pfizer or Moderna and it is even up for discussion for even the flu shot because of the reaction and there does not want to be any chances and that everything should be proceeded with caution. The reporter wanted to know what is in the COVID 19 vaccine to see about what could have caused the allergic anaphylactic reaction. The reporter stated and the fact that the epi pen did not work, she was taken aback. The reporter added that the doctor had a hard time intubating because of her throat but they were able to intubate from the second time. The reporter stated that it is taking a while but her wife is recovering and feeling it is taking a while taking a little bit longer. The reporter also stated that they kept the patient in the intensive care unit overnight and after the tube was removed in the morning, by the late afternoon she was moved to a different floor to continue to be observed and the intensive care doctor said 2 days out her wife would be safe to go. The patient stood up but it was hard for her to walk on 25Mar2021 because it could have been from the epi pen, but she is not sure. The patient stated the side effect came out of the allergic reaction and it was on Thursday 25Mar2021. Patient stated the main trouble is her breathing, she is out of breath still and really sore throat on 25Mar2021. The patient stated that the leg sore is still ongoing and is about the same. It was mentioned that the throat sore was still ongoing but some days are worse and some days are better. The patient stated that when she has a problem trying to swallow a tablet and digest it and it gets stuck on Mar2021. It was stated that the cough was not going away. The cough comes and goes away. She will cough for five minutes constantly and then it disappears then she will fall asleep and wake up coughing. It's as if she is choking (Mar2021). When she is talking, she coughs more. With regards to the allergic anaphylactic reaction, the patient stated she is experiencing the aftereffects of the allergic reaction and being intubated like being out of breath. The patient stated that will come in time and that's what happens when she gets intubated. Her breathing was heavy and comes back fully with rest on Mar2021. This has taken a lot out of her. She was feeling tired which was still ongoing it is about the same but comes and goes on 25Mar2021. The patient is experiencing lingering side effects and the patient does not feel as if she has recovered completely. It was also mentioned that the patient was intubated on 24Mar2021 to 25Mar2021. It was reported that treatment of the patient included Epi Pen, Epinephrine Autoinjector USP 0.3 mg (Epinephrine injection manufacturer was Mylan) which the patient was given at least three injections (two in the right leg and 1 on the left) then received another in the ambulance (unknown site). Patient received an Epinephrine drip and it was like 0.1 mg all the way up until 6 pm (only on 24Mar2021). The epinephrine drip was started when patient was intubated at the hospital. It was given for patient's allergic reaction through IV. The patient's lungs were filling up with fluid so her airway was restricting her from breathing and to prevent damage of the lungs that is when the intubation came in. The patient also received Prednisone which the reporter does not recall when this medication was started it may have been after the epinephrine drip was removed but she is not sure if they started the prednisone after or if it was the same evening which the reporter kind of thinks it was. The reporter stated that the patient took Propofol 24Mar2021 to 25Mar2021 which was given through the patient's IV and was given to help her airways being intubated, they sedate their patients. The patient also received fentanyl which must have been added either right before Epinephrine drip was removed or after but reporter does not recall. Patient was given Fentanyl 24Mar2021 to 25Mar2021 through her IV. Patient received this medication to relax because sometimes it is like some patients tend to want to sit up and kind of hear you, hear what people are saying and to relax patient sometimes because they can get scared and not exactly sure what is going on. The events anaphylactic reaction, pulmonary oedema, throat constriction and breathing difficult. The patient underwent lab tests and procedures which included lung was checked from a CT scan was unknown results on 12Jun2019, D dimer test was elevated on an unspecified date, ultrascan in her leg (ultrasound scan) blood clot was not there on Mar2021 and weight was probably weighs 180 or her weight may be a little less like 175 on an unspecified date. The outcome of the events anaphylactic reaction and throat constriction were recovering, as for the events leg pain, throat sore, cough and tiredness were not recovered while the outcome of the other events was unknown.
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| 56 | 2021-04-14 | pain in extremity | Both arms with unbearable muscle pain, nausea, diarrhea |
| 56 | 2021-04-16 | pain in extremity |
I have a very swollen left leg. It began slowly and became worse. I thought that I sprained my lef...
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I have a very swollen left leg. It began slowly and became worse. I thought that I sprained my left knee on March 13th. (I had my first vaccine shot in my left arm on March 11th. ) I thought that I would let it heal. My second shot was April 1st and my left leg became very painful after that. I went to the Doc. for a knee sprain, was sent to Orthopedic. I received an X-ray and an MRI. There is tricompartmental osteoarthritis, with 2 degenerative meniscus tears. It occurred to me today that my knee joint may be reacting to the vaccination. I did have swollen lymph nodes on my left side in neck and under my arm after the second shot. My knee has had arthritis and possibly the degenerative meniscus tears but it has never become swollen and inflamed. The swelling and pain has persisted for over 2 weeks now. I?m not sure if it is related but I thought that I should share this with you. If there is anything that you can help with, please do. I have been so very grateful for the vaccination. Thank you!
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| 56 | 2021-04-18 | weakness |
Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spont...
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Weakness; Lower abdominal pain; Low grade fever; felt lousy; Fatigue; Double vision; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6208, expiration date: 30Jun2021) via unspecified route of administration in right arm on 25Mar2021 15:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Patient medical history included Guillain Barre syndrome on Feb2017 and asthma on unspecified date. Concomitant medication included ongoing IVIG treatment, unspecified (one infusion every four weeks) for Guillain Barre syndrome. The patient previously received first dose of bnt162b2 (lot number EN6201) on 04Mar2021 at the age of 56-years-old for covid-19 Immunization, and experienced sore arm. On 25Mar2021, after the second dose of the vaccine, the patient felt really lousy. The patient was fatigued on unspecified date in Mar2021. On 29Mar2021, patient had lower abdominal pain and low grade fever. The left side has been the side that has been impacted by Guillain Barre syndrome CID and that was the side that was affected after the vaccine. On 28Mar2021, the patient experienced weakness; was too weak to care for herself and she and her husband decided to go into the hospital. The patient was admitted on 28Mar2021 by neurologist (for the event weakness) and she stayed 2 nights and then came home 30Mar2021. The patient had been tired and weak since discharge from the hospital. The patient was on a monthly course of IVIG but the round she got in the hospital was exactly 2 weeks in-between her scheduled monthly treatments. Complete fatigue and weakness were still ongoing. The patient also experienced double vision on unspecified date in Mar2021 which was ongoing, but this was something that starts flaring up with her condition. The patient's low grade fever experienced on 29Mar2021 lasted for 3-4 days. The patient has gone backwards in her Guillain Barre syndrome since she had the vaccine, her opinion is that this was a set back she is not sorry she got the vaccine and is grateful for it. Events resulted in emergency room visit and Physician's office visit. Outcome of the events (weakness, fatigue and double vision) was not recovered. Event (Lower abdominal pain) was recovering; event (low grade fever) was recovered on unspecified date (lasted 3-4 days); while outcome of event (felt lousy) was unknown.
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| 56 | 2021-04-18 | facial paralysis, numbness, difficulty speaking |
Her voice was hoarse and raspy; She had about 10 canker sores in her mouth.; Facial paralysis; Her l...
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Her voice was hoarse and raspy; She had about 10 canker sores in her mouth.; Facial paralysis; Her left calf felt numb; She said she saw more wrinkles on her face than she knew she had; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Pfizer product, lot: EP7534) in left arm on 23Mar2021 17:30 at a single dose for COVID-19 immunisation. Vaccination Facility Type was Hospital. Medical history included ongoing genital herpes. Concomitant medications included valaciclovir hydrochloride (VALACYCLOVIR HCL) 1gram tablet for genital herpes. Stated she had genital herpes for over 10 years, and had an outbreak about 2 weeks prior to getting her 1st COVID-19 Vaccine. She said she hadn't had a herpes outbreak in over 10 years. She said she stopped taking her Valtrex medication after the COVID-19 Virus Pandemic started. She said she restarted the Valtrex when she had the genital herpes outbreak a couple weeks before her 1st COVID-19 Vaccine. She said she had taken a 1/2 Valacyclovir 1gram tablet, off and on, to treat her recent. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. Patient experienced her left calf felt numb on 23Mar2021 with outcome of recovered/resolved; the skin from under both her eyelids to her cheek bones felt like it was being pulled down on 23Mar2021 with outcome of recovered/resolved; her voice was hoarse and raspy on 24Mar2021 with outcome of not recovered/not resolved; she had about 10 canker sores in her mouth on 24Mar2021 with outcome of recovered/resolved; facial paralysis on 23Mar2021 with outcome of recovered/resolved; her skin felt tight on 23Mar2021 with outcome of recovered/resolved; She said she saw more wrinkles on her face than she knew she had on 23Mar2021 with outcome of unknown; cholesterol was high on an unspecified date in 2021 (either late Feb2021 or early Mar2021) with outcome of unknown. She is asking for a recommendation on receipt of second dose. Clinical course: patient reported she had her first COVID-19 Vaccine shot last Tuesday (23Mar2021), and she had some side effects that were not listed on the COVID-19 Vaccine information sheet she was given. She said she was concerned about getting the second COVID-19 Vaccine shot. She said she sat for 15 minutes after she received her COVID-19 Vaccine, and was completely fine. She said she then had about a 5 minute walk to her car. She said when she was walking to car, her left calf felt numb. She said at first she thought maybe she had been sitting too long, and her left leg fell asleep. She said once she got to her car, the skin from under both her eyelids to her cheek bones felt like it was being pulled down. She described the feeling as being in the sun for days, saying her skin felt tight. She said she looked in her car mirror. She said her face wasn't red, but her face definitely looked like it was being stretched. She said she saw more wrinkles on her face than she knew she had. She clarified her face being stretched as a facial paralysis, and said the facial paralysis only lasted about 4 hours, and then disappeared. She said the next day (24Mar2021), she woke up, and her voice was hoarse and raspy. She said her voice continued to be hoarse and raspy for 2 weeks now. She clarified the hoarseness had been on and off and had improved from last week, but in the evenings her voice gets raspy. She said she had about 10 canker sores in her mouth. She said she gargled with Scope, and the canker sores would come and go. She said the canker sores were not painful like canker sores, but were just sores. Reported she had blood work done in either late Feb2021 or early Mar2021, and everything was fine, except her cholesterol was high. No further details provided. Treatment: Reported she spoke to the on-call doctor at her doctor's office on 23Mar2021 first, and then called the (name) Hospital Emergency Room and spoke with someone about her side effects on 23Mar2021. She said the doctor on-call at her doctor's office told her to take a 1/2 tablet of Valtrex (clarified as generic Valacyclovir HCL 1gram tablet). She clarified she had been taking Valacyclovir HCL since she was diagnosed with genital herpes about 10 years ago. She said she stopped taking the Valacyclovir HCL when the COVID-19 Pandemic started last year. She said she restarted the Valacyclovir HCL, taking a half Valacyclovir HCL 1gram tablet (500mg) daily. She said she spoke with her gynecologist today (02Apr2021), and he told her to take the full Valacyclovir HCL 1gram tablet for 3 months and then go back to taking a half Valacyclovir HCL 1gram tablet (500mg). She said the Valacyclovir HCL 1gram tablet was dispensed in a pharmacy bottle, providing NDC Number: 1671469701. She did not have a Lot Number and Expiration Date. She said the generic Valacyclovir HCL 1gram tablet was manufactured by NorthStar Rx and had "(3/3)" after the manufacturer's name. Reported she gargled with Scope mouthwash for her canker sores in her mouth. She said she had finished the Scope mouthwash, and disposed of the product bottle, and didn't have the UPC, Lot and Expiration Date. Reported her gynecologist was the one who told her to call Pfizer to get further direction about getting her second COVID-19 Vaccine. Follow-up attempts are completed. No further information is expected.
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| 56 | 2021-04-18 | pain in extremity |
The onset of symptoms began 10 hours after the second dose injection, including severe headache, fev...
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The onset of symptoms began 10 hours after the second dose injection, including severe headache, fever, arm pain, fatigue, and tinnitus. All symptoms persisted intensely for 24 hours, then started to lift -- with the exception of headache and tinnitus. The headache resolved at about 48 hours. Tinnitus remains severe and consistent since the day of the shot. No prior history of tinnitus or auditory disorder.
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| 56 | 2021-04-19 | weakness, tremor |
Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few...
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Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few hours then woke up feverish, bad headache, major bodyaches, nauseous with throwing up throughout the day, fatigue, weakness and sore arm at injection site so I slept most of the day in general, in between sickness. 2nd day after vaccine, April 15th I woke up with still a bad headache, bodyaches, nauseous, and sore arm. Headache subsided that night. April 16th I still was nauseous most of day and sore arm. Took extra strength tylenol a couple times on April 13th, 14th and 15th.
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| 56 | 2021-04-20 | muscle spasms |
Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unre...
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Fever; chills; severe abdominal and back pain; severe abdominal and back pain; severe cramping; unremitting liquid diarrhea; infectious colitis; rash on leg; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 56-years-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:45 AM (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included Coronary artery disease; Acid reflux; possibly Lyme disease (1-4 days prior to vaccine), known allergies was Paradoxical reaction to Benzodiazepines. Concomitant medications included clopidogrel; ezetimibe; evolocumab (REPATHA); rosuvastatin and Ome. No other vaccine in four weeks. The patient received first dose of BNT162b2, at the age of 56-years-old via an unspecified route of administration, administered in Right arm on 10Mar2021 12:00 PM (Lot Number: EN6207) as single dose for covid-19 immunisation. Patient experienced Fever, chills, severe abdominal and back pain, severe cramping and unremitting liquid diarrhea, infectious colitis, rash on leg all on 31Mar2021 with outcome as Recovering. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received was IV fluid, antibiotics. No covid-19 prior vaccination. Covid-19 test post vaccination was PCR, covid test type post vaccination was Nasal Swab on 04Apr2021, result was Negative.
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| 56 | 2021-04-21 | tingling |
55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. ...
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55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. Patient states that this is her first dose in the two-dose series. Patient denies previous vaccination reactions. Patient received her vaccination to the Right arm. Patient states that she also feels anxious and nervous. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. NP and Paramedics at patient side. Patient provided with a bottle of water and legs were elevated. Within 3 minutes patient stated that tingling resolved. Patient noted to be hypertensive (172/104) with all other vital signs normal. Patient denies medical history of hypertension. Patient moved to the partitioned off area and placed on cot. Patient vitals monitored every 5 mins for 1 hour. Patient became normotensive and stated that symptoms had resolved. Patient discharged home in stable condition.
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| 56 | 2021-04-21 | tingling | Error: Shoulder Joint Injury (prolonged pain, tingling, etc.) |
| 56 | 2021-04-22 | bell's palsy | Bell's palsy symptoms within 4 hours of shot. |
| 56 | 2021-04-24 | feeling hot, burning sensation |
tightening sensation in throat air way restricting; tightening sensation in throat air way restricti...
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tightening sensation in throat air way restricting; tightening sensation in throat air way restricting; Taste in mouth followed by burning sensation throughout my body; Taste in mouth followed by burning sensation throughout my body; Turned red skin hot to touch; Turned red skin hot to touch; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (Brand: Pfizer), dose 2 via an unspecified route of administration, administered in arm right on 13Apr2021 (Lot Number: EW0158) as single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. Known allergies: Sulfa drugs. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. The patient previously received first dose of BNT162B2 on 23Mar2021 01:15 PM (Lot number: ER5732), in left arm, at the age of 56-year-old for COVID-19 immunization. 1st shot hot spot red swelling at injection area. 2nd shot severe instant adverse reaction. The patient experienced taste in mouth followed by burning sensation throughout her body. Turned red skin hot to touch. Immediately followed by tightening sensation in throat air way restricting on 13Apr2021 at 01:45 AM. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment was received for the events which included Medics treated oxygen Dr administered Benadryl. The patient was recovering from the events.
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| 56 | 2021-04-24 | pain in extremity |
The caller tested positive for COVID-19 yesterday; The caller tested positive for COVID-19 yesterday...
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The caller tested positive for COVID-19 yesterday; The caller tested positive for COVID-19 yesterday; Right arm sore; Body was sore for a week; Tired for a week; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female consumer (reported herself). The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via intramuscular in right arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunization. The patient's familial medical history included that the patient's son passed away 10Jun2020, he had type 2 diabetes. He went to hospital with Pneumonia and keep him for 3 weeks and released him and passed away the next day. The patient's medical history included soreness. The patient's concomitant medication included ibuprofen. On 18Mar2021, the patient experienced that in the morning when she woke up around 08:00the patient's body was sore for a week and she felt tired in the afternoon around 16:00-17:00. The patient's right arm was sore at 14:00, but not much. The patient went to work and used her arm and by the end of a day it was less sore and by the next day, it was almost normal. The patient's body was so sore, like doing exercise for a couple of days. On 18Apr2021, the patient was scheduled to receive her 2nd vaccine and patient tested COVID-19 vaccine and resulted positive so that the patient was sent to home. The patient would like to know when can get the second dose. Prior to the vaccination the patient received pills for high blood pressure. The patient did not received any vaccination 4 weeks prior to the COVID vaccine. The outcome of the events body was sore for a week, right arm sore and tired for a week was recovering and other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-04-28 | burning sensation |
raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forear...
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raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on LEFT forearm & upper arm with itching & burning sensation; raised rash on RIGHT forearm; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 26Mar2021 at 10:15 at single dose for COVID-19 immunization. Medical history included allergic to penicillin, tetracycline, keflex, all sulfa drugs, Diflucan. Concomitant medication was not reported. Patient was not pregnant at time of vaccination. On 18Mar2021, patient tested nasal swab and resulted negative. Since the vaccination, the patient had been tested for COVID-19. On 26Mar2021 at 11:00, the patient experienced raised rash on left forearm & upper arm with itching & burning sensation. The patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received treatment with steroids & Benedryl. The outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 56 | 2021-04-30 | seizure |
seizures; soreness; extreme fatigue; injured; illness; This is a spontaneous report from a contactab...
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seizures; soreness; extreme fatigue; injured; illness; This is a spontaneous report from a contactable consumer, the patient. This 56-year-old non-pregnant female patient the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 08Apr2021 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunization. Medical history included seizure (not medicated), asthma, allergies, deprived of nightly decent sleep (from 24/7 low frequency torture by neighbor's ventilation system), and allergies: DILANTIN (phenytoin sodium), "1 other seizure drug" and sulfonamide drugs. The patient was receiving unspecified concomitant medication(s). The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Mar2021 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunization. On 11Apr2021 00:30, the patient experienced seizure. On an unspecified date in Apr2021, she also experienced the soreness, extreme fatigue, injured and illness. The clinical course was described as follows: "I suffer from occasional seizures for which I am not medicated and I had one after midnight 2 days after the vaccination. Other symptoms were just soreness and extreme fatigue. I suspect this seizure is due to my lack of oxygen from my laying in bed the next day in this case but wanted to report it in case it matters. I normally suffer seizures very rarely and always in bed at 3 or 4 a.m. at times when I am sick or lacking sleep. This time I had my seizure in the bathroom and I am afraid I have no further information except that I likely only had one since I was missing from the bedroom for less than an hour as near as we can tell. I woke up on the floor injured and unaware of my surroundings. I have never had a seizure while awake before unless it was a second one. I have been deprived of nightly decent sleep by several neighbors for over 3 years now by a low frequency noise from a pot grow ventilation system that has caused me illness and was bad near the time of vaccination." No treatment was received for the adverse events. The clinical outcome of the seizure, soreness, extreme fatigue, injured and illness was resolving. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
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| 56 | 2021-05-03 | pain in extremity |
Tinnitus; severe headache; Fever; arm pain; Fatigue; This is a spontaneous report from a contactable...
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Tinnitus; severe headache; Fever; arm pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 AM (at 56-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included known allergies: Sulfa drugs. No prior history of tinnitus or auditory disorder. No covid prior vaccination. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 AM (at 56-year-old) at single dose for COVID-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. On 10Apr2021 07:00 PM, the onset of symptoms began 10 hours after the second dose injection, including severe headache, fever, arm pain, fatigue, and tinnitus. All symptoms persisted intensely for 24 hours, then started to lift with the exception of headache and tinnitus. The headache resolved at about 48 hours. Tinnitus remains severe and consistent since the day of the shot. The events resulted in disability or permanent damage. No treatment was received for the events. The outcome of the events was not recovered. No Covid tested post vaccination.
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| 56 | 2021-05-04 | numbness, bell's palsy |
Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spon...
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Bell's Palsy; Headache; jaw ache; ear ache; numbness in face; Assuming ear infection; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 27Mar2021 12:45 (Lot Number: EP6955) as single dose (at 56 years old) for COVID-19 immunisation. Medical history included none. Concomitant medications included atorvastatin, cetirizine hydrochloride (ZIRTEC), Forces of Nature Skin Tag. On 13Apr2021, the patient experienced Bell's Palsy (medically significant), headache, jaw ache, ear ache, numbness in face, assuming ear infection. Therapeutic measures were taken as a result of the events included Prednisone. The outcome of the events was recovering. The patient required a visit to the emergency room and diagnosed with Bell's Palsy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination.
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| 56 | 2021-05-04 | muscle spasms, pain in extremity |
sustain cramps in her right leg; limited range of motion; not sure if there was a nerve that has bee...
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sustain cramps in her right leg; limited range of motion; not sure if there was a nerve that has been damaged or early stage of thrombosis; not sure if there was a nerve that has been damaged or early stage of thrombosis; severe arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 12Apr2021 at 09:30 (at the age of 56 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication was none. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 18Apr2021 at 18:00, the patient experienced severe arm pain that was described as arm pain was too painful and have been woken up out of her sleep and she has limited range of motion and she was not sure if there was a nerve that has been damaged or early stage of thrombosis. On 20Apr2021, the patient experienced sustain cramps in her right leg. The patient did not receive treatment for the events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 56 | 2021-05-10 | numbness |
anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache...
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anaphylaxis; headache with numbness; headache with numbness; blurred vision and nausea from headache; blurred vision and nausea from headache; has been trapping food since in her throat; had irritation in her throat; coughing; coughing; off balance; couldn't see straight; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Left Arm on 18Mar2021 10:30 (at age of 56 years old) as single dose for COVID-19 immunisation. Relevant medical history included: Asthma, immune problems, upper respiratory stuff, all ongoing; Her Diagnosed allergies include iodine fish, Propofol, and preservatives, sleep apnea, had COVID in Jan2021, and had a cough (Jan2021) from that. There were no concomitant medications. The patient previously took iodine, propofol and had allergies. Patient took first dose on 18Mar for reason that patient has lost all allergies that cannot be detected by blood work. After first short she was told to wait an extra 15 mins not vitals taken she can leave a felt like a specimen unpaid but paying with life. Patient started coughing while everyone watched her so she said she better take Benadryl cause she doesn't wanna die. Patient left had off balance couldn't see straight. She was the one that had all side effects from vaccine as well as COVID signs. She had research medicine/food that cause her to have anaphylaxis. Patient found same ingredients in vaccine but food and drug said it ok. Patient was an experiment. She need to no from your board it is ok for me to take 2nd vaccine. Patient should be getting paid. Her doctor making it seem it up to her she gotta go out and get and epi pen she cant afford. In running out of gloves and mask. The patient experienced Anaphylaxis, has been trapping food since in her throat, headache with numbness, Cough, blurred vision and nausea from headache, all on 18Mar2021. Caller has been coordinating with the CDC by email. Since day one she had a bad reaction to the COVID vaccine. This has been going on a month now. The CDC advised her not to get the second shot. She has went back and forth with the doctor. She had anaphylaxis from the vaccine. Her throat closed. She had irritation in her throat. She has been trapping food since in her throat. This has been since the anaphylactic reaction. She has to chew her food as fine as possible. She tries not to eat that much. This is still the same. It hasn't improved or worsened. She has also had a headache with numbness that is pretty much 24 hours a day. This started right after. She really felt it the next day. She tried to take Tylenol for four days, three times a day, and nothing happened. It was not going away. Her doctor also put her on a migraine medication, but it didn't work either. The headache has worsened over time. No medication is helping, and the doctors are confused. The migraine medicine is not helping. Her pressure is going up and down. She is wondering if she needs an emergency echo to see what is going on. She is still having bad effects. No doctor knows what to do. She has been to a lung specialist. Her cough just keeps getting worse. The cough started to get worse after the vaccine. She had COVID in Jan2021, and had a cough from that, but the vaccine made it worse. It is a ruff cough. She is on cough suppressant medication. Caller did not have a prescribing doctor. She got it at the hospital. She figured that was the safest, and since she is a patient there they emailed her because she was eligible to get it. She is mostly calling because the doctors don't know how to help. She is about to pass out from this headache. She is even losing vision from the headache. She feels like she is going to have a heart attack before her time. They are trying to figure out why her head is hurting. They do not think it is a migraine. Her headache is a 9/11 or a 10/12. She feels like after the vaccine she has been chemically off balance. She wants to get her thyroid checked too. Mostly because her food is getting trapped in her throat. Her throat is irritated and hoarse. The headache has given her blurred vision, and a felling like she is going to throw up. She feels off balance from the blurred vision. Caller had difficulty seeing information on Tylenol and Nurtec. She asked her husband to help. They cannot read the lot on the Tylenol. She has been to so many specialists to try to find answers, and no one has a clue. She saw on Pfizer's paperwork that she needs to reach out to a immunologist. Her allergist had no clue. From the world trade centers falling she has ongoing issues from that. She has sleep apnea, allergies, asthma, etc. She spent 30 minutes being monitored at the hospital. She had started coughing. Her husband said she needed water. She always carries Benadryl with her. Finally she felt like she needed to take her Benadryl. It saved her. She knows the Benadryl probably won't work forever, but she cannot afford an epi Pen. Time of Onset (24 hours clock): right after vaccine (18Mar2021). All events require a visit to Physician Office. She didn't have to go the ER. She was lucky with the Benadryl. She takes Benadryl with her everywhere even to restaurants. No Prior Vaccinations (within 4 weeks). Treatment received for coughing, headache with numbness, blurred vision and nausea from headache. The outcome of the event has been trapping food since in her throat, had irritation in her throat, headache with numbness, blurred vision and nausea from headache was not recovered, for other events was unknown.
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| 56 | 2021-05-10 | pain in extremity, feeling hot |
she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; ...
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she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; her heart is beating fast and she is nervous.; burning sensation in her ear; tiredness; headache; heaviness on her back and chest on the left side; heaviness on her back and chest on the left side; no appetite; nauseous; diarrhea; throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh she could feel crushing and throbbing; her heart is beating fast and she is nervous.; sharp pain in her thigh/pinching sensation on inner thigh; sick; throbbing; muscle pain; weird sensation; throbbing sensation to the left side of her belly button/It was like at her stomach; fever of 100.3F; had a feeling of heat on her neck, face, and ears; redness and itchiness at the injection site; redness and itchiness at the injection site; the injection was large, red, hot, and itchy; the injection was large/ the swelling went down; dizzy; This is a spontaneous report from a contactable consumer reported herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included disability, obese, covid-19 when she was sick with COVID last year, she has never been that sick. she thinks she made it through because she owns a nebulizer and can say her lungs have never felt like they were full of fluid. If anything, they felt heavy. It was heavy in her back and chest. She also had a fever. She guesses she would be considered obese. Concomitant medications included paracetamol (TYLENOL). The patient received the first dose of the Pfizer COVID vaccine last week and she has experienced several side effects and is very anxious and nervous. She experienced redness and itchiness at the injection site, pinching sensation on inner thigh that she thinks may be blood clot or a muscle but not really sure, fever of 100.3F from 24Apr2021, burning sensation in her ear, tiredness, headache, heaviness on her back and chest on the left side, no appetite, nauseous, diarrhea, had a feeling of heat on her neck, face, and ears, throbbing sensation to the left side of her belly button from 26Apr2021 and she felt dizzy from 22Apr2021. The patient stated there was a bad connection and she was having difficulty hearing. The patient was a little nervous. Maybe this was a psychosomatic issue and she was thinking of things too much. She was sick for 5 weeks. She was never in the hospital or intubated. The site where she had the injection was large, red, hot, and itchy. It was from 22Apr2021 (Thursday) for the next maybe 3 days. Now the color is diminishing, the color is going down more like to pink and smaller and it not itching anymore. Once in a while she got a pinching sensation on her inner thigh ever since she had the injection. In the last couple days, she has been feeling a that a little more. She wanted to make sure it was not a symptom of a blood clot. She doesn't feel short of breath. She was nervous talking the call handler so that is why she is talking fast. She doesn't want to feel so sick like she did last year when she had it in March or April. She wanted to know that it's not a symptom of a blood clot. It was a throbbing pinching pain that goes and doesn't come back for a little bit, but it might come back a little bit later. It happened when she woke up. She has no swelling in her legs or thighs or anything else. She says she would not be talking this fast, but her heart was beating fast and she was nervous. She tended to be an anxious and nervous person. The patient never had blood clot issues. She wanted to make sure with everything that she has heard about Pfizer she hasn't heard of anyone having blood clot issues. She had to read to calm herself down a bit. It is a sharp pain with throbbing that comes and goes. She didn't read where it could be a blot clot, she just wanted to know. She is horrible at running to the hospital when she feels something because she gets so nervous and she thinks knowing is better because she's a realist. It takes her a minute to go to the hospital to figure it out. If she continues to feel like this she and her daughter will go to the emergency room. It is 5 blocks away. It is a small little hospital and they will be able to ease her mind. It could be her nerves getting to her too. Her fever got up to 100.3 and that was only on Saturday, 48 hours after the vaccine. Once she took Tylenol it was gone and didn't return again. She took her temperature; it was a beeping one. She always says she would take like 2 out of 3, and every time she took it went up. She felt a weird sensation of burning in her ears, the same as when she first had Covid, feeling like a fever. It brought her back to a bad place and it freaked her out. She is on disability and has people go to the store for her. She did that for 3 to 4 months. She is not agoraphobic, but she hadn't gone out until she got the vaccine. It took her all day to get back home because she loves the outdoors. It is kind of sad, and she knows she is not the only one who experienced that. She was able to actually stay at home, and when she went out, she wanted to stay. She still has her second dose to take, not everyone in has this and she doesn't want to feel that sick again. Eventually she will perish away one day, from God knows what but a slow death of not being able to breathe she cannot picture for herself or anybody else. She tries not to watch the news, it was depressing, because it is all over the news, she tries to stay in the loop. She was tired and had a headache. She took Tylenol and slept for an hour or hour and half. When she woke up she felt heaviness on her back and chest on the left side, and as she moved around more it was on her back and less on her chest. It was the same as she felt when she had Covid. She didn't have any aches or pains. The other thing was she had no appetite for the next 3 days. Every time she woke up, she felt extremely nauseous but had nothing to vomit. For the next 3 days or 72 hours, she had diarrhea. If she ate anything, she was in the bathroom. On 24Apr2021 (Saturday) after 48 hours she started to feel the heat in her neck and face and ears like right on her ears. She was talking to her daughter and her daughter said these are normal. Where she got the injection was itchy and a little more red. She told herself not to scratch it in her sleep, she is one of those people if something itches, she scratches. What she would do is rub her arm up and down on the site. It was almost the size of an 8 ounce tomato sauce can or maybe the size of a baseball. Then the third day it got redder. In her sleep she was rubbing her arm because it got itchy. Today the swelling went down, the color is like a light pink, and the size is also minimized. The fever lasted that night. She took her temperature again the next day and it was 97.9. That is usually what it is when she wakes up. She is not just tired; she is exhausted and feels like she has to go to sleep. Her daughter came with her granddaughter who is a baby, and she didn't know how to tell them. She was happy to see them but so exhausted. She worries about the sharp pain in her thigh. The other thing is she started getting pain in the middle of her thigh, her inner thigh. A sharp pain with like a throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh, she could feel crushing and throbbing. She can feel it from touching the area. She had this before like when she is stretching. It started maybe 3 months ago and went away but then after she took the injection and heard about thing, she worried about a blood clot with Johnson & Johnson, not that she would know because she has never had a blood clot. It could be psychosomatic and all working in her head. It started the last 2 days when she woke up, she felt fine and as she was lying in bed, she started feeling a sharp throbbing pain that eventually goes away. She has no swelling of her legs or thighs, and her daughter said it looks fine. She is semi-terrified of hearing bad news. It takes her longer to go to the hospital. If she starts feeling worse, she will be there in no time. She does not want to wait until it is worse, but she does not want to spook herself into going. She suffers from anxiety. She definitely had the fever not like she was just tired it was like she was exhausted. She got up early and would take a little nap because she was doing a bunch of stuff. That hasn't happened, but that's her. It will be 2300 when she goes to sleep. She was doing a bunch of stuff and felt like she just needed to take a nap. Maybe it is part of that too, but usually she doesn't feel tired like this. After her daughter left, she read something on her phone and passed out. When she woke up, she saw she actually dropped her phone. Her thigh is now not a pinch but more a little bit of a muscle pain. Now it is not like the inner thigh, it is more behind the thigh now, but not below the knee, right behind the thigh, closest to the knee but not on the knee. It is the same thing as if the middle had gone behind her thigh a bit. The little pillow on her chair is not helping anything either. It feels like it maybe muscular, its deep feeling. It feels like it could be muscle, if she rubs it, she can feel it. When asked has it improved persisted or worsened, caller states it is there, but it is dull. She can say there is pain, but it is a little duller just because it is more in the muscle. It is hard to explain, it was not the same throbbing pain but there is a dull pain, it goes around the chunkier part of her thigh, like the inner thigh. When she rubs it there is pain but a dull pain. When she rubs it, it feels better but she can still feel the site where it hurts. When she rubs it, it is still located right in the lower middle going toward her knee but not at the knee, maybe 3 to 4 inches away from the fold of her knee, almost at the center of her thigh almost. Almost like a dull muscle ache, there is a bit of throbbing with it. She will go to the doctor if something weird happens and will call back when they have an idea of what happened to her. This will sound crazy. The next thing she felt was a light throbbing where her belly button is but more to the left side, but not at the belly button. It was like at her stomach, not right at the belly button but right on the same line as her belly button but more at her waist. It was a small throbbing started today about an hour ago. She is hoping it is gas. Her fever went away pretty fast. She was on the phone and took her temperature to tell what it was. The woman said to take some Tylenol. It went from 99.9 to 100 to 100.3. She thought oh no. That was the highest she saw. Then eventually it started going down to 99.4, and then by morning it was back to normal. She only took Tylenol the one time. She is thinking maybe it is from being nervous and causing her body to heat up. She doesn't know she is just thinking. She thinks the fever went away the same day within an hour to 2 hours. She also wasn't drinking enough water. When asked if her fever has recovered completely or with last effects, caller states that is fine now, her temperature today was 99.4 without the fan on, she says she thinks that was pretty normal. When she first wakes up it is 97.9 usually. There was also a 98.4. The redness and itching at the injection site started 3 hours after the injection. She took her 2 sons with her. She took it and then her son took it. They said to wait 15 minutes. As soon as she stepped out, she looked up and felt so dizzy. It looks like when in summer and it seems to be boiling hot, that is how it got for her. Things got blurry. It was not like she was going to black out, but she had to close her eyes because the room was going to spin. She knocked back on the door and took a seat, so she sat down because she was not feeling right. When she gets nervous, she chews gum as a coping mechanism. Her son got some gum for her. She felt better but kind of nervous waiting for 15 minutes to go by, what if she felt dizzy again. She let 20 minutes go by and she got up and was fine. She wanted to be out of there and in the cool air outside. That is the first reaction that she had. She is one of those people that feel so nervous she is sure that happens that they feel like, oh they are so nervous, and they read so much, and it is in our faces everyday no matter what. Maybe it had nothing to do with the injection, maybe more that she was so nervous, but it was a weird sensation after. She knows when people first started getting the COVID vaccine, people were just like falling to the ground, she was like that would be terrible. She went with high expectations and was also nervous. Her heart was beating, and she could hear her own heartbeat. She still feels tired and like she can go take a nap now. She asks if that is normal. She would rather talk to Medical Information now. She is over this statistics part of it. She doesn't feel a release, she is just giving her information and she doesn't feel any better. Outcome of the event throbbing sensation to the left side of her belly button/It was like at her stomach was not recovered; of the event dizzy was recovered; of the events the injection was large, red, hot, and itchy/ the swelling went down, tiredness was recovering; of the other events was unknown. Information about lot/batch number has been requested.
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| 57 | 2021-01-01 | weakness, pain in extremity |
Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired....
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Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired. Arm bruised and more sore than regular I'M injection. Feeling "off".
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| 57 | 2021-01-01 | weakness |
On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all n...
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On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all night long. I had severe body aches and chills. I was unable to find my thermometer so am not sure of tempertature. I had lower back pain so severe I couldn't lie down. I tried to take Tylenol but was unable to keep it down. By morning I got access to Tylenol suppositories, Dramamine, and a thermometer. My temperature before Tylenol was 104.4. These symptoms continued over the next 3 days though vastly improved with Tylenol, Dramamine and IV fluids. I received a negative COVID test on Thursday. I have only been this ill once before in my life. By Thursday I was not longer febrile, only weak and exhausted. I have to now determine whether or not to get the second vaccination. I know this seems to be a somewhat delayed reaction. Any advice would be appreciated.
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| 57 | 2021-01-02 | weakness |
Patient received vaccine and was fine through her 15 minute observation period. She left the clinic ...
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Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.
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| 57 | 2021-01-03 | feeling hot, tremor |
right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headach...
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right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headache. I also had a chlorine taste in my mouth. I told the nurse I wasn't feeling well. she sat with me and was asking about how I was feeling. I the started trying to clear my throat. it felt like I had something in my throat. I kept trying to swallow and it just felt like my throat was getting tighter and tighter. that's when they got me on a stretcher and took me to the ER
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| 57 | 2021-01-03 | numbness, tremor, feeling of body temperature change |
10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experienc...
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10 minutes after injection, patient reported numbness of bottom of the feet, hands, and is experiencing hot/cold episodes, shaking, and pallor of lips. She also reported intermittent nausea. No changes in mental status. Patient was transferred to the ER. In the ER, she denied shortness of breath, facial swelling, hives, vomiting or diarrhea. No chest pain or voice changes. Her EKG was unremarkable. Her symptoms resolved with time, and was discharged on prednisone 20 mg PO for 4 days
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| 57 | 2021-01-03 | numbness | Numbs hands and feet, elevated blood pressure and tachycardia. |
| 57 | 2021-01-04 | weakness |
01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss conscio...
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01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss consciousness. Pt was aroused by Spouse to awake after fall and checked pt blood pressure 115/63 and sugar levels 93. Pt feeling weakness afterwards, pain in back and neck from fall. Awaiting calls from PCP and Neurologist for appointments.
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| 57 | 2021-01-04 | flushing |
Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swel...
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Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry ("like a big dose of steroids"). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling "hungover/groggy/nauseated". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.
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| 57 | 2021-01-04 | migraine |
48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 1...
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48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 12 hour after the injection, fever 99.1
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| 57 | 2021-01-04 | muscle twitching |
metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs...
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metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 57 | 2021-01-04 | pain in extremity | DEVELOPED SORENESS IN ARM, EXTREME FATIGUE, AND BODY ACHES. |
| 57 | 2021-01-04 | tingling |
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I ...
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First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
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| 57 | 2021-01-05 | weakness, tremor, difficulty speaking |
Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakn...
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Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
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| 57 | 2021-01-05 | difficulty speaking |
post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporti...
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post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EK5730, expiry date not reported), intramuscular in 29Dec2020 12:00 at a single dose in the left arm as Covid vaccine. Medical history included diagnosis is hypothyroidism, and patient have had reaction to almost all medications, wherein PCP (primary care provider) thinks patient have a reaction to the coating on tablets and to capsules. Patient had no covid prior vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. About 20 minutes after receiving on 29Dec2020 12:00, started with post nasal drip, which caused a cough; hoarse voice. These symptoms lasted about 2 hours. Since they are not listed as side effects just wanted to share. Patient did have a negative covid test on the day of the vaccine (covid tested post vaccination on 29Dec2020). No treatments received for the events reported. The events were reported as not serious (not resulting in death, not life threatening, did no caused/ prolonged hospitalization, not disabling/Incapacitating, not congenital anomaly/birth defect). The outcome of the events post nasal drip, cough and hoarse voice was recovered on 29Dec2020 14:20.
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| 57 | 2021-01-05 | flushing, pain in extremity, numbness, tingling |
Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left ey...
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Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
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| 57 | 2021-01-05 | flushing |
10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, dev...
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10 minutes after receiving vaccine, developed flushing and tingling of tongue. 45 minutes later, developed nausea. 1 hour and 45 minutes after vaccine, developed laryngitis. Sent to ED for evaluation and treatment. Received Solumedrol and Pepsid in ED with improvement. Discharged home by or before 8pm with resolution of laryngitis and other symptoms. Reports "feeling great" this a.m.
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| 57 | 2021-01-05 | night sweats |
Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccinatio...
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Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccination), severe chills and fever of 105. Took 800 mg of Ibuprophen and 50 mg of Benadryl. Temp down to 102 by midnight. Fevers persisted, especially at night with extreme night sweats for 11 days often requiring a change of clothing up to 6 times through the night. No further respiratory symptoms past initial presentation. Night sweats have persisted but with less severity as of Day 15. Please note, I am also a healthcare provider and infectious disease epidemiologist, hence enterring my own VAERS.
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| 57 | 2021-01-05 | tingling |
Described started "itching 30 minutes after shot administered. That night she noticed a "rash all ov...
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Described started "itching 30 minutes after shot administered. That night she noticed a "rash all over her body, no problems breathing". The next day she experienced "swollen lips and tingling and itching from head to toe". She reports she is taking Pepcid and Benadryl. She also reports " no problems with breathing".
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| 57 | 2021-01-05 | tremor, pain in extremity |
Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a h...
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Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice - puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days. Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal. Contacted: a pulmonologist - Dr. and she helped with O2 questions.
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| 57 | 2021-01-06 | weakness | Patient reported pain and weakness |
| 57 | 2021-01-06 | feeling hot |
WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WI...
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WARM NAUSEOUS, RAPID HEART BEATS , OBSERVED IN CLINIC IMPROVE AND RELEASED. RETURNED 1 HOUR LATER WIT SCRATCHY THROAT AND RED NCK AND CHIN. THEATED WITH BENADRYL AND DECADRON FROM THE ED.
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| 57 | 2021-01-06 | flushing |
57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency...
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57 yo F, healthcare worker, with history of asthma and penicillin allergy who presented to emergency department for reaction to COVID-19 vaccine. Patient received first dose of COVID-19 vaccine (Pfizer) and immediately became flushed, erythema to trunk and face, and intensely pruritic. No signs of airway involvement or wheezing. Vitals were stable. Patient was treated with benadryl which improved symptoms. Anaphylactoid reaction.
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| 57 | 2021-01-06 | pain in extremity, migraine |
On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early a...
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On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches. Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous. Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone 97.4.
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| 57 | 2021-01-06 | pain in extremity, muscle spasms |
Muscle spasms in neck within 1 hour of receiving vaccine. Severe cramp L calf less than 24 hours af...
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Muscle spasms in neck within 1 hour of receiving vaccine. Severe cramp L calf less than 24 hours after receiving vaccine. Both these symptoms continued until medical evaluation on 07 Jan.
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| 57 | 2021-01-06 | pain in extremity |
Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in...
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Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the elevated BP and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-06 | tingling |
pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt s...
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pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt sat in view of Rn for extended time period. VS 198/108 HR92 SPO2 97. Pt VS rechecked BP 148/90 SPO2 97 HR 94 pt stated she felt better. Pt ambulated independently, RR even and unlabored, NAD noted, Skin NFR. Pt declined transport to ED.
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| 57 | 2021-01-06 | tremor |
ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZ...
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ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZY AND LIGHTHEADED THAT LASTED FOR 3 DAYS. SINCE THEN I HAVE A BAD HEADACHE, FEELING NAUSEA AND VERY LIGHT HEADED AT TIMES.
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| 57 | 2021-01-07 | flushing, tingling |
Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. ...
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Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. in clinic for pt. assessment. Pt. uneasy/anxious with increased facial flushing to face and some mild swelling to lips. Pt. with tingling sensation to right side of body. Benadryl 100mg IM administered immediatly per Dr.'s order. Epi-Pen also available if needed. Pt. with improved redness to face and lips after administration.
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| 57 | 2021-01-07 | numbness, pain in extremity, tingling, weakness |
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe...
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burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
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| 57 | 2021-01-07 | pain in extremity |
Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Sym...
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Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Symptom last about 24 hours.
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| 57 | 2021-01-07 | pain in extremity | arm more sore than first shot; diarrhea- mild |
| 57 | 2021-01-08 | weakness |
Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick ...
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Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick nasal/sinus mucus.
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| 57 | 2021-01-08 | numbness, bell's palsy |
2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all...
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2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all right side of face became numb.Was sent for evaluation by employer to hospital.dx with adverse reaction.bells palsy I was given Decadron IM and medrol dose pack.
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| 57 | 2021-01-08 | pain in extremity | Fever Sore arm around 12 noon; chills 10pm for an hour, then fever 101-3F; relieved with tylenol |
| 57 | 2021-01-09 | migraine | Severe Migraine |
| 57 | 2021-01-09 | muscle spasms | Rigors, fever nausea, vomiting. diarrhea Severe muscle spasming/contraction, headache |
| 57 | 2021-01-09 | pain in extremity |
Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/202...
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Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/2021
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| 57 | 2021-01-09 | tingling |
Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadr...
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Mild General whole body Itchiness ; tachycardia; body tingling sensation Administered 50mg Benadryl 4mg Dexamethasone 1-10-21 @ 11:28am monitored and resolved by 12pm
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| 57 | 2021-01-10 | inability to speak |
experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elev...
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experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
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| 57 | 2021-01-10 | weakness |
nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day ...
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nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day the vaccine was given. injection site pain swelling, severe headache, developed chills at night joint pains, rashes on my face, feeling weak as if I dont have energy. At night time i went to the restroom 5 times with an interval of 5-10 minutes and i cannot even control my bladder it comes out continuously. Slow to comphrend or response. I stayed fully awake the whole night on the night when the vaccine was given to me and was able to sleep only the following day (sat) at 5 pm.
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| 57 | 2021-01-10 | feeling hot | c/o burning/ warmth to throat |
| 57 | 2021-01-10 | numbness | muscle aches chills fever right knee where quad is, is numb |
| 57 | 2021-01-10 | muscle spasms |
Same exact signs and symptoms as Covid disease in April 2020. Fever, extreme headache, muscle pain, ...
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Same exact signs and symptoms as Covid disease in April 2020. Fever, extreme headache, muscle pain, chills, joint pain, extreme fatigue, weakness, GI symptoms, muscle cramps,
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| 57 | 2021-01-10 | pain in extremity |
HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER C...
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HEALTH CARE WORKER ARMS WAS SWOLLEN , ITCHY, HARD AND PAINFUL AFTER SECOND DOSE OF GETTING PFIZER COVID-19 VACCINE
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| 57 | 2021-01-10 | pain in extremity |
Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if ma...
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Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if making a fist. Now pain when holding a mug or glass but not other movement. Still swollen at time of report 1/11/2021 but much less painful. On the 28th and 29th of December I took 200mg ibuprofen, 3 or 4 doses over the two days, with some benefit.
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| 57 | 2021-01-10 | speech disorder, difficulty speaking |
Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled...
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Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event "Her voice became raspy, she could hardly talk, she could barely talk" caused patient's hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid. The information on the lot/batch number has been requested. Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient's details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event "Her voice became raspy, she could hardly talk, she could barely talk" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-01-10 | tremor |
Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shakin...
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Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shaking. Was so cold, had to get a heating blanket to put over me, along with 2 blankets. Was shaking so bad, could hardly walk. Was slightly disoriented at the time. This lasted for 4 hours. Temperature is normally 95.6, did rise to 98.7. Had severe body aches that lasted until the next day, but were not as severe. the following day was very tired and muscles were achy. I did take tylenol, which seemed to help.
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| 57 | 2021-01-10 | tremor |
Received Phizer COVID 19 vaccine on Tuedsay, January 5, 2021. Friday am did not feel well, Congestio...
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Received Phizer COVID 19 vaccine on Tuedsay, January 5, 2021. Friday am did not feel well, Congestion, HA and CP. Friday evening shaking chills and fever with extreme fatigue. GI symptoms and congestion Saturday. Feeling better by Saturday evening.
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| 57 | 2021-01-11 | feeling hot, numbness |
dizzy; Felt hot; acutely numb; This is a spontaneous report from a contactable other healthcare prof...
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dizzy; Felt hot; acutely numb; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 13:45 at a single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took cortisol [cortisone acetate]. The patient felt hot and acutely numb and dizzy within first few moments on 06Jan2021 13:45. The outcome of the events was recovered 06Jan2021 13:45. No treatment received for the adverse events. The reporter assessed as the events as non-serious. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Batch/lot was not available/provided to reporter at the time of report completion. Information about lot/batch number has been requested.
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| 57 | 2021-01-11 | flushing |
pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling a...
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pt reported flusing sensation, face felt normal. Felt heart racing, h was 90's. some mild tingling around lips, pt was calm sitting on chair
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| 57 | 2021-01-11 | tingling |
At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describ...
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At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describes sensation as tingling throughout her head and body. Denies shortness of breath, difficulty swallowing, tingling of the tongue or lips or lip/tongue swelling. Denies palpitations or tachycardia. Patient states that she did not eat breakfast this morning. Initial BP 151/92, HR 62, 96% on RA. Patient states that she did take her morning dose of metoprolol. Response team was called for patient to be further assessed. Repeat blood pressure at 08:42 was 124/82, HR 62, 96% on RA. Team assessed patient. Patient provided water and crackers. Physician instructed patient to be monitored for 20-30 minutes. 08:56, BP 136/82, HR 66, 97% on RA. Patient verbalizes resolution of all symptoms. Patient discharged from clinic ambulatory and stable at 09:25.
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| 57 | 2021-01-12 | face paralysis |
Bell's palsy HISTORY OF PRESENT ILLNESS Patient is a 57 y.o. female with a history of glaucoma, pre...
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Bell's palsy HISTORY OF PRESENT ILLNESS Patient is a 57 y.o. female with a history of glaucoma, pre-diabetes, and osteoporosis s/p recent fibular fracture who presents for facial weakness. Patient is a research MD in the neurology department. Patient reports that she woke up this morning with weakness of the right face and inability to close the right eye. She reports mild discomfort in the area of her right jaw, but no ear pain. Denies any change in hearing or taste. She denies any difficulty chewing or swallowing, but has noticed that water will come out the side of her mouth when she tries to drink. She reports mild dry eye on the right. No history of similar symptoms. Today is day 18 after her first COVID vaccination. No recent URI symptoms. No unilateral numbness or weakness. No autoimmune history.
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| 57 | 2021-01-12 | feeling jittery, flushing |
immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs ...
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immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs after
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| 57 | 2021-01-12 | pain in extremity, muscle spasms |
Stiffness soreness cramping severe pain. Unable to flex hands due to pain. Severe pain thru entire b...
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Stiffness soreness cramping severe pain. Unable to flex hands due to pain. Severe pain thru entire body lasting 3 days
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| 57 | 2021-01-12 | pain in extremity | severe pain in right arm, and diffuse body aches, headache |
| 57 | 2021-01-12 | pain in extremity | Arm soreness headache |
| 57 | 2021-01-12 | pain in extremity | Chills, fever, headache, body aches, upset stomach, pain in arm of vaccine |
| 57 | 2021-01-12 | pain in extremity |
Sore arm almost immediately, lightheadedness for a few hours, then onset of severe headache, body ac...
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Sore arm almost immediately, lightheadedness for a few hours, then onset of severe headache, body ache and shaking chills. Improved with Tylenol. Today still achy but I've continued the Tylenol.
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| 57 | 2021-01-12 | tingling, numbness |
C/O LEFT ARM NUMBNESS/TINGLING POST VAC. SHOT. EMS ON SITE. 1035: VS: 02 SAT R.A.: 98%, P: 95, B...
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C/O LEFT ARM NUMBNESS/TINGLING POST VAC. SHOT. EMS ON SITE. 1035: VS: 02 SAT R.A.: 98%, P: 95, BP: 147/82; T: 98.1 DEG. F. 1050: LEFT FACILITY, NO COMPLAINTS.
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| 57 | 2021-01-12 | tremor | severe tremors,tachycardia |
| 57 | 2021-01-13 | weakness |
Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous r...
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Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 57 | 2021-01-13 | weakness |
I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and...
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I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and then was transferred to hospital admitted (12/25/20) one day - discharged on 12/26/20 at night
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| 57 | 2021-01-13 | weakness |
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Wa...
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throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
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| 57 | 2021-01-13 | difficulty speaking |
Pt received covid vaccination (per pt, Pfizer vaccine) at a non-KP affiliated clinic. Within 10 min,...
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Pt received covid vaccination (per pt, Pfizer vaccine) at a non-KP affiliated clinic. Within 10 min, pt reports sore, pruritic throat, hoarse voice, difficulty breathing. Pt administered her own EpiPen and received a nebulizer treatment before transfer to ED. At ED, minimal residual symptoms but received prednisone and prn diphenhydramine.
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| 57 | 2021-01-13 | feeling cold |
Got vaccine yesterday 01/11/2021. Tuesday 01/12/2021: chill, fever, fatigue. Took Tylenol. Today ...
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Got vaccine yesterday 01/11/2021. Tuesday 01/12/2021: chill, fever, fatigue. Took Tylenol. Today 1/13/21 still a little fatigue. at work today. COVID negative 1/11/21 negative, getting tested every week. denies COVID exposure.
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| 57 | 2021-01-13 | numbness, tingling | tingling and numbness in Right hand (5 min) sweating and anxiety felt foggy 20 min. |
| 57 | 2021-01-13 | migraine |
Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, ...
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Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, fatigued, body aches, nausea, pain throughout whole body.
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| 57 | 2021-01-13 | muscle spasms |
Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; Th...
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Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 06Jan2021 16:45 at a single dose on right arm for COVID-19 immunization. Medical history included, lactose intolerance. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.), probiotics (PROBIOTICS), clarithromycin (MACROBID [CLARITHROMYCIN]), ibuprofen (MOTRIN [IBUPROFEN]), paracetamol (TYLENOL). The patient previously took Parafon Forte and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730) on 17Dec2020 17:15 at a single dose on left arm for COVID-19 immunization. The patient experienced aches, chills, menstrual like cramps, fatigue, eye burning, and low grade temp on 07Jan2021 15:00. The outcome of the events was recovering. The events were assessed as non-serious. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 57 | 2021-01-13 | pain in extremity |
exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay ...
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exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay down and go to sleep; freezing cold; slightly nauseous; not feel as zippy as she normally do; Arm hurting a little; This is a spontaneous report from a contactable consumer (patient herself, a dental hygienist) via Medical Information team. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date: Mar2021, NDC number was unknown), via an unspecified route of administration on the right arm (also reported as upper shoulder) on 07Jan2021 at 11:30 30 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported she was feeling exhausted, freezing cold, slightly nauseous, and did "not feel as zippy as she normally do" on 08Jan2021. She wanted these effects recorded, and would like to know if they were normal, and would they happen to the same or higher intensity with the second dose. The patient further reported she had no adverse reaction on 07Jan2021 other than her arm hurting a little. Starting on 08Jan2021, she had felt exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous. She had been reading and was sure or was guessing this was normal, but wanted to verify that. She was not running a fever as of yet. Every time she tried to get up, she just laid back down. She felt fairly decent when she woke up, these events started later at the time of the report on 08Jan2021. She would not say these events were life threatening, but the CDC patient vaccine record card said to call to report any adverse events. She was scheduled for a second dose on 28Jan2021 and at this time did not plan to change dosing unless event worsening would occur. The patient had the vaccination, because she was always coming into contact with people with COVID at work. The patient had no investigation assessment. The reporter assessed the events as non-serious. The patient was recovering from the event "arm hurting a little," she was not recovered from the events "exhausted/exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous," while the outcome of the event "not feel as zippy as she normally do" was unknown.
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| 57 | 2021-01-13 | tingling |
tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; g...
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tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; given water& crackers - lightheadedness subsided but states is itching all over; offered to call 911 - refused. stated is going to primary care physician. total observation 45 min
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| 57 | 2021-01-14 | bell's palsy | Bell's Palsy |
| 57 | 2021-01-14 | numbness, tremor, cold extremities |
low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body ac...
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low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body aches diarrhea nausea
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| 57 | 2021-01-14 | pain in extremity |
After receiving the first vaccine, my arm hurt all the way to my wrist and became weak. Lasted almos...
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After receiving the first vaccine, my arm hurt all the way to my wrist and became weak. Lasted almost till I got my second vaccine. The second vaccine is causing the same thing. My muscles in my upper arm hurt really bad, the pain goes down to my wrist and my arm is weak. Its been 4 days since the second vaccine and its not stopped at all.
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| 57 | 2021-01-14 | pain in extremity | Sore arm |
| 57 | 2021-01-14 | pain in extremity |
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ...
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Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
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| 57 | 2021-01-14 | pain in extremity | Dizziness, Body ache Teary eyes pain to right arm Headache |
| 57 | 2021-01-14 | tingling |
20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth...
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20 minutes after injection and after leaving the clinic, she developed a metallic taste in her mouth, feeling of thick tongue, tingling from the neck to the top of her head. Took 25 mg Benadryl while in her car. No swelling and no respiratory distress. After 30 minutes, she didn't feel worse so she drove home (50 minute drive). Her symptoms resolved around 9pm (about 1 hour, 20 minutes after taking Benadryl).
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| 57 | 2021-01-15 | weakness |
Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled a...
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Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled area
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| 57 | 2021-01-15 | discomfort |
Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain,...
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Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain, unable to sleep, vomited once, took Tylenol, went to walk in at 7 am, did blood work, urine and Covid screen, all normal and negative, pain improved after about 15 hours Day 6 , today, pain came back, mild at 10 am and then severe at 11, nausea, vomited once, took Tylenol at 11 and feels better but still quite uncomfortable. Able to drink, normal stool, no other symptoms
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| 57 | 2021-01-16 | burning sensation, muscle spasms, pain in extremity |
Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficul...
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Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficulty walking , skin self like bad sunburn when touched. lasted approximately 36 hrs. For approx 12 more hrs moderate symptoms, then 24hrs minor symptoms. Started on Tuesday night resolved by Saturday morning.
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| 57 | 2021-01-16 | facial pain |
I had the same reaction with the first dose on 12/27/20, and it resolved, I received the 2nd dose to...
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I had the same reaction with the first dose on 12/27/20, and it resolved, I received the 2nd dose today and about 40 minutes after dose I had some tingling in lips, and then left sided facial pain, along cheek behind eye. hurts to smile and use that side of face. have taken a Benadryl I haven't read about this as a side effect. With the first dose this did resolved after 24 hours
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| 57 | 2021-01-16 | pain in extremity |
I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:0...
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I noticed pruritic erythematous papules on my right little finger as I woke up the next morning (6:00 am) after the vaccine. The affected area has increased in size (about 2.5 x 1 cm now), and the finger is slightly swollen, with pain in the proximal interphalangeal joint when pressure is applied. Two days ago (1/15/2021; 8 days after vaccination), a small pruritic purple papule (2-3 mm) appeared on my ring finger over the distal interphalangeal joint, same hand, and the area is slightly painful when pressure is applied; today, the papule measures 3 x 5 mm. Skin lesions in both fingers are on the dorsal surface. I will seek medical attention.
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| 57 | 2021-01-17 | feeling cold |
Symptoms started 1/6/21 at 10 PM. Chills, body aches, no fever. Symptoms mild on 1/7/21 10am. Took T...
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Symptoms started 1/6/21 at 10 PM. Chills, body aches, no fever. Symptoms mild on 1/7/21 10am. Took Tylenol Xtra Strength.
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| 57 | 2021-01-18 | weakness |
She was so weak; Muscles in her body are heavy/her muscles hurt so bad/Her muscles were aching and h...
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She was so weak; Muscles in her body are heavy/her muscles hurt so bad/Her muscles were aching and hurting to the touch; Muscles in her body are heavy and she can not hardly move; So tired; has not been feeling well; Her body was like a rock; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730 and expiration date not reported), via an unspecified route of administration on the left arm, on 08Jan2021 at a single dose for Covid-19 immunization. There were no medical history and concomitant medications (no other medications and never goes to the doctor). The patient previously took her first dose of bnt162b2 (lot number EK5730) on 18Dec2020 for Covid-19 immunization. The patient just had the second dose of the COVID vaccine on Friday, 08Jan2021. She had to go home from work on Saturday afternoon. She has not been feeling well. Her muscles in her body are heavy and she cannot hardly move. She was asking if that is a side effect? She is also so tired, she just cannot go. Her symptoms also started on Friday, that night. It woke her up. She got out of bed and her muscles felt like she could not move. Her body was like a rock. She tried to get up but her muscles hurt so bad. They were hard to the touch. Her husband tried to touch her and it hurt so bad she told him not to. Then on Saturday she was better in the day, went to work, then she was totally wiped out. Her muscles were aching and hurting to the touch. On 09Jan2021, she was so weak and went home. The patient did not received treatment for the events. She is unsure if she should go to her doctor today. She wanted to call Pfizer to see if this was a side effect first, and would go away, of if she needs to go ahead and let her doctor know what is going on and go in. Outcome of the event of weak was unknown and other events were not recovered.
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| 57 | 2021-01-18 | weakness |
slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not ...
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slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown. Information on batch/lot number has been requested.
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| 57 | 2021-01-18 | weakness |
Reported day following vaccination: headaches, unable to sleep, feeling very tired, and weakness beg...
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Reported day following vaccination: headaches, unable to sleep, feeling very tired, and weakness beginning day of vaccination
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| 57 | 2021-01-18 | burning sensation |
sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and...
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sharp pain R side of neck along dermatome; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; vesicles break out R anterior chest with mild burning and itching; minor shingles outbreak; skin irritation; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 10:15 at a single dose on the left arm for COVID-19 immunization. Medical history included Afib/ flutter, ablation, and total hysterectomy. Patient had allergies to food: grapes. Concomitant medications included fish oil, zinc, and estradiol (1 mg, 2x/week) transdermal patch. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. On 20Dec2020 at 09:00, the patient experienced sharp pain R side of neck along dermatome, vesicles break out R anterior chest with mild burning and itching consistent with a minor shingles outbreak. MD had examined it and his opinion was that the minor shingles outbreak was most likely triggered by the vaccine. Very mild but skin irritation was also present. No treatment was given for the events. Since the vaccination, the patient has not tested for COVID-19. The outcome of the events was recovering at the time of the report.
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| 57 | 2021-01-18 | numbness, tingling |
Vaccine at 3 pm at 5:22 pm LEFT facial, jaw, neck numbness and tingling. Resolved in 2 hours by 7 p...
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Vaccine at 3 pm at 5:22 pm LEFT facial, jaw, neck numbness and tingling. Resolved in 2 hours by 7 pm.
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| 57 | 2021-01-18 | migraine, feeling of body temperature change, numbness, tingling, pain in extremity, numbness, tingling, migraine, feeling of body temperature change, pain in extremity |
Arm soreness Migraine headache Nausea Hot and cold Fatigue Unsure of fever Numbness and tingling in ...
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Arm soreness Migraine headache Nausea Hot and cold Fatigue Unsure of fever Numbness and tingling in both hands
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| 57 | 2021-01-19 | weakness |
Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday...
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Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
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| 57 | 2021-01-19 | pain in extremity |
I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I w...
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I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I was very fatigued the rest of the day and had a headache. During the night I had chills and was dizzy. My temp was only 99.1 but I felt awful. I still had a temp this morning (day 2) No dizziness but I do have an awful headache and my arm is very sore where I received the injection.
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| 57 | 2021-01-19 | tingling |
Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, f...
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Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, face turned pale for few mins, hyperventilating
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| 57 | 2021-01-20 | feeling cold |
On the monday following my vaccination is very suddenly developed SEVERE chills. It took me three ...
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On the monday following my vaccination is very suddenly developed SEVERE chills. It took me three hours in a bed with electric blankets to get warm. Headache and body aches and tiredness. That day was the worst. And here is is 4 days later and I am still not out of the woods. I am still taking tylenol and advil for the body aches and chills and I have no energy
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| 57 | 2021-01-20 | feeling hot |
At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; ...
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At 10am feel hot, took temp was 102.7; At 10am feel hot, took temp was 102.7/ Temp at 12am was 101; Red all over; Face swelling; Shot site was red; Allergic reaction; Hives; Around 8pm start to feel chill; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: el1284), via an unspecified route of administration on 09Jan2021 09:30 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included HTN, GERD, IBS, known allergies: PCN, IV contrast. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), linaclotide (LINZESS). The patient previously took morphine and percocet [oxycodone hydrochloride;paracetamol]; and experienced known allergies. The patient received first dose of bnt162b2 on 19Dec2020 09:30 at right arm. Lot number: el1284. The patient got the 2nd shot at 09:30, went back to work was fine, got home at 07:15pm, around 8pm on 09Jan2021 start to feel chill. On 09Jan2021 20:45, the patient was reported to be red all over, took 650 of Tylenol. Face swelling, the shot site was red. Went to bed at 9pm. Temp at 12am was 101. Went to the ER 12:50am. They stated the patient was having allergic reaction and hives (reported as 09Jan2021 20:45). The ER gave the patient Benadryl IV, Prednisone IV, Pepcid. They discharge the patient with Prednisone and Pepcid. On 10Jan2021 at 10am feel hot, on the same day took temp was 102.7. The patient had to miss work 1 day of work sunday 10Jan2021. The patient received treatment for the events. The patient visited the ER for the events. The outcome of the events was recovering.
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| 57 | 2021-01-20 | numbness, tingling |
Numbness and tingling to mainly L face as well as L arm and foot. Feeling as if I am going to pass o...
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Numbness and tingling to mainly L face as well as L arm and foot. Feeling as if I am going to pass out at any time. Have not passed out, just very "Fuzzy". Started approximately 15 minutes after injection and slightly worsened for the next two hours. After one night sleep, L face and L hand remain mildly numb and tingly as well as the foggy feeling mentally.
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| 57 | 2021-01-20 | pain in extremity |
Reporter describes low grade fever (99.1-100F) and lower extremity body and joint aches starting app...
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Reporter describes low grade fever (99.1-100F) and lower extremity body and joint aches starting approx 14.5 hours after receiving the vaccine and lasting 36 hours. Treated with acetaminophen and ibuprofen. Injection site was sore x1 week - "felt like there was a baseball" in arm.
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| 57 | 2021-01-20 | pain in extremity |
hyperglycemia in the 400s; I have had no other problems following the vaccine other than a sore arm....
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hyperglycemia in the 400s; I have had no other problems following the vaccine other than a sore arm.; This is a spontaneous report from a contactable Other HCP (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EK9231) at single dose at left arm on 08Jan2021 10:45 for Covid-19 immunisation, administered at hospital. Medical history included type 1 diabetes mellitus, allergies to adhesives. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication in two weeks included biotin (BIOTIN), insulin aspart (NOVOLOG INSULIN), ascorbic acid, bacopa monnieri, biotin, boron citrate, calcium, choline bitartrate, chromium, colecalciferol, copper, deanol, docosahexaenoic acid, electrolytes nos, folic acid, gamma-aminobutyric acid, huperzia serrata, inositol, iodine, iron, levoglutamide, magnesium, manganese, molybdenum, n-acetyltyrosin, nicotinic acid, pantothenic acid, phosphatidyl serine, pidolic acid, potassium, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopheryl acid succinate, trace elements nos, vaccinium myrtillus, vanadyl sulfate, vinpocetine, vitamin a nos, vitamin b12 nos, vitis vinifera, zinc (FOCUS FACTOR), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced hyperglycemia in the 400s and a sore arm on 09Jan2021 14:30. She had no other problems following the vaccine. No fever. She cannot get her blood glucose level down. She has been at this range for 6 hours. The patient underwent lab tests and procedures which included blood glucose: 400. Treatment for event hyperglycemia was insulin pump continues increasing insulin. The outcome of events was not recovered. Post vaccination, the patient has not been tested for COVID-19. She was not sure if hyperglycemia was related to vaccine.
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| 57 | 2021-01-20 | pain in extremity |
Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; So...
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Body aches; Heaviness in her chest; Pulse is in the 90s; Now her temperature was 101.2 degrees F; Soreness in her left arm; Chills; Not feeling too well/flu-like feeling; Not feeling too well/flu-like feeling; Slight headache / headache; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unknown route, on 10Jan2021 at 15:00 at single dose in the left arm for COVID-19 immunisation. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ0140) administered in the upper left arm on 20Dec2020 (at 14:45-15:00) and developed a little headache, soreness and was tired (reported under AER 2021026236). Relevant medical history included thyroid, cholesterol and blood pressure (as reported). The patient was taking concomitant medications for underlying medical history. No other vaccine was received in four weeks. In the evening yesterday she was not feeling too well. She had a slight headache; body aches and she could get rid of the headache. She clarified that last night she felt chilly, she had the chills. By 10am this morning she did not feel well, she had a pretty bad headache and felt like she had a temperature. Her temperature earlier today was 99.4 degrees F and now her temperature was 101.2 degrees F. Her whole body feels like she was having aches, stated it is like a flu-like feeling, she had heaviness in her chest, her pulse will not go out of the 90s. She took her oxygen level and it was between 97-99%. She had also soreness in her left arm. She asked if these are common side effects, or something to be concerned about. Therapeutic measures taken as result of the events included ibuprofen (ADVIL). The outcome of the events was unknown.
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| 57 | 2021-01-21 | inability to speak |
Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irri...
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Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irritation while in waiting area. Monitor personnel promptly identified patient?s condition and notified the team while staying with the patient ensuring she kept talking while the provider arrived. Officer in Charge was notified during the process and was at patient?s side approximately 0756; provider followed within seconds. Decision was made for immediate transport to ED. While in route patient stopped talking, coughed and grabbed throat prompting CPT to deliver x1 dose of Epinephrine to left deltoid at 0758 with provider?s consent. Shortly after dose administration patient resumed speech but continued to complain of dry and tight throat. Patient was able to continued speaking reciting ABCs and personal information when prompted. Patient did not experience altered mental status or loss of consciousness. Arrived to Emergency Department (ED) at 0805; report given to nurse and patient was checked in promptly. ED provider plan included observation until 1100 and discharge pending follow up assessment.
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| 57 | 2021-01-21 | bell's palsy | Bell's palsy - left |
| 57 | 2021-01-21 | involuntary muscle movements |
Patient felt faint after 10 minutes. Fainted x 3 in lobby with Involuntary movements of right uppe...
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Patient felt faint after 10 minutes. Fainted x 3 in lobby with Involuntary movements of right upper extremity. EMS called. Patient transferred to ER.
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| 57 | 2021-01-21 | feeling cold | 8 hours post - fever, severe chills - stink have 24 hours later |
| 57 | 2021-01-21 | pain in extremity | Arm, Neck pain & severe nausea |
| 57 | 2021-01-23 | weakness, pain in extremity |
After the first shot I had a mild rigidity (more than my normal) of the thoracic muscles just below ...
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After the first shot I had a mild rigidity (more than my normal) of the thoracic muscles just below my breast line and of course a sore arm. After the second shot, 3 days after I woke after working all night to a demyelination response from my MS (which can be caused by weather, stress etc. Also, so did not think much about it) but 2 hours later my lungs started reacting from an overload of mucus (which has happened before after a vaccination so it was obvious my immune kicked in to find the changes going on from the vaccination) I immediately took steps to depress my immune system (mucus and cough syrup, Immersion in an Epsom salt bath with tea tree, lavender, eucalyptus, and peppermint oils (my own breathing treatment solution) 2 glasses of wine (relaxes the muscles, then took 2 Benadryl and 4 Motrin (which knocks me out and completely immobilizes) I have been doing this successfully for years) Today, I am very sore in the rib area, weak and tired (normal for a day after an episode) my lungs still weak (cough syrup is helping) Since this has happened before only after a vaccination or TB test I decided to report it for others who have MS, so they can be prepared. I self treat since my health care plan would drain my finances and affect my quality of life. I still think the vaccine is worth the episode, however, it will be my last Coved Vaccine, since I know it will cause a reaction.
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| 57 | 2021-01-23 | weakness |
By 830 pm I was aching, had a headache, by 9 bad chills, the fever, skin was very hot. Lasted all ni...
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By 830 pm I was aching, had a headache, by 9 bad chills, the fever, skin was very hot. Lasted all night. By am I was dizzy once, Achey all day, no energy. Slept all day. Today, dizzy again for a moment. Headache when I woke up. No energy, abit Achey. Not as bad.
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| 57 | 2021-01-24 | weakness |
Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contacta...
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Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf. A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm on 30Dec2020 10:30 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Since 03Jan2021, the patient has been sick. Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away. Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00 The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit; 101.2 Fahrenheit then up 102.7 Fahrenheit ; 101.5 Fahrenheit. Sars-cov-2 test: positive on 11Jan2021 . Further information has been requested
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| 57 | 2021-01-24 | cold sweat | Nausea, vomiting , cold sweats , throat warm, lethargic fatigue. |
| 57 | 2021-01-24 | numbness, tingling | Immediately felt numbness and tingling in arm and fingers |
| 57 | 2021-01-24 | pain in extremity |
1/9/21 Fever 100.4, fatigue, and mild body aches lasting 1 day. 1/17/21 Began developing red areas o...
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1/9/21 Fever 100.4, fatigue, and mild body aches lasting 1 day. 1/17/21 Began developing red areas on left arm, which eventually blistered and extended from upper arm to thumb tip. Also associated with pain in the arm and hand. Physician diagnosed shingles on 1/20/21. Treated with valacyclovir.
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| 57 | 2021-01-24 | sensory loss |
Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right ...
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Tingling and numb tongue and lips; Tingling and numb tongue and lips; loss of sensation to my right entire side from the back of my head, face and down to my right foot, which included my back scapular region and both right extremities; sore tender lymph nodes under right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included COVID-19 prior vaccination. Concomitant medication included levothyroxine. The patient previously took essential oils and experienced known allergies. The patient experienced tingling and numb tongue and lips, loss of sensation to her right entire side from the back of her head, face and down to her right foot, which included her back scapular region and both right extremities. Also, sore tender lymph nodes under right arm. All events started from 08Jan2021. This has been going on for 4 days as of 12Jan2021. No other vaccine in four weeks. Covid test done post vaccination: nasal swab on 12Jan2021, pending result. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 57 | 2021-01-24 | tenderness | Elevation of the lymph node in the left armpit with tenderness |
| 57 | 2021-01-25 | weakness |
chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired fe...
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chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired feeling
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| 57 | 2021-01-25 | feeling jittery | 100.4 Fever fro 24 hours , Teeth chattering, body aches, head aches, jittery feeling |
| 57 | 2021-01-25 | numbness, tingling | Numbness & tingling hands & feet, throat itching, b/l ear itching |
| 57 | 2021-01-25 | numbness |
Left leg numbness; This is a spontaneous report from a contactable nurse (patient). A 57-years-old f...
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Left leg numbness; This is a spontaneous report from a contactable nurse (patient). A 57-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular (left arm) on 23Dec2020 at 15:00 at a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies (NKA). The patient had no COVID prior vaccination. The patient is not pregnant. Concomitant medications included unspecified medications administered in two weeks; no other vaccines received in four weeks. The patient experienced left leg numbness on 25Dec2020 at 16:00. Treatment done for the event included tests and procedures which included magnetic resonance imaging (MRI) and X-ray-both with unknown results on an unknown date. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not tested post vaccination. The event was resolving. No follow up attempts are possible. No further information is expected.
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| 57 | 2021-01-25 | pain in extremity |
she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all ov...
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she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all over the whole arm, it was throbbing; she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all over the whole arm, it was throbbing; This is a spontaneous report received from a contactable nurse (who is also the patient). A 57-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via intramuscular route in the left deltoid, on 18Dec2020 18:00, at single dose, for preventive/COVID-19 immunization, in the hospital. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included H1N1 flu shot (INFLUENZA VACCINE), in 2015 or 2016 (as reported), for immunization and experienced muscle stiffness and fatigue. The patient reported she is she is still tender in her left arm (unspecified date) from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing (unspecified date). The outcome of the events was not recovered. Information about lot/batch has been requested.
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| 57 | 2021-01-25 | tingling |
Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning starte...
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Starting itching, then face and lips started tingling. Took Benadryl and Pepcid. Next morning started having difficultly swallowing, went to ER-1-6-21 On 1-7-21 started itching from all over, blood pressure was 262/106, went back to ER
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| 57 | 2021-01-26 | numbness |
Pt reported to POD for vaccine very anxious and concerned about her allergies to Nsaids, Morphine an...
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Pt reported to POD for vaccine very anxious and concerned about her allergies to Nsaids, Morphine and pnc. she reports that her they cause HA and facial swelling. Pt received vaccine at 1405 and went to 30 min observation area. at 1420 this provider was contacted by the patient and she reported that feeling numbness and drooping to the right eye lid. The patient was then brought for eval by this provider and EMT. The patient continued her observation until 1510 and at that time she reported that she was back to normal and continued to be without HA.
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| 57 | 2021-01-26 | pain in extremity |
Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; pati...
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Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; This is a spontaneous report from a contactable consumer reported for self. This 57-year-old female patient received the first dose of BNT162B2 (Lot number ELD140, Expiry Date Mar2021) via unspecified route of administration on an unspecified date at single dose, and second dose of BNT162B2 (maybe the same Lot/ Expiry date as the first dose) via unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything. The patient clarified that she was tested positive at work. The patient had the nose swab 12Jan2021 at job and the patient had the second dose of the shot (vaccine). The patient stated that she felt tired in the morning and had headache and arm was sore, other than that the patient felt she was fine. The patient didn't have any chills or anything. The outcome of the events was unknown.
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| 57 | 2021-01-26 | pain in extremity |
Arm pain started around 4:30pm - hurt to pick up water bottle. Throat pain started 5:30pm - feels li...
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Arm pain started around 4:30pm - hurt to pick up water bottle. Throat pain started 5:30pm - feels like strep throat
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| 57 | 2021-01-26 | pain in extremity | Severe fatigue, radiating arm pain, chills and mild headache |
| 57 | 2021-01-27 | weakness | Chills, headaches, body aches, lethargic, and weakness |
| 57 | 2021-01-27 | migraine, weakness |
generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulde...
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generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulder, she thought it was cause of the injection site/muscle pain from the injection; pain in shoulder immediately after getting the injection and it was really swollen; body is in pain/lot of pain all of her body; achy like she is having flu like symptoms; injection was administered higher in her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 (16:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) injection in left deltoid/shoulder on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history was reported as "none". There were no concomitant medications. It was reported that the patient received the first dose on 22Dec2020 and the second dose on 12Jan2021. After she received the second dose of the vaccine, she immediately had pain in her shoulder, she thought it was cause of the injection site (12Jan2021 16:00). She had the pain in shoulder immediately after getting the injection and she got it at 4pm, and it was really swollen now. She mentioned this injection was administered higher in her left shoulder (pending clarification) and it feels like they may have gotten the injection in more of the arm muscle and she was thinking that is why she had muscle pain from the injection. She added that it was like her body is in pain, achy like she is having flu like symptoms that started the evening she got the vaccine, like 6PM or 7PM. The next day, yesterday (13Jan2021), she had a lot of pain all of her body. She also started to have a headache yesterday at noon (13Jan2021 12:00PM). The headache started at noon on 13Jan2021 and it continued for at least 8 hours and it was constant. It started to subside over the next 12 hours. She mentioned she also suffers from migraines (pending clarification). It feels like she is having residual migraine, like she is coming off of having a migraine. It is presenting, but she is not in severe pain. It is a feeling like she is coming off her migraine medication even though she did not take her migraine medication. She went to work yesterday (13Jan2021) even though she did not feel like it. She went home a few minutes early. She let her supervisor know she was in severe pain and had a headache. She was advised to stay home today and has not gotten better. However, the headache subsided. She feels foggy, like she could not just quite wake up. It is like she is in a daze or haze. She is having a hard time functioning. She continued to reiterate she was having a hard time concentrating. Now (14Jan2021) she is generally weak and is pale. In addition, the pain has not gone away. She stated she is weak, very weak. She felt it most of the day and it is worse today. She feels like she can hardly stand. She is trying to get fluids in her and trying to make coffee, however, it is a struggle. She stated, she has not gone yet, but she will call her doctor's office next and the health nurse as well to advise them she has been having symptoms. She stated she did not have a fever last night. Her temperature during the call was normal for her, 97.3. The outcome of events vaccinations site pain, vaccination site swelling, general body pain, flu like symptoms, weak, and pale was not recovered; while the outcome of other events was unknown. Information on lot/batch has been requested.
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| 57 | 2021-01-27 | pain in extremity, flushing |
Patient was getting hair colored about 6 hours after vaccine. Her face suddenly became very flushed ...
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Patient was getting hair colored about 6 hours after vaccine. Her face suddenly became very flushed and she experienced tachycardia for several minutes. Pulse was not checked. She then became extremely pale, light headed, and sick for 10-15 minutes. Chest was heavy in the evening from 8-9 pm so she took an antacid and went to bed. She woke up at 11pm, but body was still sleeping and she couldn't move. She has never experienced this before. Arm was very sore, but has improved. Has also been taking ibuprofen and Tylenol for body aches.
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| 57 | 2021-01-28 | numbness |
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar...
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fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-28 | migraine | headache like a migraine |
| 57 | 2021-01-28 | pain in extremity |
Sore arm for about 36 hours; On the 31st of December at 1:00 in pm. 100- 101.1 - fever and aches and...
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Sore arm for about 36 hours; On the 31st of December at 1:00 in pm. 100- 101.1 - fever and aches and chills for about 24 hours. I felt like I had a pressure/sinus headache. Got tested on Jan 2 - COVID negative; January 3 Urgent care - Doxycycline for 10 days. Took about two days on antibiotic and then I was fine.
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| 57 | 2021-01-28 | tingling, feeling hot |
increased heart rate after that it started getting worse; a warm feeling in her chest like tingling;...
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increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, "No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on." Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-28 | tenderness | Neck pain/tenderness, Shoulder tenderness moving to right side, lymphadenopathy |
| 57 | 2021-01-30 | pain in extremity, numbness |
Face got numb for about an hour (30 min after ) Severe arm pain Fever Chills Delirium, couldn?t thin...
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Face got numb for about an hour (30 min after ) Severe arm pain Fever Chills Delirium, couldn?t think clearly Extreme fatigue Bad headache Whole body ached, especially back and neck Lasted about 48 hours
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| 57 | 2021-01-30 | pain in extremity | right arm pain radiating into right anterior chest |
| 57 | 2021-01-31 | hot flush, weakness |
Patient states felt hot flashes following injection in waiting room went home became lethargic that ...
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Patient states felt hot flashes following injection in waiting room went home became lethargic that evening having difficulty answering questions at night patient states she became apneic and husband had to watch her breathe. Did not go to the ER. Patient states fully recover the next day and fully recovered 5 days later. No rashes fever generalized weakness that resolved.
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| 57 | 2021-01-31 | pain in extremity |
Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am C...
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Soreness on the arm/ soreness at the site; felt a little achy/ achiness like you have on flu; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140, reporter stated "could be ELO or ERO"), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included bronchitis from Oct2020 and ongoing and occasional cough. Concomitant medications were not reported. The patient reported that "I am a nurse I work with COVID patients. I got my vaccination on 28Dec2020. After the vaccination I had soreness on the arm and I felt a little achy. I felt like that with the flu shot (no further clarification) for couple of few days maybe. Then my whole family developed COVID and I am COVID positive. On 06Jan2021, I woke up with every COVID symptoms. I tested positive on the 7th. So, I have been in isolation for 10 days from work. The reason I called you guys is that I am getting 10 different answers. I am due to get my vaccination on 18th. I still have some symptoms and I did not know I am hearing where symptoms go away. I am concerned, my shot is not going to work. If I have mild symptoms can I get it? I am getting tensive for answers, she gave a little bit of information. Do you want me to tell you all my symptoms the time I contracted the COVID? What I told you about the shot was from 28th. Yes, the vaccination on the 28th was soreness at the site like achiness like you have on flu. I had bronchitis (Intent: History) back in at the month of Oct. I have an occasional cough. So, I do not even count that because that is being going on but then I got real sick with positive COVID on the 6th. I am concerned about getting my second shot. That is the reason of my call. The symptoms from the 28th is just what I told you. I have COVID so I am on a lot of medication right now. I am taking medications for the COVID. I am on budesonide (SYMBICORT) inhaler, albuterol (VENTOLIN) inhaler, I am taking acetaminophen (TYLENOL), guaifenesin (MUCINEX). As of Thursday I am taking ranitidine (ZANTAC) and some Steroids, pepper too and cough medicine as needed. When asked about causality, the patient stated "No because my whole family got COVID. Like my daughter, in-laws. It just went through our whole family. I do not think anything is related to the vaccine." Nurse added, "I do not really know what to do about this. If I feel better, I am just wondering if I should go ahead and get it because she told me there is no studies beyond that day. That was my main reason for the call." She was referring to the 'TCP'. "When I am going to get it if I am having mild symptoms because I do not want to lose my immunity. I am kind of troubling with myself what to do." The outcome of the event "I am COVID positive/ woke up with every COVID symptoms/ got real sick with positive COVID" was not recovered and of the remaining events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. It worth to note that the patient's whole family developed COVID.
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| 57 | 2021-01-31 | pain in extremity |
Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lum...
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Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lump in my throat , almost 2 hours after vaccination ears ringing and lump in throat. I took 2 Benadryl and in about hour the lump feeling was not as bad, lump feeling subsided. I had muscle joint pain the next 4 days and stayed on Benadryl those days until throat and ears felt better. On day 5 my left arm started stinging and broke out in hives , some on torso but mainly vaccinated left arm. I went to primary care to talk to her about my reactions on day -7 . She documented in my records but told me to report through Vsafe app. I did. I do not want to take 2nd dose after having this happened and no one able to tell me the 2nd wont be worse,
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| 57 | 2021-01-31 | pain in extremity |
Soreness in the arm; Conjunctivitis; Episcleritis; This is a spontaneous report from a contactable p...
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Soreness in the arm; Conjunctivitis; Episcleritis; This is a spontaneous report from a contactable physician (dentist, dental surgeon/patient's husband). A 57-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration on 30Dec2020 at 57-years-old at a single dose for COVID-19 immunization. Medical history included blood pressure increased, and blood cholesterol increased; both from an unknown date and unknown if ongoing. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) taken for blood pressure from an unspecified date to an unspecified date, "normal hormones" from an unspecified date to an unspecified date, "statin for cholesterol" from an unspecified date to an unspecified date. On 10Jan2021, the patient experienced conjunctivitis (non-serious). In Jan2021, the patient experienced episcleritis (non-serious). On an unspecified date, the patient experienced soreness in the arm (non-serious). The clinical course was reported as follows: The physician (patient's husband) stated that he and his wife received the Pfizer COVID-19 vaccine on 30Dec2020; and both had "a little bit of soreness in the arm, nothing spectacular." The patient developed a pink eye and was diagnosed with conjunctivitis 12 days (also reported as "approximately 10Jan or so") later after getting the vaccine (as reported). The doctor prescribed some topical cortical steroid eye drop. The eye was still swollen, and not totally resolved; "continually got worse." The patient consulted an ophthalmologist who gave the patient some prednisone ophthalmic (also reported as cortisone) and over the counter lubricant for the eyes. The patient was still symptomatic. The patient was diagnosed with episcleritis. The ophthalmologist classified the episcleritis as an autoimmune disease. Regarding the causality between the vaccine and the events, the patient's husband stated that his wife did not think it was related, and that the events could be totally idiopathic and there could be no correlation. The patient underwent lab tests and procedures which included COVID test: negative on an unspecified date. Therapeutic measures were taken as a result of conjunctivitis and episcleritis. The clinical outcome of the events was unknown.
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| 57 | 2021-01-31 | pain in extremity |
Fever, aches, chills, headache, exhaustion, fatigue for about 30 hours. Very sore arm for about 5 d...
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Fever, aches, chills, headache, exhaustion, fatigue for about 30 hours. Very sore arm for about 5 days.
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| 57 | 2021-02-01 | muscle spasms |
GI reaction with spasms; GI reaction with spasms; bloating and uncomfortable like you over eat and h...
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GI reaction with spasms; GI reaction with spasms; bloating and uncomfortable like you over eat and have tight pants in; bloating and uncomfortable like you over eat and have tight pants in; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at 04:30PM in left arm at single dose for COVID-19 immunisation at the age of 57-year-old. Lot number was 59267-1000-01. Medical history included no gall bladder, ongoing bloating and uncomfortable like you over eat and have tight pants in on 11Jan2021 at 02:00PM. Patient was not pregnant. Past drug history included allergy to codeine. Concomitant medications included venlafaxine, verapamil, tocopherol (VITAMIN E), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM), atenolol (ALTENOL), zopidem tartrate (ZOLPIDEM). On 11Jan2021 at 02:00PM (also reported: wishing 2 minutes, as reported), inside stomachs and gut, the patient felt it spread over that area (not warm, not painful, weird) and afterwards that night bloating and uncomfortable like you over eat and have tight pants in, then the next day (on 12Jan2021, also reported on 11Jan2021 at 02:00PM, as reported) she had a gastro-intestinal (GI) reaction with spasms that were very painful (something that happens very seldom and the patient was sitting at her desk working so no irritable factors) so she had to take strong meds because this GI spasm was very painful and hurt when you breath, so she took strong medication (hyosymin and mepitab). The patient recovered with lasting effects from abdominal distension, the patient recovered from other events.
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| 57 | 2021-02-01 | pain in extremity |
Right arm was sore for about 3 days; This is a spontaneous report from a contactable consumer report...
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Right arm was sore for about 3 days; This is a spontaneous report from a contactable consumer reporting for a patient. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant at the time of vaccination. The facility type vaccine was hospital. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced right arm was sore for about 3 days on an unspecified date with outcome of recovered. Patient didn't receive treatment for the adverse events. The event was reported as non-serious. Information on the lot/batch number has been requested.
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| 57 | 2021-02-02 | electric shock sensation |
Electrical shots on right leg, right arm, upper back, then on my right side with head, nausea, heada...
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Electrical shots on right leg, right arm, upper back, then on my right side with head, nausea, headaches went to left side of the head and still with headache on 02/03/2021
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| 57 | 2021-02-02 | feeling hot |
I noticed the itchiness and heat about an hour after I received the vaccination. By the time I went...
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I noticed the itchiness and heat about an hour after I received the vaccination. By the time I went to bed at approximately 10 PM, the site was beginning to get very hard. By the next day, the site of the vaccination was the size of a baseball and very hard in addition to very red and itchy and painful. Benedryl eliminated the itchiness. However, it is five days later and there is still a very hard and a little less than half the size of a baseball. Most of the pain, heat and redness is gone, but the site is still very hard and itchy.
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| 57 | 2021-02-02 | muscle twitching |
My left eye hurts and feels like it's twitching. It is also getting puffy and once in a while a shar...
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My left eye hurts and feels like it's twitching. It is also getting puffy and once in a while a sharp pain shoots through my eye. Thanks.
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| 57 | 2021-02-02 | pain in extremity |
immediate pain in the opposite left arm, as well as neck pain on the right side from the chin to sh...
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immediate pain in the opposite left arm, as well as neck pain on the right side from the chin to shoulder, was seen in urgent care on 1/30/21
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| 57 | 2021-02-02 | tremor, weakness | Weak, Tremor, Dizzy, Hypertensive |
| 57 | 2021-02-03 | weakness, numbness, tingling |
Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over an...
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Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over and states that her right leg is weaker than her left leg. Pt. was brought to ER by her husband, because husband states that she was to weak to walk on her own to the bathroom. upon evaluation pt. appears tired and slightly drowsy but answers questions appropriately. The patient can state her name, where she is and the current month and year.
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| 57 | 2021-02-03 | pain in extremity | EXTREMELY SORE ARM (UNABLE TO LIFT ARM), FEVER, CHILLS, UNABLE TO STAND LONGER THAN A MINUTE |
| 57 | 2021-02-04 | weakness |
I woke up in the middle of the night with a headache and body aches. I got up to take ibuprofen and ...
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I woke up in the middle of the night with a headache and body aches. I got up to take ibuprofen and when I was in my bathroom, I collapsed. I do not remember actually falling but I heard the thud when I hit the floor. I tried to get up and had absolutely no strength in any part of body. My husband came to help me up but I could not even lift up my head. He was finally able to help me up and I took a few steps and collapsed/fainted again. This has never happened to me in my life.
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| 57 | 2021-02-04 | pain in extremity | chills sore arm fever headache |
| 57 | 2021-02-05 | weakness, tingling |
General muscle aches and stiffness the day after the vaccine, fatigue, pain in right hip and weaknes...
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General muscle aches and stiffness the day after the vaccine, fatigue, pain in right hip and weakness in right leg causing difficulty lifting right leg requiring my to lift it with my hands to get in bed or to lift it into a foot rest. When lifting there was increased pain and tingling in my hip. The next day, the symptoms were resolved.
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| 57 | 2021-02-05 | weakness |
Chills/Fever 102.6 started hour 16 after vaccination with severe large bone aches which included fe...
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Chills/Fever 102.6 started hour 16 after vaccination with severe large bone aches which included femur, hips, pelvis, sacrum and scapula; body aches, back ache, headache, general malaise and weakness. 2nd fever, no chills 38 hours after vaccine, with continued bone and body aches, back ache and headache, general malaise and weakness. mild dyspnea with continued back ache after 50 hours, still experiencing this at the time of report
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| 57 | 2021-02-05 | pain in extremity | RUE 4 in x 4 in large, painful, raised area that has decreased in size and pain but still remains. |
| 57 | 2021-02-06 | cold sweat |
Patient reports lightheadedness, clammy skin. Improved when supine. Patient has history of vasovagal...
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Patient reports lightheadedness, clammy skin. Improved when supine. Patient has history of vasovagal reaction with vaccine.
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| 57 | 2021-02-07 | burning sensation, feeling jittery |
Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, w...
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Received vaccine at 5:45 p.m. I sat down to start my 15 minute wait and my heart started to race, was pounding, became jittery, felt pressure in my left jaw, couldn't catch my breath with mask on. I lifted my mask to be able to get air as I attempted to check my pulse rate, but it was too fast to count. I quickly took my coat off. I sat back down and was going to get help, but noticed my heart rate decreasing, jittering decreasing, and was able to breath with mask on. Pulse was down to 80 bpm. The skin on my face and neck felt like they were burning. The tip of my tongue felt tingly. All subsided until next day, felt fluish, temp 101.5.
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| 57 | 2021-02-07 | involuntary muscle movements |
First Vaccination on 01/13/21 right arm - pain at injection site for several days following. Brai...
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First Vaccination on 01/13/21 right arm - pain at injection site for several days following. Brain fog and some fatigue. Second vaccination on 02/3/21 left arm - approx. 3 hours later felt a little woosie and spacey. Pain at injection site. At approx. 3am the following morning experiencing chills and body jerks along with long deep breathing. Temperature 100.1. Also had a painful headache and full body aches along with some nausea and very fatigued and pain at injection site was growing in size and was also hot and red and swollen. Contacted primary care doctor about these side effects. On 2/5/21 the temperature reached 100.7 and the previous days aliments continued and fever came down to 99.6. Lots on pain in left side of neck and left arm. Let arm continues to be swollen, red and hot and is itchy. Fever finally broke on the night on Feb. 6th.
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| 57 | 2021-02-07 | pain in extremity |
Pfizer-BioNTech Covid 19 vaccine EUA- About 15 minutes after receiving the vaccine I had chills go u...
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Pfizer-BioNTech Covid 19 vaccine EUA- About 15 minutes after receiving the vaccine I had chills go up the back of my head. Severe HA started about 1600, body aches in joints and muscles began that night. Returned to work 2/3/21 as day progressed my HA became so bad I was nauseous, after 2 hors at work I had to go home. Fever of 100 that went to 101.7 the following day. HA was not relieved with Tylenol or ibuprofen . Arm was moderately sore no redness or swelling.
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| 57 | 2021-02-07 | pain in extremity |
My arm and shoulder were sore throughout the day and that evening it was really sore. I woke up at 3...
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My arm and shoulder were sore throughout the day and that evening it was really sore. I woke up at 3:00 in the morning and my head hurt very bad, and I woke up and I took two Tylenol and waited 20 minutes and then took alleve, drank four cups of coffee and half floreset and that helped a little bit and this morning I woke up with a terrible a headache and stiff neck and shoulder, and its only my left shoulder where I got the shot.
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| 57 | 2021-02-07 | tingling, breast pain, feeling of body temperature change |
At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 10...
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At midnight the same day after the vaccine she awakened feeling cold, sweating, and had a temp of 101.6 F. Pt had fever for 24 hours. She took Tylenol at that time. Her face was also red after the second vaccine and has remained red around the lower half of her face. Her face tingles at times. She feels like bugs are walking on her face and body at times, get itchy at times, gets hot, then gets cold. Pt felt a zap like electricity in her bosom for on 1 day in her left breast/ chest fleetingly. She feels it, zaps, sometimes in other places in her body since then rarely, not daily.
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| 57 | 2021-02-07 | cold extremities, tremor, muscle twitching |
Started sweating, forehead, hands and feet- that night progressed to muscles twitching and shaking, ...
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Started sweating, forehead, hands and feet- that night progressed to muscles twitching and shaking, cold hands and feet, nausea, no appetite- shaking was all over at times, would come and go- had it first night, next day and night and less intense but still there 2 nd day and night
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| 57 | 2021-02-08 | cold sweat |
20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both a...
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20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both arms and hands. Reported to doctor at site and EMS was called. Heart rate was 98, BP 218/110 taken three times by EMS. Administered Benadryl liquid by EMS and monitored for thirty minutes. Rash stopped spreading and improved heat rate and B/P. Was released to go home by EMT. While traveling home had to stop by roadside because of vomiting and nausea. Next morning rash still present on arms and fingers.
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| 57 | 2021-02-08 | flushing |
Post second COVID vaccination, started feeling a tingling sensation in her mouth and felt light-hea...
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Post second COVID vaccination, started feeling a tingling sensation in her mouth and felt light-headed. Reports that the first vaccine caused some "slight flushing". She was laid flat on a cot. VSS. Reported that her tongue was starting to swell. Rapid Response code was called and she was transported to the ED.
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| 57 | 2021-02-08 | tingling | Immediate tingling of LA/face/leg; BP 152/82 (pulse 94), BP 146/77 (pulse 102). Called 911. |
| 57 | 2021-02-09 | burning sensation |
103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it wa...
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103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible. a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-09 | feeling of body temperature change |
She said ever since receiving the COVID-19 Vaccine, she has been doing nothing but sweating; She sai...
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She said ever since receiving the COVID-19 Vaccine, she has been doing nothing but sweating; She said she will be sweating, and then she gets cold, and then she gets hot; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL9261 on Arm, Left Upper at 10:35 on 22Jan2021 at single dose for covid-19 immunization.Medical history included : Type 2 diabetes mellitus (she has been a Type 2 Diabetic for over 10 years ).She said ever since receiving the COVID-19 Vaccine,on 22Jan2021, she has been doing nothing but sweating.She said she will be sweating, and then she gets cold, and then she gets hot .She said she feels like she is overheating. She said she is calling Pfizer to see what she should do. She said she hasn't called her doctor yet, and she is due to take the second COVID-19 Vaccine dose on 09Feb2021.Her sweating, and feeling cold then hot, started on Friday night, 22Jan2021. She said her face was even sweating when she was at work, clarifying she doesn't sweat like that. She said she was even sweating when she was sleeping. She said she will throw back the covers because she feels like she was overheating, and then 5-10 minutes later the heat dissipates, and she has to cover herself back up. This morning she had an episode of sweating, and thought her blood sugar was too high. She said she had just got out of the shower, and she was sweating. She said the ceiling fan was on. She said she was not feverish, but felt hot. She said she immediately checked her blood sugar, and her blood sugar was normal at 113.Her last blood work was in Dec2020. She said she she saw her doctor 3 weeks ago, and her blood work was OK.Outcome of the events was not recovered.
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| 57 | 2021-02-09 | flushing |
Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous r...
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Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous report from a contactable nurse reporting for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:Ek4176), via an unspecified route of administration on the left arm on 12Jan2021 17:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, melanoma in situ, diverticulosis, allergies to sulfa, betadine and reacted to depo-medrol injection. Concomitant medication included lisinopril (LISINOPRIL), estradiol (ESTRADIOL), ibuprofen (MOTRIN) and cyanocobalamin (B12). The patient experienced tachycardia, dizziness, flushed feeling and sweating to hands and back of neck on 12Jan2021 17:30. Therapeutic measures (Benadryl 25mg) were taken as a result of the events. The outcome of the events was recovered on an unspecified date in Jan2021.
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| 57 | 2021-02-09 | flushing |
1452 feeling "thick tongue" flushed tingling lips BP 187/101 HR 94 Benadryl 50mg po provided 1456 BP...
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1452 feeling "thick tongue" flushed tingling lips BP 187/101 HR 94 Benadryl 50mg po provided 1456 BP 146/90 HR 91 RR 20 Sats 98 1500 BP 133/91 HR 86 RR 18 Sats 98
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| 57 | 2021-02-09 | pain in extremity, feeling hot |
her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper ...
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her upper chest, the medial aspect of her left arm and down her upper arm initially pain; her upper chest, the medial aspect of her left arm and down her upper arm initially pain/fingers ached; down her upper arm initially pain; About 15 minutes later her wrist and fingers ached/joint pain; a gradual increase of body aches; nausea; feeling 'hot'; Big time tired, fatigue the patient would go to bed early; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Left on 25Jan2021 14:15 at the 57 years old at single dose for COVID-19 immunization. The medical history included FAP (Familial adenomatous polyposis), hernia repair, ankylosing spondylitis, bipolar disorder II, chronic depression, PTSD(Post-traumatic stress disorder), anxiety, GERD, Penicillin allergy, Adhesive tape allergy, Antiemetics allergy. The concomitant medications were amlodipine, ASA, HCTZ, lamotrigine (LAMICTAL), losartan, naproxen. The patient previously took Ciprofloxacin and experienced allergy, Ativan and experienced allergy. Right after the patient received the shot on 25Jan2021 14:30, her left side of her upper chest, the medial aspect of her left arm and down her upper arm initially pain. About 15 minutes later her wrist and fingers ached. From then on 25Jan2021 14:30, a gradual increase of body aches and joint pain, some nausea feeling 'hot' but not 'hot flashes' no sweats, Big time tired, fatigue the patient would go to bed early. She was keeping very hydrated. There was no other vaccine in four weeks. There was no treatment for the adverse events. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the events was recovering. Information about lot/batch number has been requested.
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| 57 | 2021-02-09 | pain in extremity |
sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (pr...
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sore arm (briefer than with #1); malaise; fatigue; Pulsing tinnitus, eased off now; bad headache (prexisisting but markedly amplified-still; chills (no fever, 3 days for real, now fading); mild nausea/loss of appetite (largely resolved.); mild nausea/loss of appetite (largely resolved.); This is a spontaneous report from a contactable Physician reported for herself. This 57-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 09Jan2021 09:00 AM on Arm left at single dose (Lot # EK9231) for covid-19 immunisation. Medical history included Pacemaker, Insomnia, and some preexisting hearing loss, due to effusion. No known allergies. No covid prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 16:45 PM on Left arm at single dose (Lot # EH9899) for covid-19 immunisation. Covid test after #1 (December) due to sore arm, chills, aches and malaise. Was negative. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. The patient experienced pulsing tinnitus, eased off now, also sore arm (briefer than with #1), malaise/fatigue (still but better), bad headache (persisting but markedly amplified-still, chills (no fever, 3 days for real, now fading), mild nausea/loss of appetite (largely resolved.) Events all on 10Jan2021 06:00 AM. Lab data included covid test (Nasal Swab) on 22Dec2020: negative. No treatments were received for the events. Outcome of events mild nausea/loss of appetite, malaise, fatigue was recovering. Outcome of the event chills (no fever, 3 days for real, now fading) was recovered. Outcome of the events was unknown.
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| 57 | 2021-02-09 | pain in extremity |
sore arm; Chills; aches; malaise; This is a spontaneous report from a contactable physician reported...
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sore arm; Chills; aches; malaise; This is a spontaneous report from a contactable physician reported for herself. A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899), via an unspecified route of administration in left arm on 19Dec2020 16:45 at single dose for COVID-19 immunization. Medical history included pacemaker, insomnia and some preexisting hearing loss, no known allergies. Concomitant medications included unspecified medication received in two weeks. The patient was no pregnant. There was no other vaccine received at the same date of the product and in four weeks. The patient had no COVID prior vaccination. The patient experienced sore arm on an unspecified date, chills, aches and malaise in Dec2020. COVID test (Nasal Swab) post vaccination on 22Dec2020 due to chills, aches and malaise was negative. No treatment received for the events. The outcome of the events was unknown.
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| 57 | 2021-02-10 | weakness, hot flush |
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp...
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rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
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| 57 | 2021-02-10 | burning sensation, nerve pain |
bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid ca...
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bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3284), intramuscular into the left arm on 11Jan2021, at 16:00 as second single dose for covid-19 immunization. Medical history included Obstructive sleep apnea from an unknown date, oligodendroglioma from 1996 (noted as history of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits). The patient had no known allergies to medications, food, supplements or herbal remedies. There were no concomitant medications; Patient was not taking any OTC medications, prescribed medications, supplements or herbal remedies at the time as well as in the period prior to her vaccinations. The patient previously received BNT162B2 (lot number EH9899 ) on 22Dec2020. On 18Jan2021, at 08:00, the patient experienced bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands, which was medically significant and had not recovered, as it was persisting. This was elaborated as follows: patient experienced one week following 2nd Pfizer covid-19 vaccine patient developed bilateral feet, left worse than right, burning, itching sensation. the symptoms progressed up to her mid calves and to a slight extent. The events were considered medically significant. Details were as follows: The symptoms were quite intense and interfered with her life, requiring gabapentin prescription for control of neuropathic complaints. Patient denied any significant weakness, low back pain, neck pain, balance problems, dizziness, bowel or bladder involvement. Patient saw physician who performed workup for common associated etiologies of polyneuropathy, which were negative. Patient underwent EMG/NCS which were normal, and subsequently skin bx (skin biopsy) to rule out small fiber neuropathy (results pending). The patient further described the incident as a week after receiving the second dose of the covid vaccine, the patient experienced new onset bilateral feet burning that went into her upper legs, mid calves and to a slight extent in both hands. The burning was experienced more in the left foot than the right foot. Reports it was severe enough for the patient to reach out to her primary care provider. (PCP) to start Gabapentin for neuropathic pain. PCP ordered labs to rule out infection and other causes for neuropathy which all came back negative. Patient has no known underlying risk factors that would predispose her to neuropathy. Neurologist did an EMG which showed no evidence of neuropathy. The patient went into to the office, and she had a skin biopsy to rule out small fiber neuropathy. She does not have results to provide for the skin biopsy at this time, however, the neurologist feels if the skin biopsy is positive, there may be an association with the vaccine in regards to the burning pain the patient is experiencing. She is calling to ask if this is a reported side effect. Treatment was confirmed as gabapentin was prescribed by PCP, and the patient started on it a few days after the onset of the burning pain. Outcome was noted as it has not improved, and has not resolved. No COVID tested post vaccination was noted. The outcome of the events was not recovered; the condition was persisting. Causality for the events was noted as related.; Sender's Comments: Based on a compatible temporal association contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events pruritus, burning sensation, condition aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-10 | numbness, tingling |
numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness...
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numbness and tingling in mouth and cheek on left side/a little spot on the lip of numbness; numbness and tingling in mouth and cheek on left side; numbness and tingling in mouth and cheek on left side; This is a spontaneous report from contactable nurses. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left deltoid on 27Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, hypothyroidism, and hypertension. There were no concomitant medications. Patient previously took lisinopril. On 27Jan2021, two minutes after receiving the vaccine, the patient experienced numbness and tingling in mouth and cheek on left side on the same side that she got the vaccine on, so she took 50mg diphenhydramine (BENADRYL), it went away and she slept all night. She then woke up and felt fine, with the exception of a little spot on the lip of numbness on 28Jan2021, so then she took 25mg Benadryl at 11:00 and it was gone all day. In the last 15 minutes her numbness was back and so she took another 25mg Benadryl at 17:00. Patient stated that she knows if this kept continuing she will have to go to the emergency room. In detail, patient had tingling on lips and mouth. The tingling traveled up her left side of the face to the bottom of her nose. Took 50mg of diphenhydramine after she got home. Woke up morning of 28Jan2021 with tingling on her lip, so she took 25 mg at that time. The tingling came back the afternoon and she took another 25mg and another dose before bed. She reports a small area of tingling on her lip remains as of 29Jan2021. She has not take any more diphenhydramine. She does not think it was Bell's Palsy.The reporter considered the event medically significant. Patient inquired if she can take the second dose of the vaccine and that she has done that before with lisinopril (not further clarified). Patient was to receive the second dose on 18Fe2021 or later. Patient did not have anything just right before the vaccine, has had no positive Covid or antibody test prior to the vaccine and no issues with vaccines in the past. The patient has recovered from the events, numbness and tingling in mouth and cheek on 28Jan2021 and outcome of the event, little spot on the lip of numbness was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-10 | tingling |
Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded with some t...
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Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded with some tingling in her extremities. EMS evaluated patient on-site. Patient was instructed to remove her mask and take deep breaths to settle her anxiety. Patient was hypertensive (175/104), SPO2 97%, and a FSBG of 95mg/dl. Several minutes later, the patient reported a return of dizziness and tingling. EMS obtained a 12-lead EKG that was unremarkable. Patient refused transport to the hospital.
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| 57 | 2021-02-10 | tremor, feeling jittery, weakness |
dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness...
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dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness; chills; tired; This is a spontaneous report from a contactable registered nurse (patient). A 57-year-old female nurse received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) injection at single dose via an unknown route in the left deltoid on 20Jan2021 for Covid-19 immunization. Medical history included hypothyroidism. Concomitant drug included ongoing levothyroxine sodium (EUTHYROX) started about 12 years ago as of 27Jan2021 at 75mcg once a day for hypothyroidism. Patient had first dose on the 20Jan2021, Wednesday and the last two nights (as of 27Jan2021) patient had chills. Onset date of chills was 25Jan2021. She assumed it would be sooner than further out close to the second one getting side effects. She also experienced weakness and was really really tired. Onset date of tired was 24Jan2021. She was unsure if she should get the second dose, or if she needs to contact her provider about this. She did not know if these are normal side effects or not. She looked at the side effect list, which said chills and headache, which she has experienced both. She also had dizziness. She used Flonase for the fluid in her ears. She thought the headache and dizziness was from fluid from pressure or something. The FLONASE helped with that. She had no fever. She was a week out from getting the dose and was wondering if she should still be having these side effects. Headache/ dizziness and weakness started a few days after she got the vaccine. She thought the weakness started that Friday or Saturday. If she got enough sleep she was okay, but she would wake up in the middle of the night. She thought the chills were from the weakness. She was also jittery and shaky as part of the weakness. Patient was always being really really tired later in the day. She thought that if she were working full time she would be missing work and that was medically significant. Treatment included FLONASE and took paracetamol (TYLENOL) for the headache early on. The events (chills, weakness, tired, headache and dizziness) were reported as serious with seriousness criteria of other medically important condition. No Investigation Assessment performed. Outcome of the events chills, weakness, tired was not resolved. Outcome of headache and dizziness was resolved. Outcome of the other evens was unknown.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-11 | pain in extremity |
Unable to sleep all night, highly restless, tried to eat in the morning but vomited. Then only ate...
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Unable to sleep all night, highly restless, tried to eat in the morning but vomited. Then only ate a little and slept all day and night the next day. (Of course arm was sore too.)
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| 57 | 2021-02-14 | weakness, pain in extremity |
diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feelin...
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diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102° temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 57-years-old non-pregnant female patient (nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long, poor appetite/no appetite, slept all day long/had no energy, severe aches, woke up with 102° temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell. Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102° temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid. The adverse event result in Emergency Room Visit and Physician Office Visit The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling, Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. ,
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| 57 | 2021-02-14 | feeling cold |
Delayed adverse effects occurred about 8 hours after 2nd dose administered. Injection site tenderne...
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Delayed adverse effects occurred about 8 hours after 2nd dose administered. Injection site tenderness and bruising. Headache, chills, fatigue, achy joints, runny nose but no fever. Symptoms continued for 2 days after vaccine although not as severe by the 2nd day. Experienced nausea, dizziness or fogginess for 3-4 days after.
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| 57 | 2021-02-14 | hypersensitivity of all senses |
Allodynia, hyperalgesia, Universal joint pain, exaggerated symptoms of ongoing CRPS in all four extr...
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Allodynia, hyperalgesia, Universal joint pain, exaggerated symptoms of ongoing CRPS in all four extremities. Continued moderately severe pain almost 2 weeks out
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| 57 | 2021-02-14 | pain in extremity |
Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain...
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Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own. Caller states that this is not going away. She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
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| 57 | 2021-02-15 | weakness | Temperature, chills, weakness and lethargy |
| 57 | 2021-02-16 | migraine |
Severe migraine pain for 2 days and on second day, severe swelling under the underarm on the right a...
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Severe migraine pain for 2 days and on second day, severe swelling under the underarm on the right arm.
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| 57 | 2021-02-17 | nerve pain, pain in extremity, tingling |
R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; ...
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R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-18 | migraine |
* ~10 pm on day vaccine given (Friday, 1/8/21), developed mild headache * Progressed to severe mig...
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* ~10 pm on day vaccine given (Friday, 1/8/21), developed mild headache * Progressed to severe migraine with some nausea during night, and lasted all day Saturday (~20 hrs.) I took Children's Tylenol dye free liquid late in day which took slight edge off headache. * Developed severe central chest pain in night, which felt like pain I experienced with esophagitis/gastritis in past. This lasted for about 20-30 minutes, then resolved. * Awoke next morning (Saturday, 1/9/21) with low grade fever (~99.3 degrees F), and had fever for 2 days (never exceeded 100.3 degrees F that I detected)--no appetite all day * Developed central low back pain/ache on Saturday ~ mid-day, which lasted through at least Sunday * Awoke Sunday morning with rash on torso (same rash familiar to me when I have infections--biopsied in past and determined to be interface dermatitis). Rash progressed throughout day to portion of arms, neck, groin (as always does with illness), and faded until resolving Monday am/mid-day. Itching then occurred over next couple of days (as it always does with illness). Appetite still limited. * Sunday evening experienced acute abdominal pain and urgent diarrhea x 3 or 4 episodes * Monday I felt better, but was fatigued and trying to get back on my feet
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| 57 | 2021-02-18 | pain in extremity |
After the first dose the next day strong pain in my left arm from the elbow to the wrist, Ceased the...
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After the first dose the next day strong pain in my left arm from the elbow to the wrist, Ceased the next day. After the second dose strong pain in the left side of my neck and back, mild pain in the injection site, malaise and muscular ache, all these symptoms improve the next day.
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| 57 | 2021-02-18 | pain in extremity | Fever, chill, nausea, feeling sick , very sore arm |
| 57 | 2021-02-19 | muscle spasms |
Sore at injection site, used rubbing alcohol. Felt better after a few rubs. Nausea, a few days after...
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Sore at injection site, used rubbing alcohol. Felt better after a few rubs. Nausea, a few days after, drank tea and honey. Came and left for a couple days Slight headache the next day, did not take anything. Meditation, Cramps in pelvic area, did stretches and yoga.
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| 57 | 2021-02-21 | cold sweat | Rapid heart rate Burning through body Cold sweat Felt low blood pressure |
| 57 | 2021-02-21 | pain in extremity |
Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours,...
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Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours, Extreme fatigue-5 days, Chills-8 hours, Fever-3 days (reducing in severity each day), arm pain in shot area- mild and continuous for 6 days.
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| 57 | 2021-02-22 | involuntary muscle movements, weakness |
Three days after vaccine administration, patient indicates feeling weakness and involuntary movement...
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Three days after vaccine administration, patient indicates feeling weakness and involuntary movements in both legs.
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| 57 | 2021-02-22 | difficulty speaking |
Approximately 10 minutes after vaccination (during post vaccination observation), patient reported f...
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Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment. Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.
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| 57 | 2021-02-23 | weakness | Weakness to left leg. Swelling to left armpit and left breast. |
| 57 | 2021-02-23 | muscle spasms, pain in extremity |
arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area...
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arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like "ooh, my arm is sore". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.
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| 57 | 2021-02-23 | muscle twitching |
Patient had second vaccination on 2/19, and later in the evening started to feel achy, and tired, an...
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Patient had second vaccination on 2/19, and later in the evening started to feel achy, and tired, and had swelling under arm, that is still there, though it has gone done. She satted it feels like it spread to her breast. She also stated she had a twitching on the side of her mouth that lasted a second. She denies, fever, SOB, chest pain, rash, or any other symptoms. She stated she is taking Tylenol every 6 hours which is helping. RN reviewed red flags to call 911. RN reviewed would folllow up tomorrow with her.
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| 57 | 2021-02-23 | pain in extremity |
Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck,...
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Sore arm; Pain in chest to her left upper sternal border area (under collar bone); Pain in the neck, its an aching pain, a nuisance type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the left deltoid on 28Dec2020 (07:15) at a single dose for COVID-19 immunization at the hospital. The had no relevant medical history and concomitant medications. On an unspecified date, after the first dose of vaccination, the patient had sore arm; pain in chest to her upper sternal border area (under the collar bone); and pain in the neck (further described as "an aching pain, a nuisance type of pain"). The patient had chest x-ray on 25Jan2021 (results were not provided). The patient had received paracetamol (TYLENOL), naproxen sodium (ALEVE) and ibuprofen as treatment for the reported events. The outcome of the events was not recovered for 'pain in chest to her upper sternal border area (under the collar bone)'; and was unknown for 'sore arm' and 'pain in the neck'. The patient had received the second dose of vaccination on 14Jan2021. The reporter believed that it was "highly coincidental" (pertaining to causality) considering the events happened with both vaccine doses. No further information was provided or obtained.
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| 57 | 2021-02-24 | discomfort, pain in extremity |
Sore arm within two hours. Some fatigue and slight headache and slight nausea within the first 24 ...
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Sore arm within two hours. Some fatigue and slight headache and slight nausea within the first 24 hours. All very minimal. Fever, chills, bad headache, sweats, general discomfort beginning around 24 hours after shot. Fever subsided 36 hours after shot. Headache persisted for over 48 hours. Some nausea between 48 hours and 72 hours after shot. Fatigue and haziness throughout.
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| 57 | 2021-02-24 | hot flush, cold extremities |
02/20/2021 Immediate post-vaccination onset of intermittent lightheadedness & migrating sensation of...
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02/20/2021 Immediate post-vaccination onset of intermittent lightheadedness & migrating sensation of tingling over body & face; at 45 minutes also experienced a sequence of coldness of feet, then hands (w/decreased perfusion), as those resolved then core/trunk, as trunk warmed then at 75 min upper gums, then eyelids, then nose; bowel urgency; at 2 hours warm flush, mind clearer, better color vision, feeling stronger; lightheadedness resolved within 3 hours of pharmacist observation. No urticaria, angioedema or respiratory distress. No treatment. Could stand and walk with assistance, though very fatigued. Rested at home. **Re-presentation of lightheadedness & tingling on 02/22 & again mildly on 02/24 while resting.**
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| 57 | 2021-02-24 | pain in extremity |
Severe leg and hip pain; Severe leg and hip pain; This is a spontaneous report from a contactable ot...
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Severe leg and hip pain; Severe leg and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 22Jan2021 09:00 (at the age of 57years) at single dose for Covid-19 immunization. Medical history included migraine. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen (ADVIL), levothyroxine sodium (SYNTHROID), amitriptyline, rizatriptan benzoate (MAXALT), and butalbital, caffeine, paracetamol (FIORICET); all taken from an unspecified date for an unspecified indication. The patient previously took compazine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 06:00, the patient experienced severe leg and hip pain. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. This case is non-serious.
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| 57 | 2021-02-24 | pain in extremity |
General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, s...
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General fatigue, severe swelling in arm with pain, hives on scalp with horrible itching, diarrhea, stomach pain, severe back pain, nausea.
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| 57 | 2021-02-25 | pain in extremity |
bad pain in the arm; pain in the arm like can barely move it; little soreness; This is a spontaneous...
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bad pain in the arm; pain in the arm like can barely move it; little soreness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262 and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included breast cancer. Concomitant medication included letrozole. Patient received the vaccine on Saturday and last night on 25Jan2021 and the morning of 26Jan2021, patient was having a very bad pain in the arm like can barely move it. She was fine until last night. She had a little soreness on Saturday (23Jan2021) and the night of 25Jan2021 and the morning of 26Jan2021, she can barely lift it. The pain was really a lot and patient did not know if this was normal. She knew that there was supposed to be some soreness right afterwards but this was like a day and a half later. Patient took TYLENOL as treatment for the events. Outcome of the events was unknown.
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| 57 | 2021-02-26 | hot flush | Nausea, hot flashes, cleared by medic |
| 57 | 2021-02-26 | tremor, weakness | 101 degree 48 hours after , generalized weakness, exacerbated hand tremors |
| 57 | 2021-02-27 | weakness |
Three hours after vaccine, I started to get body aches, stiff neck and fatigue. Starting around 12 a...
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Three hours after vaccine, I started to get body aches, stiff neck and fatigue. Starting around 12 after vaccine I developed chills, headache, fever and extreme weakness which lasted for 10+ hrs. The weakness improved slightly, but continued. Starting 4 days after vaccine, I started to get stinging eyes, nose and mouth, increased nasal congestion and burning in my sinuses. These symptoms are debilitating and are the same ones I had when I was at my sickest with Covid. Whatever sense of smell or taste I had regained disappeared. These symptoms continues to the present.
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| 57 | 2021-02-27 | flushing |
A few minutes after receiving the vaccination, the patient complained of headache and flushing. Pat...
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A few minutes after receiving the vaccination, the patient complained of headache and flushing. Patient given Tylenol. Patient assessed by MD at chairside, after approximately 45 minutes, patient feeling better, headache subsiding. Discharged to home with spouse. Vitals stable.
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| 57 | 2021-02-28 | pain in extremity |
"57yoF requesting covid eval teacher, got 2nd covid vax 2/24 at 12:15pm, had ha started that night m...
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"57yoF requesting covid eval teacher, got 2nd covid vax 2/24 at 12:15pm, had ha started that night maybe 8 hrs later, fatigue also since 2/24 night and missed work 2/25 and 2/26. started feeling better fri 2/26 around 1pm. needs dr note to rtw or covid test. 1st vax asx other than little bit of arm pain."
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| 57 | 2021-02-28 | pain in extremity |
Arm pain x 3 days; fever for 48 hours, muscle/body pain x 48 hours; fatigue x 48 hours; severe heada...
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Arm pain x 3 days; fever for 48 hours, muscle/body pain x 48 hours; fatigue x 48 hours; severe headache has been on and off every day since the day of the injection, now 8 days in a row.
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| 57 | 2021-03-01 | pain in extremity |
Approximately 1 week post 1st vaccination became extremely fatigued, extreme sore throat at the sugg...
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Approximately 1 week post 1st vaccination became extremely fatigued, extreme sore throat at the suggestion of my doctor I got tested for mono. Came back positive on the afternoon of Jan 11, 2021 which coincidentally I had received my second vaccination that morning at 0900. I continued to have these same symptoms which worsened with extreme muscle pain especially in my legs, neck and lower back. Upon further lab work it was determined that I was in Rhabdo with my CK levels in 4,000, liver enzymes elevated, GFR low. By the way, this was a reactivation of mono that I had had as a child. I received over several days approx 10 liter of NS, zofran and toradol. To date, 3.2.2021, I remain easily fatigued by getting better. Lab work has all resolved to date.
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| 57 | 2021-03-02 | pain in extremity |
About 3am woke up with chills; headache; Arm was very sore.; Saturday, was very tired/lethargic/Felt...
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About 3am woke up with chills; headache; Arm was very sore.; Saturday, was very tired/lethargic/Felt blah all day, tired; out of breath; This 57- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on Jan2021 at 12:00 PM (at the age of 57-years-old) as a single dose for COVID-19 immunization, in right arm. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: allergy to pumpkin. Concomitant medication included: Osphena 60mg; VitD 2000IU; Vit C 1000mg; Zinc 50mg. Patient received dose 1 of Pfizer vaccine on a Friday at 12 noon. Felt fine all day. About 3am woke up with chills and a headache. Arm was very sore. Saturday, was very tired/lethargic all day. Slept 10 hrs, awoke with a headache (but no chills) and had breakfast, fell back asleep another 2 hrs, then another 2-hr nap early evening. Felt blah all day, tired and out of breath. Went to bed much earlier than normal. Felt good Sunday but arm still sore. It's Monday at 4pm and arm is still very sore to the touch. The clinical outcome of the events chills, headache, arm very sore, very tired/lethargic, out of breath were recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 57 | 2021-03-03 | weakness |
extreme fatigue, mod headache and arm/ hand weakness that became worse as days went on. to point I...
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extreme fatigue, mod headache and arm/ hand weakness that became worse as days went on. to point I couldn't use my hands - severe weakness on various fingers (comes and goes) or lift my arms above my shoulders
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| 57 | 2021-03-03 | night sweats |
reports having soreness in left arm at site of injection site. developed loss of appetite that afte...
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reports having soreness in left arm at site of injection site. developed loss of appetite that afternoon after receiving vaccine. noticed shortness of breath while walking the dog. sunday evening, developed left axillary lymph node swelling. also with fever 99.8 - 100.2 degrees F. had night sweats saturday evening (2/27/2021 PM). also with headache after vaccine.
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| 57 | 2021-03-03 | tingling | tingling all over, tingling lips. Evaluated by EMS-Cleared |
| 57 | 2021-03-03 | tenderness |
Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of...
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Swollen neck area now about 5 cm diameter. Has increased over time. Back of neck - starts at base of skull just under hairline. Tender to touch. Limits mobility range (hard to turn head, tilt forward and back). Started with small 1m area Sunday night on 2/28 and has continued to grow. No fever. No pain anywhere else on body
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| 57 | 2021-03-04 | feeling hot |
Patient complained of "lightheadedness and feeling hot". Patient denied dizziness. Patient alert and...
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Patient complained of "lightheadedness and feeling hot". Patient denied dizziness. Patient alert and oriented. Patient denies chest pain, SOB, rash, and itchiness. Patient provided with ice pack. Blood pressure 128/88, respiratory rate 16, and temperature 97.4F. Symptoms subsided at 1530 with ice pack, rest, and relaxing measures.
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| 57 | 2021-03-05 | speech disorder |
I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble sw...
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I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble swallowing. Fever escalated to 103 at 1am 3/3. By 9am 3/3 neck was much more swollen and swallowing more difficult. By 3/4 fever down to 101.3 but throat so swollen difficult to talk, drink, unable to eat. Went to ER at 3:30pm 3/4.
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| 57 | 2021-03-06 | tremor, burning sensation, flushing |
Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left delt...
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Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left deltoid and, was escorted to the 15 minute observation area. She noted feeling burning sensation in her chest and bilateral arms after a few minutes. Patient brought to EMS for evaluation. EMS obtained several sets of vital signs, notable for hypertension (170's/90's). Patient placed on stretcher. She was flushed, had a dry/thick tongue, developed rash on bilateral arms, began shaking and shivering but stated she was not cold only nervous. She was given 50 mg benadryl IM, 18 g IV started in her right antecubital. She declined solumedrol due to past experience with steroids. Her flushing and rash began to resolve, patient stated her tongue felt better. Patient was transported by EMS for evaluation. She had her phone with her, but her husband took her other belongings and will meet her there.
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| 57 | 2021-03-07 | inability to speak |
Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tong...
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Stated often has panic attacks when receives shots or has IVs placed. Stated after vaccination, tongue started to feel bigger and to itch at the back, throat also started to feel tight. Monitored by EMTs in parking lot. Given oral Benadyl. Was not transported to hospital. Husband came to pick her up. Stated a few hours later felt pressure in windpipe at level of clavicles & had difficulty breathing. Stated sleep the rest of the day. Denies HA, fever, or chills. Stated throat felt better the next day though still feels pressure at base of throat. Also complaining of occasional "brain zap" (zing in brain that then causes eye to twitch). States that since tongue started feeling big she has had trouble talking--words coming out funny. States that is still happening.
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| 57 | 2021-03-07 | weakness |
I became sluggish at first, then just wanted to sleep, woke up and all my muscles in my body seemed ...
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I became sluggish at first, then just wanted to sleep, woke up and all my muscles in my body seemed to be on fire. Pain was quite intense. I would say on scale of 1-10 a 10. Felt like a very bad case of my Crohns coming on. I took Tylenol for pain relief every 4-6 hours. From Friday evening through Saturday March the 6th I had no appetite did not have strength to hardly leave the bed. I had some stomach cramping and diarrhea on morning of March 6th. I slept and off for close to 38 hours. I could not make a fist with my left hand at all and had very little strength in my right side. I ran a slight fever of 99.My head was splitting. My husband had the vaccine on March 2nd and he had only slight discomfort and weakness for about 16 hours. Said he felt like he had a hangover. I was expecting some type of reaction but decided Saturday evening if I got any worse I would go to urgent care. I slept about 5 solid hours on March 6/7 and awoke Sunday morning feeling somewhat better. Pain was at about a 5. Today March 8, 2021 I am feeling better, just weak, still no appetite, headache has eased and I can grip both left and right hand now. I am better today than yesterday. I will continue to monitor myself. With my history of Crohn's I am very aware of body and how it reacts. My normal is not everyone's normal, but want to make you aware of how miserable I was. I am thankful I received and pray that his helps me to not get Covid. If you have further questions, please do not hesitate to contact me.
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| 57 | 2021-03-07 | numbness |
Numbness/tingling in both checks, lips, tip of tongue approximately 30 mins after vaccine, improved...
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Numbness/tingling in both checks, lips, tip of tongue approximately 30 mins after vaccine, improved with Benadryl 50 mg, similar symptoms 4 hours later which again improved with Benadryl
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| 57 | 2021-03-07 | tingling |
first dose vaccine given at a blitz immunization event pt complained of non-specific tingling sensa...
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first dose vaccine given at a blitz immunization event pt complained of non-specific tingling sensation mid face after receiving pfizer covid vaccine denied lip/tongue swelling, rash/urticaria, wheezing, sob, cp, cough observed for total of 30 minutes no abnormal clinical findings present pt received 12.5mg po benadryl discharged from blitz event with instructions to seek medical attention if sx's worsen or persist - pt was not sent to the ER
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| 57 | 2021-03-07 | seizure |
Passed out within 10 minutes of getting the shot Went into a seizure An EpiPen was administered with...
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Passed out within 10 minutes of getting the shot Went into a seizure An EpiPen was administered within a few minutes Transported to the hospital via ambulance and monitored at the hospital for about an hour after that.
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| 57 | 2021-03-07 | seizure |
0900 PT arrived on site, expressed that she had a recent mild reaction to PEG during a recent colono...
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0900 PT arrived on site, expressed that she had a recent mild reaction to PEG during a recent colonoscopy. States that she broke out with hives on her face and arms. PT was administered 0.5ml of benedryl prior to administration of vaccination and had her wait 10 min for medicine to take effect. 0913 PT was administered 0.3ml of Pfizer COVID vaccine. 0922 PT's started to show signs of distress with heavy breathing. Upon first contact with PT she was speaking with labored breathing. 0924 PT started to seize. Dr. attempted to communicate with PT and reclined her car seat gain better access. 0925 EMS was called 0925 Epi Pen was administered (successfully) PT started to communicated again but started to feel light headed and nauseous and was returned to a sitting position. RN had taken over and was assisting with PT care. 0938 Paramedics arrived on scene 1005 Paramedics cleared scene and transported PT to ER.
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| 57 | 2021-03-08 | hypersensitivity of all senses |
Body aches. Joint pain. Fever. Chills. headache. Skin sensitivity. Thirst. Started about 7:00 pm an...
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Body aches. Joint pain. Fever. Chills. headache. Skin sensitivity. Thirst. Started about 7:00 pm and pain and symptoms lasted about 24 hrs
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| 57 | 2021-03-08 | numbness |
on the 7th, started experiencing grogginess and gassy stomach. next day on the 8th, symptoms worsene...
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on the 7th, started experiencing grogginess and gassy stomach. next day on the 8th, symptoms worsened and began to feel dizziness. severe numbness on the right side of her body. right arm/right leg, trouble with breathing and cannot perform daily activities
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| 57 | 2021-03-08 | pain in extremity | Left arm pain, chills, body aches, fever, fatigue |
| 57 | 2021-03-08 | tingling, burning sensation |
hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, ...
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hospital visit, increased b/p, pain in center of sternum, tingly limbs, bottom of feet felt burned, dx of Epigastric abdominal pain, vomiting 48 hours, dr visit, hospital visit for dehydration, lack of smell and taste, tingly limbs gone but severe pain behind right knee, ruled out blood clot, smell back, taste not all the way returned, pain continuous
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| 57 | 2021-03-09 | tingling |
Patient reported tingly face within 3 minutes of vaccine. Gave pt 50mg diphenhydramine and monitored...
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Patient reported tingly face within 3 minutes of vaccine. Gave pt 50mg diphenhydramine and monitored for 30 minutes. No worsening symptoms/signs. Patient left to return to work. Contacted patient at 1:30 to check up. She face was still tingly but less than before. She was tired.
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| 57 | 2021-03-09 | tingling |
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild,...
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Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient did not have any anaphylaxis, main complaint was mild tightness under chin between jaw and lymph nodes 20 minutes post immunization lasting for a max of 30 minutes. Also mild tingling in forearm a few minutes after injection.
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| 57 | 2021-03-09 | tingling | tinging to hand distal to injection site. No rash, sob, throat swelling |
| 57 | 2021-03-09 | tingling | tingling to left arm distal to injection site |
| 57 | 2021-03-09 | tremor |
Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/...
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Approx 5 minutes after I received the IM injection I developed SOB, Heart rate was in the 160's, b/p-158/90. I was lightheaded and thought I was going to pass out. My blood pressure has never been that high. Nor have I ever had a HR like that. My body was shaking so much that I couldn't hold on to the water bottle they gave me( d/t developing a very dry mouth.) This lasted about 8 min and then my HR started to go back down.
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| 57 | 2021-03-10 | weakness, burning sensation, nerve pain |
brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; ex...
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brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-03-10 | cold sweat, flushing | Cold sweat, flushing, evaluated by EMS, patient refused transport. |
| 57 | 2021-03-11 | feeling hot |
Approximately 10 minutes post Pfizer 1st dose vaccination patient began to complain of dizziness. Pa...
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Approximately 10 minutes post Pfizer 1st dose vaccination patient began to complain of dizziness. Patient walked on own to stretcher and was assisted to lay down. Vital signs were assessed 158/72 70 18 99 % RA. Patient stated dizziness was continuing and she was feeling like she had an "out of body experience" she noted she feels strange like she was floating. She also reported feeling a sensation of warmth through her body which was concentrated from her knees down. Patient began dry heaves and stated she feels like she felt when she had chemo. After 20 minutes of observation the patient's symptoms were not improving. The patient stated she was genetically tested at the medical center due to her body's response to certain medications and she stated she was concerned due to her reaction to the vaccine. She never became short of breath and did not have itching. Her dry heaves subsided quickly and she did not have any nausea.
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| 57 | 2021-03-11 | feeling hot |
During observation felt hot and sweating No LOC vision blurred Responded to lying down and fluids di...
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During observation felt hot and sweating No LOC vision blurred Responded to lying down and fluids discharged home with daughter
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| 57 | 2021-03-12 | feeling hot, tingling |
As soon as I received the vaccine , I felt the same as if I were stung by a bee. I felt warm and I...
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As soon as I received the vaccine , I felt the same as if I were stung by a bee. I felt warm and I could feel my tongue getting numb. I told the pharmacist & after about 15 minutes I asked if I could take my Benadryl. So it sort of slowed it down but I still had the tingling and numbing . It?s been 3 days and I?m still experiencing the numbing of my tongue .
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| 57 | 2021-03-12 | feeling hot |
I observed patient fanning herself with a piece of paper. Patient reports feeling lightheaded, hot a...
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I observed patient fanning herself with a piece of paper. Patient reports feeling lightheaded, hot and nauseous. Wheeled patient to private area. Vital signs at 1612 were BP 113/62, P 81, R 20, O2 99% on RA. Patient removed mask and drank water. After 15 minutes patient reported feeling back to baseline and daughter wheeled patient to the car.
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| 57 | 2021-03-12 | pain in extremity |
Fever from 99.6-101.8 with chills and aches 3/8/2021-3/11/2021. Sore arm and unexplained diverticul...
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Fever from 99.6-101.8 with chills and aches 3/8/2021-3/11/2021. Sore arm and unexplained diverticulitis flare up 3/6-3/8. Not sure flare up related to vaccine.
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| 57 | 2021-03-13 | pain in extremity | Pain and inflammation in hand previously broken (which had been pain-free). |
| 57 | 2021-03-13 | pain in extremity |
arm very sore initially, and very HEAVY, but that passed within 24 -48 hours. However, soreness has ...
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arm very sore initially, and very HEAVY, but that passed within 24 -48 hours. However, soreness has now returned to the left arm.
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| 57 | 2021-03-14 | inability to speak, flushing |
Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives...
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Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse. Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed. Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
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| 57 | 2021-03-14 | feeling hot, migraine, flushing |
11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizzin...
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11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizziness, she denied any SOB or breathing difficulty. Assisted Pt. back to sitting in chair. 11:50 AM ? Client states she had her vaccine at 11:20 AM and stayed for 30 min at which time she started to experience the numbness and tingling of lips. B/P 150/70, Pt had own O2 Sat monitor which included pulse, O2 sat was 96%, pulse 92, no respiratory distress noted. 11:51 AM- 12.5mg Benadryl given P.O. Pt states she gets very tired with ?full dose?. Pt states she is ?queasy?, light-headed, dizzy and has vasovagal responses to vaccines. She carries an Epi-pen for various food allergies, an O2 sat monitor and emesis bags in case she has a vagal response which she states this is what she feels like. 12:00 PM ? B/P 156/90, HR ? 92, O2 sat 97%, RR ? 20, No swelling, redness or irritation at Right Deltoid injection site. 12:06 ? Pt denies any dizziness or lightheadedness at this time but continues with tingling at lips and thick front of tongue, numbness B/P 152/92, HR 76, o2 sat 95%, RR- 20, cool cloth applied to back of neck, lower legs elevated on chair. Pt wearing compression hose. 12:20 PM ? Consult with Pharmacist who stated another dose of Benadryl would not be recommended and suggested lying down on stretcher and possible anxiety reaction. Pt refuses to lie down on stretcher and states is fine sitting with legs elevated. 12:24 PM B/P 146/90, P ? 64, RR ? 20, O2 sat 97%, Pt has flushed face and states her cheeks feel tight. She states she has Rosecea but her cheeks aren?t usually very flushed. She c/o warmth on cheeks and numbness in front area of tongue. No difficulties noted with swallowing water. Daughter arrived. Site director consulted to determine next steps and decision made to transfer to ED. Discussed transfer to ED with pt who verbalized agreement. 12:34 PM Pt states dizziness resolved however she now has a H/A and possible onset of a migraine. 12:35 PM B/P 162/90 P- 80, RR-20, O2 sat 98%. Pt denies any respiratory distress, refuses food due to many food allergies. Continues to tolerate water without swallowing difficulty or emesis. 12:40 PM Assisted Pt to wheelchair and transferred to Emergency Department for further evaluation and observation. Dtr present and verbal report given to ED RN.
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| 57 | 2021-03-14 | pain in extremity |
felt tired; Headache; arm was sore; This is a spontaneous report from a contactable consumer. A 57-...
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felt tired; Headache; arm was sore; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL0140, expiry date Mar2021), on 12Jan2021 12:00 in the left arm at a single dose as COVID-19 vaccine. Medical history included ongoing COVID-19 from 12Jan2021; and mold allergy, pollen allergy, bleach allergy, and lactose (intolerance), all from an unknown date and unknown if ongoing. There were no concomitant medications reported as no other products that were taken together with the COVID vaccine. The first dose of bnt162b2 for COVID-19 immunization was given on an unknown date and was tested positive at work (12Jan2021) and had the nose swab in 12Jan2021 (reported as yesterday) at her job. Patient he had the second dose of the shot (vaccine) on12Jan2021 (reported as yesterday); and all was like she felt tired in the morning of 14Jan2021, and on 13Jan2021 had headache and her arm was sore, other than that she felt she was fine. She didn't have any chills or anything and they said she was tested positive. She did the nose swab that they did at the nursing home. Patient asked that she has gotten the reaction to this, does it mean that she has Covid or not. Before second dose, patient confirmed that she was tested positive with the nose swab test then she received the second dose, and she was then sent home. It was confirmed that the issues occurred after use of a Pfizer product. No admission to hospital involved and no treatment received in response to the events. The events recovered on an unspecified date in 2021.
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| 57 | 2021-03-14 | pain in extremity |
Vaccination burned slightly, some arm soreness, but no other immediate reactions. Eight days after ...
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Vaccination burned slightly, some arm soreness, but no other immediate reactions. Eight days after vaccination I developed skin tenderness on L forearm. Days 9-13 have resulted in rash in several areas on forearm and additional tenderness on upper arm. At regularly scheduled dermatologist appt they advised it was shingles and prescribed an anti-viral medication (Valcyte HCL 1000mg).
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| 57 | 2021-03-16 | numbness |
Had tingling in the tongue and numbness in right side pf the face, around eyelid, down the cheek and...
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Had tingling in the tongue and numbness in right side pf the face, around eyelid, down the cheek and to side of the nose. It lasted until I went to bed. Symptoms had disappeared by the time I woke up the next day
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| 57 | 2021-03-16 | pain in extremity |
My entire left arm has been stiff and sore ever since injection. Pain has traveled from injection si...
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My entire left arm has been stiff and sore ever since injection. Pain has traveled from injection site down to my fingertips. Weeks later I am in moderate pain.
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| 57 | 2021-03-16 | pain in extremity |
Fatigued; Arm sore; Irritable; This is a spontaneous report from a non-contactable Other Health Prof...
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Fatigued; Arm sore; Irritable; This is a spontaneous report from a non-contactable Other Health Professional (the patient). A non-pregnant 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249), via an unspecified route of administration, in the left arm on 09Feb2021 at 11:30 AM (at the age of 57 years) as a single dose for COVID-19 immunization. Medical history included covid-19, prior to vaccination. The patient did not have any known allergies to medications, food, or other products. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Feb2021, the patient experienced fatigued, arm sore, irritable. Therapeutic measures were taken as a result of fatigued, arm sore, irritable, which included 2 Tylenol. The clinical outcome of the events fatigued, arm sore, irritable was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 57 | 2021-03-16 | pain in extremity |
Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days af...
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Tinnitus left ear has not stopped since vaccine. Severe chest pains and heart pounding for 2 days after vaccine. Pain in right leg calf muscle
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| 57 | 2021-03-16 | pain in extremity |
Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told ...
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Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told me that this was acute thyroiditis. My heart rate was very high (122 bpm) when I visited my doctor's office and it was 130 bpm when I was triaged in the Emergency Room. Upon my doctor's advice, I went to the ER in the afternoon of 03/12/2021 where I was further tested. I was given medications to counteract inflammation, nausea and headache. In addition, I was given medication (beta blocker) to lower my heart rate. When my blood pressure was taken after a couple of hours, the readings revealed that my pressure had also started to fall. I spent overnight in the telemetry unit of the ER - I was given 2 liters of IV fluids to stabilize my vitals. The following day (03/13/2021), I met with endocrinologists who told me to what extent my thyroids were affected and what further medications to take. I had told them and other ER doctors as to what precipitated all of this. I was given anti inflammatory medication and a beta blocker that day before I was discharged in the evening. I have no history of thyroid issues or heart issues. I do not suffer from any chronic illness. I was not sick before I took the second dose of the vaccine. I started to feel ill within 5 hours of taking the vaccine shot, and the symptoms worsened over nearly the following two weeks. Now, following medical intervention, I am continuing treatment with various medications. I don't feel well yet, and I understand that the process towards recovery is going to be slow and unpredictable. I wanted to report this, since I feel that scientists and researchers should have this knowledge that thyroiditis can happen as an adverse reaction to the COVID-19 vaccine (Pfizer/BioNTech).
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| 57 | 2021-03-17 | bell's palsy | Bell?s Palsy |
| 57 | 2021-03-17 | grand mal seizure, seizure |
Recipient with history of epilepsy induced by stress started seizing approximately 5-6 minutes after...
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Recipient with history of epilepsy induced by stress started seizing approximately 5-6 minutes after receiving her vaccine. Before onset of first seizure pt reported throat tightness and had a mild dry cough. Dr. (Med eval) evaluated patient- lung sounds clear, pulse strong and steady 92 bpm, heart sounds normal. Pt reported that she felt like she was going to seize. Generalized tonic clonic seizure lasting approximately 1 minute. Post ictal period noted with minimal responsiveness but good color and respirations x 1 minute. Second seizure lasted approximately 1 minute, again generalized tonic-clonic with good color and respirations. Post ictal for approximately 3-4 minutes. Pt was transfered from car to stretcher. Sats 97% on room air. lung sounds clear with good respirations. 3rd generalized tonic clonic seizure ensued (lasting approximately 1 minute). EMS gave 5mg IM midazolam in her right deltoid. Transfered into ambulance, 3 lead EKG reviewed by Med Eval and no acute findings were noted. Recipient transferred to emergency department.
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| 57 | 2021-03-17 | numbness, facial paralysis |
Left side face drooping , worsening numbness in hands (lasted from afternoon of vaccine until next ...
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Left side face drooping , worsening numbness in hands (lasted from afternoon of vaccine until next morning)
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| 57 | 2021-03-18 | weakness | Low grade fever, chills, headache, nausea, body aches, lack of energy, lack of appetite |
| 57 | 2021-03-18 | cold extremities |
3-17-21 6:30PM 'LT ARM FEELS COLD'. LT ARM IS SLIGHTLY COOLER THAN RT ARM TO TOUCH. GOOD CAP REFIL...
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3-17-21 6:30PM 'LT ARM FEELS COLD'. LT ARM IS SLIGHTLY COOLER THAN RT ARM TO TOUCH. GOOD CAP REFILL. NO NEURO OR MOTOR DEFICIT. AMBULATORY TO EXIT WITHOUT ANY ACUTE DISTRESS. 3-19-21 8:50AM TC: 'LT ARM FEELS FINE NOW'.
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| 57 | 2021-03-18 | tremor | SEVERE headache and nausea. Chills, shakiness, fatigue |
| 57 | 2021-03-18 | tremor |
Tachycardia (124), lightheaded, tremulous, dysphagia. Premedicated with Allegra 180mg PO(9.45am). P...
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Tachycardia (124), lightheaded, tremulous, dysphagia. Premedicated with Allegra 180mg PO(9.45am). Pepcid 20mg PO(1.30pm)., Tylenol 1g PO (1.56pm). Observation for 1hr, HR reduced to 92. Able to drink and swallow meds. HA & lightheadedness resolved and mild dysphagia, HR 82 at 3.13pm.
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| 57 | 2021-03-19 | difficulty speaking |
Patient complained about SOB, stridor and feeling of airway obstruction. Patient said she took her A...
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Patient complained about SOB, stridor and feeling of airway obstruction. Patient said she took her Albuterol inhaler right after she started feeling the SOB. Called 911 and arrived @ 1455. Noticed diminished voice when patient when talking, and directly administered 1st dose EpiPen @ 1446. Called for assistance, and EOA arrived @ 1447. BP taken @ 1447 156/100 with O2 sat 98%. Patient condition was not improving and per EOA, 2nd dose of EpiPen was given @ 1454. Took 2nd set of VS @ 1454 right after EpiPen administered BP 130/100 O2 sat 99. Patient stated of feeling better and noticed patient voice coming back to normal. AMR assessed patient. However, patient denied transportation to hospital stating to the AMR that she feels much better and her voice is coming back. AMR left and recommended patient to stay for an extra 30 min for monitoring. Patient finally left at 1540 with her partner, stable and walk steadily.
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| 57 | 2021-03-20 | hot flush, weakness |
lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph n...
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lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph node under left arm down to the left breast was swollen and painful; temp of 99.4 to 99.9; chills; joints ached; fatigued; With in 3 hours of injection, I got hot and flushed in my face; This is a spontaneous report from a contactable nurse (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available) via intramuscular on right arm on 13Jan2021 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation at Workplace clinic. The patient's medical history included Asthma and Arthritis. The patient had allergies to medications, food, or other products (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included first dose of influenza vaccine at the age of 57 years in nasal on 02Dec2020 which was given within 4 weeks prior to the COVID vaccine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown via intramuscular on left arm on 23Dec2020 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation. On 13Jan2021 at 17:00 (05:00 PM), within 3 hours of injection, the patient got hot and flushed in her face. The next morning on 14Jan2021, she woke up and her lymph node under left arm down to the left breast was swollen and painful. The patient also had a temperature of 99.4 to 99.9 and had chills and body aches enough to keep her home from work. The patient had joints ache and felt weak and fatigued. This lasted for about twenty-four hours. The reporter assessed the events as non-serious. The outcome of the events was recovered in Jan 2021. Information regarding lot/batch number has been requested.
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| 57 | 2021-03-20 | pain in extremity |
I had a sore arm and a headache for 24 hrs. after receiving the vaccine, but otherwise fine. Three ...
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I had a sore arm and a headache for 24 hrs. after receiving the vaccine, but otherwise fine. Three and a half days after receiving the vaccine, I woke up in the middle of the night, very dizzy. The room was spinning. Spent the next three days in bed with chronic fatigue, chills (but no fever), and VERTIGO. It has now been over a week since my vaccine, and I am still experiencing joint pain and dizziness every time I stand up or lie down.
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| 57 | 2021-03-20 | tingling |
Five minutes after receiving the vaccination on her left deltoid, she developed tingling over her le...
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Five minutes after receiving the vaccination on her left deltoid, she developed tingling over her left arm as well as her left lower s and her left hand, primarily over the dorsum of the second through fifth digits. Denies any shortness of breath, itching, counseling, facial swelling, no evidence of anaphylaxis.
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| 57 | 2021-03-21 | involuntary muscle movements |
About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a...
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About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a short time she experienced tingling in lips. We moved her to the floor and laid her flat with head raised as she began to experience uncontrolled movements in arms and legs (seizures?) I administered epinephrine for tightness in chest and tingling lips and 911 was called. Rescue squad arrived stabilized her and transported to hospital.
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| 57 | 2021-03-21 | difficulty speaking |
21Mar2021, At 1820, 20 min post injection, allergic reaction including throat and chest tightness, w...
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21Mar2021, At 1820, 20 min post injection, allergic reaction including throat and chest tightness, wheezing, voice became barely audible. Coughing. At 1830, 30 min post injection, EMTs administered IM epinepherine, 25 mg IV Benadryl, 1 albuterol neb. At 1851 on ER arrival, BP 206/87, pulse 95, resp 18, temp 97.5 F, SpO2 99%. At 1913, attending physician administered solumedrol 125 mg. At 1755, blood drawn for total complement, CH50, and tryptase At 2240 improved, stable, discharged from ER with instructions to take 50 mg oral prednisone for next two mornings and follow up with primary care physician as necessary
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| 57 | 2021-03-21 | muscle spasms |
57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left...
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57y/o female presents with mild throat tightness ~15min after receiving Pfizer vaccine into the left arm. She states that it feels as though something small got stuck in her throat and is causing mild discomfort. She reports associated injection site pain, body cramps, and headache. She denies itching, difficulty breathing, shortness of breath, chest pain, palpitations, blurry vision, presyncope, difficulty swallowing water, or lip/tongue swelling. She reports no change in symptoms after 40min. post-injection. Physical Exam: Heart Rate 66bpm, Blood Pressure 115/74, Repeat Blood Pressure at 40min post-injection 120/80 Cardiac: regular rate and rhythm Lungs: unlabored breathing, clear to auscultation bilaterally Skin: no injection site erythema or swelling. No rash. No lip/tongue swelling or narrowing of oropharynx. Plan: Patient reports that her symptoms have improved at 1hr post-injection and would like to leave. I advised her that she should wait until all of her symptoms have resolved as throat tightness is a concerning adverse reaction. I provided her with options including contacting EMS right now to take her for observation at the hospital, however, the patient declined and said she would not go in the ambulance. She insisted that she wanted to go home and that her husband was driving and would take her to the emergency room if her symptoms worsen. Patient was well-appearing when she left the vaccination site.
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| 57 | 2021-03-21 | muscle twitching |
I developed a non stop under eye twitch on my left eye 2 days post vaccine. Today is 6 days later a...
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I developed a non stop under eye twitch on my left eye 2 days post vaccine. Today is 6 days later and it's still twitching. I also feel extra fatigue.
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| 57 | 2021-03-21 | pain in extremity, numbness |
Right arm pain and numbness, shoulder, both back area on right side and pain and chest heaviness. ...
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Right arm pain and numbness, shoulder, both back area on right side and pain and chest heaviness. Shortness of breath. Pain when trying to take deep breath. The shoulder, chest and back pain was unbearable for seven days
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| 57 | 2021-03-21 | pain in extremity |
Ringing in the ears (both), began within hours of my second dose and still happening 4 days later Le...
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Ringing in the ears (both), began within hours of my second dose and still happening 4 days later Legs ached the day of the shot and the day after but ok now
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| 57 | 2021-03-22 | weakness | Dizziness, faint, weak. Patient drank 2 bottles of water. BG 299, BP 129/86, RR 14, 99% room air. |
| 57 | 2021-03-22 | burning sensation |
4 days after vaccination, burning, itching right middle back and front torso, transient burning patc...
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4 days after vaccination, burning, itching right middle back and front torso, transient burning patches on left thigh at top and top of left foot: side of neck and ear
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| 57 | 2021-03-22 | pain in extremity, numbness, tingling |
Felt fine, no pain in right arm where vaccine was injected. Next day around 2pm felt muscle pain in ...
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Felt fine, no pain in right arm where vaccine was injected. Next day around 2pm felt muscle pain in lower part of left arm and right leg, thought it was just muscle pain like the flu. My arm and leg started tingling and going numb, would wake me up at night. Had a Dr. appt. on March 18 when I mentioned I had numbness and tingling, but thought it was just side effect from the injection. Saturday, March 20 called 811 and nurse recommended I get it checked out. Monday, March 22 called my Dr. office, but no openings. Started noticed tingling and numbness is left leg as well. March 23 went to ER regarding my concerns. Dr. checked me and said to keep an eye on my symptoms; GBS was brought up and he said it could show in up to six weeks.
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| 57 | 2021-03-22 | tingling |
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tin...
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Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tingling in arms and lips burning/numb, no difficulty breathing was monitored in store for 1 hour, no epipen needed, advised to take benadryl
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| 57 | 2021-03-23 | weakness, unresponsive to stimuli, discomfort |
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: F...
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Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild
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| 57 | 2021-03-23 | weakness |
Pfizer-BioNTech COVID-19 Vaccine EUA Debilitating Exhaustion/Fatigue loss of appetite symptoms pres...
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Pfizer-BioNTech COVID-19 Vaccine EUA Debilitating Exhaustion/Fatigue loss of appetite symptoms presented 16 hours after 2nd dose and continued for 48 hours.
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| 57 | 2021-03-23 | difficulty speaking | Horseness, SOB and itching |
| 57 | 2021-03-23 | numbness | Face became numb, had mild hives, continue itchiness for 2 days |
| 57 | 2021-03-23 | numbness |
Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vac...
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Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vaccine. Within 1 hour the feeling was almost gone. Next few days left lower side of face still felt different. 10:00 pm (29 hours after vaccine) started with chills and body aches. Next morning 6:00am was very tired and felt the same. Took 2 Ibuprofen. Dozed on and off in morning. Felt better in afternoon. Around 6pm started feeling chills and achy. Took 2 more ibuprofen. Arm was sore. Next morning, had to work. Felt tired and brain fog all day. Slight achy. Next day, felt about 90% back to normal.
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| 57 | 2021-03-23 | seizure |
0900 PT arrived on site, expressed that she had a recent mild reaction to PEG during a recent colono...
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0900 PT arrived on site, expressed that she had a recent mild reaction to PEG during a recent colonoscopy. States that she broke out with hives on her face and arms. PT was administered 0.5ml of benedryl prior to administration of vaccination and had her wait 10 min for medicine to take effect. 0913 PT was administered 0.3ml of Pfizer COVID vaccine. 0922 PT's started to show signs of distress with heavy breathing. Upon first contact with PT she was speaking with labored breathing. 0924 PT started to seize. Dr. attempted to communicate with PT and reclined her car seat gain better access. Additional information for Item 18: 0925 EMS was called 0925 Epi Pen was administered (successfully) PT started to communicated again but started to feel light headed and nauseous and was returned to a sitting position. RN had taken over and was assisting with PT care. 0938 EMS arrived on scene 1005 EMS cleared scene and transported Pt. to ER.
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| 57 | 2021-03-23 | unresponsive to stimuli, flushing |
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension...
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Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient lost consciousness for ~1 minute, around 5 minutes after receiving first dose of Pfizer COVID-19 shot. Patient was spotted by other patients in waiting area and nearby technician immediately. Breathing never stopped, no epinephine/benadryl administered. Patient was sweating and was provided water. As soon as she regained consciousness, she was able to recite her name and DOB. 911 was called and paramedics arrived within 5 minutes. Taken by EMS to ER.
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| 57 | 2021-03-23 | unresponsive to stimuli |
Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension...
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Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe
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| 57 | 2021-03-24 | weakness |
5 minutes after receiving first dose of vaccine, patient was sitting in observation area and began t...
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5 minutes after receiving first dose of vaccine, patient was sitting in observation area and began to complain of dizziness, weakness, fatigue and nausea. Patient had rapid breathing and stated she was scared. EMS staff addressed patient and began to assess her when she vomited and had a brief syncopal episode. She was taken to a private area and was monitored. All vital signs repeated, EKG done, Patient was given IV fluids and antiemetic, and the transferred to ED. Patient was alert and oriented with vital normal vital signs upon transfer.
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| 57 | 2021-03-24 | bell's palsy, numbness |
I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The sym...
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I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The symptoms lasted a few weeks. Most of the symptoms resolved, but I still have areas of weird sensations that has not gone away. For the immediate treatment, I was given a prescription for steroids and was told I shouldn't have any additional problems for future vaccinations. I was scared to get the COVID vaccine thinking I could have another severe reaction, but I was assured it should not happen again. I had the COVID vaccine on 3/10/21. Yesterday, 3/24/21, exactly 2 weeks to the day, I'm feeling like the Bell's Palsy symptoms are returning. I have had a large fever blister on my mouth and one side of my face is feeling somewhat numb.
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| 57 | 2021-03-24 | tingling |
Tingling down left arm, hand, into right arm, & hand, down both legs And rapid heartbeat. Occurred w...
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Tingling down left arm, hand, into right arm, & hand, down both legs And rapid heartbeat. Occurred within 5 mins of getting vaccine, lasted A couple minutes. Should I not get the 2nd vaccine?
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| 57 | 2021-03-24 | tingling | Tingling in head on left side, tiredness and some nausea |
| 57 | 2021-03-24 | tenderness |
Swelling of the lymph node under my right arm, which is the arm I received the shot. Significant sw...
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Swelling of the lymph node under my right arm, which is the arm I received the shot. Significant swelling and tenderness. No other symptoms.
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| 57 | 2021-03-25 | breast pain | Extreme breast pain, both right and left for six days. Swollen lymph glands in both arm pits. |
| 57 | 2021-03-25 | feeling cold | Severe Head ache Body aches Temp spike Chilling Lump under arm |
| 57 | 2021-03-25 | muscle spasms, hot flush | Racing Heart beat, Hot Flash no fever, muscle aches and cramps, feeling unwell |
| 57 | 2021-03-25 | pain in extremity |
Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious,...
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Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious, very painful swelling extending around back of neck and down left arm. No sore throat, fever.
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| 57 | 2021-03-26 | numbness, tingling |
I have degenerative back disease and my doctor had given me a prednisone dose pack for me to have on...
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I have degenerative back disease and my doctor had given me a prednisone dose pack for me to have on hand if the pain got out of hand. When I started having numbness on the right side of my head (especially my eye lid, upper teeth on the right side, right cheek, ear and behind the ear), I first just used prednisone cream, and found it to help, but not fully. After reading that others had bells palsy after having the shot, and my symptoms seemed similar to bells palsy, I looked up the treatment for bells palsy to be prednisone dose pack. Since I had one on hand, and online stated it would be best to start immediately to avoid any long term effects, I took the first dose on Friday, March 26th. Within 20 minutes my tingling started to subside. I still am experiencing numbness on the right side of my face, but it is significantly reduced, I would say approximately 90% better.
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| 57 | 2021-03-26 | pain in extremity |
4pm, 1 hour after shot, throad swelling, stuffy headache, heart bm 99 to 87 to 96, started itching o...
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4pm, 1 hour after shot, throad swelling, stuffy headache, heart bm 99 to 87 to 96, started itching on left arm near wrist, arm where shit was. etc., For next 3 hours. Took antihistamine chlortrimitron 2, mucinex 1, drank water. 6pm, hbm 87, 78, felt like palpations, throat more swollen. Kept clearing throat to keep open. 9pm, bm 82, 78, 93, throat not worse, drank water. With heart rate so high, I didn't take epipen. 9:10pm went to bed 12am woke up throwing up intensely. Took prescription promethazine let dissolve in mouth, went to bed. 9am woke up with little nausea, light headache, swollen raw throat. 4:30pm, 25+ hours after shot, throat still really swollen, arm sore, tired.
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| 57 | 2021-03-26 | pain in extremity |
day 2 - Left arm sore - like when you get a tetnus day 3 - whole arm and hand sore, some joint pain ...
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day 2 - Left arm sore - like when you get a tetnus day 3 - whole arm and hand sore, some joint pain and fatigue - very tired end of day 3 - Lymph nodes swollen - under left arm 4th day lymph nodes swollen in neck and under arm - left side took Tylenol 2 x a day starting day 2 by 7th day, was no Tylenol needed, lymph nodes gradually went down.
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| 57 | 2021-03-26 | tremor, flushing |
approx. 3:10 pm lightheaded, dizzy, flushed, sweaty, shaky, nauseous, headache 5/10 after interventi...
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approx. 3:10 pm lightheaded, dizzy, flushed, sweaty, shaky, nauseous, headache 5/10 after interventions, feet elevated, ice pack, water, cracker, patient reported improving symptoms at 4;11pm BP 3:20 122/88 HR 87 pulse ox 97 on room air recheck bp 116/74 at 3:45pm HR 82 pulse ox 98 on room air Patient departed vaccine clinic at 3:15pm a friend was called to drive her home. she stood and ambulated with steady gait unassisted patient alert and oriented to name, dob, place, time at all times
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| 57 | 2021-03-27 | hot flush, feeling hot |
fuzzy; confused; got really hot; dizzy; flash of heat; This is a spontaneous report from a contactab...
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fuzzy; confused; got really hot; dizzy; flash of heat; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) intramuscular in the right arm on 10Mar2021 (time the vaccination was given: 08:45-09:00) at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no family medical history. There were no additional vaccines administered on same date of the Pfizer suspect. No previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks. Adverse event (AE) following prior vaccinations were noted as none (never had a reaction to a vaccine before). It was reported that the patient would like to know if she should receive her second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects she experienced after receiving her first dose yesterday. She already has an appointment scheduled for second dose. She waited in store 10 minutes after receiving it and felt fine. On the drive home, she felt a little fuzzy or confused and then got really hot and felt a little dizzy, but that went away within 15 minutes. It was further stated that within 15 minutes of getting the vaccine on 10Mar2021, she "got kind of fuzzy" (felt fuzzy) and first confused 09:10, then felt hot and then dizzy 09:15; these events were assessed as serious medically significant. Additionally, she experienced a "flash of heat that went through her body" on 10Mar2021 which went away within 10 minutes. No ER or physician's office required. She felt like if she just got some water, she would be fine. No test was done. The feeling of confusion was what lasted the most and the dizziness did not last very long. The outcome of the events was recovered on 10Mar2021. The events felt fuzzy, confused, hot and dizzy was related to BNT162B2 per reporter.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events fuzzy, confused, feeling hot and dizzy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-03-27 | pain in extremity, nerve pain |
left scars to her left breast still, that look like white crust on them/scars on her left breast; le...
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left scars to her left breast still, that look like white crust on them/scars on her left breast; left scars to her left breast still, that look like white crust on them; bumps on her chest that won't heal up; skin blistered up like shingles centered to her left breast in the middle; spots were white and puffy, and some left a bump around; pain in her left chest still from the middle to her arm down to her elbow; pain goes from her front to the back of her shoulder blade and around; nerve pain; every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping; bumps on the left side of the chest/still has lumps, some were white and some have busted open; broke out with what thought as a nurse was shingles; arm swelling after the injection; pain/stabbing pain/nagging pain; pain in her arm that went to her chest area/Under her arm and going down she feels a pinching sensation; Her left arm was swollen at the injection site; This is a spontaneous report from a contactable nurse (patient) from the medical information team. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 22Jan2021 at a single dose (at the age of 57-years-old) for COVID-19 immunisation. The patient was given the vaccine in a pharmacy/drug store. Medical history included diabetes and hypertension. There were no concomitant medications. The patient experienced arm swelling after the injection, then a little later on in the day experienced pain. The next day or so, she got bumps on the left side of the chest. Thought it was shingles and was given medicine for shingles but ended up not being shingles. She still has lumps, some were white and some have busted open, approximately 4. She still had arm pain and back. Arm was still swollen. Went back to doctor on 10Mar2021 and gave another round of antibiotics. Still has a stabbing pain from the from to the back. "1 cm to 1.5 cm." She had scheduled for a breast screening done. She was still having pain almost 2 months later. The patient provided further information: the patient only got her first dose of the vaccine. Her side effects began that day then gradually got worse. Her left arm was swollen at the injection site since 22Jan2021 and was still swollen at the time of the report. A couple of hours afterwards as the day went on, she had pain in her arm that went to her chest area. The next day (23Jan2021), she broke out with what thought as a nurse was shingles, but was just in one little spot, so she went to the doctor and gave her medicine, antibiotics, and then she took those for 7 days three times a day. The first antibiotic she was on when they thought it was shingles was azithromycin (ZITHROMAX). After then, the pain would not go away and has left scars to her left breast still, that look like white crust on them. She has pain in her left chest still from the middle to her arm down to her elbow. She has two different types of pain, and when she went back to the doctor a day before (10Mar2021), she was given more antibiotics. The pain goes from her front to the back of her shoulder blade and around and was a stabbing pain. Under her arm and going down she feels a pinching sensation that won't go away, and was all the time. They wouldn't give her the second vaccine dose while she was on antibiotics that appointment reached its due. The pharmacist came on 05Mar2021 which would be her third appointment to get the vaccine and told the pharmacist her reaction to the COVID shot. The pharmacist asked to look at her injury and then wouldn't give the vaccine to her. Her doctor gave her some pain medication that would be good for nerves. She can't take gabapentin and doesn't like to take pain pills for the nerve pain, so she does paracetamol (TYLENOL) and ibuprofen every other time to relieve the pain. She says she has been taking paracetamol 500mg extra strength twice a day by mouth, and ibuprofen 400mg twice a day by mouth. She was wondering if there was any information on if her pain would get better since she doesn't want to stay the same or for it to get worse that what it is. It was a nagging pain that she can't seem to get rid of and every once in a while she loses her grip with her left hand though not too much and she can grab again what was slipping. The gabapentin for her nerve pain gave her side effects, she was taking 300 mg one pill four times a day. She took about three days worth and starting in Feb2021 she thought. The new antibiotic given on 10Mar2021 that she takes for the bumps on her chest that won't heal up was cefdinir 300 mg. She says after her vaccine her skin blistered up like shingles centered to her left breast in the middle, which she thought originally would spread all around but it didn't, it stopped right there. She says that the spots were white and puffy, and some left a bump around in them where they healed up. She says her doctor wanted her to get a mammogram done, which is scheduled for the first Monday in Apr2021. No labs were done, "they just looked at them". The patient felt bumps on the left side of the chest was medically significant because the scars and bumps have been there a while and several were not healing well. The patient has not recovered from the events. Information on the lot/batch number has been requested.
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| 57 | 2021-03-27 | tingling, tremor |
At 1206 called RN over since pt was shaking and sweaty. @1207 shaking but talking. EMS arrive. @12...
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At 1206 called RN over since pt was shaking and sweaty. @1207 shaking but talking. EMS arrive. @1208 lower to the ground, feet elevated. @1209 114/72, OSat 99%, HR 68. @1211 c/o tingly hands. @1212 BP 142/86, OSat 100% HT 72. @1214 131/84, OSat 100%, HR 69%. 1221 c/o headache, sitting up, drinking water. @1225 Pt is sitting up and eating a snack. @1240 Pt is standing and states she is feeling much better and ready to go. @1244 Pt escorted to the door and advised to sit and call for help if necessary.
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| 57 | 2021-03-27 | tenderness |
Stiff neck muscles, especially at base of skull accompanied by pain at the base of skull traveling u...
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Stiff neck muscles, especially at base of skull accompanied by pain at the base of skull traveling up both sides of head into temples. Painful temples when touched. Headache was constant throughout the day (1-2) and would flare up 3-4 times a day (6-7). Sometimes relived by Tylenol. Often caused eye pain when severe.
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| 57 | 2021-03-28 | bell's palsy |
Bell's Palsy; Sharp headaches; cold; This is a spontaneous report from a non-contactable consumer. A...
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Bell's Palsy; Sharp headaches; cold; This is a spontaneous report from a non-contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, on an unspecified date at 57 years old (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced sharp headaches and cold then she went to ER, diagnosed with Bell's Palsy on an unspecified date. The events resulted in a Doctor or healthcare professional office/clinic visit and/or Emergency room/department or urgent care. Treatment was received for the events. The outcome of the events was unknown.
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| 57 | 2021-03-28 | hypersensitivity of all senses |
Temp 102 on Saturday, reduced with ice packs and 650mg tab Tylenol to 101.3 on Sunday. Fever broke t...
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Temp 102 on Saturday, reduced with ice packs and 650mg tab Tylenol to 101.3 on Sunday. Fever broke through night Sunday using ice packs w slight 99 on Monday. Severe headache and joint pain Saturday morning- took 600 mg advil no affect, took 400mg advil Saturday afternoon, 2 rounds of 400mg advil Sunday. By late afternoon Sunday joint pain subsided. Monday feel sore and very stiff with mild headache. Also experienced skin sensitivity Saturday morning. Hurt to touch my skin. Had difficulty with moving clothes across my legs. Monday general fatigue. Throughout weekend took in water and B complex drink supplement to maintain hydration. Staggered advil and tylenol by 4 hours.
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| 57 | 2021-03-30 | pain in extremity |
Sore arm extending up to neck; Sore arm extending up to neck; fatigue; This is a spontaneous report ...
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Sore arm extending up to neck; Sore arm extending up to neck; fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 25Feb2021 at 12:30 (at the age of 57 years old) (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunisation. Medical history included sjogren's syndrome from an unknown date, breast cancer female with radiation from an unknown date, cholecystectomy from an unknown date, right knee arthroscopic surgery for chondromalacia from an unknown date, bilaterial fusion L4/L5 from an unknown date, vertigo from an unknown date, and allergy to bee sting from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; berberis vulgaris root, camellia sinensis leaf extract, coptis chinensis root, curcuma longa rhizome, fallopia japonica root with rhizome, origanum vulgare leaf, rosmarinus officinalis leaf, scutellaria baicalensis root, zingiber officinale rhizome (ZYFLAMEND) taken for an unspecified indication, start and stop date were not reported; glucosamine (GLUCOSAMINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm extending up to neck on 25Feb2021 at 17:00 with outcome of recovering, and fatigue on 25Feb2021 at 17:00 with outcome of recovering. Treatment was not received for the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 57 | 2021-03-30 | pain in extremity |
After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I ...
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After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I experienced fever, headaches, sore arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration, administered in left arm on 06Feb2021 at 16:30 (at age of 57 years old, no pregnant at vaccination) at a single dose, for COVID-19 immunization. Medical history included Known allergies: food reactions to shrimps, crabs, lobsters- and occasionally to pineapples, avocado and eggs; also had reactions to penicillin, sulfa- type medications. Other medical history: none. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. After the patient got the first dose, she experienced fever, headaches, sore arm-however they went away in a couple of days. The outcome of the events was recovered.
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| 57 | 2021-03-30 | seizure, weakness |
nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the sc...
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nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the scene; tired; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 at 00:30 as single dose for COVID-19 immunization. Medical history included hypertension (HTN), and known allergies to erythromycin. Concomitant medication included atenolol and furosemide, both for unspecified indication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 12Feb2021 at 15:00 in left arm for COVID-19 immunization. Within a few hours after administration of the second vaccine on 05Mar2021, the patient became tired so went to bed early. Upon awakening the following morning (06Mar2021), the patient was nauseous and vomited. She got herself ready for work but noticed she was feeling weak, tired and had short of breath resulting in worsening of symptom. The patient then got in her car hoping to feel better with fresh air. However, her condition significantly worsened resulting in me calling number due to fear that she may expire. Upon arrival of emergency services, her condition significantly worsened, the patient was weak and unable to open car door. She was informed by medical personnel that she began seizing at the scene, in the ambulance and in the ED. Once she was stabilized in the ED, she was admitted for 3 days to continue tests and evaluations. The outcome of the events was recovering. The patient had no COVID-19 prior to vaccination. The patient was tested post vaccination via nasal swab on 06Mar2021 and was negative. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage.; Sender's Comments: Considering the plausible temporal association and lacking any reported alternative explanation, a causative role of BNT162B2 vaccine for all reported SAEs cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-03-31 | pain in extremity |
1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE. SECOND VACCINE WAS GIVEN O...
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1ST VACCINE- 1/11/2021 VERY SORE ARM, SAME DAY AS VACCINE . 1ST VACCINE. SECOND VACCINE WAS GIVEN ON 2/01/2021 AND ARM WAS ALSO SORE SAME DAY, DAY TWO, HORRIBLE HEADACHE BEHIND MY RIGHT EYE, NAUSEA, WEAKNESS IN LIMBS. ON 2/25/2021 HAD HORRIBLE STOMACH PAINS, THE NEXT MORING WENT TO ER. HAD ACCUTE APPENDICITIS. HAD APPENDIX REMOVED THE EVENING OF 2/26/2021. I NOW HAVE SOMETHING WRONG WITH MY LUNGS OR HEART. I AM CURRENTLY SEEKING TREATMENT AT CARDIOLOGY.
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| 57 | 2021-04-03 | tingling, cold sweat, numbness, pain in extremity |
Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. F...
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Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. Felt terrible and went to be early. Did not sleep well. Woke up Wed 3/31 feeling better but lightheaded/dizzy; dull headache; arm swollen /sore. Thursday 4/1 still lightheaded and more dizzy when I bent down or turned suddenly; arm still sore. Friday 4/2 morning left side of face started to feel numb/tingling , then left fingers/hand, then left toes/foot, then left calf. Checked possible stroke symptoms and no other symptoms so called Dr. NP said to go to ER since it was unilateral numbness/tingling. Admitted to ER about 11:15am and did stroke protocol to rule out stroke...got CT scan, EEG, and MRI with & without dye. All normal. Discharged about 5:45pm. Very lethargic. Sat 4/3 still lightheaded/dizzy and lethargic. Woke up about 3am early Sun (Easter 4/4) in cold sweat and nauseous; vomited; hardly slept. Feel very lethargic today and still lightheaded/dizzy.
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| 57 | 2021-04-07 | tremor |
24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 24Mar2021 Went to se...
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24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 24Mar2021 Went to see Neurologist now have optical neuritis and balance issue.; 19Mar2021 headache and shakiness; 19Mar2021 headache and shakiness; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot Number: Er2613), via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (with no symptoms) and known allergies to Flagel, aspirin, dairy, oats, tomatoes, and garlic. The patient did not have COVID prior to the vaccination. The patient had no other vaccine in four weeks but had other medications in two weeks (unspecified). On 19Mar2021 at 07:00 AM, the patient experienced headache and shakiness. On 24Mar2021, she went to see a Neurologist and now had optical neuritis and balance issue. She was the scheduled an MRI. The patient wanted to know if she should get her second dose. The patient was not COVID tested post-vaccination. The patient received no treatment for the events. Outcome of the events was not recovered.
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| 57 | 2021-04-08 | pain in extremity | INTENSE PAIN IN THE HAND OF THE LEFT ARM, IMMOBILITY OF THE HAND AND FINGERS. EMERGENCY ADMISSION |
| 57 | 2021-04-09 | pain in extremity |
my gums were slightly inflamed or puffy, particularly the upper gums; Left side of face slightly swo...
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my gums were slightly inflamed or puffy, particularly the upper gums; Left side of face slightly swollen/left side of face was slightly puffy; full muscular control of my face; Polyneuropathy symptoms were stirred up; Throat felt slightly itchy; Left upper forearm pain; Pain upper arm; This was a spontaneous report from a contactable consumer, the patient. A 57-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration in left arm on 06Mar2021 at 08:11 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy, asthma (very mild), polyneuropathy from Aug2020 and ongoing, anxiety, and sinusitis. Patient was tested positive for Covid in Jan, she tested positive on 14Jan2021. This was a mild case and antibodies were confirmed afterwards. It was 7 weeks after she tested positive that there were confirmed positive antibodies. Concomitant medications included bupropion (MANUFACTURER UNKNOWN); gabapentin (MANUFATURER UNKNOWN), guaifenesin, pseudoephedrine hydrochloride (SUDAFED) (MANUFACTURER UNKNOWN) and Wilson's Wash (MANUFACTURER UNKNOWN). The patient previously took theophylline for asthma and experienced swelling face and pharyngeal swelling. On 06Mar2021, the patient experienced throat felt slightly itchy, left upper forearm pain, pain upper arm. On 09Mar2021, the patient experienced polyneuropathy symptoms were stirred up. On 12Mar2021, the patient experienced full muscular control of my face, at 05:30 she experienced left side of face slightly swollen/left side of face was slightly puffy. On 14Mar202, the patient experienced my gums were slightly inflamed or puffy, particularly the upper gums. It was reported that patient received the 1st dose on 06Mar2021 and Friday on 12Mar2021, when woke up, the left side of face was slightly puffy, face looked normal and had full muscular control of face, but it just went form the jaw all the way to the eyelid only on the left side. On 14Mar2021, gums were slightly inflamed or puffy, particularly the upper gums. Patient called neurologist the next day, 15Mar2021, went to see him on Thursday to have him take a look. He confirmed there was no muscular damage, but the left side of my face when poked was duller than the right side. It started 2 weeks ago today, it hasn't gotten worse and hasn't gotten better. Patient was scheduled to get 2nd dose this Sunday but going to hold off because she was concerned about this side effect. Patient tried using Claritin and Benadryl to see if that might make it go away, but it didn't. Her face does not look disfigured in any way. It's not getting worse or better. Just staying the same. She also has polyneuropathy. She got it in Aug2020 from a needle biopsy of the lymph node in her left breast. It was supposed to decrease over time over one or two years. Prior to having Covid she didn't think about it most days. When she got Covid it stirred up the symptoms. When she got the vaccine it also stirred up the polyneuropathy symptoms. She started to notice it being stirred up 09Mar2021. Her neurologist said it was her immune system working and it was aggravating it. On 12Mar2021, she had the left face thing, which was completely new, she never had symptoms like that. It has been 2 weeks and hasn't gotten worse, hasn't gotten better. She was super healthy. She doesn't drink, doesn't smoke, and exercises every day. On the needle biopsy last year by the radiologist in Aug2020. She got small fiber polyneuropathy, which causes tingling prickly sensations in different parts of the body. It was acute form and will go away in a year or two. By Jan it had minimized, but Covid stirred up the symptoms. The neurologist said any illness can cause polyneuropathy symptoms to increase. Then they started to subside. When she got the vaccine, by that Tuesday the polyneuropathy symptoms were greatly aggravated, by the 09. She was confident that they would resolve and have lessen in severity. The clinical outcomes of the left side of face slightly swollen, throat felt slightly itchy was not resolved, for the throat felt slightly itchy, left upper forearm pain was resolved on 06Mar2021, for the pain upper arm was resolved on 07Mar2021 and for event Polyneuropathy symptoms were stirred outcome was resolving. No follow-up attempts are possible. No further information was expected.
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| 57 | 2021-04-10 | weakness |
Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symp...
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Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symptoms: lack of taste, muscle pains in lower extremities/back/arm, ringing ear, itching, throat narrowing/shortness of breath, weight loss, extreme fatigue and weakness for several days; brain fog, dizziness, difficulty swallowing/sleeping.
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| 57 | 2021-04-13 | one side paralysis |
pt got vaccine in AM of 4/1/21- she said she then went to sleep a few hours later and slept x 18 hou...
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pt got vaccine in AM of 4/1/21- she said she then went to sleep a few hours later and slept x 18 hours. when she awoke the next day she had left arm and left leg weakness. she was seen in provider office and her weakness was noted- shse was sent for stat non-contrast CT of brain which was negative for acute ischemic event. Her neurologist was informed, the pt was stasrted on daily baby aspirin and she is scheduled for an MRA/MRI of brain/neck and f/u appt w/neurology
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| 57 | 2021-04-17 | bell's palsy, tingling, muscle twitching, tremor |
breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started q...
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breathing out; cheeks, lips, and mouth started quivering/trembling; cheeks, mouth and lips started quivering and twitching; swelling sensation on her left side of her face; left cheek area felt swollen and tingly; pressure around the eye sockets; Could this be a sign of Bell's Palsy, and is it likely that she develop Bell's Palsy?; This is a spontaneous report from a contactable consumer (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in left arm on 30Mar2021 14:00 at a single dose for covid-19 immunization. Medical history included has back issues, but nothing serious probably for about 7 years and patient stated that she had a Pilates injury and after that her back has never been the same; and patient stated that she was pretty healthy, adding that she was allergic to sulfa, cow's milk, wheat, and almond. Family medical history relevant to events reported included mom has osteoporosis, and severe dry eye syndrome. The patient's concomitant medications were reported as she doesn't take any regular medicines but she does take regular supplements and herbs and stated that she was very lucky. Patient stated that Pfizer COVID-19 vaccine was the he one she trusted the most and she doesn't want to die from COVID if she gets it. Patient received her dose in her left arm, at the time of administration, on 30Mar2021 14:00, she was breathing out, then her "cheeks, lips, and mouth started quivering/trembling and it was definitely noticeable". Patient further stated that while it was being administered her cheeks, mouth and lips started quivering and twitching. She also reported that immediately afterward (30Mar2021), she experienced a swelling sensation on her left side of her face, "kind of how it feels when you have novocaine, but no visible signs of swelling or drooping". Her left cheek area felt swollen and tingly. She stated that it felt swollen but it didn't look swollen, like when you go to the dentist. She also experienced pressure around the eye sockets. She added that both areas under eye sockets felt a little bit weird, tight or something but not like a pain, hard to describe. All of these symptoms resolved within a few hours, and 24 hours later she's "pretty much back to normal". The pressure around eye socket, lasted for a few hours; while trembling and quivering only happened when the shot was being administered, and 24 hours later, she was pretty much back to normal. Patient asked if this has this been reported before and if she should she get her second dose. Patient stated if this could this be a sign of Bell's Palsy, and was it likely that she develop Bell's Palsy (30Mar2021). Patient stated that all her family have all received their doses and no one had this kind of reaction. She wanted to take the second vaccine, just doesn't want to have a stroke or heart attack or anything like that. She stated that all of her events are completely gone except she still has a little bit of swollen feeling left in her cheek on a scale of 1-5 with 5 being the worst, she would say it is a 1, its pretty much gone, the swollen feeling. She stated that provider was aware of the events because she called and told her yesterday. Her family got their vaccines either moderna or Pfizer and have had no issues, other than typical ones such as forearm, a little bit of nausea, or fever but nothing like what the caller has experienced. She was the only one in her family that has had this issue. She did not have any kind of rash, no fever nausea or headache, and stated it was just like getting her flu shot. The patient did not require emergency room and physician office visit. The event swelling sensation on her left side of her face was recovering. The outcome of the other events reported was recovered on 31Mar2021.
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| 57 | 2021-04-17 | numbness, pain in extremity |
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ...
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tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
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| 57 | 2021-04-19 | seizure |
Nausea, vomiting, multiple falls, and ongoing multiple seizures. Patient required intubation and se...
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Nausea, vomiting, multiple falls, and ongoing multiple seizures. Patient required intubation and sedation. After admission, the patient experienced cardiac arrest.
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| 57 | 2021-04-24 | numbness and pain in extremities |
the intensity of the CIPN increased exponentially; the intensity of the CIPN increased exponentially...
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the intensity of the CIPN increased exponentially; the intensity of the CIPN increased exponentially; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 57-year-old, via an unspecified route of administration, administered in left arm on 20Mar2021 13:30 as single dose for COVID-19 immunisation. Medical history included metastatic breast CA, known allergies to oak tree and pollen, and residual bilateral CIPN in the balls and toes and feet. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination and has not been tested post vaccination. Concomitant medications included olaparib, durvalumab, and levothyroxine sodium (SYNTHROID). On 22Mar2021 07:30 (also reported as two days after receiving the first dose), the intensity of the CIPN increased exponentially. This lasted about 5 days when it slowly started to return to normal levels at 2.5 weeks after the first dose. No treatment was received for the events. The outcome of the events was recovered on Apr2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported "intensity of the CIPN increased exponentially" cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-04-24 | seizure |
possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal p...
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possible seizure; fainting; chills; headache; joint and long bone pain; dizziness; Right abdominal pain; temperature spike at 101; unquenchable thirst; sweating; This is a spontaneous report from a contactable consumer (patient) reported for herself that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 08Apr2021 04:00 PM (Lot Number: EW0151) at single dose for covid-19 immunization. Medical history included multiple allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, orthostatic hypotension from an unknown date and unknown if ongoing , traumatic lung injury from an unknown date and unknown if ongoing , metaplasia from an unknown date and unknown if ongoing , hiatus hernia from an unknown date and unknown if ongoing , polyp from an unknown date and unknown if ongoing , diverticulum intestinal from an unknown date and unknown if ongoing , exposure to toxic agent from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine taken for an unspecified indication, start and stop date were not reported; calcium carbonate;soya isoflavones;vitamin d nos taken for an unspecified indication, start and stop date were not reported; ibuprofen;phenylephrine hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously took firs dose of bnt162b2 (BNT162B2) intramuscular, administered in Arm Right on 18Mar2021 04:15 PM(Batch/Lot Number: ER2613) at single dose for covid-19 immunisation. The patient experienced possible seizure on 08Apr2021 20:00 with outcome of recovering , chills on 08Apr2021 with outcome of recovering , headache on 08Apr2021 with outcome of recovering , joint and long bone pain on 08Apr2021 with outcome of recovering , dizziness on 08Apr2021 with outcome of recovering , fainting on 08Apr2021 with outcome of recovering , right abdominal pain on 08Apr2021 with outcome of recovering , temperature spike at 101 on 08Apr2021 with outcome of recovering , unquenchable thirst on 08Apr2021 with outcome of recovering , sweating on 08Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included body temperature: temperature spike at 101 on 08Apr2021. Therapeutic measures were taken as a result of possible seizure. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical course was reported as follows: 4 hrs post vax: chills, sub normal temperature drop >96 f oral, eat, and airmpit , sub normal low BP, headache, joint and long bone pain, dizziness, 2 episodes of warned fainting (vasovagal); followed by temperature spike at 101 F oral onset @21 hrs. post vax riggors and falls, with warned loss of consciousness & possible seizure, followed by lower right abdominal pain w/rebound tenderness, sweating, unquenchable thirst, until fever broke 30 hrs post onset. At febrile onset 400 mg ibuprofen, followed by 200 mg every 8 hrs until symptom resolution. The adverse event result in any of the following Doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event included Public Health RN telephone consult, ibuprofen see. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products:Yes a long list that does not include PG. Other diagnosed illnesses/medical history/chronic health conditions:IMMUNE SYSTEM: multiple allergies including anaphylaxis; R.A., reactive asthma; CARDIOPULMONARY: reactive asthma, chemical exposure lung injury scaring, COPD, orthostatic hypotension; GI: Barrets esophagial metaplasia, hiatal hernia, colonic polyps adenocarcinoma, diverticula. Follow-up (20APR2021): Follow-up attempts completed. No further information expected.
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| 57 | 2021-04-27 | facial pain |
4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis,...
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4/24/21 1:05pm first dose Pfizer vaccine 1:10pm huge allergic reaction, felt like pre-anaphylaxis, like I was going to die 1:13pm took 2 Benadryl 25mg 5:30pm took 1 Benadryl 25 mg Loose stools all day, stayed home as Benadryl was working 4/25/21 12:30am took 1 Benadryl 25mg (weird feeling in my tongue) 1:25pm took 1 Benadryl 25mg for pain in my cheekbones & teeth and rash on both cheeks below eyes 1:58pm took 1 Benadryl 25mg " " 2:19pm took 1 Benadryl 25mg " " 2:49pm checked into hospital emergency room as allergic reaction would not subside 4:30pm got IV with Benadryl 25mg, Methylprednisolone & Pepcid (throat felt strange) 7:26pm discharged from ER 4/26/21 Medrol 24g 4/27 Medrol 20g
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| 57 | 2021-04-28 | pain in extremity |
Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe ge...
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Diagnosed with cryptogenic posterior cerebellar CVA; severe dizziness; vomiting; arm pain; severe general back pain; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 20Jan2021 13:30 (at the age of 57 years old) as single dose for COVID-19 immunisation, at a workplace clinic. Medical history included hypertension (HTN) and depression, both from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. The patient has no known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT); and benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ) both taken for an unspecified indication. On 22Jan2021 the patient experienced arm pain and severe general back pain. On 23Jan2021, the patient experienced severe dizziness and vomiting. She went to urgent care and symptoms were treated. The patient was advised to have follow-up with the patient's professional care provider; she had MRI and CT angio of head on an unknown date with unknown results. The patient was diagnosed with cryptogenic posterior cerebellar CVA on 23Jan2021. Due to the events, the patient was recommended to have full diagnostic working including cardiac and neuro workup as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for three days. The patient underwent lab tests and procedures which included CT angio of head and magnetic resonance imaging (MRI): both with unknown results on an unknown date, and Nasal Swab: negative on 12Apr2021. The patient was recovering from the events.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that vaccine BNT162B2 contributed to the reported events; these are likely intercurrent medical conditions in this patient with underlying hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-04-30 | weakness |
feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; inject...
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feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; injection site itchy; armpit swollen/armpit swollen; 103 fever; sweats; severe pounding headache; no energy; tired; chills; wiped out/weak; nausea; diarrhea; no appetite; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8729) dose 2 via an unspecified route of administration, administered in right arm on 07Apr2021 11:00 as SINGLE DOSE for covid-19 immunization. Medical history included Blood pressure, Diabetic, potassium and some known allergies of Sulfa, Bees. Historical vaccine was covid 19. The patient's concomitant medications were not reported. On 08Apr2021 at 12:00 AM, the patient experienced chills, sweats, up to 103 fever, severe pounding headache, no energy, tired/wiped out/weak, nausea, diarrhea, no appetite, red rash at injection site, itchy, armpit swollen, started about about 12 hours after shot. The patient stated that first 3 days was roughest. Everything above lasted for 4 days. Day 5 just little energy, feeling unwell and slight rash at injection sight/sight swelling armpit and no appetite. Just stayed in bed and rode it out. The outcome of the events was reported as recovering. The action taken in response to the events for bnt162b2 was not applicable.
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| 57 | 2021-04-30 | hot flush |
Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; Th...
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Low blood pressure (87/46mmHg); hot flashes little by little; Headache; Arm was also sore; Fever; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 12Apr2021 10:30 am (Lot Number: EW0158) as single dose for covid-19 immunisation. Medical history included anxiety attack. The patient's concomitant medications were not reported. The same day that she received the Covid 19 vaccine on 12Apr2021, she had a little bit of fever but the next day the fever was gone. On the 13Apr2021 she had a headache, she took some Tylenol and the headache went away that same day. Her arm was also sore on the first and second day. Patient reported she did have a headache but she thought it was related to the weather because the weather affected her sometimes. She did not think her headache today was related to the vaccine. On 13Apr2021, she started getting hot flashes little by little. She is doing fine now. She has had hot flashes for the last 2 days. She also had low blood pressure. She reported she had taken her blood pressure and gotten the following results. 94/60mmHg, 99/63mmHg, 87/46mmHg. This morning (unspecified) her blood pressure was 99/63mmHg and now it's 107/65mmHg. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No emergency room and physician office required. No prior vaccinations within 4 weeks. The event outcome for low blood pressure (87/46mmHg) was recovered on unspecified date, for hot flashes little by little was recovered on 15Apr2021, for fever and headache was recovered on 13Apr2021, for arm was also sore was unknown.; Sender's Comments: A contributory role of BNT162B2 to the event headache cannot be excluded based on a compatible temporal relation and known safety profile of suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-04-30 | pain in extremity |
sore arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 57-year...
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sore arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 57-year-old female non-pregnant patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EN6206), via an unspecified route of administration on 08Mar2021 at 16:00 in the left arm at a single dose for covid-19 immunisation. The patient received the vaccinations in a health clinic/administration facility. The medical history was not reported. There were no allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]); biotin (BIOTIN). No other vaccinations administered within 4 weeks prior to bnt162b2 vaccination. On 31Mar2021, the patient experienced sore arm for 1 day, which were non-serious. There was no treatment given in response to the event. There was no covid prior to or post bnt162b2 vaccination. The clinical outcome of the event not recovered. No follow-up attempts are required. No further information is expected.
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| 57 | 2021-05-03 | inability to speak |
2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea w...
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2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; She had terrible depression. She said she had a history of depression and took medication for the depression; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female consumer reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 09Mar2021 (at the age of 57-year-old female) as single dose for COVID-19 immunisation. The patient medical history included depression for at least 30 years and breast prosthesis user. She said when she takes her medicine, Fluoxetine, she could not even tell she had depression. She had been on Fluoxetine for a decade. She had breast implants placed from about 31 years ago and wondered if her old breast implants triggered an immune response. She grasped at straws to try and figure out what was going on. On an unspecified date in 2021, with her first Pfizer COVID-19 Vaccine, she only had a little fatigue, clarifying the fatigue was very slight. Concomitant medications were not reported. The patient previously took she her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021. The patient reported that her doctor encouraged her to report adverse side effects that happened after the second Pfizer COVID-19 Vaccine shot. She said that she was okay on 10Mar2021. On 11Mar2021, two days after her second vaccine shot, she had terrible nausea and stomach ache. She clarified the nausea was like morning sickness or being punched in the stomach and that her nausea had nothing to do with her bowels. In Mar2021, she said maybe the next day, she had terrible depression. She clarified of having a history of depression and took medication for it. She said it had been about a month since the nausea and depression started and she felt she had just turned the corner on both of them. Reported she had not been feeling too depressed since 14Apr2021 (last Wednesday). In Mar2021, she started having cognitive issues, struggling with words and following instructions since Dec2020. She was having trouble expressing herself and speaking as well. She found it very difficult to find words during a conversation. She also had trouble processing information and things got jumbled easily. Her cognitive issues worsened. She had been to see so many doctors with her nausea and enquired if other people had complained about terrible nausea and depression after receiving the vaccine. She was advised to be transferred to Pfizer Medical Information for further assistance with her questions. She said she was a teacher and had not gone to school since 08Mar2021 because she was so depressed and sick to her stomach. Report was not related to a study or programme. No further details provided. The outcome of events stomach ache and having trouble expressing herself and speaking was unknown while rest of all events outcome was not recovered. Information about lot/batch number was requested.
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| 57 | 2021-05-04 | inability to speak |
she was spent; She had terrible depression. She said she had a history of depression and took medica...
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she was spent; She had terrible depression. She said she had a history of depression and took medication for the depression; 2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation.; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; Event: her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE (at the age of 57 years-old) for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing for at least 30 years, breast implant placed about 31 years ago and started having cognitive issues, struggling with words, and following instructions since Dec2020. She said when she takes her medicine, fluoxetine, she couldn't even tell she had depression. She said she had been on fluoxetine for a decade fluoxetine. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) and experienced slight fatigue in 2021 and recovered. She said she was OK on 10Mar2021. In Mar2021, the patient was having trouble processing information since her second Pfizer covid-19 vaccine shot. She said things get jumbled easily on Mar2021, 2 days after her second pfizer covid-19 vaccine shot, she had terrible nausea like morning sickness or being punched in the stomach on 11Mar2021, stomach ache on 11Mar2021, terrible depression, having trouble expressing herself and speaking, found it very difficult to find words during a conversation on Mar2021, her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose on Mar2021, event: her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose was reported as worsened on Mar2021. She said she had seen many doctors with her nausea. She said her nausea had nothing to do with her bowels. She said it had been about a month since the nausea and depression started, and she felt she had just turned the corner on both of them. On an unknown date, she was spent. Treatment for depression worsened included depression medication. The clinical outcome of trouble processing information and cognitive issues had gotten worse was not recovered, recovering for nausea, stomach ache and depression and unknown for trouble expressing herself, spent and speaking. Information on the Lot/Batch number has been requested.
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| 57 | 2021-05-05 | seizure |
16 hours later chills, fever, nausea and extreme tiredness. Lasted for 24 hours. A week and one day...
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16 hours later chills, fever, nausea and extreme tiredness. Lasted for 24 hours. A week and one day later had an unexplainable seizure of two to three minutes and afterwards being unconscious for 25 minutes. Cat scan and MRI all normal.
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| 57 | 2021-05-06 | pain in extremity |
8 days after both injections excruciatingly painful back of arm, side of arm, and shoulder pain. ...
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8 days after both injections excruciatingly painful back of arm, side of arm, and shoulder pain. I have head aches now periodically as well which I never had before these injections. Returned to the doctor after the second shot 4/26/2021 and was giving a prednisone prescription for 3 days of 20 mg and was told to take the Norco I am given for spine pain management for three days. I took all the meds and the pain subsided for 3 days. I call the doctors office back and asked if he wanted to send the prescription again because the pain persist. I was told that he has done all that he can do and I would be referred to an orthopedic doctor on Monday May 3rd, 2021. Its May 6th and I am in screaming pain and still no appointment.
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| 57 | 2021-05-06 | tingling |
anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150...
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anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat is starting to close up; trouble swallowing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 14:45 (Batch/Lot Number: EW0162), at the age of 57 year, as single dose for COVID-19 immunization. Medical history included anaphylactic reaction to spider bites, pruritus, ongoing hypersensitivity, ongoing allergy to arthropod sting. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Lortab [hydrocodone bitartrate;paracetamol] and experienced drug hypersensitivity, singulair and experienced drug hypersensitivity. Concomitant medication included neocell super collagen, 6g collagen six per day as supplement. On 17Apr2021 the patient experienced anaphylactic shock, reported as medically significant. The patient reported "I started to pass out. She had tingle in her lip/her tongue was tingling. Her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat was starting to close up, she had trouble swallowing. She went to the hospital straight from the clinic where she received the vaccine. The patient reported the following: she went for shot at 14:30 and they didn't take her in until like 14:45. Patient stated after the shot, she sat down and knew she had to wait for at least 30 minutes because 10 years ago she had a couple events of anaphylactic shock due to spider bites. So patient stated she knew she should wait. Patient stated she started reading her book and had trouble swallowing at 5 minutes later, but she decided to keep reading book. Patient stated that 10 minutes she started to feel a tingle in her lip and then she started paying attention. Patient stated she then went over to the staff and found someone who was not busy and explained to them what was happening. Patient stated that staff member walked her over to the nurses station and at that time her tongue was tingling and this is not even 15 minutes later. The patient stated they gave her 10 ml of Benadryl and at about 15:05 at about 15:20 they had to give her the epinephrine because her throat was starting to close up and they called 911. The patient stated unfortunately the epi didn't; it may have slowed it down but she started to pass out. She don't know what her oxygen level was at that point. The patient recalled that her BP was 150 something over 90, she thinks she heard 159 before they gave her the Benadryl or at the same time. The patient stated once the EMT's showed up they gave her an IV and gave her steroids and that stopped her throat from closing and they gave her oxygen and that made her feel so much better. The patient stated it's like reliving the story here and her throat is starting to close up, patient clarified she is just choking up thinking about it and denied that her throat is actually closing up during call. The patient stated they did a lot of testing after did not show any signs of clotting which was good. Patient stated she did have trouble breathing, and they checked heart and her heart was fine. Patient states her throat, that is the part she needs to talk with her doctor about. Her throat didn't start to completely relax. Patient stated it was still tight on Sunday and Monday and that was a little concerning for her, but as far as lab work, no. Patient stated she was not admitted to the hospital, she spent 5 hours in the emergency room (ER) for observation and got sent home with an epi pen which she is not going to get and steroids which she finished yesterday. Patient stated she is not going to get the EpiPen because she does not foresee any need for it due to the amount of money it costs. Patient stated it costs $232 dollars and that is just too much, not to mention the amount of money she will have to give to hospital for the bill due to this event. Patient stated she is pretty clear that she won't or shouldn't get the next shot. The clinical outcome of Anaphylactic shock was recovered on 20Apr2021. The clinical outcome of her throat is starting to close up was not recovered. The clinical outcome of the remaining events was unknown.
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| 57 | 2021-05-07 | weakness |
Getting severe vertigo; diagnosed with vertigo; started to feel very ill/Just doesn't feel too good;...
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Getting severe vertigo; diagnosed with vertigo; started to feel very ill/Just doesn't feel too good; Had stroke like symptoms, but didn't have a stroke, had vertigo; Having a little bit of nausea and a little bit of weakness; Having a little bit of nausea and a little bit of weakness; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:45 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) as a single dose (at the age of 57 years) for covid-19 immunization. The patient's medical history included diabetic, high blood pressure (diagnosed with this 5 years or more ago, caller was not sure). The patient's concomitant medications were not reported. The patient was previously given flu shot (tries to stay up on taking flu shot. Tries to stay up on them as much as caller can, tries to get every year as long as didn't catch flu, as long as not some reason not to receive the shot), pneumonia shot in 2019 and arm was sore. The patient experienced getting severe vertigo; diagnosed with vertigo, started to feel very ill, and had stroke like symptoms, but didn't have a stroke on 01Apr2021. It was further reported that patient got severe vertigo and it was like if she took her shot it was like 30 minutes after the shot. Patient was still having vertigo side effects. She went to the hospital, was in hospital from 02Apr2021 to 03Apr202 1and they diagnosed her with vertigo and they done tests and all her tests came back normal. Patient was trying to find out if she should I take the second Pfizer shot. It was also reported that later on that day patient called paramedics and was hospitalized for two days. Patient had stroke like symptoms, but didn't have a stroke, had vertigo. Patient had stroke like symptoms, but didn't have a stroke, had vertigo. Wasn't sure if first dose Pfizer Covid Vaccine had anything to do with it, but could have dislodged something in caller's ear that led the vertigo on. Had to go see another specialist, eye ear, throat doctor and test came back fine with this doctor. The patient told the specialist she didn't feel comfortable just going to site where caller received first dose Pfizer Covid Vaccine, patient was more comfortable with hospital setting. The specialist told caller she probably needed to talk to someone that had something to do with the Pfizer Covid Vaccine. Caller was waiting on a call back from her Primary Care Doctor. Patient was supposed to have second dose Pfizer Covid Vaccine on 29Apr2021, next week, patient canceled the appointment due to trying to find out more information. iIt was mentioned that the patient was 75% back to the way usually feels. Having a little bit of nausea and a little bit of weakness. Patient does not have spinning of the room, dizzy and all of that like it was. Just doesn't feel too good. On an unknown date, the patient was having a little bit of nausea and a little bit of weakness. The patient was hospitalized for getting severe vertigo; diagnosed with vertigo, started to feel very ill and had stroke like symptoms, but didn't have a stroke, had vertigo from 02Apr2021 to 03Apr2021. The outcome of the events severe vertigo; diagnosed with vertigo, started to feel very ill, and had stroke like symptoms, but didn't have a stroke was recovering and unknown outcome for the remaining events.
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| 57 | 2021-05-09 | weakness | Swelling of site arm, increased heart rate, dizziness and weakness, hospitalization |
| 57 | 2021-05-12 | bell's palsy |
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old fema...
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Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 57 years, administered in Arm Left, on 12Mar2021 14:00 (Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included High Blood Pressure. The patient was not pregnant at time of vaccination. Concomitant medications included labetalol; furosemide; spironolactone. The patient previously took naproxen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Bell's Palsy (medically significant) on 16Mar2021 21:00. The adverse event result in "Emergency room/department or urgent care". The patient received treatment of steroids and antibiotics for event. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Event outcome was recovering.
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| 58 | 2020-12-31 | flushing |
Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which t...
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Face flushing about 30 minutes after vaccine followed by torso rash -- noticed on day after, which totally cleared by third day post-vaccine.
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| 58 | 2021-01-03 | flushing |
15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood ...
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15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood pressure 169/92, pulse 100. Increased difficulty breathing.
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| 58 | 2021-01-03 | flushing |
30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain...
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30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-03 | numbness |
I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous repor...
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I have lost hearing in my right ear; the right side of my face was numb; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number number EJ1685, expiration date Mar2021, on 25Dec2020 09:30 at single dose on left arm for Covid-19 vaccination. Medical history and concomitant medications were none. The patient had not received other vaccine in four weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient received her first Covid-19 vaccination on Christmas morning. She worked at a medical center. Within an hour of when she got home, she lost hearing in one ear and also had some numbness on the same side of her face, She was wondering if that was something she should be concerned and she still didn't have hearing in her right ear. Treatment received for the events included Tylenol. The outcome of the events was not resolved.
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| 58 | 2021-01-03 | tremor |
patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; ...
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patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; This is a spontaneous report from a non-contactable other hcp reporting for a patient. A 58-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EH9899), intramuscular on 21Dec2020 16:00 at single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 minute waiting period after the injection (21Dec2020 16:15), the patient began to experience dizziness/shakiness. This provider was notified of patient reaction and she was then transferred to the emergency bay via wheelchair where she was assessed. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, hypotension, dysrhythmia, chest pain and collapse. Treatment included no therapy, but did continue with vital checks at approximately 5 minute intervals. Patient discharge: stable to go home and follow up with PCP. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the compatible time association, the dizziness and shakiness are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-01-03 | tremor |
The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the inject...
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The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the injection but at 2AM on the 22nd I woke up from my sleep with chills, and shaking even my teeth were clacking. Took Tylenol and it got better around 30 min later. Felt very fatigued and still nauseated almost threw up. By the end pf the day it resolved itself.
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| 58 | 2021-01-04 | difficulty speaking |
tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spont...
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tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a Contactable nurse reporting for herself. A 58-years-old female patient received bnt162b2 (BNT162B2; Lot # EK5730) vaccine , via an unspecified route of administration on 18Dec2020 10:30 at single dose for covid-19 immunisation . Medical history included hypertension from an unknown date and blood cholesterol increased. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), ezetimibe (ZETIA), famotidine (PEPCID). The patient started having a headache and cough on 25Dec2020 and these symptoms worsened on 26Dec2020 in addition to her voice being hoarse. On 26Dec2020 she went to get tested at an urgent center and tested positive for Covid-19. The outcome of the event was not recovered.; Sender's Comments: The association between the event "tested positive for COVID-19, headache, cough, and dysphonia" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-04 | flushing |
Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contacta...
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Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: unknown), intramuscularly in the upper left arm on 22Dec2020 at 08:48 at 58-years-old at a single dose for COVID-19 immunization; which was received at a hospital. The patient stated the hospital had a line for employees to drive up and receive the vaccine, she was in her car when the vaccine was administered. Medical history included ongoing allergy to sulfates from an unknown date (diagnosed at least 20 years ago). The patient had an allergy to sulfates. The patient had a bad reaction to sulfamethoxazole and trimethoprim (BACTRIM) many years ago. The patient did not have the Lot and NDC numbers, or expiration date to provide. The patient stated the reaction was so bad she had to receive multiple injections because her throat was closing off and she had big hives. This occurred years ago. There were no concomitant medications. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced bad reaction, throat was closing off and big hives from an unknown date to an unknown date. On 22Dec2020, the patient experienced: flush, itching, and felt like she was going to wet herself; all assessed as non-serious. The patient called about the COVID-19 vaccine. The patient was wondering if there was any sulfa in the vaccine. The patient had the vaccine on 22Dec2020, and she was fine for the first hour and then she became flush and started itching an hour later. The patient stated " you know when you get a CT scan and the contrast makes you feel warm down there", states she got that same feeling where she felt flush and where she was warm down there and she felt like she was going to wet herself. The patient stated, "the bladder feeling came on so harsh and fast." The patient took diphenhydramine hydrochloride (BENADRYL) for two days and she felt better. The patient later clarified that she recovered completely as of 25Dec2020. Therapeutic measures were taken as a result of flush and itching. The clinical outcome of the events, flush and itching, was recovered on 22Dec2020. The clinical outcome of the event, felt like she was going to wet herself, was unknown. There was no history of previous immunization with the Pfizer vaccine considered as a suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The events did not require a visit to an emergency room or physician office. The patient did not receive any prior vaccinations within 4 weeks of the suspect vaccine. There were no adverse events (AEs) following prior vaccinations. There were no relevant tests performed.
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| 58 | 2021-01-04 | hot flush, feeling hot |
Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was emp...
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Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.
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| 58 | 2021-01-04 | pain in extremity |
Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health profess...
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Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 16:15 to 28Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history was none. Allergies to medications, food, or other products was no. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient was not pregnant at the time of vaccination. The patient experienced sore arm, fatigue, lightheaded on 29Dec2020 14:00. No treatment was received for all event. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about Lot/Batch number has been requested.
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| 58 | 2021-01-05 | weakness | Pfizer COVID vaccine gine. Headsche weakness and extreme conjunctivitis present |
| 58 | 2021-01-05 | flushing | Tachycardia, palpitations, elevated blood pressure, feeling faint, nausea, flushing |
| 58 | 2021-01-05 | numbness |
Both Legs Became Completely Numb; This is a spontaneous report from a contactable nurse (patient). A...
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Both Legs Became Completely Numb; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the right arm on 28Dec2020 07:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes and blood pressure (BP) abnormal. The patient was not pregnant. Concomitant medications included losartan potassium (LOSATAN), metformin, and amlodipine besilate (NORVAC), clopidogrel bisulfate (PLAVIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 29Dec2020 19:00, the patient was sitting and both of her legs became completely numb for 20 minutes and then the symptoms went away. This never happen before. No treatment was received for the adverse event. Outcome of the event was recovered on 29Dec2020 19:20. The event was considered non-serious. Information on the lot/batch number has been requested.
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| 58 | 2021-01-05 | muscle spasms |
Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to s...
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Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D). The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-01-05 | pain in extremity |
Headache; My arm is sore; This is a spontaneous report from a contactable consumer. A 58-year-old fe...
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Headache; My arm is sore; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (BNT162B2, batch number:5926710001), intramuscular in the arm on 30Dec2020 at a single dose for covid-19 immunisation. The patient's medical history included bacterial infection from an unknown date and unknown if ongoing. There were no concomitant medications. On 30Dec2020, the patient got the vaccine and had a little headache and her arms were sore. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
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| 58 | 2021-01-05 | pain in extremity |
Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spon...
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Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient receive first dose of BNT162B2 (lot number: EL1284) on left arm via an unspecified route of administration on 30Dec2020 15:45 at single dose for covid-19 immunisation. Medical history Environmental allergies, diverticulosis, uterine fibroids, and Known allergies: Broccoli and Bell peppers. The patient was previously diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PROTONIX), levocetirizine dihydrochloride (XYZAL), famotidine (PEPCID), fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF). The patient experienced left arm sore around 4 am 31Dec2020. Gradual onset of generalized muscle aches and headache. Worse as day progressed. Xhills late afternoon. Temp at home in evening was 101.2. The patient received tylenol (self administered) for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
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| 58 | 2021-01-05 | tingling |
LEFT SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYS...
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LEFT SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYSICIAN
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| 58 | 2021-01-06 | weakness | body aches, weakness, sore throat, headache |
| 58 | 2021-01-06 | burning sensation | hives, burning sensation around mouth |
| 58 | 2021-01-06 | pain in extremity |
Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third...
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Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third day, swollen lymph node to left neck lasting several days . Did not prevent me from doing anything.
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| 58 | 2021-01-07 | flushing |
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizzine...
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5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat. Throat tightness and difficulty swallowing. Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
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| 58 | 2021-01-07 | muscle spasms |
Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad t...
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Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown. Information on the batch/lot number has been requested.
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| 58 | 2021-01-07 | muscle spasms |
severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her ...
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severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle cramping; pain in her arm; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 5K5730/expiration date unknown), dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose on the left arm for COVID Prevention. The patient had no relevant medical history. Historical vaccine included flu vaccine for immunisation which caused arm pain. The patient had no concomitant medications. She had no other vaccines on the same day as the COVID vaccine. The patient received her first dose of the COVID vaccine on 18Dec2020, and at first, she just had pain in her arm. It started getting sore in the evening of 18Dec2020. She suspected that would happen, because she gets that with the flu shot too. A few days after receiving the vaccine, she had pretty severe neck pain, and at first she just thought that maybe she slept wrong, but she still had neck pain. She was sitting with hand warmer packs on her neck because the pain was at the point bad enough that she could barely turn her neck. She experienced muscle pain that was almost like a horse in the muscles above her hips and in her back. The pain in her hips and back is bad enough that it almost takes her down. The patient also experienced muscle cramping. She further stated that she had not done anything different; she did not got to the gym. She remembered that when she signed off to get the vaccine, there was something about not taking the vaccine if someone had ever had a side effect to a lipid. The outcome of the events was recovered on 20Dec2020 for pain in her arm, recovering for neck pain, not recovered for muscle pain that was almost like a horse in the muscles above her hips and in her back, unknown for muscle cramping.
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| 58 | 2021-01-07 | pain in extremity | Vaccine injected too low, causing redness, warmth, swelling and pain at injection site. |
| 58 | 2021-01-07 | pain in extremity |
Start with the normal sore arm continues on day five, normal headache two days. On the second day, v...
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Start with the normal sore arm continues on day five, normal headache two days. On the second day, very stomach pain so bad could not sleep now for three days.
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| 58 | 2021-01-07 | pain in extremity | Severe arm pain. Unable to open and close fingers. Back hurts Chills Cough |
| 58 | 2021-01-07 | tingling |
Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling ton...
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Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling tongue and fingers; This is a spontaneous report from a contactable physician (patient). A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 02Jan2021 at 09:45 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, migraines. Concomitant medication included losartan 100mg/d, ergocalciferol (VIT D) 4000u/day, ascorbic acid (VIT C) 1000 /day. The patient experienced blotchy rash on chest, neck, shoulders and arms on 02Jan2021 at 10:05, mild tingling tongue and fingers in Jan2021. No urticarial lesions. Rash noted 20 minutes post injection. Took 25mg Benadryl and rash resolved. The outcome of the events was resolved in Jan2021. There was no other vaccine in four weeks. The patient was not diagnosed with COVID 19 prior vaccination, and was not tested for COVID 19 post vaccination. This case was reported as non-serious by reporter.
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| 58 | 2021-01-08 | tingling, feeling hot |
Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow....
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Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow. At 5:34 pm when 15 min wait was done told staff what was happening. Was triaged by NP and MD on standby along w/EMT treated w/50 Benadryl/20 Pepcid/125 Solumedrol IVP. Waited in onsite Immediate Care and was given 1L 0.9 NS bolus. Transferred by ambulance to ER at 6:45 pm after experiencing tingling to chest and dizziness. Tingling changed to warmth in route to ER. Observed in ER and discharged home at 9 pm.
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| 58 | 2021-01-08 | tingling, numbness | Facial tingling and numbness, left side of face (same side as shot). Lasted for several hours. |
| 58 | 2021-01-08 | tingling |
Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, mya...
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Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia Narrative: tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia
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| 58 | 2021-01-09 | weakness |
Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck followi...
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Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck following vaccination. Patient was sent home from work and symptoms persisted after rest.
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| 58 | 2021-01-09 | pain in extremity, feeling cold |
10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, ba...
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10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, basically flu like symptoms. My skin hurt everywhere
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| 58 | 2021-01-09 | pain in extremity |
Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than ...
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Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than the first dose. Tired in evening so went to bed early. Around 2100pm chilling/fever began lasting about 5 hours. This was associated with headache, nausea, and arthralgias. No sleep. All day on 1/9/21 very lightheaded, headache, and some nausea. Spent the day lying on the couch. On 1/10/21 while headache still there in am, much improved. Still some uneasiness of stomach. L axillary soreness. Over all feel much better though not fully normal on afternoon of 1/10/21.
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| 58 | 2021-01-10 | facial paralysis, bell's palsy |
Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye an...
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Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye and nose on the right. Fatigue, cough
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| 58 | 2021-01-10 | pain in extremity, weakness, feeling cold |
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ...
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tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
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| 58 | 2021-01-10 | pain in extremity | Patient refers developed general malaise, headache, feverish, joint pain, nausea and left arm pain |
| 58 | 2021-01-10 | tingling |
Patient experience pin needle sensation all over the body including arms, legs, hands and feet. Symp...
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Patient experience pin needle sensation all over the body including arms, legs, hands and feet. Symptoms started on 01/04/2021 is still present, however, patient admits to symptoms improving. Patient received medical care from primary care provider however they could not determine any causes and was advised to keep monitoring the symptoms.
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| 58 | 2021-01-10 | cold extremities | Fatigue, muscle aches, mental fogginess, syncope, cold hands |
| 58 | 2021-01-11 | burning sensation |
swelling and painful at injection site within first 24hrs in left arm. Red, itchy raised rash after ...
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swelling and painful at injection site within first 24hrs in left arm. Red, itchy raised rash after 7 days post injection that increased in area. Burning sensation experienced. Skin still discolored more than 20 days after 1st shot. 2nd dose in right arm: same reaction within 48hrs. redness, burning , itchiness sensation spreading to upper arm.
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| 58 | 2021-01-11 | discomfort, feeling hot |
About 12 hours after vaccination experienced chills, body aches, intermittent headache and general d...
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About 12 hours after vaccination experienced chills, body aches, intermittent headache and general discomfort. This lasted about 5-6 hours after which there was less aching but could tell that fever persisted, felt sluggish and warm. Temp was 99.9 at the highest over a 2-3 hour period. Ibuprofen was taken about 5 hours after the symptoms started, but only once. Late morning of 01/12 symptoms subsided and felt normal.
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| 58 | 2021-01-11 | feeling of body temperature change, numbness, feeling hot, discomfort |
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe...
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immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
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| 58 | 2021-01-11 | numbness | numbness of the lower extremities |
| 58 | 2021-01-11 | pain in extremity, weakness |
chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours...
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chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy. Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
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| 58 | 2021-01-11 | pain in extremity, weakness |
1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headac...
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1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headache and R arm pain where vaccine was given.1000 mgs. Tylenol was taken, which offered very little relief. 1/8/2021; I awoke with extreme fatigue, unable to sit up, nausea, and diarrhea with stomach pain, headache, which wasn't unrelieved by 1000mgs of Tylenol, unable to raise R arm due to swelling and pain, aching and weakness all over body, joints, and muscles. It also caused a Fibromyalgia flare-up, which I wasn't experiencing prior to vaccine. It was 1/10/2021 before I was starting to feel better.
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| 58 | 2021-01-11 | pain in extremity |
Severe Arm Pain; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old f...
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Severe Arm Pain; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular in the left arm on 17Dec2020 at 08:00 AM (at the age of 58-year-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, and asthma. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), vitamin B complex, magnesium, vitamin D3, and ascorbic acid (VIT C). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Dec2020 at 6:00 PM, the patient experienced severe arm pain within hours of the first injection. It was significantly reduced after a dose of Acetaminophen. The event was reported as non-serious. The clinical outcome of the event severe arm pain was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-01-11 | pain in extremity |
Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with...
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Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect. Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well. Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM. Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
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| 58 | 2021-01-11 | pain in extremity |
Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild...
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Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild headache, cotton headed, fatigue, left arm pain, neck/shoulder aches
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| 58 | 2021-01-12 | burning sensation, tingling | Patient reports tingling and burning sensation at the tips of her right fingers. |
| 58 | 2021-01-12 | hot flush |
Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (pat...
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Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (patient recovered before leaving for ER, only sent due to past cardiovascular events)
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| 58 | 2021-01-12 | pain in extremity | Chills, Headache, Feeling Unwell, Sore Arm |
| 58 | 2021-01-12 | pain in extremity |
fatigue; patient received the second dose in less than 21 days from the first dose; tenderness in t...
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fatigue; patient received the second dose in less than 21 days from the first dose; tenderness in the arm; This is a spontaneous report from contactable nurse, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the left arm on 04Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), vitamin B complex (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), and multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 on 17Dec2020 at 08:00 (Lot Number: EK5730; at the age of 58-years-old) for COVID-19 immunization in the left arm and experienced severe arm pain. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 04Jan2021, the patient had tenderness in the arm. The patient took acetaminophen (MANUFACTURER UNKNOWN) which helped. On 05Jan2021, the patient experienced fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the tenderness in the arm and fatigue were recovered on unknown dates in Jan2021.
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| 58 | 2021-01-12 | pain in extremity | arm discomfort and mild headache |
| 58 | 2021-01-13 | feeling hot, burning sensation |
Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lighthead...
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Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lightheadedness and elevated blood pressure of 210/110. BP down to 170/100 at the time of leaving appointment (20 minutes after shot). The next day she felt nausea, Ha, body aches and burning sensation down the arm of the injection.
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| 58 | 2021-01-13 | pain in extremity | Body Aches, Headache, Sore Arm, Diarrhea |
| 58 | 2021-01-13 | pain in extremity | Arm soreness, headache , body aches, dizzy, ears ringing |
| 58 | 2021-01-14 | feeling hot |
reported symptoms of one wave of nausea (which quickly resolved) and a warm pulsing sensation to her...
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reported symptoms of one wave of nausea (which quickly resolved) and a warm pulsing sensation to her left posterior hand from wrist distally to index finger.
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| 58 | 2021-01-14 | pain in extremity |
Right arm became painful and could not touch or move without lots of pain; Muscle pain; Pain; very a...
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Right arm became painful and could not touch or move without lots of pain; Muscle pain; Pain; very achy all over; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in right arm, on 07Jan2021 at 10:00, at a single dose, COVID-19 immunization. The patient's medical history included hypertension (HTN), exercise induced asthma, allergies to sulfa, and hormones. The patient's concomitant medications included lisinopril, carvedilol (COREG), acetylsalicylic acid (ASA), levothyroxine sodium (SYNTHROID), and unspecified hormones. The patient previously took the first dose of BNT162B2 on 16Dec2020 (also reported as 20Dec2020) at 2:00 PM for COVID-19 immunization (intramuscular in left arm; Lot Number: EK5730). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 07Jan2021 at 10 PM (also reported as 7 hours after shot), the patient's right arm became painful and could not touch or move without lots of pain. 1 hour later, the patient went to bed, only to be woken with excruciating muscle pain all over. The patient was unable to lie down, sit, stand, or move without severe pain. The patient took ibuprofen (MOTRIN) and applied heat and lied down on stomach. Within 4 hours, that pain decreased, and the next 24 hours was very achy all over. The patient used heat most of the day. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-01-14 | pain in extremity |
Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever...
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Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever; nausea; This is a spontaneous report from a contactable Other HCP reported for herself (patient). This 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via an unspecified route of administration from 07Jan2021 at 15:45 at single dose on left arm for COVID-19 immunisation. Medical history included COVID-19 and was sick for 17 days, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The patient experienced left arm pain from shoulder to elbow, extreme fatigue, headache, joint pain, chills, low grade fever, nausea on 07Jan2021 at 21:00. Symptoms started five hours after injection and did not abate until about 64 hours after vaccination. No treatment was received for the events and all considered as non-serious. The outcome of the events was recovered in Jan2021.
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| 58 | 2021-01-14 | pain in extremity |
Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle ach...
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Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle aches (8/10 on pain scale). Headache (4/10). Fatigue. Temperature 100.1. Took Ibuprofen and Tylenol 1st through 5th day. Temperature was under 99.0 by 4th day. Above side effects were bearable with Ibuprofen by 4th day and only arm soreness by 5th day. **Of note, I was diagnosed with COVID on September 11, 2020 and had since recovered.
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| 58 | 2021-01-14 | tingling |
Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little...
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Diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face; This is a spontaneous report from a contactable other HCP. A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration in left arm on 29Dec2020 11:00 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included Scleroderma, Interstitial Lung Disease, and Raynaud's. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tadalafil (ADCIRCA), amlodipine, pentoxifylline, ASA, and fish oil. The patient experienced diffuse pins and needles feeling that affected my feet, legs, hands, arms, trunk, and (only a little) face that started around 03Jan2021 and was at its worst on 04Jan2021. The patient went to the doctor's office on 05Jan2021. The outcome of the event was recovering. The event was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.
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| 58 | 2021-01-14 | tingling |
Patient c/o tingling in hands a few minutes after vaccine. Was found to be hyperventilating. No airw...
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Patient c/o tingling in hands a few minutes after vaccine. Was found to be hyperventilating. No airway compromise, SOB, CP, or dizziness. Transported to ED from vaccine clinic.
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| 58 | 2021-01-15 | numbness |
Chills,fever,almost fainting,numbness in hands ,arms,shins,hyperventilating. Symptoms started the ni...
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Chills,fever,almost fainting,numbness in hands ,arms,shins,hyperventilating. Symptoms started the night of the vaccine. Went by ambulance to ED
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| 58 | 2021-01-17 | burning sensation |
Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on...
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Rec'd 1st dose on 1/9/2021 in the morning. By Sunday afternoon, face started burning and itching. on 1/11/2021 was seen in the ED for bilateral eye swelling, right side greater than left.
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| 58 | 2021-01-17 | feeling cold |
1/17/21 Received dose at 0800. Fever started at 2330. Fever started at 100 then progressed to 103. ...
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1/17/21 Received dose at 0800. Fever started at 2330. Fever started at 100 then progressed to 103. Also had muscle aches, joint pain, feeling chilled, and severe headache. Took ibuprofen at 0300 1/18/21. Followed by Tylenol and Motrin (alternating). Headache still ongoing. Aches and chills subsiding as of 1500 1/18/21. Temperature still 100.
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| 58 | 2021-01-17 | pain in extremity, muscle spasms |
Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour afte...
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Sore arm x 2-3 days, itching arm started on 1/15 through 1/16, tingling lips for the first hour after vaccine, felt fatigued the day of the vaccine for about an hour after, On 1/14 at 0530 woke up with a horrible right calf cramp was relieved by massage. Sat at side of bed began feeling extremely nauseated, diaphoretic then syncopal episode that lasted approximately 5 seconds.
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| 58 | 2021-01-17 | pain in extremity | ARM PAIN, FEVER 101, JOINT PAIN FOR 24 HRS. TOOK TYLENOL 500MG 2 TABLETS |
| 58 | 2021-01-17 | tremor, pain in extremity | LEG PAIN,CHILLS,WEAKNESS IN LEGS,SHAKING,HEADACHE,DIZZINESS AND FATIGUE 24 HOURS FOLLOWING INJECTION |
| 58 | 2021-01-18 | weakness | Fever, chills, weakness, exhaustion lasting approximately 32 hours. |
| 58 | 2021-01-18 | weakness |
Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath,...
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Severe generalized muscle pain and weakness, general bone pain, general organ pain, short of breath, itching, severe chills alternating with fever, chest pain, facial nerve numbness, blurry vision, sore throat, nausea, diarrhea. Treatment was a Medrol Dose pack for 6 days. Outcome was severe symptoms decreased after 4 hours of taking first dose (6 tabs) of prednisone. As the prednisone dose decreases each day there is increased muscle pain and shortness of breath/lung tightness with activity, and severe fatigue
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| 58 | 2021-01-18 | depressed level of consciousness |
The evening of receiving the vaccine every muscle and joint in my body was achy, started feeling anx...
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The evening of receiving the vaccine every muscle and joint in my body was achy, started feeling anxious and depressed, just to the point that I could not leave my bed for a week, extreme fatigued. I feel a little better, started making myself get up and do stuff and went back to work on 01/11/2021.
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| 58 | 2021-01-18 | migraine | Nauseous, extremely sore and aching muscles and body, migraine |
| 58 | 2021-01-18 | muscle spasms, pain in extremity | Day 10 post number 2 vaccine. Muscle aches, cramping and pain in lateral back and legs. |
| 58 | 2021-01-18 | pain in extremity, tingling |
Finger tips on right hand tingling and painful. Slightly inflamed and swollen. Just monitored for im...
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Finger tips on right hand tingling and painful. Slightly inflamed and swollen. Just monitored for improvement.
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| 58 | 2021-01-18 | pain in extremity |
I had a sore arm right away. The next morning I felt like I could have a fever and had body aches an...
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I had a sore arm right away. The next morning I felt like I could have a fever and had body aches and did not feel good. When I got to work I talk to Dr. and he gave me a shot of Depomedrol and Solunedrol shot.. The shot helped for a while but starting feeling worse, I took a second dose of Advil. I woke up the next morning with a head ache and body ache, I stayed home from work. I rested all day and by that evening I felt all better.
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| 58 | 2021-01-18 | pain in extremity |
I started feeling tired the day after my injections (day 2) and didn't think much of it until i got ...
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I started feeling tired the day after my injections (day 2) and didn't think much of it until i got home around 6:00 pm and i was exhausted. I couldn't even open my eyes without putting effort into it. By the next morning (day 3) i was extremely tired and it hurt in my leg muscles, butt muscles, arms and stomach. I woke up at 2:30 PM and threw up. The next day (day 4) i had diarrhea and was still exhausted and just felt lousy. Today is day 7 and i finally came back to work. I still have a slight headache and nausea and stomach cramping on/off.
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| 58 | 2021-01-18 | cold extremities |
Severe Head/Neck ache Body Aches Fever (101 - 102) Hard Chills Nausea All Fingers were cold to the ...
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Severe Head/Neck ache Body Aches Fever (101 - 102) Hard Chills Nausea All Fingers were cold to the touch and severely aching (felt as though they were frost bitten) Fatigue
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| 58 | 2021-01-19 | burning sensation |
1:55 sitting in chair in observation area, began feeling a "burning" sensation in her arms. 2:06 mo...
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1:55 sitting in chair in observation area, began feeling a "burning" sensation in her arms. 2:06 moved via w/c to private observation with EMT on site in Gave patient ice packs for both arms. States that the ice reliefs to burning. attendance. HR 78; O2 97%. Unable to obtain BP due to obesity. Per exam noted on Left lower arm a solid red raised area about 3 inches in diameter about 1/8 cm height. States it burns. Has mildly red scattered hive like areas on right lower arm. 2:15 Gave patient ice packs for both arms. States that the ice reliefs to burning.. Denies any burning or swelling in throat. BBS CTA per EMT assessment. No shortness of breath note; 2:25 States she drove on her own and lives in a senior adult complex. EMT recommended ambulance for further evaluation. Patient declined. EMT instructed patient to contact medical physician or emergency if problems persist or if symptoms worsen. Patient agreed and left ambulatory to private vehicle.
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| 58 | 2021-01-19 | burning sensation |
Approximately 1.5 hours after receiving the vaccine, she noticed redness on her arms, upper chest an...
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Approximately 1.5 hours after receiving the vaccine, she noticed redness on her arms, upper chest and back of her neck which was mildly itchy and burning. She took Benedryl 25 mg prior to the vaccine and 25 mg after the symptoms appeared. Symptoms resolved within about 24 hours.
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| 58 | 2021-01-19 | discomfort |
Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort d...
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Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort developed during the late night following injection.
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| 58 | 2021-01-19 | pain in extremity |
On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home,...
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On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home, but not the flu because I had my flu shot in Oct.2020 Wednesday 1/13 I left work because I started with vomiting, diarhhea , a light headache and my arm was real sore. That continued on through that night and into the next morning. So I had to call in at work that morning 1/14. I finally started feeling better by friday night, 1/15. The headache was gone and the chills were only slight and I could finally keep some toast down. Before that I could only slightly keep liquids down.
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| 58 | 2021-01-19 | tingling, feeling cold |
Left side facial tingling and perception of face feeling cold. Occurred approximately 20-25 minutes ...
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Left side facial tingling and perception of face feeling cold. Occurred approximately 20-25 minutes after receiving vaccine and lasted 45-60 minutes.
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| 58 | 2021-01-19 | seizure like phenomena | Chills, seizure like activity, body aches, injection site soreness |
| 58 | 2021-01-19 | tenderness |
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21...
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1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery. Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.
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| 58 | 2021-01-19 | unresponsive to stimuli |
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w...
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I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-20 | numbness, pain in extremity |
Da of Vaccine-1/11/21-at about 7:00 pm in the evening employee started having nausea, left arm (vacc...
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Da of Vaccine-1/11/21-at about 7:00 pm in the evening employee started having nausea, left arm (vaccine arm) pain, all left side pain and numbness down to left foot, fever 99-100, diarrhea, joint soreness, stomach cramps. Day 2-1/12/21-headache, diarrhea, left side all felt heavy, left arm remained sore and limited ROM in left arm. Day 3-1/13/21-Mild diarrhea only and on Day 4 1/14/21-nothing, all symptoms gone.
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| 58 | 2021-01-20 | numbness, pain in extremity |
Day 1-1/11/21-Vaccine provided, employee started having nausea at about 7:00 pm with, left arm pain ...
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Day 1-1/11/21-Vaccine provided, employee started having nausea at about 7:00 pm with, left arm pain and left side body pain and numbness down to foot, fever 99-100, diarrhea, joint soreness and stomach cramping. Day 2-1/12/21-diarrhea, headache, heavy feeling on left side of body, left arm soreness with limited ROM in left arm. Day 3-1/13/21-mild diarrhea only, Day 4-1/14/21-no symptoms, nothing.
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| 58 | 2021-01-20 | numbness |
I had the shot in my left arm. Stayed for about 10 minutes and headed out. I told my coworker my ton...
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I had the shot in my left arm. Stayed for about 10 minutes and headed out. I told my coworker my tongue felt like it was a little swollen. A little later on I felt like something was on my neck so I reached up felt some swelling on my lower neck and shoulder. Before reaching back to work my face felt like it was swelling only on the left side. As the day went by the workers at my school could tell that my face was swelling. Got home called the hospital and the told me to go to the ER. I went and they checked me out and put me on prednisone and benadryl. Second day I still feel like my face feels numb and still have to swelling at the bottom of my neck.
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| 58 | 2021-01-20 | migraine |
Dose 1: I had a high fever (101.6), serve body ache and migraines this lasted for about 2 1/2 days. ...
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Dose 1: I had a high fever (101.6), serve body ache and migraines this lasted for about 2 1/2 days. This caused me not to drive Dose 2: Fever 102-104 took Tylenol , body ache and bad migraine
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| 58 | 2021-01-20 | pain in extremity | DEVELOPED LUMP IN RIGHT ARMPIT AND PAIN IN RIGHT ARM MORNING AFTER INJECTION |
| 58 | 2021-01-20 | tingling | Systemic: tingling in legs, chills-Mild |
| 58 | 2021-01-20 | tremor | Nausea, headache, chills, sweats, swelling to the tongue, SOB, loss of appetite, shakiness, |
| 58 | 2021-01-20 | tremor |
I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throa...
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I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throat get bad; I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe; I started hyperventilating because I was scared; I started hyperventilating because I was scared; I felt strange but not sick or anything like that, it hit me like with a ton of bricks; I was shaking so bad I couldn't even hold anything; I was aching all the way from head to toe; I got my first Pfizer BioNTech COVID 19 Vaccine on 22Dec/And then I had my second one on 08Jan; I have residual like I am sill aching in my back; I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally; I had sort of a cough but not like I urge to cough but it was not like chronic; Muscle soreness; still tired; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient received the second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on right deltoid on 08Jan2021 08:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on left deltoid on 22Dec2020 at single dose for covid-19 immunisation. The patient stated she got her first Pfizer BioNTech COVID 19 Vaccine on 22Dec2020 and had no issues really with that one. And then she had second one on 08Jan2021. The first she got in her left deltoid and the second one she had on 08Jan2021, she had in her right deltoid. It's towards 8:30 in the morning roughly is when she had it. So, during the day went on 08Jan2021, she felt strange but not sick or anything like that. And the day went on to eat something and then came home. And then she'd say at around 7:30 it hit her like with a ton of bricks. She was shaking so bad, she couldn't even hold anything. And then she was aching all the way from head to toe. And she was like she will get her tooth brush at least. So, she brushed her teeth and then all of a sudden her throat closed up on 08Jan2021 around 7:30 pm and she couldn't breathe. And she stated she was like "oh my gosh and then it sort of opened up enough for me to scream for my husband, I yell for him to come and then it did it again, it closed up again. And when he came, I started hyperventilating because I was scared. And he calmed me down and rub my back and everything, and it went away. But it scared me. But the shaking lasted probably all through night maybe till 3 in the morning because I tried not to take anything and I probably took 2 Advil. And now I have residual like I am sill aching in my back. And it's weird, in morning I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally. And then I had sort of a cough but not like I urge to cough but it was not like chronic. Not a lot but it's there like if you urge to cough, it doesn't happen a lot. " The patient stated "It started on 08Jan2021 around 7:30 pm, when my throat get bad. I have muscle soreness specially in my back and I don't know in the taste in the morning the food doesn't taste right but then like it's fine towards the afternoon. And I am still tired and a slight like cough. But the cough isn't really anything, if I get urge to cough. It's not all day, it's not chronic at all." The patient started to took Advil as a treatment and stated "Well I started to because it was like 3:30 in the morning, or 2 or 3 in the morning I did take 2 Advil. And they helped with that pain." The outcome of the event taste abnormality was recovered, outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-01-21 | numbness, tingling |
Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation s...
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Post-Vaccination Paresthesia course: About Sunday, 1/17/2021, I began to feel a numbing sensation spreading on the top of my head. Since I was recovering from a severe allergic reaction to the Covid vaccine (numb, swollen lips, face, tongue), I initially thought it may be a recurrence. However, by the morning of Tuesday, 1/19/2021, the numbness was complete from the tops of my eyebrows, over my scalp, my ears and down the center of my back to my buttocks. The numbness was bilateral. Alarmed, I went to the Emergency Room. (I am a hospital pharmacist there.) The ER consulted Neurologist. After MRI results, diagnosis was Post-Vaccination Paresthesia. I was released from work by the ER through 1/21/2021. The height of the paresthesia was 1/21/2021. This included some auditory buzzing and mild blurred vision. Today, 1/22/2021, I am beginning to regain feeling on my back and forehead. I estimate that I have regained about 50% feeling on my scalp.
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| 58 | 2021-01-21 | migraine | Sick to stomach, migraine head ache |
| 58 | 2021-01-21 | pain in extremity |
On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen ...
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On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen - slight headache. On 1/21 3:45am right eye swollen, (but not swollen shut) a little ache -slight headache.
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| 58 | 2021-01-21 | paralysis |
Systemic: Patient experienced temporary paralysis from the shoulders down lasting approximately 20 m...
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Systemic: Patient experienced temporary paralysis from the shoulders down lasting approximately 20 minutes-Severe
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| 58 | 2021-01-24 | weakness |
24 hours post vaccine developed heavy fatigue, chills, body aches, headache, and weakness for 8 hour...
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24 hours post vaccine developed heavy fatigue, chills, body aches, headache, and weakness for 8 hours, then slight headache and weakness continued an additional 12 hours.
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| 58 | 2021-01-24 | pain in extremity |
On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fe...
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On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fevers & headaches. On the third day on 12/30/2020 I had hives I had them in my face they were the size of a dime they are lumping I had them on my eyebrows & on my right cheek, & continued nose bleeding, fever continued, fatigue continued, headaches continued, pain on my arm & I felt with no energy. I had a lot of nose bleeding. On 12/30/2020 I called the doctor and they gave me an appointment for 12/31/2020 & they gave me a zoom meeting. The doctor said every symptom I had was a normal reaction to the covid vaccine except the nose bleeding. The symptoms continued but the nose bleeding is the only thing it has stopped.
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| 58 | 2021-01-25 | cold sweat, weakness |
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received firs...
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This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.
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| 58 | 2021-01-25 | nerve pain | Nerve pain on her back. It is in the same spot where she had previously had shingles pain |
| 58 | 2021-01-25 | throat numbness |
tingling / burning sensation in throat about ~12 minutes after vaccine. Did not progress to airway c...
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tingling / burning sensation in throat about ~12 minutes after vaccine. Did not progress to airway compromise. Sensation changed to a numbness but did not worsen. Patient given Benadryl and Pepcid, monitored. Improvement in symptoms noted, discharged home.
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| 58 | 2021-01-26 | migraine |
Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date ...
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Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered. Information on the LOT/Batch number has been requested.
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| 58 | 2021-01-26 | tenderness |
Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move m...
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Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon. It hurt to move my neck, and is very tender to touch. It is still present now, 10 days after receiving the vaccination. I saw my MD today who assured me it is a typical appearance for a lymphadenopathy, but it still bothers me, especially never having had such an occurrence before.
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| 58 | 2021-01-26 | tremor |
15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud...
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15 minutes after her second dose of the injection, patient reported ringing in both ears. Very loud. She also reports her parkinson symptoms are increasing. Shaking of arms and legs were observed. Patient also reported nausea.
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| 58 | 2021-01-27 | weakness, pain in extremity |
Sore right arm within one hour of receiving vaccine. Headache developed later in day. Not really con...
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Sore right arm within one hour of receiving vaccine. Headache developed later in day. Not really concerned as were told this was normal. Arm soreness improvid within 2 days. However, it has now been 9 days and I wake up with a throbbing severe frontal headache every day. I have periods of extreme fatigue; I suddenly feel like I no longer have the strength to stand. i sit or lay for 20 minutes or so to recover my strength. I have rarely had headaches in my life only with strep throat infections and a couple of sinus infections. So this is very unusual for me. I am afraid to take the second dose if the first caused this severe of a reaction.
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| 58 | 2021-01-27 | weakness | Weak Dizzy sleepy pain at injection site feels like she is going to get the flu |
| 58 | 2021-01-27 | feeling cold, pain in extremity |
Arm was very sore. Felt nausea and very frigid for hours with a slight headache starting late in th...
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Arm was very sore. Felt nausea and very frigid for hours with a slight headache starting late in the afternoon after vaccine administered. By next morning still had a slight headache and tired. Within 36 hours felt much better.
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| 58 | 2021-01-27 | flushing, tremor |
It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (vi...
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It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (violent shaking); difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EL3246; expiration date not provided), via an unspecified route of administration on 12Jan2021 16:30 at a single dose at left arm for COVID-19 immunisation, glatiramer acetate (COPAXONE), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for unspecified indication. Medical history included multiple sclerosis, hypothyroidism and osteoporosis. The patient was not pregnant. The patient received the first dose of BNT162B2 (lot number: EKS730) on 22Dec2020. The evening after the patient had her second Covid vaccine, the patient gave herself Copaxone shot. On 14Jan2021, the patient stated that there was an idiosyncratic reaction that happens periodically. Symptoms were flushing and palpitations. It ends quickly. About 15 minutes after that occurred, the patient had shaking chills (violent shaking) and difficulty breathing. The symptoms lasted about 1 hour. During that hour, the patient had someone drive her to the hospital but during the drive the symptoms calmed down. The patient spoke with one of the nurses that does screening in the lobby and they said many people had been reacting to their second shots, so she didn't really need to be seen in the ED since her symptoms had resolved. No treatment was received. The action taken in response to the event for glatiramer acetate was unknown. The outcome of the events was recovered on an unspecified date.
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| 58 | 2021-01-27 | flushing | IMMEDIATELY DEVELOPED FLUSHING, NAUSEA AND DIZZINESS. |
| 58 | 2021-01-27 | pain in extremity |
The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphore...
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The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphoretic, pain to entire right side; right side teeth and jaw pain; general malaise. I took 2 -650mg Tylenol before bed. Pain in the right arm from neck to elbow lasted for 1 week, used 2-650mg Tylenol to tx
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| 58 | 2021-01-27 | pain in extremity |
1st dose just sore arm mild headaches, body aches lasted 2 - 3 days. 2nd dose had not in arm, sore ...
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1st dose just sore arm mild headaches, body aches lasted 2 - 3 days. 2nd dose had not in arm, sore arm hot for about a week, mild headaches, body aches, diarrhea, chills out of breathe, fatigue - but no temp. This has being going on and off for last 2 weeks. Just had diarrhea on 1/25/21 again with chills, fatigue, little out of breathe, mild headache. 1/28/21 went back to work with chills, mild headache, out of breathe but no temp. 97.1 this morning.
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| 58 | 2021-01-27 | seizure |
on Jan 20th, I took my dogs to their grooming appt and stopped at store for a few things. I woke up...
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on Jan 20th, I took my dogs to their grooming appt and stopped at store for a few things. I woke up in store to EMS putting me in ambulance. I asked them what was going on and they said I had a seizure. I had no pre-warning, hit head, right shoulder, and bit lip. EMS took me to Emergency Department. Had labs and head CT, all normal. MD felt seizure was due to vaccine.
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| 58 | 2021-01-28 | weakness |
After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, ...
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After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, and shedding an excessive amount when brushing. She started noticing this about 1-2 weeks after her first vaccine, and it got worse after the second vaccine on 1/7/21 (Pfizer Lot#EK9231). It is an even thinning, no patches of hair loss. She was diagnosed with COVID on 10/7/20 which resulted in hospitalization. Reporting fatigue, continued loss of sense of taste and smell, decreased appetite, and hair loss. Experiencing fatigue and decreased energy, worse in the evening, falls asleep easily when she gets home after work, started when she got COVID.
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| 58 | 2021-01-28 | weakness | Left sided weakness, headache, chills, hypertension (normally hypotensive), bradycardia. |
| 58 | 2021-01-28 | difficulty speaking |
Within 4 hours of vaccine, I had fatigue. By the next morning, I developed fever. Sublingual temp u...
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Within 4 hours of vaccine, I had fatigue. By the next morning, I developed fever. Sublingual temp up to 100.8 but also had chills. I had fever, fatigue, chills, and myalgia that peaked at 33 hours post vaccination. I took multiple doses of 600mg - 800 mg ibuprofen. By 41 hours post vaccination, symptoms had resolved completely. Dose 1 Dec 23, 2020, Lot EH 9899 Laryngitis like illness (cough, phlegm at larynx, hoarse voice) December 29,30, 2020 resolved. + Covid PCR on Jan1, 2021 (frontal headache, fatigue, fever) Delayed dose two until January 27, 2020 I am a pediatrician and I work in an Urgent Care with Covid positive patients. This report is for your tracking purposes. I would have considered seeing a PCP if I were not a physician.
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| 58 | 2021-01-28 | flushing |
flushing, redness, right hand sign of face, ear and right arm 45 minutes post vaccine; took Benadryl...
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flushing, redness, right hand sign of face, ear and right arm 45 minutes post vaccine; took Benadryl; over the course of time, no worsening of symptoms; pt took another Benadryl on advice of visiting nurse about 4 hours after 1st dose
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| 58 | 2021-01-28 | migraine |
Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit...
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Arm pain at injection sight 6 hours later along with swollen glands. Four days later a migraine hit around 2:00 pm and lasted at least 12 hours. Also swollen shoulders and shoulder and back pain. The following week I experienced sudden shortness of breath that last for approximately 10 minutes while I was at work with profuse sweating on my lower back. The shortness of breath occurred agin the next day while working around the home. and lasted about 5 minutes.
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| 58 | 2021-01-28 | pain in extremity |
2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (l...
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2 to 3 hours after the shot was given the area around where the shot was given was extremely sore (level 9). I began taking Tylenol which caused the pain to subside to a reasonable level. I took Tylenol every 6 hours to keep the pain in my arm, which seemed to cause some neck stiffness, down to a 2 or 3 level (10 being the worst pain). The next morning pain was down to 1 or 2 level, I took Tylenol again. By noon the second day pain was gone.
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| 58 | 2021-01-28 | tingling |
Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat...
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Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events. No follow-up attempts are possible; information about batch number has been obtained.
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| 58 | 2021-01-28 | speech disorder, flushing |
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the...
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Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
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| 58 | 2021-01-29 | weakness |
Experienced the typical symptoms described on fact sheet, fever, chills, tiredness, headache, inject...
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Experienced the typical symptoms described on fact sheet, fever, chills, tiredness, headache, injection site soreness, and body aches. My body aches were severe and I had severe episode of my fibromyalgia symptoms to reoccur. I was totally wiped out for a full day (literally stayed in bed) my arms and legs were heavy and hard for me to lift so I was extremely weak; and thus far for today I am still not 100% as the pain is still very noticeable and I?m totally exhausted. Fibromyalgia symptoms are still present and just don?t feel well at all.
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| 58 | 2021-01-29 | pain in extremity |
sore arm, fever up to 102, chills, body aches and pains, severe nausea, vomited x1, stomach cramps, ...
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sore arm, fever up to 102, chills, body aches and pains, severe nausea, vomited x1, stomach cramps, diarrhea x2 - total severe symptoms lasted about 24 hours, but total symptoms lasted 60 hours
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| 58 | 2021-01-30 | weakness, involuntary muscle movements |
Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immedia...
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Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immediately after injection. They sent me to doc on site and applied ice. After 29 minutes symptoms started to subside. By the evening pain moved across back of shoulders blades. Increased headache with chills and alternating fever. Could not sleep due to pain. Next morning,today. Had abdominal pain cramping and diarrhea. Unable to sit up or walk much due to weakness and feel will pass out.
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| 58 | 2021-01-30 | weakness |
The nxt morning of vaccination on 1/9/2021 when I woke up I started feeling leg muscle pain, ankle p...
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The nxt morning of vaccination on 1/9/2021 when I woke up I started feeling leg muscle pain, ankle pain, I felt very very tired, very weak I could not due my normal activities, I also had a headache & chills. The first 2 days where the worst I could not do anything but all the symptoms lasted about a week.
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| 58 | 2021-01-30 | unresponsive to stimuli |
After being observed for approximately 20 minutes and patient walked to her car without assistance I...
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After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing. EMS was called as I made my way outside. Upon my arrival patient was leaning out of the car and stating that she could not breath. She was able to tell me that she was allergic to penicillin. Oxygen was immediately placed on the patient with minimal relief. Lung sounds were coarse throughout. She then began to vomit about every 20-30 seconds. Epipen was administered in the right leg with no relief. Patient continued to complain of troubles breathing and vomiting. A second epipen was administered in the patients right arm again with no relief. A few minutes later patient was given racemic epinephrine through the oxygen mask. There appeared to be mild improvement in her breathing as she appeared more comfortable, but still complaining of shortness of breath and vomiting. When EMS arrived patient was unable to transport herself to the stretcher. When EMS and clinical staff transferred patient to the stretcher she became unresponsive. She appeared to still be breathing. She did not respond to verbal stimuli. Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance. When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned. At that time patient was found to be in PEA, shock was delivered. Shortly thereafter no cardiac activity was found and patient pronounced dead.
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| 58 | 2021-01-31 | weakness |
Fever up to 102.4, tachycardia to 140, fatigue, chills, pain under left axilla, weakness, generalize...
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Fever up to 102.4, tachycardia to 140, fatigue, chills, pain under left axilla, weakness, generalized body aches
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| 58 | 2021-01-31 | burning sensation |
Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavic...
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Jan 31, 430 pm - Red splotches front part of neck, chest, shoulders. A red welt above Left clavicle, did not itch, but burning sensation. Small node swelling in the clavicle space. Asthmatic flare in the evening and at midnite. Feb 1 - Less redness on skin, but, welt still present. Having chest tightness in the morning and continues as of this report.
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| 58 | 2021-01-31 | discomfort |
Severe pain and swelling in the lymph nodes of the left armpit. Swelling in the area of the vaccine....
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Severe pain and swelling in the lymph nodes of the left armpit. Swelling in the area of the vaccine. The pain started on Friday night and today Monday continues. It has decreased in intensity but I am also having discomfort in the lymph nodes of the right arm and some discomfort in the breasts.
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| 58 | 2021-01-31 | difficulty speaking |
chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received E...
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chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl reports rash at IV site from (Benadryl?) No rash anywhere else. Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time. To follow up with PMD. Headache.
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| 58 | 2021-01-31 | feeling cold |
She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Dia...
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She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.
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| 58 | 2021-01-31 | flushing |
Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administratio...
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Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administration the patient developed itching and a flushed feeling, tingling lips, racing heart rate, and headache. Patient reports these symptoms lasted several hours and then resolved.
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| 58 | 2021-01-31 | migraine, pain in extremity |
sore arm; massive migraine; fever of 102.5; achy body; not feeling well; room spinning; This is a sp...
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sore arm; massive migraine; fever of 102.5; achy body; not feeling well; room spinning; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 16Jan2021 at single dose for covid-19 immunization. The patient's medical history andconcomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EH9199), via an unspecified route of administration at left arm on 26Dec2020 at single dose for covid-19 immunization, after the first dose she had sore arm. The patient received second dose on 16Jan2021 after getting her first one 21 days ago, she had a terrible reaction to the second one and experienced massive migraine, fever of 102.5 degrees Fahrenheit, achy body, not feeling well, sore arm, room spinning, and it has been 48 hours or if this is an adverse reaction, or what is normal. she wants to if that is side effect with the vaccine, her side effects were much stronger after the second dose. She said that she was not sure because the first time she had vaccine she had minor side effect. The patient's fever that is better today (18Jan2021), it is 100 degrees Fahrenheit. She said she still doesn't feel 100%, but her husband who was a dentist, and their friends that were dentists, no one else was having a reaction, and she was not having an allergic reaction, it was just weird. For her fever she took Tylenol. The outcome of the fever was recovering, and the outcome of the other events was unknown. Information about lot and batch number was requested.
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| 58 | 2021-01-31 | pain in extremity | Had Shot on Thursday. My arm is still red and sore. Hot to the touch. Worried it might be infected. |
| 58 | 2021-02-01 | speech disorder, flushing |
felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and...
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felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and speech slowing; Mild cognitive and speech slowing; Felt strange sensation on top of head; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 14Jan2021 04:00 PM (vaccine location: right arm) at single dose for COVID-19 immunisation.The patient's medical history included hashimotos, fibromyalgia, known allergies to sulfa drugs and extreme shellfish. There is no other vaccine in four weeks. The concomitant drug included levothyroxine sodium (SYNTHROID), Amitriptyline, Valsartan, Vitamin D. After about 12 mins from shot on 14Jan2021 04:15 PM, patient felt extremely thirsty. Then spouse noted facial flushing and called an advanced registered nurse practitioner (ARNP) on site to eval. Mild hives on face neck and upper chest developed then. Then increase flushing on face. Mild cognitive and speech slowing. Felt strange sensation on top of head. Self medicated with 50 mg Benadryl capsule. Emergency medical technician (EMT) and ARNP insisted should go to emergency room (ER), in ambulance not with spouse. Other treatment included OTC ongoing Benadryl and Pepcid. The outcome of events was recovered in Jan2021. Information on the batch number has been requested.
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| 58 | 2021-02-01 | unresponsive to stimuli |
Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfa...
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Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfast around 8:45 am. Housekeeper reported seeing resident between breakfast and time found unresponsive. Resident had voiced no complaints. Code was initiated until EMS arrived and transported resident to hospital. Resident expired.
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| 58 | 2021-02-02 | feeling hot |
About 2hr after the shot I got light headed, dizzy and hot. I got my bp taken of 173/100 and I sat ...
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About 2hr after the shot I got light headed, dizzy and hot. I got my bp taken of 173/100 and I sat for a while to see if it would go down being monitored by 2 NPs in the office. The BP remained elevated for a while and after about 2hrs it came down. I developed a headache that got more profound over time but the dizziness and feeling of being hot left and about 5hrs the headach left and I felt better. Went to work the next day feeling a little better but got a massive headache so I took some advil and after about 4hrs it finally let up. The next day I got a slight headache but it left after about an hour and hasnt had anymore symptoms since.
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| 58 | 2021-02-02 | flushing |
Patient c/o dizziness, flushed feeling, and syncope 10 min post-vaccine. Hx of same related to vacci...
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Patient c/o dizziness, flushed feeling, and syncope 10 min post-vaccine. Hx of same related to vaccines/venipuncture in past. Epi-pen given prior to obtaining vasovagal syncope hx. Patient awoke and symptoms improved.
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| 58 | 2021-02-02 | pain in extremity |
Night of vaccine had right leg pain from hip to ankle. On 12/22/2020 knee began to stiffen and swell...
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Night of vaccine had right leg pain from hip to ankle. On 12/22/2020 knee began to stiffen and swell while leg pain subsided. Knee swelling and pain continued for next week.
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| 58 | 2021-02-03 | feeling cold |
Received Shot at 9 am worked all day and was fine. Arrived home at 5:30pm same day had chills and Ac...
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Received Shot at 9 am worked all day and was fine. Arrived home at 5:30pm same day had chills and Aches all over and couldn't get warm (teeth chattering cold) also having dinner and couldn't eat much and was burping up dinner but never got sick. then the fever hit around 7pm 99.9 then elevated and through out the night took temperature. The highest got to 102.7. Had bad stabbing pains in the top of my head. Didn't take anything until 9 am next day was trying not to because they said if you can hold off so finally I couldn't take it anymore and I took 1000mg Tylenol. It helped, my fever is lower now 11:50 am but still not feeling well and have a slight headache.
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| 58 | 2021-02-03 | pain in extremity |
sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female p...
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sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EH9199) via an unspecified route of administration in left arm on 26Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown.
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| 58 | 2021-02-04 | weakness |
Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospita...
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Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospitalized on 2/3 @ 11:30 am on 2/3/2021 2/5 @ 4 :30 pm Primary Care visit @ 3:30 pm on 2/5/2021
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| 58 | 2021-02-04 | migraine |
2/1 awakened with multiple fingers swollen and painful middle joints only. Sausage fingers. This inc...
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2/1 awakened with multiple fingers swollen and painful middle joints only. Sausage fingers. This increased in severity I took nsaids topical steroids Saw rheumatologist who ordered prednisone snd multiple lab tests. Suspect autoimmune reaction triggered by vaccine in some way. Also have migraine
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| 58 | 2021-02-05 | feeling cold, tremor | Headache , shaking a lot , to cold (my body) |
| 58 | 2021-02-05 | tingling |
Two hours after injection severe soreness, next day loss of range of motion, persistent pain around ...
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Two hours after injection severe soreness, next day loss of range of motion, persistent pain around shoulder, radiating pain down arm and tingling in fingers which continues into sixth day. Unable to sleep, loss of appetite, taking Tylenol prn, was taking Motrin prior.
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| 58 | 2021-02-08 | weakness, tremor | fever, weakness, chills, shakiness, body aches |
| 58 | 2021-02-09 | weakness |
Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost abi...
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Pfizer COVID vaccine, symptoms still evolving and mimic COVID but negative COVID test. Have lost ability to walk without a walker, severe weakness, fatigue, dizzy, distortion in hearing, metellic taste, body aches and joint pain, intermittent headache and nausea. No fever no cough.
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| 58 | 2021-02-09 | pain in extremity, numbness, tingling |
Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbn...
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Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
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| 58 | 2021-02-09 | tingling |
2/8/21 -10:00am patient noticed tingling in all ten fingers. Pt. denies taking anything for it. Pt. ...
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2/8/21 -10:00am patient noticed tingling in all ten fingers. Pt. denies taking anything for it. Pt. states that symptoms are improving.
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| 58 | 2021-02-10 | migraine | Migraine headache, body & muscle aches, fever, insomnia |
| 58 | 2021-02-11 | pain in extremity, tingling |
Patient developed tingling/pins and needles twenty minutes after receiving first COVID vaccine. This...
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Patient developed tingling/pins and needles twenty minutes after receiving first COVID vaccine. This lasted about 30 minutes. Her legs ached and she had difficulty walking the next am (1/7/21). Patient usually takes the steps at work, but had to take steps 1/8/21 due to pain and generalized difficulty walking. On 1/9/21 patient was exhausted. Was standing on the bed of the truck and could not lift leg over tailgate. She also fell that day. She steadily improved beginning 1/10/21 until she was back to normal 1/17/21. MD advised that she could not get second vaccine.
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| 58 | 2021-02-13 | numbness, tingling, pain in extremity |
My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI...
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My right arm has been extremely painful ever since. To date I have been to 4 Dr's. I have had a MRI, steroid injections, 4 medications. All with no relief. My arm shoots numbess feeling, tingling, tightness from shoulder to fingertips. It is getting worse. I am unable to do my job and household work.
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| 58 | 2021-02-14 | discomfort |
Developed a lump in left axilla(lymph node?) about golf ball sized. Lasted about 24 hours before beg...
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Developed a lump in left axilla(lymph node?) about golf ball sized. Lasted about 24 hours before began to resolve. Over next 48 hours resolved completely. Extreme discomfort!
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| 58 | 2021-02-15 | difficulty speaking |
Pt reported feeling symptoms approx 10 minutes after receiving injection. She complained of mild sho...
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Pt reported feeling symptoms approx 10 minutes after receiving injection. She complained of mild shortness of breath and "itchy throat." She was questioned about having any other symptoms and immediately escorted to the medical attention tent. She was seated, and EMS began evaluation; her vital signs were taken: RR 22, HR 82, BP 156/102, PULSE OX 98%. She then reported an increase in symptoms, as face itching, increased tightness in her throat. Objective symptoms observed by myself and EMS: cough/clearing of the throat, increased SOB/labored breathing, facial erythema, hoarseness. EMS asked for her consent to give her Benadryl and Epinephrine. She repeatedly refused this, and refused any attempt at IV placement. She eventually agreed to IM Benadryl, of which 50mg were administered by EMS. Both EMS and I suggested more than once that she allow us to transfer her to the hospital for further management and preparation in the event that she needs further care. I explained that she was having symptoms of anaphylaxis. She repeatedly refused transfer. She reported a decrease in symptoms, saying she felt well enough to go home. Her objective symptoms observed by myself: continued hoarseness and clearing of the throat. VS were repeated: RR 18, HR 68, BP 160/98, PULSE OX 99%. Airway remained patent and clear. Patient again requested to leave, and agreed to EMS escorting her to her car.
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| 58 | 2021-02-15 | feeling hot | muscle aches; joint aches; tired; chills; hot spells; stiff muscles |
| 58 | 2021-02-15 | numbness, tingling | Numbness and tingling in hands, legs and face. |
| 58 | 2021-02-16 | weakness |
The morning after 2nd dose of Pfizer. I was weak and actually couldn't get my legs to go forward the...
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The morning after 2nd dose of Pfizer. I was weak and actually couldn't get my legs to go forward they gave out and I was on the floor unable to get back up on my own without staff assistance. I was very sweaty very dizzy and disorientated. not knowing who was around me. I had pain at injection site, no headache no body pain. Very tired slept took tylonal.
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| 58 | 2021-02-18 | weakness |
Patient developed extreme fatigue 2 days following the COVID vaccine which caused a clinical relapse...
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Patient developed extreme fatigue 2 days following the COVID vaccine which caused a clinical relapse of MS. No new radiographic lesions, but patient was/is much weaker than baseline.
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| 58 | 2021-02-18 | tingling |
Everything was good the first day. The next morning, I had severe chills that lasted about 6 hours. ...
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Everything was good the first day. The next morning, I had severe chills that lasted about 6 hours. During that time, I started getting a temp, the highest was 103.3. I called my doctor and she seemed convinced that it was something else because she hadn't seen that reaction before. I then had developed a headache. The fever took several days to go away. My doctor (via phone) told me to take Tylenol. I also had tingling in my right hand, extreme fatigue, joint stiffness and swollen lymph nodes, which remained swollen for at least a week. I was in bed for over 24 hours. It eventually started it get better after a few days. I also had an antibodies test before I got the vaccine and two days later I found out I had positive antibodies--and this was 6 months later (I had COVID in July). I had the same reaction with Dose 2.
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| 58 | 2021-02-21 | migraine | soreness at injection site. then a mild migraine the following evening. |
| 58 | 2021-02-21 | pain in extremity |
The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and ...
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The first symptoms was pain in the injection site. Then felt pain traveling down to my left arm and fingers. I was told I was only to stay 15 minutes after the shot. On my way home from the vaccination about 30 minutes after the shot, I felt sick. I had a rapid heart rate and itch red hives on my left chest and left palm of my hand. My husband stopped along the road and gave me benadryl. I still had hives the next day. On the third day I had vaginal spotting and I am in menopause and I had extremely bad pain in my left hip, left thigh and left buttocks for 2 weeks. I could not sit or stand up to get relief. I cried with pain and thought I would never recover. I visited a urgent care and he suggested I see a neurologist for the pain. I was tested for covid at that time and was negative. I went to an allergist to see if I am allergic to the PEG in the vaccine. I am not allergic to the compound. She believes my body had a very strong immune response to the vaccine which caused all the symptoms described above. All symptoms were strictly limited to just the left side of my body. I do not know what to do about taking the second dose because I am afraid it will be worse.
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| 58 | 2021-02-23 | feeling hot |
Patient felt warm and lightheaded upon standing. Walked with assistance to lie down on a cot in the ...
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Patient felt warm and lightheaded upon standing. Walked with assistance to lie down on a cot in the patient care tent. BP: 128/70, P: 90, Resp: 17. Patient drank some water and ate pretzels while sitting and denied dizziness after 20 minutes of sitting up. Patient left the building feeling well and denied any dizziness.
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| 58 | 2021-02-23 | flushing, pain in extremity |
Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort wi...
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Within a few minutes of vaccination, flushing/sweating, throat swelling to a level of discomfort with swallowing. I took 1 Benadryl and then another 15 minutes later, then drove home once rxn seemed to stabilize. Took 2 more Benadryl through the course of the evening as flushing stopped but still had throat discomfort and new headache. Also took Tylenol. In AM, allergic symptoms were resolved, but had significant arm pain (upper arm around site was very firm and warm to the touch), mild headache, moderate fatigue, and diarrhea. This continued for another 24 hours. Took Tylenol 3 times. Felt fine by Wednesday (2 days after vaccination).
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| 58 | 2021-02-23 | pain in extremity, numbness, tingling |
had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that...
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had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago. The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious. Information on lot/batch has been requested.
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| 58 | 2021-02-25 | feeling hot |
Fatigue, body aches, joint pain, feeling overly warm accompanied by sweating on face, headache, diar...
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Fatigue, body aches, joint pain, feeling overly warm accompanied by sweating on face, headache, diarrhea, mostly FATIGUE
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| 58 | 2021-02-25 | migraine |
continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneou...
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continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneous report received from a contactable consumer (patient's husband). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history concomitant medications were not reported. It was reported that the patient got the COVID-19 shot in the morning of 25Jan2021 (yesterday) which developed into a migraine headache that has done nothing but gotten worse and on 26Jn2021, she had continued vomiting. The reporter asked if these were normal and how long will these last. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 58 | 2021-02-25 | pain in extremity, feeling of body temperature change, muscle spasms |
After the second vaccination employee experienced minor symptoms on day 1 and day 2 with headaches, ...
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After the second vaccination employee experienced minor symptoms on day 1 and day 2 with headaches, feeling hot/cold alternating, arm pain, muscle aches. Day 3-5, employee became more sick with mild intermittent chest pains, extreme exhaustion, muscle aches and spasms, dizziness, headaches, feeling hot and cold alternating, but no fevers noted. Day 7, employee started to feel better, but symptoms continued with fatigue which persisted for a several days until she was back to baseline
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| 58 | 2021-02-26 | weakness | Weak, dizzy, nausea, shoulders ache, cleared by medics |
| 58 | 2021-02-27 | numbness |
Numbness in face 10 minutes after injection. This lasted 15 minutes but has returned intermittently ...
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Numbness in face 10 minutes after injection. This lasted 15 minutes but has returned intermittently since vaccination. Intermittently have had some rashes and itching on neck and torso.
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| 58 | 2021-02-28 | flushing | Dizziness, sweating, flushed followed by Syncopal episode, EMS called |
| 58 | 2021-02-28 | pain in extremity |
I received my 2nd dose of COVID 19 vaccine at around 1 p Thursday afternoon. Saturday around noon m...
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I received my 2nd dose of COVID 19 vaccine at around 1 p Thursday afternoon. Saturday around noon my arm started to itch a little and when I scratched it there was a large hard lump a little bigger than a golf ball under my skin. The skin was mildly rashy in appearance. It was red and warm to the touch. The affected area was approximately 3 inches below the injection site. The lump got smaller on Sunday and is smaller today. It is still red, warm to the touch, and sore when I rub over it. I did not seek medical treatment wanting to observe the area first. Since the lump has gotten smaller I will continue to observe it. I was advised by a friend who is a nurse that if it gets larger to seek medical treatment. That will be my plan.
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| 58 | 2021-02-28 | tingling |
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT1...
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This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration by injection once to left arm, upper part, on 26Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient experienced tingling on right side by cheek bone on 27Jan2021 and she did not have it yesterday, and the shot was on the left side, later clarified as the left arm. The outcome of the event was not recovered.
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| 58 | 2021-03-01 | migraine |
Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it fel...
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Broke out it a hot rash the first night. Both my knees exhibited excruciating pain to where it felt I was having knee surgery without anthesis nothing helped with the pain. General aches through out whole body settling in the joints. Fatigue, migraine headache, loss of smell on and off through day. Loss of appetite on and off. Injection site has a large redden area warm to touch approximate size of a silver dollar if not bigger, lymph node under left arm pit is swollen and sensitive to the touch, movement aggravates the arm pit. Evening time body breaks down in an allergic rash.
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| 58 | 2021-03-02 | weakness, feeling hot |
After about 10 minutes I felt a wave of heat wash over me. Then I felt brief light-headedness and be...
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After about 10 minutes I felt a wave of heat wash over me. Then I felt brief light-headedness and begin experiencing shortness of breath. The shortness of breath would intensify and then abate but not like a panic attack it was directly related to the shot. After about 20 minutes is subsided 9 days later I still feel weak and fatigued. There was no emergency rescue precautions available for me had at the site had the situation worsen 3 weeks prior I had The first shot of my shingles vaccination.
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| 58 | 2021-03-02 | weakness |
slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a s...
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slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9262 and expiry date unknown, via unspecified route of administration at the left arm on 28Jan2021 11:15 at single dose for Covid-19 immunization in a hospital. Medical history included high blood pressure, depression, asthma, wheat allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lisinopril, paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), cyanocobalamin (VIT B12), ergocalciferol (VIT D); all from unspecified date for unspecified indication. The patient previously took amoxicilin, morphine, vicodin; all experienced drug allergy. Historical vaccine included first dose of BNT162B2 lot number EH9899 at the left arm on 07Jan2021 11:15 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 19:00, the patient experienced chills, fever 103.8 (temperature), weakness, headache, until 30Jan2021 6:30 am. Then again, on 30Jan2021 11 pm, the patient experienced fever, chills headache until 6:30 am. On 30Jan2021, the patient experienced arm redness at injection site. On 31Jan2021, the patient continued to experience redness and slight swelling (injection site). The patient has the patient been tested for COVID-19 since the vaccination. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
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| 58 | 2021-03-02 | unresponsive to stimuli, weakness |
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotens...
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Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe
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| 58 | 2021-03-03 | weakness |
zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous...
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zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318), via an unspecified route of administration single dose arm left on 29Jan2021 09:00 (at the age of 58) for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced zapped of energy on 31Jan2021 16:00, chilled on 31Jan2021 16:00, body aches on 31Jan2021 16:00, mild sore throat on 31Jan2021 16:00, slept about 15 hours on 31Jan2021 16:00. No treatment administered. The events outcome was recovered.
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| 58 | 2021-03-03 | breast pain | Right Under arm Lymph node and right breast discomfort/ pain |
| 58 | 2021-03-03 | pain in extremity |
Having severe left arm pain which is affecting activates of daily living. Site of injection is not ...
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Having severe left arm pain which is affecting activates of daily living. Site of injection is not red or swollen, but I cannot lift my arm or sleep on my left side without pain. I have been treating with acupuncture and advil.
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| 58 | 2021-03-04 | feeling cold |
Heart palpitations, very cold feeling, chills. Wore full winter clothing in my house and while sleep...
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Heart palpitations, very cold feeling, chills. Wore full winter clothing in my house and while sleeping with blankets and a space heater
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| 58 | 2021-03-04 | numbness |
History of HTN, left-arm numbness, and ipsilateral dilated (blown) pupil about 2 minutes post vaccin...
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History of HTN, left-arm numbness, and ipsilateral dilated (blown) pupil about 2 minutes post vaccine. Transported to ED. Patient left the ED without treatment.
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| 58 | 2021-03-04 | nerve pain |
herpes zoster recurrence--typical neuropathic pain in right abdominal region. As I'm a physician who...
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herpes zoster recurrence--typical neuropathic pain in right abdominal region. As I'm a physician who is immunosuppressed and have experienced this previously and had valtrex on hand, I started it immediately and the pain resolved within three days. No rash developed due to rapid treatment.
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| 58 | 2021-03-05 | cold extremities |
Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, ...
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Severe body aches at joints, headache, fever of 103, BP 197/110, heart rate 100-110, dizzy, nausea, difficulty focusing eyes. Aches started at 6:30 am. High heart rate noted at 10:00 am. The rest came on in the afternoon. Took my vitals when I got home from work (7 pm). Chills, cold extremities through the night. By 5am, temp down to 100. By noon next day, BP and HR normal. Dizziness still comes and goes.
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| 58 | 2021-03-06 | pain in extremity | Dizzy, nauseous, fever, headache, arm pain, feeling unwell. Went back to bed to rest- so far. |
| 58 | 2021-03-07 | migraine |
felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Simila...
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felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time. These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering. Information on the lot/batch number has been requested.
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| 58 | 2021-03-07 | pain in extremity |
big bump that came on her right thumb/ It is on the hand right below the thumb where there is a norm...
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big bump that came on her right thumb/ It is on the hand right below the thumb where there is a normal bone, but on the side of the thumb it is enlarged./ she has a bump on her bone on the bottom of her thumb that is on the same arm as the vaccine; arm pain the next day and sore while sleeping the night of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown), via an unspecified route of administration on 22Jan2021 at 01:30 (age at the time of vaccination was 58-years-old) on right arm at single dose to prevent from getting COVID. Medical history was none. The patient reported that, she is calling because she had her vaccination for COVID on the 22Jan2021. She has a big bump that came on her right thumb. She doesn't know if that is side effect. It is on the hand right below the thumb where there is a normal bone, but on the side of the thumb it is enlarged on 22Jan2021. She works in health facility. she is on two medications. One is a topical medication. The reporter did not provide the medication names. She doesn't think it is relevant. History of all previous immunization with the Pfizer vaccine considered as suspect were one. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No adverse event requires a visit to Emergency Room or Physician Office. No Prior Vaccinations (within 4 weeks). The patient stated that she has a bump on her bone on the bottom of her thumb that is on the same arm as the vaccine she reported arm pain the next day and sore while sleeping the night of the vaccine on 22Jan2021. she wanted to know if this is a side effect. Potential duplicate AE. She was provided information from the attached documents and referred her to HCP. The outcome of the event was not recovered.
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| 58 | 2021-03-08 | weakness |
Patient received second dose of Covid 19, Pfizer, at 8:10 am. Stated she was doing fine and left the...
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Patient received second dose of Covid 19, Pfizer, at 8:10 am. Stated she was doing fine and left the Clinic. At approx. 8:14 ambulance was called to truck stop. Patient was having weakness, shortness of breath and tongue swelling. Patient brought to Emergency Room. See enclosed notes.
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| 58 | 2021-03-08 | pain in extremity | Sore arm and headache for 24 hours |
| 58 | 2021-03-09 | cold sweat |
I began feeling cold sweats and very tired that evening a few hours after taking the vaccine. Durin...
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I began feeling cold sweats and very tired that evening a few hours after taking the vaccine. During the night, I began having a severe headache, body aches, extremely lethargic and continued being feverish with sweats. I basically slept the next 2 days as These symptoms lasted in their severity until Friday, February 26th. I continued with a headache and lethargy until Saturday February 27th and finally felt better by Saturday evening and was 100% back to normal by Sunday. I missed 3 days of work dealing with the response to the vaccine but would do it all over again as I work as medical support and fully support the vaccines.
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| 58 | 2021-03-09 | feeling hot |
A few minutes after vaccine- patient felt light headed in the lobby. She did not feel well and got ...
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A few minutes after vaccine- patient felt light headed in the lobby. She did not feel well and got hot and felt like she was going to pass out. Patient did pass out while sitting in chair. She came back alert and felt much better. THe patient stayed in the lobby for a bit until she felt ok
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| 58 | 2021-03-09 | feeling jittery |
Dizzy/ Lightheaded Vitals: B/P: 140/70 HR: 77 Resp.: 14 O2Sat: 99% Skin signs: Warm and dry Circulat...
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Dizzy/ Lightheaded Vitals: B/P: 140/70 HR: 77 Resp.: 14 O2Sat: 99% Skin signs: Warm and dry Circulation: Cap refill <2sec Treatment: Pt placed in supine. States she still feels dizzy but room not spinning. Had patient sit up, no noted increase or decrease in symptoms. LOI 2 hours. Toast with peanut butter. No Hx of anaphylaxis. @ 11:30 pt states she feels "jittery" Repeat Assessment @11:32 Vitals: B/P: 134/70 HR: 68 Resp.: 14 O2sat: 98 % Skin signs: Cool/ dry Resp.: No noted increase in effort AOx4 Cap refill <2sec Treatment Pt remained supine. Pt states gradual return to normal. Vitals stable. Repeat Assessment @11:47 Vitals: B/P: 121/82 HR: 69 O2sat: 97%
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| 58 | 2021-03-09 | numbness | Numbness in center of face numbness tongue dry eyes dry mouth restless leg |
| 58 | 2021-03-09 | pain in extremity |
Pain in left arm from shoulder to elbow. Can?t lift arm above head or behind back without intense pa...
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Pain in left arm from shoulder to elbow. Can?t lift arm above head or behind back without intense pain.
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| 58 | 2021-03-10 | feeling hot, flushing | warm feeling, flushing. Evaluated by EMS-Cleared |
| 58 | 2021-03-10 | numbness |
15 minute waiting period I had no events, but 20 minutes after receiving vaccine I had metal taste i...
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15 minute waiting period I had no events, but 20 minutes after receiving vaccine I had metal taste in mouth on right side along with numbness on right side of face, right jawline, ear area, and small portion of tongue. No pain. No swelling. The metal taste dissipated in approximately 1/2 hour but numbness lasted until evening. By next morning, all symptoms were gone.
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| 58 | 2021-03-10 | pain in extremity |
I could not move my right side from neck to finger tips by 5:30 p.m. I have never been in more pain ...
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I could not move my right side from neck to finger tips by 5:30 p.m. I have never been in more pain in my whole life. It was difficult to do anything and laying down hurt the most. This has been 8 nights now that I cannot sleep through the night because I wake up with shooting pains in my shoulder blade/shoulder/arm area. Even with ipruprophen and/or Tylenol - the pain still comes back. As of yesterday, I can use my arm better as the day goes by but lifting my arm over should height is extremly difficult and painful without the assistance from my other hand. I believe this is called a Shoulder Injury Related to Vaccine Administration. I writhed with pain the first night and got no sleep. I took 2 days off of work and even working today is difficult to write on the board, lift things or reach higher than my shoulder. Even last night I woke up 4 times because of the pain. I couldn't get back to sleep for about 1 hour each night since this happened 8 nights ago. When I visited my Doctor 2 days ago, she said maybe it was Shoulder Injury Related to Vaccine Administration. She said to come back for another visit if the pain lasts for a few more days. Physical Therapy, Steroids or ? I just want to be able to sleep, be able to dress myself and to wash my hair without pain.
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| 58 | 2021-03-10 | tenderness, pain in extremity |
Slight shortness of breath lasting 15-20 minutes occurring 2 hrs. after injection Joint stiffness/...
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Slight shortness of breath lasting 15-20 minutes occurring 2 hrs. after injection Joint stiffness/soreness early next morning in limbs, with need to stretch, resulting in muscle soreness, lasted 2 hrs . Subsided after sleeping 1-2 hrs. (Possibly attributable to MEcfs symptoms, similar symptoms in past) Injection site stiffness/soreness during movement, early next morning, lasting 1-2 hrs (same time frame as above). Experienced no side effects with initial injection other than very slight tenderness to touch night of injection
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| 58 | 2021-03-10 | tremor | Tremors, Itching, Tongue feeling numb, |
| 58 | 2021-03-10 | tremor |
Racing heart, dizzyness, shaking, heavy breathing.... Sort of like an anxiety attack. Started abou...
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Racing heart, dizzyness, shaking, heavy breathing.... Sort of like an anxiety attack. Started about 35 minutes after shot Directly after shot I felt a rush of blood and felt uneasy. They watched me for about 20 minutes but the severe symptoms started about 35 minutes after shot
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| 58 | 2021-03-13 | weakness, pain in extremity |
Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, naus...
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Day of, severe arm pain which was gone the next day. However, on 3/11/2021 woke with headache, nausea, all over muscle and joint pain, weakness. By mid day, eyes were irritated and sensitive to light. By 5:00, fever, chills, muscle aches, headache, joint pain, nausea, rapid pulse rate when walking. Symptoms lasted 3 days. On 4th day, no fever or chills but still painful headache and some muscle/joint pain and weakness.
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| 58 | 2021-03-13 | weakness |
Approximately 12 ours after the injection I was awoken with chills, and malaise, then felt tightenin...
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Approximately 12 ours after the injection I was awoken with chills, and malaise, then felt tightening around my back and abdomen and then started vomiting, dry heaves as if my stomach was cramping into knots. By morning , the nausea and vomiting continued and I had asked my health care provider to order Zofran. The Zofran helped , but I continued with some stomach cramps and general flu like symptoms for a total of about 48 hours. . My temp ranged from 100.3-102.4. After my symptoms subsided, I was still feeling weak enough that I was glad I did not have to go to work. It was probably after 3-4 days that I felt up to going to work.
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| 58 | 2021-03-13 | burning sensation |
About 2 days after vaccine my arm developed a red rash, not raised, just within the tissue . Oval in...
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About 2 days after vaccine my arm developed a red rash, not raised, just within the tissue . Oval in shape and slight spread down bicep area . Not itchy, but a slight warm as well as slight burning sensation. 5 days later still present but slowly disappearing.
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| 58 | 2021-03-13 | pain in extremity |
Arm was extremely sore for 24-48 hours. Aching from shoulder to below elbow is still present now ov...
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Arm was extremely sore for 24-48 hours. Aching from shoulder to below elbow is still present now over two weeks later - worse if I sleep on it. On Mar 3 both arms went completely limp and then discomfort/pain in upper back/neck area. Also became slightly nauseous and light headed. On Mar7 the exact symptoms happened again. I went to emergency room. Was also sent to a Cardiologist. So far nothing extreme has shown up. Mar 14 I had similar pain/discomfort in upper back/neck, but no limp arms. I'm advised to see a Neurologist, but am worried I won't get there before my next shot on Mar 18.
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| 58 | 2021-03-14 | bell's palsy | Bell's Palsy |
| 58 | 2021-03-14 | burning sensation, tingling |
She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her h...
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She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her head; She noticed burning and tingling on the left side of her head; Shingles was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) via unknown route of administration on 12Jan2021 14:00 PM at single dose in left arm for COVID-19 immunization at nursing home. Medical history included ongoing high blood pressure. Ongoing concomitant medication included metoprolol orally at 50 mg, once a day taking for 10 years and hydrochlorothiazide orally at 25 mg, once a day taking for 3 years both for high blood pressure, mecobalamin (B12) orally at 1000 ug, once a day taking 6 years for low b, colecalciferol (D3) orally at 100 ug, daily (50mcg; take two daily by mouth) taking for 6 years for low d. Patient received the first dose of the Pfizer covid vaccine on 12Jan2021 and her second dose was scheduled 02Feb2021. She had symptoms of shingles last Sunday on 29Jan2021 and was given famciclovir and was advised to not take the scheduled second dose of the vaccine. The next time that the vaccine will be given in their facility is on 22Feb2021-23Feb2021, and she wants to know if she can get the vaccine despite having shingles. However she came down with shingles. Adds she is being treated with Famciclovir 50mg; take three times daily by mouth. Her doctor recommended she not get the next dose of the Pfizer COVID 19 vaccine on 02Feb2021 so she stayed home and did not get it. Should she get the second dose? She noticed burning and tingling on the left side of her head in Jan2021 and then shingles on 29Jan2021 on the left eyebrow and hairline. Also shingles was reported as worsened in 2021. Adverse events required a visit to physician or ER was reported as Urgent care but not to the hospital. No Prior Vaccinations (within 4 weeks). The outcome of events shingles and condition worsened was not recovered, while for other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-03-14 | migraine |
Migraine headache, severe body ache pain, runny nose, swollen glands in the neck, arms, legs, feet, ...
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Migraine headache, severe body ache pain, runny nose, swollen glands in the neck, arms, legs, feet, and hand swelling.
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| 58 | 2021-03-15 | weakness | Chills,headache,diarrhea,nausea,tired feeling,weak |
| 58 | 2021-03-15 | involuntary muscle movements, muscle twitching, hot flush, weakness |
-1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chip...
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-1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chips,- ended up treating with ondansetron 2- 5 mg doses-no appetite for at least 4 days and resultant weight loss of 6-8 lbs -balance impaired, vision blurred about 12 hours after-lasting 12 hours -confusion from about 12 hours post vaccine until 24 hours post vaccine -weakness, and hand and leg diskinesia about 12 hours after -lasting 12 hours -sore throat, phlegm 48 hours after for 12 hours -hyper alertness and unable to sleep almost 48 hours -twitching during sleep (throughout body, arms and legs) and in evenings which lasted 6 days, slowly abating over time -headache -multiple hot flashes 3-4/hour first 2 days mostly at night, way more than I normally have (I usually have 2-3 a night and 1-2 during the day-4 days/week) Shot on 2/8/21 and finally felt back to normal, resumed all normal activities including exercise 2/14/2021
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| 58 | 2021-03-15 | pain in extremity, weakness |
I had a headache on 3/10 throwing up 3/11 muscle pain, chills, joint pain, fever, trouble breathing,...
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I had a headache on 3/10 throwing up 3/11 muscle pain, chills, joint pain, fever, trouble breathing, weakness, sore throat, runny nose, left side of throat felt swollen. on 3/12 I felt like the inside of my body arms legs etc all hurt. Tylenol and Hydrocodone didn't help and i was drinking lots of water but vomiting and not peeing a lot. I took meds for my nose and throat but it didn't help. I have weakness still and chills come and go.
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| 58 | 2021-03-16 | numbness | Numbness in face, neck and mouth. Red Rash on face and neck. Dizzy. |
| 58 | 2021-03-16 | numbness | facial and tongue numbness for 1 full day and still feeling it at this time |
| 58 | 2021-03-16 | pain in extremity |
I few hours after I received a shot my arm hurt, within 12 hours right above where I received a shot...
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I few hours after I received a shot my arm hurt, within 12 hours right above where I received a shot waas incredibly painful. I took Tylenol ,it subsided it has continued to hurt since then. If I touch the spot above my shot it hurts worse. When I received a shot it did hurt when she stuck me, but I do have upper arm muscles .I am in shape, no fat on my arm. Some wondering if injecting it into my muscle is the reason why my arm hurts so bad. I compared notes with my friend whose 40 also in shape and his arm hurts like heck also.
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| 58 | 2021-03-16 | pain in extremity |
swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks...
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swollen fingers; joint started hurting; cannot hold fine item; My both hand fingers were drum sticks painful/Fingers hurting, I am cutting and dropping things more frequently; This is a spontaneous report from a contactable nurse (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9899) intramuscularly in the left arm on 26Dec2020 at 08:30 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included migraine from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") were reported as none. The patient previously received epinephrine on an unspecified date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 06:00 the patient experienced swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently. The events all resulted in doctor visits and were all serious for disability or permanent damage. The clinical course was reported as follows: "I developed swollen fingers, joint started hurting. My both hand fingers were drum sticks painful (as reported). I had no idea what was going on, things getting my ankle knees (as reported). I consulted internal medicine; I was referred to Rheumatology Clinic. All blood work was negative. All serology testing done was negative. Joints hurting. The doctor asked me to start taking Motrin which made my situation worse. I gave up. Miserable situation. I consulted another FPC who advised I give it time. I cannot hold fine item. Fingers hurting, I am cutting and dropping things more frequently. I am a healthy person. No medication. No complications." The patient asked if there were any solutions. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN9231) intramuscularly in the left arm on 15Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization. The patient received treatment for the adverse events which included Ibuprofen 400mg for pain. The clinical outcomes of the events swollen fingers, joint started hurting, cannot hold fine item and my both hand fingers were drum sticks painful/fingers hurting, I am cutting and dropping things more frequently were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-03-16 | tingling |
Patient presented with numbness/tingling in mouth, a slight cough. Progressed to become nauseated wi...
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Patient presented with numbness/tingling in mouth, a slight cough. Progressed to become nauseated with tingling down arms and legs. Blood pressures in the 150/90s, HR 86, 98% O2 saturation, and alert/oriented. Patient was placed in a supine position and monitored. EMS was called as symptoms persisted and increased.
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| 58 | 2021-03-17 | weakness |
extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like...
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extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like jelly; felt unsteady & like I would fall; felt so bad/felt awful/talking about end of life wishes; no appetite; chest tightness; This is a spontaneous report from a contactable other health care professional reported for herself. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 09Feb2021 16:30 (at the age of 58-year-old) at single dose in left arm for covid-19 immunization. Medical history included Heart Failure, Sarcoidosis, Asthma, Obesity and Covid from Apr2020 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included prednisone, carvedilol (COREG), spironolactone (ALDACTONE), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The day of injection on 09Feb2021 at 16:30 PM that same night 8 pm the patient started experiencing some chest tightness. Since the patient live in country when she left work(hospital). At that point she took 50mg of P.O. benadryl (diphenhydramine). So the patient just took time and hung around town. She went to family dollar then publix. She felt better at 9 pm so and went home. The next morning (on 10Feb2021 her legs were like jelly when she woke up to go to bathroom. She felt unsteady and like she would fall. Next thing she just felt so bad and no appetite so she ate nothing that day. Her temp started rising and by 2PM on 10Feb2021 it was up to 102.4, the patient felt so awful then the feeling of doom set in so she was talking about end of life wishes. She had Covid back in Apr2020 and it was like reliving it again. On 11Feb2021 she felt better but had to call out low grade 99.4 only she was able to eat some but extremely weak and right shoulder pain (moderate). Friday (on 12Feb2021) she went to work but still felt weak. She felt better over the weekend (Feb2021). Here we were 17Feb2021 and still not completely there but 90% better. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for other adverse event. The patient underwent lab tests and procedures which included body temperature: 102.4 on 10Feb2021, body temperature: 99.4 on 11Feb2021, Nasal Swab Covid-19/SARS: negative on 16Feb2021. The outcome of the events was reported as recovered in Feb2021. Information on the lot/batch number has been requested.
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| 58 | 2021-03-17 | breast pain |
After first vaccine I developed a rash under both arms that was hard pustules and then the skin beca...
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After first vaccine I developed a rash under both arms that was hard pustules and then the skin became very sensitive and my breasts became sore and swollen. I also had swelling under my injection site arm. This almost cleared up before my 2nd vaccine except for the skin sensitivity and swelling under both arms. After the 2nd vaccine 3/3/21 within 48 hours my breasts became very swollen and painful and the under arm sensitivity became much worse. It is 2 weeks since the second dose and my breasts are still slightly swollen and tender. This is hopefully resolving, but was very painful and uncomfortable.
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| 58 | 2021-03-17 | numbness |
Approximately 30 minutes after receiving vaccine patient experienced numbness on the left side of he...
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Approximately 30 minutes after receiving vaccine patient experienced numbness on the left side of her tongue and cheek. This lasted about one hour, but the numbness progressed to her left jaw and left cheek and then her whole head. The next morning the numbness was at the base of her skull and lasted most of the day. All symptoms resolved within 48 hours of the vaccine. On 3/16/2021 patient reported slight numbness of her whole head during the day. This resolved within a few hours.
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| 58 | 2021-03-17 | pain in extremity |
Chest pain, shortness of breath, pain in the left arm, joints , head and neck. She also had itching ...
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Chest pain, shortness of breath, pain in the left arm, joints , head and neck. She also had itching all over, as well as a sore throat. She did not go to the ER. She treated symptoms with Tylenol. Symptoms were intermittent and lasted 2 weeks
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| 58 | 2021-03-18 | cold sweat, numbness, pain in extremity, weakness |
Day 1. 3/10/2021- In the evening my left arm was sore and achy. Day 2. 3/11/2021- In the morning, ch...
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Day 1. 3/10/2021- In the evening my left arm was sore and achy. Day 2. 3/11/2021- In the morning, chills, headache, sweats. Early afternoon in the car I had trouble breathing, cold sweats, chills, coughing trying to breathe. My husband went immediately to the pharmacy to purchase Benadryl and opened the capsules and poured in my mouth along with water as my body became completely limp. At home my husband helped me get to bed and gave me 2 rapid release Tylenol tablets. Day 3. 3/12/2021- In the morning, I felt better until I had a cup of coffee and the chills, sweats, nausea, vomiting and blood pressure started escalating 135/98. I had no previous concerns with blood pressure before the vaccine. I had difficulty speaking (stuttering, confusion and brain fog. I was still so so tired. Day 4, 3/13/2020 - Unable to remain awake after having a sip of water. Blood pressure 150/101 and ate 3 nuggets and body became limp again and unable to walk and husband carried me to bed. (Difficulty speaking and repeating words over and over-confusion). Day 5, 3/14/2020- In the morning, I felt better and my husband gave me a blood pressure pill (Triamterene/Hctz) . I slept most of the day and had no water, no food. I was extremely exhausted and ate in the evening. I had chills, sweats, headache and my body became limp again and husband carried me to bed. Day 6. 3/15/2020- In the morning called Dr. for tele-visit and gave her details of what was happening. I had no food or water and still felt tired. I went to office for lab work around 4:30. I was walking, but extremely exhausted and speech difficulty. Day 7. 3/16/2021 -. In the morning blood pressure was 139/96 - took another blood pressure tablet and had a smoothie and felt much better only chills, no headache. Blood test were normal, and I ate dinner and then chills, sweats, headache and husband helped me walk to bed. After about 30 minutes, legs were movable, but upper body was numb for an additional 30 minutes and then everything seemed fine. I got up and walk around and went back to bed later in the evening. Day 8. 3/17/2021-First day no meds at all, no BP meds, no Tylenol and I was feeling so much better. I ate throughout the day with few symptoms except stuttering and repeating words when speaking. Day 9. 3/18/2021- I spoke with Dr. for appointment on the 19th. I felt stronger and ate breakfast, Lunch and dinner and was feeling normal except for occasional stuttering in speech. Day 10 3/19/2021 - No food in the morning, I visited Dr. at 8:35 for examination and she sent me for ct-scan. Blood pressure was back to normal 122/82 with no meds. I felt fine and later today received normal results from CT-scan. I am hopeful that in the coming days, my speech will completely back to normal.
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| 58 | 2021-03-18 | numbness |
Numbness along the entire length of left arm, back of hand, shoulder (front & back), left side of ne...
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Numbness along the entire length of left arm, back of hand, shoulder (front & back), left side of neck (front, back & side), left side of face, left ear and left backside of head. Noticed approximately 1 hour after injection and continues through this moment.
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| 58 | 2021-03-18 | numbness |
tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, an...
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tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; tip of her tongue, lips, and part of cheek close to her mouth went numb; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 58-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on Left arm on 03Feb2021 15:59 at single dose for covid-19 immunisation administered at state facility. Medical history included Asthma (diagnosed about 5 or 6 years ago, states she has probably had it all her life) and Fibromyalgia (diagnosed about 20 years ago). Historical vaccine includes Shingrix shot on an unspecified date, she did not feel well for a day, she felt sick but then it resolved it. The patient's concomitant medications includes pregabalin (LYRICA) at 250 mg (It is a 50mg capsule, she takes 100mg in the morning and 150mg in the evening) for Fibromyalgia; budesonide, formoterol fumarate (SYMBICORT) at 2x/day (two puffs twice a day) for Asthma and montelukast sodium (SINGULAIR) at 20 mg, 1x/day (once a day). The patient reported that she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. 45-60 minutes after, she felt the tip of her tongue, lips and part of her cheek become numb. She said this went away after 30 minutes. Consumer wants to know what reactions can she expect after she receives the 2nd dose, and if it would be worse than her reaction with the 1st dose. Asking if she should take Benadryl before the second dose. She is asking if she would have more of a problem. States she is an allergic person. She stayed at the facility for 30 minutes. Event occurred while she was driving, she thought if it got worse, she would go to the hospital but then it went away. The patient took covid vaccine for preventive action. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events resolved. Information on the lot/batch number has been requested.
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| 58 | 2021-03-18 | numbness |
Patient started with teeth numbness, tongue numbness, became nauseated. Tongue started swelling, fin...
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Patient started with teeth numbness, tongue numbness, became nauseated. Tongue started swelling, finger numbness. Benadryl was given at 1046.u
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| 58 | 2021-03-18 | night sweats |
5 days after my FIRST COVID shot, I experienced symptoms identical to what others have reported foll...
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5 days after my FIRST COVID shot, I experienced symptoms identical to what others have reported following the second shot: extreme fatigue, headache, achiness, night sweats, and fever. I did have a UTI at the time but I believe the symptoms are unrelated to that. It was a mild UTI and cleared up quickly on antibiotics, while the other symptoms persisted for 3 days.
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| 58 | 2021-03-18 | pain in extremity | FEVER JOINT PAIN HEADACHE BACK PAIN ARM PAIN NAUSEA, same as when I actually had covid back in Nov |
| 58 | 2021-03-18 | pain in extremity |
arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/pu...
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arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/puffed up underneath her arm, thinks is a swollen lymph node; Itchy; restless; seems like she has a rash in her upper chest neck area, neckline; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK9231) via an Intramuscular route of administration on 27Jan2021 at single dose on left arm for covid-19 immunization. The patient medical history included allergies. The patient concomitant medications were not reported. On 27Jan2021, in evening patient was really restless that night because she was itchy. Physician stated that patient has been experiencing some itching, but it seems like she has a rash in her upper chest neck area, neckline. The itching/rash has stayed the same so far. On 28Jan2021, next day morning It was really sore to touch, like when patient was putting deodorant on, its all puffed out underneath her arm that she had the vaccine administer in. It's swollen, but patient thinks its her lymph node. It doesn't feel like its effected any other one, but just that one lymph node. The outcome of the event Itchy, rash was not recovered while outcome of rest all events was unknown.
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| 58 | 2021-03-18 | cold extremities |
Reaction to vaccine similar to historical reaction to flu vaccine. Starting with cold hand and progr...
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Reaction to vaccine similar to historical reaction to flu vaccine. Starting with cold hand and progressing to coughing fit. Patient took medication recommended by allergist. 50mg Benadryl and 2x puffs albuterol inhaler from home.
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| 58 | 2021-03-19 | numbness |
Right hand numbness 5 minutes after vaccine administration, coughing fit 20-25 minutes after vaccine...
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Right hand numbness 5 minutes after vaccine administration, coughing fit 20-25 minutes after vaccine administration that lasted for several hours
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| 58 | 2021-03-19 | tingling |
She had received her first Covid vaccination this afternoon and following that she became dizzy and ...
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She had received her first Covid vaccination this afternoon and following that she became dizzy and had a syncope spell. She tells me that with previous vaccinations this has routinely happened and so it is not different. She was not aware of her surroundings for about 2 minutes after this happened although there was no witnessed jerking or seizure movement. At this point she feels about 90 to 95% back to normal and denies any pain anywhere including in her chest. Initially she had some tingling in her arms although that has resolved.
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| 58 | 2021-03-20 | burning sensation | slight burning sensation R chest. Evaluated by EMS-Cleared. |
| 58 | 2021-03-20 | feeling hot |
Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of m...
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Severe red rash and swelling on right side of the of my face/Spreading gradually to other areas of my face and scalp; Severe red rash and swelling on right side of the of my face; extremely tender and hot to the touch/ very painful; Extremely tender and hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration in left arm at the age of 58-years (non-pregnant at the time of vaccination), on 10Feb2021 at 08:30 AM at single dose (dose number: 1) for COVID-19 immunization. The patient's medical history included alopecia areata and allergy to Xatham gum. Concomitant medication included valsartan at 160 mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. It was reported that on 10Feb2021 at 03:00 PM, "severe red rash and swelling on right side of my face. Extremely tender and hot to the touch. Spreading gradually to other areas of my face and scalp. Very painful". The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received diphenhydramine (BENADRYL) and 20 mg prednisone for 5 days and paracetamol (TYLENOL) as treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-03-21 | weakness |
Unlike first shot, these are different: headaches, diarrhea, sore throat, tired and sleepy lethargi...
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Unlike first shot, these are different: headaches, diarrhea, sore throat, tired and sleepy lethargic, not much energy.
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| 58 | 2021-03-21 | breast pain | Pain in left breast and under armpit |
| 58 | 2021-03-21 | burning sensation |
As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotc...
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As I was driving home my face started to burn like a bad sunburn. When I got home my face was blotchy and my eyes started to swell. I took benedryl and applied a cool pack. Redness and swelling around mybeyes lasted for 2+ days. Still not feeling well and have scheduled a doctor appointment for tomorrow.
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| 58 | 2021-03-21 | hot flush, tingling |
Patient states she had hot flashes and feeling funny, tingling in fingers. Had patient sit. BP monit...
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Patient states she had hot flashes and feeling funny, tingling in fingers. Had patient sit. BP monitored every 5 minutes x 7. Patient states she had not eaten this morning. Patient was given water and a snack, tolerated well. BP 191/93 HR 73 8:50 am, 187/100 HR 69, 188/89 HR 61, 148/87 HR 61,130/64 HR57, 155/80 HR 65,156/90 HR 68 Patient transported to Urgent care Walk in clinic. Reported off to urgent care nurse.
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| 58 | 2021-03-21 | numbness |
Swelling tongue, swelling throat, numbness on face, lips, headache nausea, numbness feet, numbness ...
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Swelling tongue, swelling throat, numbness on face, lips, headache nausea, numbness feet, numbness hands
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| 58 | 2021-03-21 | pain in extremity |
acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pai...
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acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pain; headache; nausea; Severe arm pain; feeling of unwell set in; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, mixed connective tissue disease, COVID-19 from Mar2020. Patient was not pregnant. Patient had no known allergies. Concomitant medications included estrogens conjugated (PREMARIN), tizanidine, hydroxychloroquine, acyclovir [aciclovir], all taken for an unspecified indication, start and stop date were not reported. 4 hours later (28Feb2021 20:30), severe arm pain & feeling of unwell set in. 24 hours later (01Mar2021 16:30) 102 fever, body aches, chills joint pain, headache and nausea for 15 hours and although it improved, patient never felt back to normal. Day 10 (10Mar2021 19:00) patient started having severe abdominal pain, nausea, headache and body pains. Day 11 (11Mar2021) it was worse and day 12 (12Mar2021) patient went to ER and was diagnosed with acute appendicitis and had surgery for appendix removal. Patient feel the vaccine caused this as patient had no issues that would allude to a problem and after receiving the vaccine never felt good. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient was hospitalized for 1 day. Patient had nasal swab: negative on 12Mar2021. Outcome of the events was resolving.
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| 58 | 2021-03-21 | cold extremities, numbness |
Woke up with my feet feeling like they were freezing cold, toes on left foot feeling some what numb ...
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Woke up with my feet feeling like they were freezing cold, toes on left foot feeling some what numb and toes on right foot tingling like they were very cold BUT I WAS NOT COLD. Put feet next to heater, put on socks/shoes, walked around but not much better. Massaged feet often for several hours and around noon they started feeling normal although left big toe and the bottom of my toes still kind of tingly. I'm not a diabetic. My feet didn't feel cold to the touch; even when get next to heater I my feet felt the warmth of the heater but they still felt freezing cold, like the end of a day snow skiing.
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| 58 | 2021-03-21 | tenderness, discomfort |
I woke up Sunday morning (about 40 hours after the vaccine) with pain in my shoulders, clavicle, col...
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I woke up Sunday morning (about 40 hours after the vaccine) with pain in my shoulders, clavicle, collarbone - also had pressure on collarbone, sensitive to touch, and some cough. Pressure and cough have subsided this morning , pain is still present. It hurts once in a while when swallowing and neck area I checked the lymph nodes at hurt some (I examined my neck like a doctor would to feel for possible swollen lymph nodes but can't tell if they are swollen or not). I put "no" under recovered because the pain is still there.
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| 58 | 2021-03-22 | weakness |
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a co...
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faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events. Information on the batch/lot number has been requested.
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| 58 | 2021-03-22 | cold sweat, weakness |
patient became clammy weak and almost fainted after shot she appeared pale and disoriented we call 9...
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patient became clammy weak and almost fainted after shot she appeared pale and disoriented we call 911 and EMT came checked vitals her blood pressure was low and they took her by ambulance to hospital
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| 58 | 2021-03-22 | flushing |
I became flushed and it lasted a few days. it feels like a sunburn from the inside out and it was fr...
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I became flushed and it lasted a few days. it feels like a sunburn from the inside out and it was from the neck up. then I had a tingly tongue and a metallic taste in my mouth. it did NOT swell, it just didn't feel right. has resolved by today 03/23
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| 58 | 2021-03-22 | numbness |
Patient received first dose Pzifer vaccine on 3/2/21. On 3/6/21, patient went to emergency room with...
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Patient received first dose Pzifer vaccine on 3/2/21. On 3/6/21, patient went to emergency room with right side body numbness, wheezing, and high anxiety. She was given nebulizer treatment , prednisone, and an albuterol inhaler. She was tested for covid and flu, and both were negative. She also states that since her dose, she has had "covid arm", which consists of pain at the injection site and hand/lower arm numbness.
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| 58 | 2021-03-22 | muscle spasms |
Patient reported muscle spasms starting 3/14/21 in evening, on 3/17 patient reported a red spreading...
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Patient reported muscle spasms starting 3/14/21 in evening, on 3/17 patient reported a red spreading area on arm below the site of injection. Patient sought medical help that day and initial diagnosis was possible cellulitis.
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| 58 | 2021-03-22 | pain in extremity | Arm pain, headache, fever, chills, body aches, nausea, dizziness, sore throat |
| 58 | 2021-03-22 | pain in extremity |
Severe pain throughout body but especially in the back radiating into right leg Wednesday, Thursday,...
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Severe pain throughout body but especially in the back radiating into right leg Wednesday, Thursday, Friday, Saturday nights to present. Leg weakness Saturday to present.
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| 58 | 2021-03-22 | tremor, numbness | Arm feels dead, heavy, lifeless. Face numb. shortness of breath, shaking |
| 58 | 2021-03-23 | weakness, tremor |
Starting at approx 12 hours after shot, had severe shaking, chills, pain and weakness. THese severe ...
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Starting at approx 12 hours after shot, had severe shaking, chills, pain and weakness. THese severe teeth chattering shakes and chills lasted about 8 hours, the severe weakness lasted about 10 hours and the extreme pain lasted about 10 hours. The pain started in left shoulder and spread and seemed to be lingering in my joints for many hours. After the initial 10 hours the extreme sysmptoms were less, but I had a fever of about 102. The fever lasted about 2 -3 days total with the addition of a headache that came in waves throughout those 2 days. I was somewhat weak throughout that, but by day 3 I was feeling much better. 100% better by day 5. I took some tylenol starting the morning of the 19th at about 10am. Tylenol occasionally for 2 days. 500mg every 4 hrs or 1,000 mg every 6-8 hrs.
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| 58 | 2021-03-23 | feeling jittery |
I received the vaccine and waited the 15 minutes with no issues (just felt a little jittery). I beg...
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I received the vaccine and waited the 15 minutes with no issues (just felt a little jittery). I began the drive home and began feeling some nausea around 10 am. I thought it was because I had not eaten, so I stopped and picked up breakfast (scrambled egg with cheese and bacon). I got home, ate breakfast and then began logging in for work and the nausea grew. Around 11:30 am, I felt tired and the need to lie down, which I did for a while, then around 20 minutes later, I got up to go to the bathroom, feeling like I was going to vomit and have diarrhea. When I stood up, I felt really lightheaded, managed to only remove my pants and then got in the tub where I could lie down. I vomited (once) and had diarrhea for I don't know how long. At some point I was able to sit up and use my handheld shower to rinse off and get back to bed where I slept until about 4:30 pm. No more nausea although I am playing it safe and eating crackers and drinking ginger ale. I feel better now. Not sure it this was related to not eating and taking my antidepressant, food poisoning, or the vaccine. But felt I should report.
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| 58 | 2021-03-23 | numbness |
After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/...
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After about 40 minutes after administration, developed left facial numbness and chest pain rating 2/10. First response called and patient taken to ER for further monitoring.
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| 58 | 2021-03-23 | tingling |
Within 1 minute I felt it run down my arm and my 3 fingers , middle , ring, pinkie finger when ting...
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Within 1 minute I felt it run down my arm and my 3 fingers , middle , ring, pinkie finger when tingling , then I felt it run across my chest and my heart or lungs physically hurt then it went to my head and from the moment on if I turned my head in any direction left or right I would be very dizzy. I could keep my head and vision straight ahead and only felt a distance and had to concentrate very hard .
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| 58 | 2021-03-24 | discomfort |
Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: ...
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Situation: Pt here for covid vaccine #2. After vaccination pt experienced reaction. Background: @ 0815 TEAM ALERT was called to covid vaccine clinic. This RN arrived @ 0818 to find pt sitting in chair in observation room. Received report from RN, pt received covid vaccine #2 and began experiencing cough, clearing throat, runny nose, and chills. Benadryl 25mg PO given @ 0810. Overall discomfort 1/10. 0818: VS: BP 132/98. HR 63. R 14. O2 Sat 98%. Pt c/o clearing throat, chills, coughing, itchy throat, itchy chest. Pt alert & oriented. 0820: overall discomfort 3/10. 0828: VS: BP 124/92. HR 63. O2 Sat 100%. Still experiencing above symptoms plus dizzines, lip numbness and discomfort in diaphragm region. "feels like it won't go down. Like something is stuck there." pt moved to gurney in hallway. 0842: VS: BP 122/86. HR 63. O2 Sat 100%. Pt still feeling diaphragm discomfort. States other symptoms are resolving. Noted pt no longer clearing throat. States lip numbness improved and diaphragm discomfort improving. Pt alert & oriented. 0855: Manager, spoke to pt. Advised pt she may go home when she feels okay. Pt states she feels well enough to go home. This RN advised pt to go home and relax for the remainder of the day, benadryl will make her feel sleepy. Advised pt to watch for symptoms of shortness of breath, difficulty breathing, and chest pain and go to ED if she experiences any of those symptoms. Pt verbalized understanding. VS: BP 118/72. HR 63. O2 Sat 100%. 0857: Pt left covid vaccine clinic ambulatory in stable condition. COVID Vaccine Worksheet 1. Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)? Yes 2. Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol? No 3. Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause? No 4. Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine? No Assessment: Pt had reaction to covid vaccine. Pt reported previous reaction to first dose with similar symptoms. After close observation and benadryl 25mg PO pt symptoms resolved and pt was able to leave clinic ambulatory in stable condition.
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| 58 | 2021-03-24 | flushing |
Client reported feeling flushed shortly after being vaccinated. Described itchy "red blotches", hiv...
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Client reported feeling flushed shortly after being vaccinated. Described itchy "red blotches", hives on face and chest. Client with hx of Lupus and multiple allergies to various medications. Client stated hives resolved after taking Benedryl. Client with no other symptoms or complaints at this time.
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| 58 | 2021-03-24 | hot flush, burning sensation |
Rash on face and body, burning sensation and hot flashes: began the evening after shot and mostly re...
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Rash on face and body, burning sensation and hot flashes: began the evening after shot and mostly resolved by day 4, took Benadryl Mild shortness of breath: began the evening after shot and only lasted 24 hours Severe nausea and diarrhea: developed that evening and better by day 4
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| 58 | 2021-03-24 | numbness and pain in extremities |
1/14 received vaccine. Presented to clinic 1/19 with headache and dizziness. Blood presure at home 1...
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1/14 received vaccine. Presented to clinic 1/19 with headache and dizziness. Blood presure at home 157/80, took an additional 5mg amlodipine and tylenol and came to work. Headache and dizziness returned, BP in clinic 168/90. She ended up taking a leave of absence from work and is currently complaining of neuropathy and headaches, has been referred to neurology.
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| 58 | 2021-03-24 | pain in extremity | fever, chills, headache, arm pain, nausea, tiredness -2 days |
| 58 | 2021-03-24 | pain in extremity |
Intense, chronic pain on my neck, shoulder and upper arm (even if my arm is stationary). Pain exacer...
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Intense, chronic pain on my neck, shoulder and upper arm (even if my arm is stationary). Pain exacerbated when I lift or move my arm.
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| 58 | 2021-03-24 | pain in extremity | Severe arm pain, chills, body aches, severe fatigue |
| 58 | 2021-03-24 | tingling, numbness, pain in extremity |
Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day ...
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Rash all over body, body aches, teeth hurting Right leg numbness tingling swelling pain From day one
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| 58 | 2021-03-25 | weakness, pain in extremity |
Arm still sore,. dizzy, feet and ankles swollen, stomach hurts, all my muscles hurt,. headac...
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Arm still sore,. dizzy, feet and ankles swollen, stomach hurts, all my muscles hurt,. headache,. nausea,. feel tired no energy
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| 58 | 2021-03-25 | pain in extremity, cold sweat |
3/24, 8 a.m. shot 5p, right arm was a little sore 6p, right arm, shoulder, and neck could not move 8...
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3/24, 8 a.m. shot 5p, right arm was a little sore 6p, right arm, shoulder, and neck could not move 8p, massive chills all through the night. 3/25, 6a, clammy, whole body sore, back ache, headache 7a, massive chills again, went back to bed. 11a, then a slight fever all day, stayed in bed 5p, chilled again. laid on couch all day until going to bed 3/26, Morning started out foggy, arm hurts just a bit, by my back aches terrible. Hoping by 3/27, I am back to normal.
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| 58 | 2021-03-25 | throat numbness |
Within a minute or receiving the COVID 19 vaccine I began experiencing tingling and numbness in my l...
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Within a minute or receiving the COVID 19 vaccine I began experiencing tingling and numbness in my lips, tongue, mouth and throat. My throat felt like it was closing or tightening and I had difficulty swallowing. I was administered Benadryl at the vaccine site and then transported by ambulance to the Hospital. There I was given an IV with peptide, steroid and benadryl. After a couple of hours, my symptoms began to improve and I was released. I continued to experience irritation of my tongue and mouth and a sore throat until the next day.
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| 58 | 2021-03-25 | tenderness |
Breast swollen, red and hot to the touch. This is the area where I previously had radiation. Area ...
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Breast swollen, red and hot to the touch. This is the area where I previously had radiation. Area where lymph nodes were removed were sore and tender
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| 58 | 2021-03-26 | flushing | flushed and feeling lightheaded, patient waited extra time and left after improvement. |
| 58 | 2021-03-26 | pain in extremity |
Trouble sleeping during night, achey legs started around 6am and continued throughout day along wit...
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Trouble sleeping during night, achey legs started around 6am and continued throughout day along with some chills, fever of 100.6, headache. Fully better by next morning.
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| 58 | 2021-03-28 | difficulty speaking |
pt states that her ears started itching and became red. She noticed her back, legs, and arms were r...
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pt states that her ears started itching and became red. She noticed her back, legs, and arms were red and very itchy. She says her skins is raised like a rash. Her voice became strange and she lips were swollen. She went to bed and when she got up her lips were more swollen. She took Benadryl for her symptoms and went back to bed. She says she has some itching but feels like she seems to be improving.
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| 58 | 2021-03-28 | facial pain, numbness and pain in extremities, pain in extremity |
slight neuropathy in fingers; Very itchy - almost painful itchy zings in my elbow area, face and leg...
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slight neuropathy in fingers; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Mar2021 11:15 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation at a Pharmacy or Drug Store. The patient has no medical history. The patient has no Covid prior to vaccination. The patient had other medications in two weeks but no other vaccine in four weeks. On 13Mar2021 11:30, the patient experienced very itchy, almost painful itchy zings in her elbow area, face, and legs. The patient also had some slight neuropathy in fingers. This has continued for three days and started immediately after receiving the vaccine. The patient was not tested for Covid post vaccination. The events were not treated. The outcome of the events was not recovered.
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| 58 | 2021-03-30 | pain in extremity |
Patient felt pressure on chest & weakness on inside of left are in the bicep area shortly after gett...
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Patient felt pressure on chest & weakness on inside of left are in the bicep area shortly after getting up at 6 am 3/29/2021. Slight light-headedness was felt shortly afterwards. Symptoms did not change after moving around & on the advice of patient's insurance company's Nurse Line, she went to the Emergency Room shortly after 7 am. Patient underwent a heart catheterization that day (3/29/2021) and a cardiac MRI the following day (3/30/2021). Cardiologist informed patient he suspected either Stress Cardiomyopathy or Myocarditis. Patient was discharged 3/31/2021 with 4 medications and follow-up appointments scheduled
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| 58 | 2021-03-30 | pain in extremity |
sore left arm; chilled; head was throbbing; temperature was 103 but went down a little bit; lighthea...
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sore left arm; chilled; head was throbbing; temperature was 103 but went down a little bit; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore left arm, chilled, head was throbbing, temperature was 103 but went down a little bit, and lightheaded; all in Feb2021. Clinical course: The patient stated that she got the first shot of Pfizer vaccine yesterday afternoon. She stated she had a sore left arm, 2-3 hours ago she got chilled and her head was throbbing. Her temperature was 103 but went down a little bit. She felt lightheaded when she was doing lunches for daycare. She was not lightheaded anymore. She knew that it was normal. She went to check in online but cannot do it right. She took an Ibuprofen 40 minutes ago. The outcome of event temperature was 103 but went down a little bit was resolving, outcome of event lightheaded was resolved in Feb2021, outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 58 | 2021-03-30 | pain in extremity |
sore left arm; got chilled; head was throbbing; temperature was 103 but went down a little bit; felt...
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sore left arm; got chilled; head was throbbing; temperature was 103 but went down a little bit; felt lightheaded; This is a spontaneous report from a contactable consume (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (at the age of 58 years) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she got the first shot of Pfizer yesterday afternoon. In Feb2021, she had a sore left arm. She stated that 2-3 hours ago that she got chilled and her head was throbbing. Her temperature was 103 but went down a little bit. She felt lightheaded when she was doing lunches for daycare. She stated that she was not lightheaded anymore. She knew that it was normal. She went to check in online but cannot do it right. She stated that she took an ibuprofen 40 minutes ago. She wanted to know if this was normal. Outcome of felt lightheaded was recovered in 2021, outcome of other events was unknown. Information about lot/batch number has been requested.
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| 58 | 2021-03-30 | pain in extremity |
tired; nauseous; headache; her arm was sore; This is a spontaneous report from a contactable consume...
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tired; nauseous; headache; her arm was sore; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-sponsored program COVAX Support. A 58-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 around 12:20-12:30 (at 58 years old) as single dose for covid-19 immunisation. Medical history included ongoing atrial fibrillation, anxiety, underactive thyroid and cholesterol. Concomitant medications included paracetamol (TYLENOL EXTRA STRENGTH), via an unspecified route of administration on 23Feb2021 (Batch/Lot number Other: DAE30 could be an O 37A; Expiration Date: Aug2021, NDC number of Top Care Extra Strength Tylenol: 36800-484-71) at 1000mg, 2 caplets for headache and magnesium for atrial fibrillation. She does take other medicines, because she was in atrial fibrillation, she took extra of her atrial fibrillation medications. She also took magnesium. She took that every day anyway but sometimes she takes an extra pill or 2 to help go back to sinus rhythm if she was in atrial fibrillation. The patient also had an underactive thyroid. She took a very low dose medicine for cholesterol only 10 mg. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EN6198) intramuscular injection, left arm on 29Jan2021 (at 58 years old) and experienced atrial fibrillation and headache. The patient previously received the second dose of the varicella zoster vaccine. Illness at vaccination included atrial fibrillation and headache. Before getting the vaccine on 23Feb2021 she had a bad headache, and so she took 2 extra strength Tylenol a couple of hours before receiving the 2nd dose of the vaccine. The patient experienced tired, nauseous, headache, her arm was sore on 23Feb2021. The patient recovered from tired, nauseous, headache on 24Feb2021, from arm sore on 26Feb2021. The events did not require an emergency room visit nor a physician office visit. The clinical course was reported as follows. The patient was in distress over this, she can't sleep or eat, experiences anxiety anyway but now she's worried that she's not as protected because she took the Tylenol before the second dose of the vaccine. The patient reported that on 22Feb2021 at 10PM her atrial fibrillation started. The atrial fibrillation was still going on when she went to get the dose, when she got the dose, and even after she got the dose. The atrial fibrillation didn't go away until that evening, 23Feb2021 around 5-6pm. Then she went back to sinus rhythm. After she got home from getting the Covid 19 vaccine she took a shower she didn't feel good. She was tired but she didn't sleep the night before because she was in atrial fibrillation and was exhausted. Because she didn't sleep much she doesn't know if the tiredness was from the vaccine or atrial fibrillation. She reported an headache but she stated she may have had a headache before because she got headaches and took Tylenol, but thought she had after too. She ate breakfast then she didn't eat until dinner time and she felt nauseous. She felt more nauseous, she didn't throw up and she took Tylenol again that evening on the 23Feb2021. When she woke the next day on 24Feb2021 she got nauseous again but after the second day she didn't have nausea anymore. She wasn't sure if the nausea was from the vaccine. She's not positive. She just felt under the weather, but no fever or anything. She's a very anxious person and very worried. She reports her arm was sore, did not see any swelling or anything for 2 or 3 days. She feels pretty good today, back to normal. Information on the lot/ batch number has been requested.
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| 58 | 2021-03-30 | tingling, numbness |
numbness, tingling and swelling on the right side of face and head down right arm and chest; numbnes...
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numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), via an unspecified route of administration on 08Mar2021 at 11:15 (at the age of 58 years) at a single dose in the right arm for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included irbesartan; nifedipine; spironolactone; and estradiol. The patient did not receive any other vaccines within 4 weeks prior COVID vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not pregnant at the time of vaccination. On 08Mar2021 at 11:30, the patient experienced numbness, tingling and swelling on the right side of face and head down right arm and chest. The events resulted to Emergency room/department or urgent care visit. The patient was hospitalized on an unspecified date due to the events. Patient was given Benadryl antihistamine w/IV Cat-Scan other work up as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
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| 58 | 2021-04-01 | weakness |
3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours afte...
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3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little. 3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27
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| 58 | 2021-04-04 | unresponsive to stimuli |
4am, 4/3/21, chest pain unresponsive to 2 chewed Gaviscon. 5 baby ASA taken po and drove to hospita...
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4am, 4/3/21, chest pain unresponsive to 2 chewed Gaviscon. 5 baby ASA taken po and drove to hospital ED at 4:30am. First EKG negative for changes. First tryponin lab 0 and negative. Approximately noon, 2nd tryponin elevated at 0.54. Right radial access heart catheterization at approximately 1pm shows small branch of LAD with SCAD. Medical management with IV heparin, Plavix, and daily baby ASA 81mg. Discharged to home 4/4/21.
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| 58 | 2021-04-06 | weakness |
Nausea; Vomiting; Achy muscles and joints; Achy muscles and joints; I had no energy; This is a spont...
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Nausea; Vomiting; Achy muscles and joints; Achy muscles and joints; I had no energy; This is a spontaneous report from a contactable consumer reported for self. A 58-year-old female patient (No pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:30 PM (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included lupus. The patient did not have covid prior vaccination, no covid tested post vaccination, and did not have Known allergies. Concomitant drug was reported as too many to list. The patient experienced nausea, vomiting, achy muscles and joints, and she had no energy on 25Mar2021 03:00 AM with outcome of not recovered. All events considered serious due to Disability or permanent damage. No treatment received for the events. This has lasted for 5 days as of this date.
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| 58 | 2021-04-06 | weakness |
Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went t...
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Patient felt fatigue day one, then fever day two, then developed weakness and blurred vision, went to see eye doctor a few days later, was recommended to come to pcp due to eye findings, pt went home and checked sugar which glucometer read HI, which prompted her to go to er because this has never happened to her before
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| 58 | 2021-04-08 | nerve pain |
Extreme increase in neuropathic pain refractory to medications that continues to this day. Other my...
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Extreme increase in neuropathic pain refractory to medications that continues to this day. Other myalgias, fatigue related to second dose have resolved.
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| 58 | 2021-04-15 | numbness |
Woke in night with left arm numbness two days after second vaccine. Resolved spontaneously, but sym...
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Woke in night with left arm numbness two days after second vaccine. Resolved spontaneously, but symptoms returned on 3/18 and progressed to numbness over left arm, leg, trunk and face. Seen in ED and admitted for observation. Negative CT head, CTA Head and Neck, MRI brain. Started on Plavix, Atorvastatin and baby aspirin. Linq device implanted.
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| 58 | 2021-04-15 | tremor, inability to speak |
Approx. 5 minutes post second pfizer vaccine, patient began to have shaking of her bilateral upper e...
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Approx. 5 minutes post second pfizer vaccine, patient began to have shaking of her bilateral upper extremities, pursing lips and moaning, unable to speak, symptoms persisted, EMS was called.
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| 58 | 2021-04-17 | facial paralysis |
facial drooping; chills; nauseated; tired; stomach cramping; a little wheezy; This is a spontaneous ...
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facial drooping; chills; nauseated; tired; stomach cramping; a little wheezy; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), dose 1st via an unspecified route of administration, administered in Left arm on 23Mar2021 14:00 as single dose for covid-19 immunisation. Medical history included Immunocompromised. Concomitant medications included levothyroxine sodium (SYNTHROID), amlodipine, eszopiclone (LUNESTA), rabeprazole. The patient previously took hydrocodone, oxycodone, augmentin and experienced Known allergies. On 24Mar2021 13:00, patient experienced facial drooping, chills, nauseated, stomach cramping, tired, a little wheezy. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and nasal swab was tested post vaccination. The outcome of the event was recovering.
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| 58 | 2021-04-19 | weakness, tingling, numbness | back pain, weakness, chills, fevers, numbness and tingling of arms |
| 58 | 2021-04-24 | burning sensation, feeling hot, numbness |
numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; ...
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numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; tongue has been numb; really feel weird on her face; burning sensation that shot across the top of her left ear and nose/burning sensation down the left side of her body; left side of her face started to feel hot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left, at the age of 58-year-old, on 31Mar2021 18:45 as SINGLE DOSE for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 31Mar2021, a half an hour later, as the patient was driving home, the left side of her face started to feel hot and she kept putting her right hand on it to cool it off. The patient got a burning sensation that shot across the top of her left ear and nose. Once at home, she started to really feel weird on her face, and she had a burning sensation down the left side of her body. Her face felt strange for 1 hour and then declined. The patient went to bed at 09:30P.M. and she noticed numbness in her left leg. The next morning, the numbness in her left leg was much worse and she had numbness in her left arm down to fingers. States she called the doctor when they opened at 09:00 A.M. and they said to go to the ER right away because of all the numbness. The ER treated her like a stroke patient, and wanted to make sure she didn't have a stroke so she had a full MRI, Cat Scan, and Bloodwork done that all came back normal. The patient was in the ER on 01Apr2021 morning and she was admitted for observation and she came out of the hospital 02Apr2021 before 5:00P.M. The doctor ordered more bloodwork and a CT with contrast was ordered for her spine to see if she has any spinal damage. The patient saw a neurologist on 05Apr2021, she has had more numbness on the right side. Clarified that her right foot feels numb intermittently along with the right side of her face. Her tongue has been numb on 31Mar2021, like a line across it, most of the time. The numbness ebbs and flows and where she feels it, moves around. It is not as strong as a week ago but it moves around. No treatment was given in response to the events. She stated the neurologist and no one has recommendations on if she should receive the second dose. Outcome of left side of her face started to feel hot, really feel weird on her face was recovering; tongue has been numb was not recovered;Burning sensation recovered on 31Mar2021, numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side was unknown. Follow-up attempts are completed. No further information is expected.
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| 58 | 2021-04-24 | difficulty speaking, numbness |
Hard to swallow; Voice went hoarse; Scalp itched/ Insider ear canals itched; face went numb; This is...
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Hard to swallow; Voice went hoarse; Scalp itched/ Insider ear canals itched; face went numb; This is a follow-up spontaneous report received from a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscularly, administered in left arm on 24Feb2021(at the age of 58 years old) at 16:15 (Batch/Lot Number: EM9809) as a single dose for COVID-19 immunization. Medical history included ongoing asthma (10 years) and ongoing fibromyalgia (40 years). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient previously received dose 1 of BNT162B2 intramuscularly in the left arm on 03Feb2024 at 16:00 (Batch/Lot number: EL9262) and 1 hr. after dose, tongue, lips and cheeks went numb. Last 30 min went away (recovered same day). On 24Feb2021, 5min after 2nd dose, her face went numb, it was hard to swallow, her voice went hoarse, her scalp itched, and inside inside ear canals itched. She called over paramedics who monitored me for an hour. The events did not get worse and she went home. After 2 and half hours passed since getting the vaccine, all events resolved (on 24Feb2021) except itch (not recovered). She took Benedryl and woke up fine. The patient assessed the Pfizer product had a causal attribution to the events. The reporter assessed the events as medically important. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-04-24 | feeling cold, hot flush |
She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my...
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She felt unstable and felt like she might pass out; swelling of my tongue and cheeks; swelling of my tongue and cheeks; cold rush throughout my body; hot flash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 58 years of age), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 09:45 (Batch/Lot Number: ER8734) as a single dose for COVID-19 immunisation. Medical history included acid reflux, pre type II diabetes, Hashimoto's disease and possible Sjogrens; she was allergic to shellfish and berries. The patient had unspecified concomitant medications. The patient previously took and had allergies to sulfur, epinephrine and lidocaine. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number EN6207) (at 58 years of age), dose 1 in the left arm on 16Mar2021 for COVID-19 immunisation. The patient was not pregnant. The patient had no covid prior vaccination. She has not been tested post vaccination. It was reported that on 06Apr2021 10 AM, after just 13 minutes (as reported) of the shot, the patient experienced swelling of her tongue and cheeks along with a cold rush throughout her body followed by a hot flash. She felt unstable and felt like she might pass out. The events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events- treatment included BENADRYL day 1 and Prednisone added day 2. The patient was recovering from the events.
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| 58 | 2021-04-27 | tremor |
after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was goin...
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after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was going to drop or die, tremors, body felt like it was growing fur, lymph nodes under tongue, fingers, toes, started to swell.teeth chattering, restless legs, itching legs, sugar swings
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| 58 | 2021-04-28 | seizure |
Had 5 seizures with in 36 hours 5 days after the first vaccine./Other medical history: Seizures; Had...
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Had 5 seizures with in 36 hours 5 days after the first vaccine./Other medical history: Seizures; Had 5 seizures with in 36 hours 5 days after the first vaccine./Other medical history: Seizures; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER8727), via an unspecified route of administration on 01Apr2021 13:30 (58-years-old) as single dose for COVID-19 immunization. Medical history included seizure. Patient is not pregnant. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medication included valproate semisodium (DEPAKOTE) for seizure. The patient previously took Paxil and experienced allergies. The patient had 5 seizures within 36 hours 5 days after the first vaccine (06Apr2021 11:45). They had to increase semisodium which has helped keep the seizures at bay. She have not had seizures in two years. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of event (Increase in routine medicine). The outcome of the event was recovering.
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| 58 | 2021-04-29 | weakness, tenderness, discomfort |
This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose ...
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This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose Pfizer on 4/27/21 (Lot# EW0151). Of note, the patient was in a motor vehicle accident on 4/12/21 with a diagnosis of concussion and cervical/thoracic strain/sprain (see history under patient information). On 4/29/21, the patient's sister contacted the patient's primary care clinic with the following documented concern: "Pt's sister calling to report that two days ago pt got 2nd dose Pfizer vaccine and has been sick. This morning they found her passed out against the her bedroom door. Pt reports that she can't remember much other than going to the bathroom. Pt's sister states that patient totaled her car a week ago, and that it was determined she had a concussion. "She hasn't been herself since the wreck and I am very concerned." This caller recommenced the Ed or UC but caller denied stating that either needs to see her today. This writer is reaching out to nurse to see if they can advise from here." A RN assessed the patient virtually with the following documentation: "RN note: Call transferred from patient's sister. Pt noted to be found on her floor this morning. Pt unsure if she hit her head. Spoke to patient. She reports body aches, and feeling weak. Pt is slow to answer questions, and had a lot of difficulty hearing me (sister did not have any difficulty hearing me). Pt is noted to have more rapid breathing, and some slight wheezing. Speech is clear when she is speaking. Sister gave patient water to drink. She drank out of bottle and was able to hold on her own (though had difficulty with this at first). Sister noted some water dripping down face, but was able to swallow okay. Sister also noted that patient's lips seem to be pursed. Plan: Given recent concussion, and patients change in behavior per sister (pt more irritable, speaking more slowly, moving slowly, breathing faster, and wheezing), recommended patient be taken to the ED today--recommended ambulance since it took 2 men to help patient back to bed this morning. Sister states patient is not agreeable to going to ED at this time. Advised to try to encourage her to drink more fluids, and continue to monitor her sxs, and if any worsening, to call for ambulance transport. Sister agreeable to plan, and will discuss with sister, and recommend ED visit today." On 4/30/21, the patient's sister contacted the clinic to inform them that the patient was found dead that morning. The medical examiner is completing the further investigation. If additional information is needed from the primary care physician for this patient.
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| 58 | 2021-04-29 | pain in extremity |
Vaccine date Fri 4/23/21 Starting at 5pm I had a low grade Fever 99.1 and Chills lasted until appro...
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Vaccine date Fri 4/23/21 Starting at 5pm I had a low grade Fever 99.1 and Chills lasted until approx 9pm and then went away. Sat 4/24/21 woke up with Sore L. Arm at site of Vaccine, but felt better. Sun. 4/25/21 woke up at 7:30am and didn't feel well, nausea, chills, needed to lay down, about 8:00am severe Headache at my Sinuses, Behind my Eyes, Forehead, and Back of Head at Base of Neck through 10pm. I took Speedy Release Tylenol, 3 hrs later Headache was returning I took 2 Ibuprofen and slept. Slept most of the day until 9pm when I felt I could tolerate Chicken Noodle Soup. I woke up Mon. 4/26/21 w/mild Headache just behind my Eyes.
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| 58 | 2021-05-02 | migraine |
1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlarge...
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1 day after vaccine lumps under arms and along collarbone, migraine, chills, fatigue, breast enlargement. 3rd day after vaccine left ear pain, difficulty swallowing, but could breath, fever,migraine, chills, ,fatigue, tender breast, breast enlargement. My primary said not to get second dose. Also rash on right arm.
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| 58 | 2021-05-04 | pain in extremity |
Next day had diarrhea x2; abdominal cramping; mild GI upset for 2 more days; sore arm; chills; fever...
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Next day had diarrhea x2; abdominal cramping; mild GI upset for 2 more days; sore arm; chills; fever around 12 MN, fever 102.0; severe nausea; vomiting x1; severe H/A; body aches; stomach cramps; This is a spontaneous report from a contactable Nurse (patient herself). A 58-years-old non-pregnant female patient received second dose via bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in Arm Right on 26Jan2021 at 11:00 as SINGLE DOSE for COVID-19 immunization. Medical history included arthritis, depression and the patient had covid prior the vaccination; Known- allergies included: Penicillin, flagyl, Clindamycin and the patient previously took flagyl [metronidazole] and clindamycin and experienced drug hypersensitivity. The patient previously took first dose of BNT162B2 (BNT162B2,Solution for injection, Lot number: EL3246), via unspecified route of administration to the Left arm on 05Jan2021 at 14:00 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks. Concomitant medication(s) within-two weeks included sertraline hydrochloride (ZOLOFT); lithium (LITHIUM); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]); docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]). On 26Jan2021 at 17:00, the patient experienced sore arm, started having chills, fever around 12 MN, fever 102.0, severe nausea, vomiting x1, severe H/A, body aches, stomach cramps. Severity subsided at 36 hours. Next day had diarrhea x2 and abdominal cramping, mild nausea, mild GI upset for 2 more days. The events resulted in a Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included fever: 102.0 on 26Jan2021 fever around 12 MN. The patient had not tested covid post vaccination. The patient did not received any treatment for the events. The outcome of the events was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.
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| 58 | 2021-05-10 | bell's palsy |
After the second dose I had fever, body aches and swollen lymph nodes. I went to the doctor and got ...
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After the second dose I had fever, body aches and swollen lymph nodes. I went to the doctor and got antibiotics. Nine days after the vaccine I got Bells Palsy and I have not been able to work since then. I noticed when I gargled that night the water was coming out. The following day was a holiday and everything was closed. I was able to see my doctor. My left eye was not closing and I had difficulty eating because the left side of my face was effected. I had to tape my eye shut at night. It is very sad and upsetting because I don't know if it will get better. I have seen a Neurologist. It has been four months and I am still getting therapy for the Bells Palsy. Physical therapy since 04/19/2021 with electrical stimulation. My eye closes a little better and my smile is a little straighter.
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| 58 | 2021-05-10 | involuntary muscle movements, seizure |
Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips ...
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Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips started to swell; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; Then my body would jerk and I groaned; Then my body would jerk and I groaned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0169) at left arm on 24Apr2021 09:45 AM at second dose, single for COVID-19 immunisation. Medical history included chronic rhinitis and Lyme disease. Patient previously received Morphine, cefzil and grass. Patient previously received the first dose of BNT162B2 on 03Apr2021 09:45 AM (lot number: EP7533) on Left arm for Covid-19 Immunization. Concomitant medication included loratadine, astaxanthin (BIOASTIN), spirulina spp. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 5 hours after the second shot (also reported as 24Apr2021 22:00), her lips started to swell. she took her allergy medicine and she felt better. Twelve hours after the second shot, she had convulsions. she had a pain that started in her left armpit, shot down to her inner elbow, and caused her whole arm to get rigid. Then her body would jerk and she groaned. It stopped and started in intervals, with calm in between. It was unknown prior to vaccination, if the patient diagnosed with COVID-19. Not tested for COVID-19. Outcome of the events was recovering. Follow-up information requested.
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| 59 | 2020-12-31 | weakness |
High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness a...
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High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness and reduced range of motion causing reduced ADLs for 10+ days
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| 59 | 2020-12-31 | numbness, tingling |
DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE...
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DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE FEELS FINE 20MINS AFTER THE EVENT.
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| 59 | 2021-01-01 | pain in extremity |
Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore a...
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Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore arms, fatigue then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms. I knew then I needed to get swab. Symptoms is still current.
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| 59 | 2021-01-01 | pain in extremity |
I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 h...
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I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 hours I felt soreness at a level of 2-3/10 at the injection site. Starting at - 19:00 the pain radiated down toward my elbow and up into my neck and base of skull. The soreness in my neck and base of skull was at a lever of 4/10. By 12/24/20 at approximately 18:00 the side effects had dissipated.
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| 59 | 2021-01-03 | numbness |
I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (a...
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I experienced numbness of my chin and lips. Also, I had stiffness of my jaws. I was given a Zetec (allergy Tablet PO) and monitored for 1 hour, with vital signs being taken.
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| 59 | 2021-01-03 | tingling, numbness |
Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling...
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Half an hour after receiving vaccine in left arm, my left face started with a tingling, numb feeling like when you get anesthesia from a dental procedure and it is thawing out. It was just the left side of my face, same side I got the vaccine. Could feel a dividing line in the middle of my face. It lasted with the same intensity for 3 days. It then started to subside slowly for the next 3 days and then was totally gone.
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| 59 | 2021-01-04 | discomfort |
Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and sh...
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Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and she got the head cold in Dec2020; little whooping cough; I had severe headaches and it was just too uncomfortable; my head was so congested; worst headache; it was just too uncomfortable; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female patient received BNT162B2 via an unspecified route of administration on 22Dec2020 at the 59-year-old at single dose for Covid virus. The medical history included Congested, head cold and Covid virus. There was no concomitant medication. The patient work at a hospital and she went for a Covid shot (clarified as Covid 19 vaccine) on 22Dec2020 and she got a very bad reaction from it which bothered her, she had severe headaches in Dec2020 and it was just too uncomfortable and on 24th she was very tired, she didn't had too much of upset stomach in Dec2020 but it was not all that bad by 9 in the clock by morning she was at work and everything and she was told by if she was not feeling well she can walk by a day, but her question and her concern was back on November okay she had called in sick around, she had a funeral that she gone too and people that were at the funeral, unfortunately were smoking outside and smoke bothers me very much, she get congested and she get head cold from it you know and I was thinking it's nothing it's just a cold and somebody told her no (name) you better go get yourself to the employee health office and get checked out and she didn't bother doing that, she said no it's just the cold she will be fine but then it just got worse down the road and she said to herself may be she better just to say she did it, so she called in sick on 24th because she had the cold still and she called and she went to employee health office on 25th she still had the headache and she still had the cold, however when she went to the health office they said to her well stay out of work and we will get back in touch with her and she said okay and she will do that so when they got back in touch with her they said they do have the Covid and she said ohhh she said okay so she stayed out of work and she went to work on the 07Dec so she was wondering whole time, so her confusion was this she was told if you already had the virus in her which at that time, she did not know what it was she just thought it was from cigarette smoke because it got her all congested and she got the head cold in Dec2020 and the whole thing that went along with it and the health employee officer know you had the virus and it's just the virus and she go oh great and that's when they told her to stay out of work and she said okay fine then she just have to that, so in the meantime everybody in the work said hi calling me checking up on her and she said it's so nice of you people, she appreciate it but then she went back to work she was still feeling you know much better than she was but she had little whooping cough in Dec2020 but that was not really that bad, so they said you going to get the shot or not, and she said she don't know she kind of debatable, she don't know if she should get it, because she work in the hospital or she should not get, she said she don't know she was kind of up and some people like she get it sometime your health was not that good but on the other hand everybody that is working here in the hospital working with patients because was work right in the ICU, all over the floor you know spreading right there so she said oh alright so she kicked myself and said go get the shot, get it just over with and get it out of here so that is when she took her shot that was on 22nd and on 24th she was very tired all day no she was tired all day but she was kind of dragging most of the day but she had on the 20th no that was fine on the 20th okay for some reason she guess it was after work that week on 19th, she came home and her head was so congested and she had the worst headache and she felt like a wand had hit her over the head, it was horrible and all she could smell was cigarette smoke, like is her neighbor smoking here so she went down the hall because in live in building that used to be hotel but now they turned that into Condominium and she walk up and down the hall and she was like was somebody smoking or why this or why smell this so strong and the all the lights off in a hallway and she don't want to offend anybody but they had to go to work and somebody elsewhere and she am like she can't stand this smell and they gave this shot and she went for this shot, and they told us to come back she think it was a week or something like that to get the second shot, and she am saying if this going to cost her going to feel this way again, she don't want to get the second shot, she told them that and they told her to call this number and talk to them.The only reason she got it because they encouraged to get it. Even though she had the Covid virus, people said if you already have the virus you don't need to get a shot but people were encouraging because that's she thought well she guess she will get it. But she was mad that she got because it made her sick in Dec2020. And because we already got it they want us to go back and get the second shot and what she was m trying to say to you is, without take and hour 3 hour of conversation here she just want to say she don't want to get back and get the second shot and if it is okay by you guys somehow send her a letter or whatever it is, whoever she have to talk to because she don't want to go back and get the second shot just because of getting sick. She took Excedrin because that works for my headache. She didn't understand why you need all this information history with all this when all she want to say was she didn't want to get a second shot. The outcome of events Head cold and Headache was not recovered, the other events was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-01-04 | numbness, tingling |
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea ...
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Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
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| 59 | 2021-01-04 | tingling |
Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED...
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Patient states to feeling nauseated and had tingling in the arm and hand. Patient was sent to the ED to rule out TIA but left before being evaluated. Patient states symptoms have resolved and did not want to be seen by ED physician. Patient was educated on returning back to ED with any new concerns.
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| 59 | 2021-01-05 | weakness, feeling jittery |
1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 ...
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1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 pm dizziness, tightness around right upper arm, swelling in right axilla. afebrile. 1/6/20: 5:00 am; chilling subsided. dizziness, weakness and jittery feeling in both legs, soreness at injection site, no redness, swelling in axilla slightly improved. Heart rate 72, respirations 16, 02 sat 96%. bp 129/75. 9:00 am: dizziness, right axilla swelling gone. Soreness in right axilla, weakness in lower extremeties improving. 11:00 am : weakness and jiters subsided, right axilla remains sore.
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| 59 | 2021-01-05 | weakness |
Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness...
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Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness, near syncopal episode, blurred vision, chest tightness, tachycardia, weakness, shortness of breath. . Returned to vaccination room, in obvious distress. Ushered by staff to chair. Unable to obtain BP via electronic machine, obtained manual , after about 10 or so minutes NIPB 106/69. Remained in room for 45 more minutes, symptoms slowly resolved. Remained with mild to moderate dizziness x 4 days. Headache, chills, chest tightness, weakness, lethargy, x 7 days..
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| 59 | 2021-01-05 | weakness | Fever between 99.6-100 degrees fahrenheit for 24 hours. Weakness and mild nausea. |
| 59 | 2021-01-05 | weakness |
Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with...
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Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with no stamina. Lasted until 12 /25/2020. Felt horrible like I also had a fever. Although I never did run a temp.
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| 59 | 2021-01-05 | feeling hot, pain in extremity |
It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the s...
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It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the shoulder to the neck is painful; Her whole arm is sore up to her neck and down the arm/It is very painful/it throbs; Last night she was up all night, every 3 hours; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiration date Apr2021), via an unspecified route of administration at left arm on 30Dec2020 09:30 at single dose for COVID-19 immunization, at a hospital. The vaccine was not administered at military facility. The patient's medical history included ongoing asthma from 2005 (diagnosed 15 years ago) and allergies. For asthma She has ProAir rescue inhaler to use as needed. Breo inhaler she uses at night. She has been on it for 2 years. She has been on different inhalers. Family medical history relevant to events was reported as none. Concomitant medication included montelukast sodium (SINGULAIR) from 2005 (had been on it probably 15 years) and ongoing at 10 mg, daily for allergies; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler via resp Inhalation from 2018 (has been on it for 2 years), uses it at night, for asthma; and salbutamol sulfate (PROAIR HFA) rescue inhaler via resp Inhalation, to use as needed for asthma. The patient had no history of previous immunization with the Pfizer vaccine. For historical vaccine, the patient received Tetanus for immunization and had allergic to Tetanus, her arm swelled and she couldn't move it (which was kind of like this, but not as severe). She didn't know the brand name for the tetanus vaccine she had reaction to. She didn't have NDC, lot, or expiry. It was 40 years ago. She had the reaction when she was 18 years old. There was no vaccine administered on same date of the Pfizer suspect, and tno vaccinations within 4 weeks prior to the Pfizer suspect. It was reported that last night (30Dec2020) she was up all night, every 3 hours. She was taking Advil. Her whole arm was sore up to her neck and down the arm. She had a nurse look at it this morning (31Dec2020) and it was not red. It was warm and it throbs. No rash. It was very painful. Even up to the back of the shoulder to the neck was painful. Her arm being sore and painful was ongoing at the time of report. She had been taking Advil. The pain had stayed the same even with the Advil. The events started probably between 14:00 and 14:30, it started off sore then became more painful. At the time of reporting, she was not at home and didn't have the bottle to provide NDC, lot, and expiry for Advil. She was taking some at the office, but that was in a travel bottle and didn't have the lot, expiry, and NDC. No emergency room or physician office visit. Relevant tests was none. The outcome of the events was unknown.
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| 59 | 2021-01-05 | numbness, tingling |
Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes afte...
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Numbness/tingling in fingers/hand approx 5 min after injection; pain in wrist approx 10 minutes after injection which has extended into hand 48 hours after injection
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| 59 | 2021-01-05 | muscle spasms | I had tiredness, Headache , Muscle Spasms |
| 59 | 2021-01-05 | pain in extremity |
made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (p...
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made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization. The patient's medical history was concomitant medications were not reported. The patient stated, "where I got my shot made my arm really sore for about three days. On the third day, I ran a low-grade fever-100F. The fever lasted 12 hrs. Now I'm fine. I was a little nervous about traveling but read that there was a side effect." The outcome of the event was unknown. Information on lot/batch number was requested.
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| 59 | 2021-01-05 | tingling |
This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had g...
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This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had gotten the vaccine at approximately 8:30 AM and had stayed at the vaccination area for about 15 minutes and felt okay. She got up to walk outside and started feeling dizzy. Her hands felt tingly. She also felt a little short of breath. She came back in and sat down and the symptoms did not seem to really improve. She states they have been about the same over the last 20 minutes or so. She was then escorted to the ED of the facility for evaluation & treatment if needed. Per the ED doctor's notes: " The patient did feel much better after just being observed here and after getting Benadryl." She was released home. Employee health followed up with her at 4:30 PM the same day & at 9:45 am 1/6/21--she reported that she was doing well at both follow ups, a little tired but had not had any repeat of previous symptoms.
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| 59 | 2021-01-05 | cold extremities, tremor, feeling jittery |
6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in righ...
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6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in right axilla. Tightness around upper arm/axilla area. No redness at injection site. 5 am weakness in lower legs, shakey/jittery, and dizziness. Bp 129/75, HR 65, resp 16, O2 say 96. 9 am dizziness subsided 11 am weakness in legs subsided, axilla swelling subsided, soreness remains.
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| 59 | 2021-01-06 | difficulty speaking | Patient felt dizzy quickly progressed to hoarse voice, cough and expressed difficulty breathing |
| 59 | 2021-01-06 | pain in extremity |
Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,ho...
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Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,hot and swollen after the allergy shot . Itching whole body and also the roof of mouth and the back of throat was itching . Head aches . No new symptoms.
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| 59 | 2021-01-06 | tingling, numbness |
Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/...
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Vaccination 1/5 @ 10:30 am - mild left arm discomfort @ injection site, otherwise no symptoms On 1/6 eve, approximately 10 pm, noted worsening to severe pain in left anterior shoulder/ subclavicular area into axilla with prominent & well delineated area of swelling & tenderness, most prominent in & just below axilla, associated with numbness & tingling down the ulnar side of arm to 2 fingers (ring & little finger).
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| 59 | 2021-01-06 | tension headache |
Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also r...
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Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also reported worsening tinnitus which started 12/22/2020, prior to the vaccine administration date.
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| 59 | 2021-01-07 | weakness, pain in extremity |
Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left ar...
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Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.
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| 59 | 2021-01-07 | weakness |
Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slig...
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Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slight nausea. Notified supervisor at work, took Tylenol 1000 mg and slept for 2.5 hours. Woke up with symptoms much reduced and went to work
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| 59 | 2021-01-07 | flushing | tingling tounge and flushed, monitored until resolution, |
| 59 | 2021-01-07 | numbness | Numbness on the left side of face and ear. Lasted only about 4 hours from about 5pm to about 9pm. |
| 59 | 2021-01-07 | migraine |
Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse...
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Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 30Dec2020 10:30 at Left arm at single dose for covid-19 immunization. Vaccine was administered at hospital and not administered at military site. Medical history included ongoing spondylolisthesis diagnosed 15-20 years ago and overweight. Her vertebrae were not in physical alignment. The patient was given steroids, but it didn't help. Steroids didn't do anything. There was no name or NDC/Lot/Exp of steroids. The patient no longer has steroids. Her back will hurt when she gains weight. Height was now under 5 feet 5 inches (164 cm). The patient had no family medical history. There were no concomitant medications. No additional vaccines administered on same date of pfizer suspect and no prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient experienced multiple side effects 10 hours after the vaccine and lasted 20 hours. Side effects started 20:00 - 21:00 on 30Dec2020. Side effects were classified as: Nausea, migraine headache, chills, and joint pain. The events was waxing and waning. On 31Dec2020, side effects were 75% gone by 16:00. Joint pain was completely going by 22:00-23:00 on 31Dec2020. Chills were gone between 08:00-09:00 on 31Dec2020. Nausea and migraine headache stayed until 16:00-17:00 on 31Dec2020 and then it went away. At the time of vaccination, there was a low-pressure center coming through. There was also an ice and snowstorm. She was wondering if the headaches and joint pain were due to the weather. The patient took no medication or treatment for spondylolisthesis and wondered if that had something to do with it. The patient really want to have second shot in two weeks. Investigation assessment was no. The outcome of the events was recovered on 31Dec2020. Causality assessment by primary reporter via global introspection was unknown.
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| 59 | 2021-01-07 | pain in extremity, pain in extremity |
3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and ...
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3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and had a fever, horrible joint and leg pain, horrible leg pain, terrible bouts of nausea until I couldn't puke anymore. I went into the ER and got fluids and they ran tests and everything was normal. ER said it could be a moderate reaction to the vaccine.
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| 59 | 2021-01-07 | pain in extremity, tingling, numbness |
From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbnes...
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From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbness and tingling. I went back to work I also had some weakness and being tired but that went away and weakness in my legs but that went away didn?t last long. The numbness and tingling in my face and neck did not go away. My arm is still sore. I did go to the er last night cause my blood pressure was high at home and face still numb and tingling. Just thought I better check things out. Dr wasn?t sure if it was a reaction from the covid shot he was checking for stroke issues all tests he ran were good.
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| 59 | 2021-01-07 | pain in extremity |
Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontan...
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Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events 6 patients. This is 2nd of 6 reports. A 59-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 29Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. This patient had a low grade temperature that last 6 hours, nausea, vomiting and diarrhea on 05Jan2021. She also experienced the arm soreness on 29Dec2020. patient says that they had employees get the COVID Vaccine on 29Dec2020. Most said that they maybe got a little arm soreness that lasted a few hours. They took tylenol and were fine. reporter confirmed that this patient is herself. She did not have a specific physician that she sees. She sees whoever is there that day. She received the vaccine on 29Dec2020. These symptoms hit her early this morning. They hit her, then she called out of work. She talked to her provider and they were going to revisit if they wanted to do another COVID test. she has already had two negative tests. Treatment was none. Patient states she just got off the phone completing a report of side effects from several of her employees that happened within 24 hours of receiving the Covid vaccine on 29Dec2020. reporter states several employees reported headaches, tiredness, and malaise. reporter would like to know if the onset and duration for these symptoms are expected. Her question it, since they all got the vaccine on 29Dec2020, would they be experiencing these side effects 7 days post injection, this far out. No Investigation Assessment. Patient was recovered from low grade temperature that last 6 hours, vomiting and diarrhea on 05Jan2021, recovered from arm soreness on 29Dec2020, recovering from nausea. Reporter seriousness of low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was not serious. The reporter considered the events Low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was related. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
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| 59 | 2021-01-07 | pain in extremity |
Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous re...
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Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous report from a contactable Nurse. This Nurse reported events for 6 patients. This is a 1st of 6 reports. A 59-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 29Dec2020 at single dose, once by injection in the right arm, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm soreness on 30Dec2020 that lasted a few hours, malaise and extreme tiredness on 05Jan2021. Therapeutic measures were taken as a result of arm soreness included Tylenol. The patient worked in a healthcare facility and had not had COVID. The outcome of event arm soreness was recovered on 30Dec2020, and of malaise and extreme tiredness was not recovered. Reporter seriousness for arm soreness, malaise and extreme tiredness was non-serious. The reporter considered the events arm soreness, malaise and extreme tiredness were related to COVID Vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006243 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006329 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006376 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006151 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021005968 same reporter/ drug , different patient /AE.
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| 59 | 2021-01-07 | pain in extremity |
CDC called and requested I complete this report, but I do see these reactions within the normal rang...
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CDC called and requested I complete this report, but I do see these reactions within the normal range reported to us prior to getting vaccine. 6 hrs after 2nd shot fever of 99, headache, and arm pain. 20 hrs after shot significantly worse headache, arm pain and fatigue to point of not getting up, not walking around, and not interested in eating until later in the day. 30 hrs after shot I was up and eating normally, but continued headache 46 hrs after shot but ibuprofen adequate to cover pain today.
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| 59 | 2021-01-07 | tingling |
Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizzi...
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Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizziness upon standing and reported tingling in lower limbs. Patient was monitored for an additional 20 minutes and symptoms resolved. Patient had no other complaints.
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| 59 | 2021-01-07 | tingling | tingling LUE, LLE, Left face and left side of tongue/cheek Narrative: condition C called |
| 59 | 2021-01-07 | tremor, feeling cold |
Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she ...
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Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
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| 59 | 2021-01-08 | discomfort |
First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: Abou...
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First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: About 3 hours after receiving the 2nd injection, I had terrible headache requiring dosages of OTC Tylenol, terrible abdominal pain/pressure similar to menstral cramping, extreme fatigue requiring prolonged sleep, nightmares (which I never have). All symptoms lasted for approximately 38 hrs.
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| 59 | 2021-01-08 | cold extremities |
Developed fever/chills next day and following day which resolved but also began having having purple...
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Developed fever/chills next day and following day which resolved but also began having having purple/blue fingertips - both pads and nails - when my hands are cold. This began on day after vaccine and continues to date.
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| 59 | 2021-01-08 | tremor |
Pt reported onset of "quivering" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted...
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Pt reported onset of "quivering" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted & interviewed (Dr.) patient. Ambulance called. Vitals re checked Benadryl 25 mg PO given. Paramedic & Ambulance arrive 4:35 59 y/o who states she had anaphylaxis before her symptoms started the same as today. C/o quivering lips & H/A No rash or respiratory comp (EMT's exam - normal except ? movement. Assessment - Possible allergic RXN Plan - Ambulance transport to ED
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| 59 | 2021-01-09 | tingling, feeling hot |
I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 210...
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I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).
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| 59 | 2021-01-10 | numbness |
Patient experienced right eyelid and cheekbone numbness following the first dose. She received her s...
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Patient experienced right eyelid and cheekbone numbness following the first dose. She received her second dose 11 days after the first in error. Following the second dose, she reported cheek numbness and nausea, which had resolved when I spoke with her on 1/11/21.
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| 59 | 2021-01-10 | numbness |
Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 ...
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Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 days later instead of 21 days). The patient reported experiencing right eyelid and cheekbone numbness and a minor headache after the first dose. She had numbness to her right cheek again on 1/8/21 and some nausea that has resolved. I spoke with the patient on 1/11/21 and she is feeling well.
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| 59 | 2021-01-10 | pain in extremity |
06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than t...
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06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than the 6th, 99.9-T Sat the 9th vomiting 2 times---she took Tylenol 325mg times 2 for her fever-T-99.7 Sunday the 10th vomited 10 times-99.9 T This Am the 11th of January@0100-cramping--------99.1 T
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| 59 | 2021-01-10 | pain in extremity |
Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen ar...
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Arm sore over night Sunday to Monday and began to itch. Area still itches and is red and swollen area where shot was given
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| 59 | 2021-01-10 | pain in extremity |
soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 o...
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soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-10 | pain in extremity |
That evening developed itching and had a rash over upper body and arms, still on arms in AM, went aw...
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That evening developed itching and had a rash over upper body and arms, still on arms in AM, went away on it's own, since then have episodes of chills and a trigger finger developed while sleeping on right #4 digit of Right hand, tightness in chest and last night developed pain in left arm and fingers that was very painful and did not respond to 800mg of Ibubrofen. Not sure if related.
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| 59 | 2021-01-10 | pain in extremity | Hand Pain |
| 59 | 2021-01-10 | tingling, pain in extremity |
sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips o...
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sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips of fingers (feeling pricked in the fingertips).
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| 59 | 2021-01-10 | tremor |
She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsen...
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She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-11 | weakness |
12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21...
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12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21; woke up 'not feeling well'; weakness, faint, shaky. You contacted your brother and proceeded to the ER. 2am started to feel better 3:30 am dishcarged home. Wope up at 6:30 am. Chills, achy. Went to work; felt chilled all Monday into the evening until eventually subsided. **2 negative COVID in Nov **Flonase for allergies **2nd Pfizer vaccination on 1/9/2020. Milder symptoms for couple of days, into Tuesday. 1/12/2021; mild chills, mild body aches.
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| 59 | 2021-01-11 | numbness, tingling, cold extremities |
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev...
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After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
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| 59 | 2021-01-11 | numbness, tingling |
numbness in right fingers along with tingling. moved to back of neck and side of face. right side ...
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numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; numbness in right fingers along with tingling. moved to back of neck and side of face. right side of face was completely numb. began with tingling and then moved to numbness. right eye was blurred; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL01284, expiry date not reported), via an unspecified route of administration in the right arm on 31Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included pituitary tumor/prolactinoma. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Concomitant medications were none. On 31Dec2020 at 10:45, the patient experienced numbness in right fingers along with tingling. The patient moved to back of neck and side of face. The right side of face was completely numb. It began with tingling and then moved to numbness. Her right eye was blurred for short period. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
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| 59 | 2021-01-11 | pain in extremity | Arm aching Fatigue Minor hives for three days Treated with Zyrtec and Benedryl |
| 59 | 2021-01-11 | tingling, feeling cold |
Patient describes feeling of "cool waves" over her whole body. States it lasts on a few seconds and ...
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Patient describes feeling of "cool waves" over her whole body. States it lasts on a few seconds and then goes away. Some tingling in upper extremities noted initially , but none now. Patient declined to remain longer for observation. She had her husband here for transportation home. Advised patient to call Health Services if other symptoms occurs She will do this. Advised ER if symptoms emergent.
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| 59 | 2021-01-12 | burning sensation, tingling |
Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving he...
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Patient called at 12pm to inform us that about 3 hours after her 1st Covid vaccine she was moving her arms around to prevent soreness and then both arms began to feel itchy, tingling, & burning & this moved up into her neck. She was encouraged to come in and be seen, but she does not feel that is necessary at this time. She reported her symptoms have since improved and that she had a similar reaction when she received the shingles vaccine. I encouraged patient to monitor her symptoms and to come be seem if she gets worse. She reported that she is feeling much better at the end of our phone call.
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| 59 | 2021-01-12 | depressed level of consciousness |
Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arou...
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Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arouse me. When he tried to get me up out of bed I collapsed and then had syncopal episode. He call 911. Paramedics could not get blood pressure and I was diaphoretic and body temp was cold. They rushed me to the hospital. My blood pressure was dangerously low along with my body temperature. I was given epinephrine and LEVOPHED to get a blood pressure. I was warmed up. Then I had GI issues of vomiting, diarrhea, nausea. I spend 4 days in hospital.
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| 59 | 2021-01-12 | flushing, pain in extremity |
Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under...
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Dose #2 received on 1/11 at 11:30. Pt began to feel itchy all over at 1500. She noticed a rash under both of her breasts as well as her face, scalp. She felt " flushed". No tongue or lip swelling, No wheezing. she had arm soreness and muscle " weakness" in the left arm after dose #1 and completed a VAERS form at that time but had completely recovered prior to receiving injection #2
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| 59 | 2021-01-12 | pain in extremity, flushing |
Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:3...
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Generalized itching, hives, after receiving second dose of COVID 19 vaccine today, 1/11/2021 at 11:30 in right deltoid. Pt tolerated dose #1 in left deltoid. She developed mild arm " weakness" and soreness that lasted several days. She completed a VAERS report after her first dose. She began to feel " itchy all over" at 15:00. She noticed hives under her bilateral breasts. She felt " flushed" and her scalp and face felt itchy as well. No SOB or CP. NO wheezing. She has a hx of allergies to KEFLEX/PCN.
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| 59 | 2021-01-12 | cold extremities |
1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter...
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1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter 5:30pm Shivering muscle pain temp 101 took motrin 1/9/2021 Felt 80% ok 1/10/2021 and 1/11/2021 95% better Appetite decreased from 1/8/20201-1/11/20201 ( dry mouth, fever, chills, lightheadedness, muscle pain)
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| 59 | 2021-01-12 | tremor |
Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a ...
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Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a check up with my doctor with no symptoms.. Injection on left high upper arm redness around . Muscles pain and tremors of my hands , tired Diarrhea for two days and sweats.
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| 59 | 2021-01-13 | weakness |
Fever, chills, headache, major joint pain (hips, shoulders, knees, elbows, ankles), generalized weak...
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Fever, chills, headache, major joint pain (hips, shoulders, knees, elbows, ankles), generalized weakness
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| 59 | 2021-01-13 | feeling hot |
Patient began to experience neck pain on the same side she received her injection along with tightne...
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Patient began to experience neck pain on the same side she received her injection along with tightness and stiffness. Patient also experienced pressure, popping and burning in and around bilateral ears. Patient expressed she felt hot, and had a headache. Patient verbalized she had a lot of allergies to environmental substances.
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| 59 | 2021-01-13 | muscle spasms |
wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; h...
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wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; headache, muscle spasms in abdomen; headache, muscle spasms in my abdomen; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 02Jan2021 at a single dose in left arm for COVID-19 protection. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 18 or 19 years ago), COVID-19 previously and did not have side effects like this (the patient had COVID 19 last month and did not feel this bad at all. Patient was asymptomatic). Concomitant medication included ongoing liraglutide (VICTOZA), ongoing insulin detemir (LEVEMIR), both started about 2 or 3 years ago for diabetes Type 2. She received the product vial workplace policy, so it was not specifically prescribed to her. The patient received the first dose of the vaccine on 02Jan2021, and starting on 06Jan2021, she started with headaches, and muscle spasms all over her abdomen and back. Headaches was reported as worsened. The headache will not go away and even with Tylenol it still lingers. Muscle spasms all over her abdomen and back was reported as worsened. Her eyes were weak and hurting, started on 08Jan2021. She was so tired, she wanted to sleep. The tiredness, started on 06Jan2021, and it is like in the morning she is okay, but then during the day she just got worse and worse and worse. Her sore throat starting 07Jan2021 night, and this morning it was really bad. Throat was very sore was reported as worsened. She received no other vaccines on the same day at the COVID vaccine. The patient was wondering if those are side effects of the vaccine, because the patient had COVID-19 previously and did not have side effects like this. This is a non-serious report. The outcome of event eyes being weak and hurting, and wanted to sleep was unknown, outcome of the other events was not resolved.
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| 59 | 2021-01-13 | tremor |
1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking o...
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1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking of hands, chills and present at this time 1/14/21
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| 59 | 2021-01-14 | weakness | chills slight fever headache fatigue body aches no energy exhaustion |
| 59 | 2021-01-14 | involuntary muscle movements, tremor |
Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Resi...
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Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Residents blood pressure was elevated as well and she complained of nausea. Resident was fine this morning and the past several days with no complaints. This resident has a history of muscle spasms and tremors as well as some catatonic states in the past.
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| 59 | 2021-01-14 | feeling hot |
I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had ...
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I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had taken one 325mg Tylenol and one 200mg Ibuprofen approximately 60 minutes prior to receiving vaccine (which is what I did prior to the first vaccine). I was doing great initially following the vaccine. I took another 325mg Tylenol and 200mg Ibuprofen when I went to bed at 2000 1-12-21. At 0300 1-13-21 I woke up feeling nauseated and when attempting to turn over to my right side I moaned loudly because I could not hardly move my left arm. My husband was woken and turned on the bedroom light and we noted a 3 inch bruise and large knot on my left deltoid at the injection site. He told me that I felt warm. I took my temperature that was 101.2 degrees. I took 650mg Tylenol and that time. At 0500 1-13-21 I was having chills, muscle and joint aches. I could not fully close my hands into a grip. My "brain" hurt, not a headache but literally it hurt to move my head. I would occasionally get a sharp pain in the front and back of my head. My temperature went to its highest at approximately 1500 1-13-21 to 102.5 degrees. I continued to offset Tylenol with Ibuprofen throughout the day. At 2000 1-13-21 my temperature was 101.8 and began to trend downward. I went to bed and when I woke up on 1-14-21 I felt 100% better with just a little fatigue from the inability to sleep the day prior.
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| 59 | 2021-01-14 | flushing |
About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my...
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About 2 min after receiving injection, I felt an intense flushing feeling all over, it felt as if my blood had turned into lava. About a minute after that I felt a "tickle" in my throat. The same sensation I felt when I had my reaction to Gadolinium. I tried to swallow, and it was a little difficult. I did NOT feel short of breath. I tried to calm down by doing slow concentrated breathing. I continued to take small sips of water to gauge my swallowing ability. After about 2-3 minutes, the flushing sensation subsided, and swallowing started to improve. I had brought my Epinephrine pen with me. About 1-2 min after the flushing sensation had subsided,, it came back and my swallowing ability got much worse, to the point I couldn't swallow a small sip. I was breathing well, and did NOT feel short of breath, but gave myself my Epinephrine injection at that time. A Rapid Response was called at that time, my vitals signs taken, an IV inserted, 911 called. O2 sats were fine mid 90's, heart rate was mid 80's, BP was elevated, I don't remember the exact systolic 170-180, but my diastolic was 116. It took the ambulance approximately 10-15 min to arrive. By the time the ambulance arrived, I was feeling close to my baseline and my BP was improving. I was seen by the ER MD, and feeling fairly well, my throat still felt a tiny bit tight, but no difficulties swallowing. The plan was to complete treatment with IV steroids, Benadryl, and Pepcid, then be observed for a few more hours. This was approximately around 16:30. Not more than 5 min after MD left my room, I got the flushing feeling, and throat closing feeling again. While the medications were being prepared these symptoms increased, ( I could still breath adequately and vital signs were still OK. It took about 10 minutes after meds were given for symptoms to begin to subside ( No epi given) I was observed until 21:30 then discharged. I am taking 50 mg daily x 3 days, 25mg Benadryl q 8hrs x 3 days, and 20mg Pepcid bid x 3 days. I feel fine , no further episodes
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| 59 | 2021-01-14 | pain in extremity | Severe arm pain; severe body aches and headache. Fever |
| 59 | 2021-01-14 | pain in extremity |
Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare ...
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Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) then received the second dose (lot number: EK 9231, expiration date: not reported) on 08Jan2021 13:45 both via an unspecified route of administration on the left arm at a single dose for COVID-19 immunization. Medical history included that the patient had allergies to medications, food, or other products such as Penicillin, Sulfa drug and pork. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), ergocalciferol (VIT D) and biotin (BIOTIN). On 08Jan2021 22:45, 9 hours after vaccine the patient experienced diarrhea, severe chills and sore arm. As treatment, patient received ibuprofen (ADVIL) and fluids. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number (first dose) has been requested.
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| 59 | 2021-01-15 | pain in extremity |
Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later ...
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Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later severe pain in L shoulder with marked restriction in movements. Persisting pain in L shoulder which wakes me up at night. Unable to do my daily workouts and yoga.
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| 59 | 2021-01-16 | tingling |
Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and n...
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Noted prior to having drug reaction and was planned to wait 30min post-vaccine. She felt "pins and needles" 20minutes after vaccine admin and then began itching. Presents to observation unit with red rash, 3-4 hives across upper and mid-back. Endorses itching on scalp as well as trunk. No rash noted on hands, arms, or face. Benadryl given after pt consulted with Dr. mild relief of symptoms. MDs spoke extensively with patient. She was ok to go home after her spouse arrived to drive her.
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| 59 | 2021-01-16 | tingling |
left arm became red with rash that was raised like small pimples, I felt like something was prickin...
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left arm became red with rash that was raised like small pimples, I felt like something was pricking me from the inside out then felt a little uneasy and face was itching with a small hive on my right cheek. My arm became bright red, I took a 25 mg benadryl which subsided some of the redness. I finished my shift and drove home about 5 pm still felt like I had prickly heat I took another 25 mg benadryl slept. I was extremely tired the next day which I could not tell if it was from the vaccine or benadryl or both. I work in a doctors office .
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| 59 | 2021-01-16 | tingling |
Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes s...
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Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes she started to feel a "pins and needles" sensation on her arms and head. Right after that, pt describes diffuse puritis on scalp, across upper and lower back. Itching continues down extremities while being observed. Red rash, 4-5 hives on upper and mid-back. She is visibly scratching her neck, head and back and appears restless because of the intense itching. Assessed by Dr (IM) and Dr(ID); 50mg po Benadryl ordered and given to pt. She endorses mild relief from symptoms.
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| 59 | 2021-01-17 | feeling hot, muscle spasms, tremor |
Dizziness, weakness is extremities. Cramping in legs. warm sensation in chest, back arm legs. Shaki...
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Dizziness, weakness is extremities. Cramping in legs. warm sensation in chest, back arm legs. Shakiness. Feeling of passing out. Foggy thoughts.
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| 59 | 2021-01-17 | feeling hot | Became hot and nauseated |
| 59 | 2021-01-17 | pain in extremity |
Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning w...
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Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning with chills, low grade fever, mild nausea, a headache, and a very sore arm. By late morning I had a fever of 100.9 and a severe headache. Early afternoon fever went up to 102.1. At this time I took ibuprofen 400mg and sumaptriptan 100mg. Fever came down and heaeache lessened.
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| 59 | 2021-01-17 | pain in extremity |
On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vo...
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On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vomiting. At midnight I went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement. I had complete occlusion of the right coronary artery
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| 59 | 2021-01-17 | pain in extremity | I experienced soreness in my right arm at the injection site and a few days later it went away. |
| 59 | 2021-01-18 | weakness |
Pt had nausea after 2 hours and felt tired/heavy feeling. Took Ibuprofen. On day later, experien...
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Pt had nausea after 2 hours and felt tired/heavy feeling. Took Ibuprofen. On day later, experienced more nausea and lack of appetite, and then had a terrible headache. It got worse and she experienced neck stiffness and her blood pressure was 175/95 at 4pm on 1/8. She rested and felt better about 24 hours later. She felt normal again after a few days.
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| 59 | 2021-01-18 | weakness |
Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden...
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Difficulty breathing, high blood pressure and heart rate. Very sick for the next 3 days...bedridden due to sickness; nausea, shaking, weakness, muscle aches, joint aches, severe headache, stomach pain, skin blisters, fever and chills, injection site pain, tiredness, dizziness. By the 4th day I am still weak and now I have skin blisters on my body in various places. Today is the 5th day and I still feel weak and slightly sick, nausea and fatigue and more skin blisters, fever.
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| 59 | 2021-01-18 | breast pain |
I received my shot in upper left arm 1/15/21 @ 1:45pm and on Sunday 1/17/2021 in am I'm noticing pai...
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I received my shot in upper left arm 1/15/21 @ 1:45pm and on Sunday 1/17/2021 in am I'm noticing pain on the left side of my breast and armpit area. I felt my lymph nodes and they are swollen as well. I stopped wearing a bra because it was painful.
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| 59 | 2021-01-18 | numbness |
Within 1 hour of vax, with numbness to left chin/neck and ear region. Neg PMH. Stable. Directed to ...
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Within 1 hour of vax, with numbness to left chin/neck and ear region. Neg PMH. Stable. Directed to f/u with occupational health services.
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| 59 | 2021-01-18 | pain in extremity | Sore muscles , especially legs. My legs are achy. |
| 59 | 2021-01-19 | flushing |
Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy ...
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Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy head" feeling. Hypertensive at time BP left arm 171/95 HR 79, RR 26, 99% RA. Apple juice, and cracker provided, and emesis bag provided. Patient was already waiting for thirty minutes time (she was 15 minutes into her wait time). She reported having a progression of nausea and dizziness Repeat vital signs at 1345 139/100 HR 76, RR 24 Pox 96% RA. First responder was called and patient was assisted into wheelchair and taken to the ER for further evaluation.
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| 59 | 2021-01-19 | tingling, flushing, weakness |
Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minut...
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Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minutes. Two hours later, itching began on left leg and arms. Noted red blotches to these areas. Face began to feel very prickly and flushed, felt lower lip swelling and left eye began to feel funny. Observed one hive to cheek. Was able to take a Benadryl 25mg capsule within about 10-15 minutes after this developed. Symptoms began to subside after this. Felt back to normal the next day. Just moderate injection site pain for 1-2 days.
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| 59 | 2021-01-20 | weakness |
severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; ache...
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severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; achenes and weakness; first dose of BNT162B2 on 20Dec2020/second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 59-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) intramuscular at left arm on 06Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included diabetes and hypertension. no allergies to medications, food, or other products. other medications in two weeks included hydrochlorothiazide, lisinopril, atorvastatin, metformin and colecalciferol (D3) and fish oil, tocopherol (OMEGA 3 [FISH OIL;TOCOPHEROL]). the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of BNT162B2 (brand=Pfizer, Lot number: EJ1685) on 20Dec2020 04:00 PM via intramuscular at left arm at single dose for COVID-19 immunization (59 years old) and had muscle soreness at greater injection site. Patient experienced soreness at injection site, Fatigue, Fever up to 101.8, severe heartburn, achenes and weakness, all on 07Jan202101:00 AM. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect.
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| 59 | 2021-01-20 | weakness |
Extreme fatigue, I even had to take days off where I sat in the dark in my living room unable to do ...
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Extreme fatigue, I even had to take days off where I sat in the dark in my living room unable to do anything due to lack of energy. The week of the vaccine I had to go 3 days early due to the exhaustion. I also had stomach pain and bowel issues. I went to the clinic and the first time they thought it was diverticulitis and the second time they ordered a CT scan of the abdomen and some labs and they all came normal.
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| 59 | 2021-01-20 | difficulty speaking |
1430 - Employee vaccinated, observed for 15 minutes, no symptoms... returned to work. 1600- develop...
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1430 - Employee vaccinated, observed for 15 minutes, no symptoms... returned to work. 1600- developed headache while working, took Excedrin 325 mg, (x2), by mouth. 1630- tightness of throat, raspiness, dizziness.... returned to where vaccine was given. METS team called and taken to ER.
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| 59 | 2021-01-20 | difficulty speaking |
Covid Vaccine (Pfizer)administered at 1430..... observed for 15 minutes... went back to work. 1600 ...
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Covid Vaccine (Pfizer)administered at 1430..... observed for 15 minutes... went back to work. 1600 - started with headache, took two tablets of Excedrin 325 mg by mouth. 1630-- tightness of throat, raspiness, dizziness..... return to where vaccine was given initially., heart rate 104 Emergency team called and taken to ER.
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| 59 | 2021-01-20 | feeling jittery | 2 Hours post vaccine pt started feeling dizzy, lightheaded and "weird inside"/jittery |
| 59 | 2021-01-20 | migraine |
I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my...
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I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my balance. I developed very severe migraine headaches and was hospitalized. I still have not regained my balance. I have had a couple of courses of prednisone and migraine medication. My neurologist is setting up IV I G transfusions feeling that I?m having an auto immune response to the vaccine.
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| 59 | 2021-01-20 | pain in extremity | Pain at injection site Arm, shoulder, neck pain Headache Fatigue Chills Nausea |
| 59 | 2021-01-20 | pain in extremity |
she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hur...
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she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hurt (injection site); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration in the arm on 02Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine dose on 02Jan2021. She gets tested regularly at work. On 04Jan2021, she tested positive for the Covid virus. She had a headache, not feeling great on Friday, after she was diagnosed with the Covid virus, but no symptoms before. No side effects from vaccine, other than her arm barely hurt (injection site) in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-20 | pain in extremity | chills , muscle ache , arm hurting more than 1st shot |
| 59 | 2021-01-20 | tingling, facial paralysis |
Pfizer-bioNtech COVID-19Vaccine EUA Approximately 2-3 hours after the vaccine was administered, I no...
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Pfizer-bioNtech COVID-19Vaccine EUA Approximately 2-3 hours after the vaccine was administered, I noted tingling and a "tight" feeling on the right side of my face. I have had bells palsy before and if felt the exact same way. I noted drooping of the right side of my mouth, stabbing pain in my right ear. This lasted for 24 hours, currently, slight numbness remains at corner of right side of mouth and occasional stabbing pain right ear.
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| 59 | 2021-01-20 | tingling, tremor |
Body shaking; Chills; Tingling; Nauseous; Body ache; Tiredness; having like little sweat; This is a ...
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Body shaking; Chills; Tingling; Nauseous; Body ache; Tiredness; having like little sweat; This is a spontaneous report from a contactable nurse (reporting for herself). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration from 08Jan2021 07:40 at single dose for COVID-19 immunization. Medical history included hypertension, high cholesterol and COVID-19 survivor from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had historical vaccine of first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient stated, "I am calling to report a side effect from the vaccine (Clarified COVID-19 vaccine). I am a health care worker, I got the first dose I was fine but I got the second dose last Friday and I woke up hour later with terrible chills, tingling, my body shaking. It was not half an hour later, it was hours later. I took it at 07:40 in the morning at work and then I came home, I was fine but then chills woke me up in mid night Friday it was Saturday, let's say Saturday morning 12 am. I woke up with chills like, I am in refrigerator and I felt like I wanted to warm it but I did not, I felt nauseous, it happened like two different times and after that I took like Motrin (treatment) I did not have any temperature but I have like body ache and after that I started having like little sweat and tiredness. I just call my job now. Having the same symptoms now." The patient took Motrin and Tylenol and underwent lab work at the hospital with unknown result. The patient think that the events were related to COVID as the patient stated, "I think so because I woke up with the chills extreme chills. I never felt that way, it's like the last time when I felt it, when I had COVID, I woke up with extreme chills the only difference between this one was that I didn't have a temperature with these chills but with COVID I have temperature but this one was extreme chills." The outcome of the events was unknown.
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| 59 | 2021-01-21 | numbness, weakness |
Patient began complaining of weakness and chest pressure after receiving COVID-19 vaccine. A code bl...
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Patient began complaining of weakness and chest pressure after receiving COVID-19 vaccine. A code blue was called, and the patient was taken to the emergency department for further workup. In the ED, the patient was evaluated for hypertension and chest pressure and subsequently discharged after a negative workup (normal EKG, normal troponin). On 1/17, the patient returned to the ED with complaints of numbness in the left arm from fingertips to elbow, with sensation slowly returning over the next 10 minutes. A head CT scan was performed, showing bilateral acute on chronic subdural hemorrhage (possibly related to fall patient reported having on 12/5/20 down 10 steps of stairs). The patient was eventually discharged on 1/19.
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| 59 | 2021-01-21 | numbness, speech disorder, hot flush, tingling |
Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and ting...
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Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.
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| 59 | 2021-01-21 | tenderness, pain in extremity |
Fever, chills , body aches, for 24 hours. Fever finally broke after soaking 2 sets of pjs. Back ach...
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Fever, chills , body aches, for 24 hours. Fever finally broke after soaking 2 sets of pjs. Back ache. Sore arm. I've recovered from all of that with tylenol. but I have swelling and tenderness under the arm, lymph nodes?
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| 59 | 2021-01-23 | weakness |
10 pm started with uncontrollable chills and headache about 5 am fever body ache nauseated Next day...
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10 pm started with uncontrollable chills and headache about 5 am fever body ache nauseated Next day sat 1/9 2pm diarhea lasted 24 hours Monday fatigue headache and body ache continued Tues headache fatigued and short of breathe wed woke up with sl headache and weak by dinner time felt better
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| 59 | 2021-01-23 | pain in extremity |
1630 developed sore shoulders, left arm. 1800 developed minor HA No treatment, went to bed 1/20 0500...
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1630 developed sore shoulders, left arm. 1800 developed minor HA No treatment, went to bed 1/20 0500 awoke to severe HA, muscle aches. Took Tylenol. Symptoms resolved over 48 hours
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| 59 | 2021-01-24 | difficulty speaking |
Approximately 10 minutes post injection, subject began to feel throat tighten. After taking a drink ...
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Approximately 10 minutes post injection, subject began to feel throat tighten. After taking a drink of water, the subject felt the throat tightness becoming worse. The patient could talk but her voice wounded horse. Heart rate increased. After consulting with physician at vaccine administration site, patient was transferred to the emergency room for treatment. Blood pressure was 200/100 in the emergency room. Patient was treated with benadryl, steroids and pepcid. Patient recovered
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| 59 | 2021-01-24 | feeling cold, pain in extremity | sore arm for five days extremely cold body aches dry cough extreme fatigue |
| 59 | 2021-01-24 | numbness, tingling, pain in extremity, muscle spasms |
Started with arm pain one day after vaccination. Pain gradually got worse bilateral leg cramps four...
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Started with arm pain one day after vaccination. Pain gradually got worse bilateral leg cramps four days later escalating into tingling, numbness and pressure. Office visit with primary on 1/11/2021. Pain escalated into not being able to walk Patient went to ER on 1/20/21. Patients condition is ongoing.
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| 59 | 2021-01-24 | numbness |
Left side of my face became numb. Then my eye, tongue and throat began to swell. I stopped and purch...
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Left side of my face became numb. Then my eye, tongue and throat began to swell. I stopped and purchased Benadryl. The swelling started to diminish after about 4 hours, but tingling and slight numbness continued for about 3 days.
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| 59 | 2021-01-24 | muscle spasms |
muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 59-year-old fem...
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muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 19Dec2020 for the first dose (lot number and expiry date unknown), and on 09Jan2021 for the second dose (lot number: E11685, expiry date: May2021) both at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first shot on 19Dec2020 and had some muscle spasms on Dec2020, but it was gone after two (2) days. On Saturday (09Jan2021), she got her second shot and she was in a giant muscle spasm from head to toe. It was like a whole-body Charlie horse that won't quit, and it hurts. It started three (3) hours after the shot and is not going away. It hurts and worked her up. The patient called to ask what she can request to treat the muscle spasm; a muscle relaxer? Patient didn't want to take anything that will counteract the vaccine. The event was reported as Non-serious. The patient recovered from muscle spasms on an unspecified date in Dec2020. information on the lot/batch number has been requested.
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| 59 | 2021-01-24 | pain in extremity, migraine |
Less than 24 hours after vaccine started stomach cramps, diarrhea and sore arm, next day ocular migr...
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Less than 24 hours after vaccine started stomach cramps, diarrhea and sore arm, next day ocular migraine(never had before) with flashing lights and severe headache, extreme fatigue, sore throat, felt terrible Had vaccine on Friday and by Monday, I felt recovered
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| 59 | 2021-01-24 | tingling, numbness |
On 1/18/21, 20minutes after receiving the shot, I started having numbness and tingling in my right ...
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On 1/18/21, 20minutes after receiving the shot, I started having numbness and tingling in my right arm, all the way down to my finger tips. it lasted for 10-20 minutes then slowly improved. This also happened after the first shot but I didn't think much about it because it only lasted for 3-5 minutes was mild and it was mostly just tingling.
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| 59 | 2021-01-24 | seizure |
On Jan 25th, 2021 patient went to the Covid clinic to get the first dose of covid vaccine at 5:50 pm...
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On Jan 25th, 2021 patient went to the Covid clinic to get the first dose of covid vaccine at 5:50 pm. After receiving the vaccine , patient was advised to wait at the waiting room to watch for any adverse reactions. Around 6:05 pm patient had a seizure and was around by the hospital staffs. The rapid response team came and took the patient to the Emergency Department on a wheelchair. Patent was alert when she left the Covid clinic.
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| 59 | 2021-01-25 | hot flush |
Extreme exhaustion, mental cloudiness, chills and hot flashes, diaphoresis, temp spikes, 99.5. norm...
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Extreme exhaustion, mental cloudiness, chills and hot flashes, diaphoresis, temp spikes, 99.5. normal temp is 97.6 to 98.0
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| 59 | 2021-01-25 | muscle spasms |
Muscle spasm and get hurt from head to toe; major muscle spasm; think if my husband touch me I would...
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Muscle spasm and get hurt from head to toe; major muscle spasm; think if my husband touch me I would kill him; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included Crohn's disease ("it's auto immune disorder in the digestive system"). The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization and was a little sore. On Saturday the patient got her second Pfizer vaccine (Covid Vaccine) and stated, "I feel like I am in a "giant" "terrible" (not clarified) because one time muscle spasm from head to toe. I think if my husband touch me I would kill him and I am taking a single. Just a major muscle spasm and I wanted to know, what should I tell my doctor to give me? Should I tell him to give me pain medication, muscle relaxers (Unspecified Medication)? Is it going to affect the effectiveness of the shot?" The patient took ibuprofen to try ease it out that didn't work. The outcome of the event was not recovered. Vaccination type facility was hospital. Information about Lot/Batch number has been requested.
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| 59 | 2021-01-25 | nerve pain |
nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare...
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nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration in the right arm on 08Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included ongoing ideopathic neuropathy and high cholesterol. Concomitant medications included duloxetine (DULOXETINE), acetylsalicylic acid (ASPIRIN BP), and simvastatin (ZOCOR). The patient experienced nerve pain which began in feet, arms and hands on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the event was not recovered.
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| 59 | 2021-01-25 | pain in extremity, weakness |
Achy legs/Sore arm; Weak and very tired; Weak and very tired; Slight headache; This is a spontaneous...
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Achy legs/Sore arm; Weak and very tired; Weak and very tired; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 14:45 at single dose for COVID-19 immunisation. Medical history included multiple sclerosis and Raynaud's phenomenon. Concomitant medication included natalizumab (TYSABRI) from 30Dec2020. The patient previously took and experienced allergies with celecoxib (CELEXIA), amoxicillin, desipramine and pantoprazole. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 13:30 at single dose for COVID-19 immunisation. On 12Jan2021, the patient had achy legs. The patient was also weak and very tired that afternoon, with slight headache. She was much better on 13Jan2021. Her sore arm developed the day after vaccination after both injections lasted a day or two. No treatment was received for the adverse events. Clinical outcome of the events was recovered on Jan2021.
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| 59 | 2021-01-25 | pain in extremity |
Patient reported experiencing extreme pain in her right arm approximately 4.5 hours after the inject...
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Patient reported experiencing extreme pain in her right arm approximately 4.5 hours after the injection which progressively became worse overnight. Limited mobility of right arm. Only with assistance and extreme pain can she move her arm above her head, in front of her outstretched, or behind her. Resting pain 2 days later still high at 6 and 10 with motion. Prickling sensations in her neck periodically as well. Taking 440 mg of naproxen for pain. 7 days later still in significant pain but slightly better. Migrating pain also now down the front of the arm, across the shoulder blade, and neck.
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| 59 | 2021-01-25 | tremor, feeling cold, pain in extremity |
headache, fluey, shaking and felt cold, deep muscle ache. Pt still has aching ,headache ,and sore ...
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headache, fluey, shaking and felt cold, deep muscle ache. Pt still has aching ,headache ,and sore arm.
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| 59 | 2021-01-25 | tremor |
Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint ...
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Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 59 | 2021-01-26 | weakness | nause, stomach cramps, fever blisters, lethargic, weakness |
| 59 | 2021-01-26 | weakness | Nausea, stomach cramps, fatigue, and weakness |
| 59 | 2021-01-26 | burning sensation, numbness |
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20...
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1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20 and 1/21. 01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea. In the evening hives started on hands/back/legs. 01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
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| 59 | 2021-01-26 | feeling hot, discomfort |
VERBAL CONSENT OBTAINED, MONITORED FOR 15 MINPER POLICY, AT THE 15 MIN MARK PATIENT COMPLAINED OF M...
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VERBAL CONSENT OBTAINED, MONITORED FOR 15 MINPER POLICY, AT THE 15 MIN MARK PATIENT COMPLAINED OF MY BODY FEELS IMMEDIATELY TIRED AND WARM AN HEAVYBP 126/78 HR 74 POX 99 RA, KEPT FOR ANOTHER 15 MIN TO MONITOR
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| 59 | 2021-01-26 | numbness |
Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pai...
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Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pain, diarrhea x2, nausea,
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| 59 | 2021-01-26 | migraine |
14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down,...
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14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down, but has joint pain and dull headache.
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| 59 | 2021-01-26 | migraine |
severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable ...
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severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable nurse. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142/expiration date unknown) dose number 2, via an unspecified route of administration on 08Jan2021 09:00 at a single dose on the right arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included asthma, arrhythmia, sulfonamide allergy, and latex allergy. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine included BNT162B2 (COVID-19, lot number EJ1685, dose number 1) on 18Dec2020 06:30 on the right arm. There were no other vaccinations within 4 weeks. Concomitant medications included ASA, acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), cyanocobalamin (VIT B12), ergocalciferol (VIT D), and cetirizine hydrochloride (ZYRTEK). The patient experienced severe arthralgias, migraine headache, and mild nausea on 08Jan2021 20:00. The outcome of the events was recovered in Jan2021.
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| 59 | 2021-01-26 | muscle spasms, throat numbness, pain in extremity |
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest...
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Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-26 | pain in extremity, tingling |
Vaccine was received at 7:12 a.m. on 1/26, I did not feel any adverse effects except for a sore arm...
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Vaccine was received at 7:12 a.m. on 1/26, I did not feel any adverse effects except for a sore arm until approximately 8:30 p.m. when I noticed the area of my upper neck and under my chin started feeling tingly and slightly numb. It is now 1/27, 7:00 p.m. and I still have a similar feeling. I have not noticed shortness of breath or major difficulty swallowing.
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| 59 | 2021-01-26 | tingling, numbness |
Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for al...
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Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for almost 2 weeks , headaches, dizziness Completely normal on 1/22/21
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| 59 | 2021-01-26 | tingling, numbness |
NUMBNESS AND TINGLING IN CHIN, NOSEM JAWLINE, TO EAR ON RIGHT SIDE, AND LESS ON THE LEFT ALSO HAD T...
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NUMBNESS AND TINGLING IN CHIN, NOSEM JAWLINE, TO EAR ON RIGHT SIDE, AND LESS ON THE LEFT ALSO HAD TIGHTNESS IN THE BACK OF THE THROAT
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| 59 | 2021-01-26 | tingling |
My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later i...
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My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later it went away. But as it started to go away my lip was tingly and prickly.
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| 59 | 2021-01-26 | tingling |
Immediate ear to throat throbbing, arms tingling, chest heaviness, extreme fatigue within 25 minute...
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Immediate ear to throat throbbing, arms tingling, chest heaviness, extreme fatigue within 25 minutes of injection, lasted approximately 30 minutes
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| 59 | 2021-01-27 | weakness, pain in extremity |
achy legs/Sore arm; Weak; very tired; slight headache; This is a spontaneous report from a contactab...
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achy legs/Sore arm; Weak; very tired; slight headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration from 11Jan2021 at site of left arm at 14:45 at single dose for COVID-19 immunization. Medical history included multiple sclerosis and raynauds. The patient had known allergies: celecoxib (CELEXIA), amoxicillin, desipramine and pantoprazole. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and natalizumab (TYSABRI) from 30Dec2020. The patient received first dose of BNT162B2 with lot number: EH9899 on 21Dec2020 at 01:30 pm at site of left arm for COVID-19 immunization and experienced sore arm. The patient experienced achy legs at 06:00 on 12Jan2021, and weak and very tired that afternoon on 12Jan2021, slight headache. Much better 13Jan2021. Sore arm also developed on 12Jan2021. Facility type vaccine was in hospital. No other vaccine received within four weeks. No treatment for adverse event. No COVID prior vaccination. No COVID tested post vaccination. The outcome of events was recovered in Jan2021.
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| 59 | 2021-01-27 | facial pain |
Covid vaccine- injection site pain; her face and neck is red like a sunburn; her face stings; This i...
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Covid vaccine- injection site pain; her face and neck is red like a sunburn; her face stings; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number not known) via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had been allergic to Bactrim since that age of 20 and she had she blisters on her lips. The patient had her first dose of Pfizer Covid vaccine on Monday, 11Jan2021 and after that in Jan2021, her face and neck were red like a sunburn. She said she had injection site pain, her face stings and it has been two days out. She wanted to know if she should get her second shot. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-27 | tingling |
Vaccine given in left arm. Tingling in left breast started yesterday and continues on and off today...
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Vaccine given in left arm. Tingling in left breast started yesterday and continues on and off today.
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| 59 | 2021-01-27 | tremor, pain in extremity |
I received my vaccine Tuesday @ 1300, I felt good Wednesday morning taking Motrin alternating with T...
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I received my vaccine Tuesday @ 1300, I felt good Wednesday morning taking Motrin alternating with Tylenol around the clock. At 1400 I felt achy with mild chills, at 1700 symptom were a lot worse. Shaking chills, temp 100, back, neck, and leg pain. I went to bed slept off and on. Woke up this morning, Thursday feeling a little better thought I could work but after getting to work symptoms got worse again.
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| 59 | 2021-01-27 | unresponsive to stimuli |
Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1...
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Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1/27/21. At approximataely 16:30, patient complained of abdominal pain and was given Levsin 0.125mg and morphine 5mg orally. At approximately 19:30 patient was found on the floor covered in a large amount of emesis, unresponsive without a pulse.
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| 59 | 2021-01-28 | pain in extremity |
This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-...
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This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176), via an unspecified route of administration in left arm on 14Jan2021 10:15 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Medical history included ''Known allergies: Penicillin; Bee stings; Red meat; seasonal''. No COVID prior vaccination. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO), ergocalciferol (VITAMIN D). The patient previously received first dose bnt162b2 (lot number= EH9899) via an unspecified route of administration in left arm at the age of 59-year-old on 28Dec2020 10:15 for COVID-19 immunization. The patient experienced severe body aches, severe headache, arm sore on 14Jan2021 21:00. No treatment received for the events severe body aches, severe headache, arm sore. No COVID tested post vaccination. The patient not received other vaccine in four weeks. Patient was not pregnant. The outcome of events severe body aches, severe headache, arm sore was recovering. The outcome of other event was unknown.
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| 59 | 2021-01-28 | pain in extremity | Back Pain and Arm pain |
| 59 | 2021-01-28 | tremor |
Elevated heart rate; Elevated blood pressure; Lightheadedness; Shakiness; This is a spontaneous repo...
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Elevated heart rate; Elevated blood pressure; Lightheadedness; Shakiness; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9261), via an unspecified route of administration on 15Jan2021, on 15:45 as the first single dose for an unspecified indication. Medical history included breast cancer from an unknown date, osteoarthritis from an unknown date, vasovagal syndrome from an unknown date, and sulfa allergy. Concomitant medication included ergocalciferol (VIT D), tocopherol (VIT E [TOCOPHEROL]), glucosamine (MANUFACTURER UNKNOWN), curcuma longa (TURMERIC). The patient previously took cefalexin (KEFKEX) and experienced drug hypersensitivity, levofloxacin (LEVAQUIN), and experienced drug allergy. The patient experienced elevated heart rate on 15Jan2021, at 16:00 with outcome of recovered with sequelae; elevated blood pressure on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021; lightheadedness on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021; shakiness on 15Jan2021, at 16:00 with outcome of recovered with sequelae in Jan2021. The patient recovered with lasting effects with no treatment. There was no Covid test post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement and heart rate which were elevated in 15Jan2021.
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| 59 | 2021-01-29 | pain in extremity | Temperature 99.7 F, chills, right arm pain |
| 59 | 2021-01-31 | feeling hot |
red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spont...
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red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number BNT162b2), at age of 59-year-old via an unspecified route of administration in left arm on 31Dec2020 11:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), valsartan, rosuvastatin (ROSUVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at Time of Vaccination. The patient experienced red rash, bruise, slight nausea, slight feeling of fever but temp registered normal on 12Jan2021 01:00 with outcome of recovering. The patient received topical antibiotic, diphenhydramine (BENADRYL) for treatment. The events resulted in doctor or other healthcare professional office/clinic visit.
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| 59 | 2021-01-31 | pain in extremity |
extreme arm pain---goes down to fingers. Also a general feeling of being "off" and dizzy spell/vert...
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extreme arm pain---goes down to fingers. Also a general feeling of being "off" and dizzy spell/vertigo post vaccination day 5.
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| 59 | 2021-01-31 | pain in extremity |
Lymphadenopathy, severe Left SI joint and low back pain, including Left leg down to foot. chills,hea...
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Lymphadenopathy, severe Left SI joint and low back pain, including Left leg down to foot. chills,headache, nausea, Ibuprofen every 12 hours with Tylenol in between. Warm compresses
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| 59 | 2021-02-01 | flushing |
I was in my car about 8-10 minutes after injection felt flush like feeing coming over me; felt nause...
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I was in my car about 8-10 minutes after injection felt flush like feeing coming over me; felt nausea and like I might faint, blew my horn on my car, Physician came over checked on me , EMT came over checked my pulse, 62, made me lie back in my car, could not get a blood pressure reading because of BP cuff. Brought me some cold water watched me for an extra 20 minutes I felt a bit better, drove home and laid down for a while. Felt nauseous and dizzy most of the day. I felt like either blood sugar or Blood pressure dropped. My blood sugar was elevated that day. I refused offer to go to ER
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| 59 | 2021-02-01 | pain in extremity |
Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that...
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Next day following 2nd dose of Pfizer vaccine, developed a sore left arm at the injection site. that evening felt exhausted after work, fell asleep around 6:30 pm woke up around 8 pm and went to bed around 9:30 pm took Aleve for achy body. Friday morning, Jan 27th woke up with left arm pit and side of left breast swollen, tender to touch. and left arm very sore to lift up. Apply cold packs, taking Tylenol and area of tenderness lasting multiple days.
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| 59 | 2021-02-01 | pain in extremity |
Runny nose; allergies; sore arm; This is a spontaneous report from a contactable consumer (patient)....
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Runny nose; allergies; sore arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration at the left arm on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure (has had for 10+ years), ongoing high cholesterol (has had for 10+ years) and pulled a muscle in her arm on an unspecified date prior to vaccination. She received the vaccine because she is considered a front-line worker. She works for the department of Children and Family Services and must go into homes. She also adds that her mother in law was buried because she died from COVID. There were no concomitant medications. The patient received her first dose of the Covid-19 vaccine on 14Jan2021. She was fine other than a sore arm which started on 15Jan2021. On 19Jan2021, she has a runny nose. It is more like allergies. The outcome for the event sore arm was recovered on 16Jan2021; outcome for runny nose and allergies was unknown.
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| 59 | 2021-02-01 | seizure | Resident had seizure activity |
| 59 | 2021-02-02 | weakness, seizure |
Reports she suddenly felt ill the morning of January 22, chills, weak, fatigue. Followed by what app...
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Reports she suddenly felt ill the morning of January 22, chills, weak, fatigue. Followed by what appeared to be a Grand Mal Seizure. Reports she has not had a seizure in 20 years. However writer found documentation of a seizure in 2014. Patient feels it was related to the vaccine.
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| 59 | 2021-02-02 | weakness | Hi blood pressure, high blood sugar, weakness left side |
| 59 | 2021-02-02 | weakness |
My PCP advised I take benedryl and tylenol after the vaccine because of the AE I experienced to the ...
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My PCP advised I take benedryl and tylenol after the vaccine because of the AE I experienced to the 1st vaccine so I am unsure if because I was extra tired is d/t all of the vaccine or if the benedryl played a part in it. But about 2hr after I begin getting a headache but had already taken tylenol so I didnt take anything. I got a little dizzy and super sleepy but nothing else on the first day. The next morning I was so tired, drained feeling and very fatigued. I got up for a while but had to lay back down because I was feeling foggy, tired and very fatigued causing me to miss work. About 4pm I felt a little better. The next day I had a mild headache and still felt a little tired but was able to go to work and nothing else since.
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| 59 | 2021-02-02 | unresponsive to stimuli |
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilati...
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45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
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| 59 | 2021-02-03 | migraine |
lost all sense of balance; developed very severe migraines; This is a spontaneous report from a cont...
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lost all sense of balance; developed very severe migraines; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, on 21Dec2020 13:00 at single dose in right arm for COVID-19 immunization. Medical history included Hypertension, Depression, PCN allergy, Topical Iodine allergy. The patient was not Pregnant at the time of vaccination. Concomitant medications included metoprolol, HCTZ, bupropion hydrochloride (WELLBUTRIN), methylphenidate hydrochloride (CONCERTA), omeprazole (PRILOSEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately eight days after receiving the Pfizer Covid vaccine, the patient lost all sense of balance on 30Dec2020. She developed very severe migraines. She was hospitalized for four days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was on multiple doses of steroids. She was now starting IV I G infusions. Treatment received for the events included Relpax, steroids, IV Infusions. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 since the vaccination. Lab data included Nasal Swab: negative on 30Dec2020. The outcome of both events was not resolved.; Sender's Comments: Based on the available information causality between events lost all sense of balance and very severe migraines and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-02-03 | pain in extremity |
Temp 100; malaise; body aches; very sore arm; This is a spontaneous report from a contactable nurse ...
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Temp 100; malaise; body aches; very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK5730), via an unspecified route of administration (left arm), on 22Dec2020 19:00, at single dose, for covid-19 immunization. Medical history included asthma and; Covid (prior to vaccination). The patient has no known allergies. Concomitant medications included niacin; colecalciferol (D3); cyanocobalamin (B12); loratadine and; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient was also taking ginger. The patient experienced temp 100, malaise, body aches, and very sore arm - all on 23Dec2020 10:00. The patient recovered from all the events on an unspecified date. No treatment was received for all the events reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination and; have not been COVID tested post vaccination.
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| 59 | 2021-02-03 | pain in extremity |
Fever, chills, body aches, headache, fatigue, arm soreness. Onset of mild body aches around 1:30 pm ...
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Fever, chills, body aches, headache, fatigue, arm soreness. Onset of mild body aches around 1:30 pm - 2:00 pm on 2/3/21 23 hours post COVID vaccine # 2. Symptoms worsened by 5:30 -6 pm. Highest temperature was 101.7. Took Tylenol and ibuprofen alternately. By 12pm 2/4/21 temp down to 99.1. Fatigue and residual headache remains. Other symptoms resolved.
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| 59 | 2021-02-03 | tenderness | Woke with lymphadenopathy and tenderness left supraclavicular area |
| 59 | 2021-02-03 | tremor |
Symptoms: c/o dizziness, palpitations, tremors, chills. HR 132. Other vitals stable. Intervention: ...
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Symptoms: c/o dizziness, palpitations, tremors, chills. HR 132. Other vitals stable. Intervention: Rest, reassurance, warm water, HR down to 98. Stabilized.
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| 59 | 2021-02-04 | numbness |
numbness on the left side of her face; very stressed; This is a spontaneous report from a contactabl...
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numbness on the left side of her face; very stressed; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was having numbness on the left side of her face after receiving the first dose of the COVID-19 vaccine. She inquired about the symptoms in question and if Pfizer recommends receiving the second dose given her reaction to the first dose. She mentioned that she was very stressed about this symptom. The outcome of the events was unknown. The following information on the batch/lot number has been requested.
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| 59 | 2021-02-04 | numbness and pain in extremities |
severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomac...
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severe generalized burning pain, tachycardia, elevated blood pressure, dizziness, chest pain, stomach pain, headache daily starting on 01/06/2021 to 01/27/2021; moderate generalized burning pain, tachycardia, elevated blood pressure 1/27/2021 to now; daily use Cymbalta for neuropathy pain; Amlodipine for high blood pressure; undergoing cardiology evaluation, continuing neurology visits; pending endocrinology evaluation
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| 59 | 2021-02-04 | pain in extremity, numbness, tingling |
Pain , swelling very achy in ankles and knees for a few days. Later serious pain in hands and finge...
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Pain , swelling very achy in ankles and knees for a few days. Later serious pain in hands and fingers, numb feeling, tingling for about a week. Still have.
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| 59 | 2021-02-04 | pain in extremity |
general pain in the arm for the first 2 to 3 days feeling of being unwell started 6 days after injec...
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general pain in the arm for the first 2 to 3 days feeling of being unwell started 6 days after injection date. no fever. just a feeling of general fatigue that lasted for 2 to 3 days
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| 59 | 2021-02-05 | numbness |
2/4/21- nothing 2/5/21- chills and numbness in fingertips of left hand. Slept from 8:30am-10:30am ti...
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2/4/21- nothing 2/5/21- chills and numbness in fingertips of left hand. Slept from 8:30am-10:30am tingly went away but not congested 2/6/21 - no chills, no numbness but still congested, plus sore are which is expected
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| 59 | 2021-02-06 | flushing | Extreme headache, nausea, body aches, flushed skin, swelling of face, diarrhea |
| 59 | 2021-02-07 | pain in extremity |
basically flu-like symptons: woke up with splitting headache-lasted approx 22hrs: tylenol 1000mg 2pm...
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basically flu-like symptons: woke up with splitting headache-lasted approx 22hrs: tylenol 1000mg 2pm, rizitriptan ODT 10mg 10pm , tylenol 1000mg 4:50am injection arm very very sore-hurt to move-lasted all day & night; woke up Sunday am not near as sore & could move. fever 2.2 degrees over normal ( normal 97.2 after injection 99.4) all morning; went down after took tylenol @ 2pm Sat, came back then went away in evening body very achey all day after/Sat.-back to normal next day/Sun
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| 59 | 2021-02-07 | tingling, throat numbness |
Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roo...
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Patient began having "tingling" in fingertips within 30 minutes of vaccine. Numbness of tongue, roof of mouth, and back of throat started approximately 35 minutes later. No Shortness of Breath, Difficulty Breathing, or problems swallowing. Administered 50 mg Benadryl. Symptoms improved slightly, symptoms did not worsen. Observed for an additional 40 minutes. Went home with husband. Instructed to follow-up with 911 if symptoms worsened.
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| 59 | 2021-02-08 | muscle spasms, weakness, feeling cold, hot flush, pain in extremity |
Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 day...
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Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 days. Ongoing symptoms: waves of being hot/sweating, blurred visions, intermittent loss of taste and false sense of feeling of drowning or suffocating and/or breathing in heavy smoke, which last for a few seconds to a few minutes. diminished appetite, more easily fatigued, loss of energy. On February 8th, these symptoms began: feeling anxious, fatigued,sleepy, head feels spacey, slight headache, somewhat dizzy, intermittent buzzing sound in head, body aches, severe ache and muscle tenderness in left shoulder blade area down left arm, and muscle spasms in left shoulder and arm. Loss of taste again.
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| 59 | 2021-02-08 | pain in extremity |
Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my ri...
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Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my right hand up into my right elbow and swelling of all my right fingers except my right thumb. It took several days for the symptoms to clear and required that I take one PTO day since I couldn't type or hold a mouse.
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| 59 | 2021-02-09 | cold sweat, muscle spasms |
Charlie horses in legs; multiple cold sores on lip; Chills; Fatigue; headache; cold sweats; This is ...
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Charlie horses in legs; multiple cold sores on lip; Chills; Fatigue; headache; cold sweats; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unable to locate or read the details), via an unspecified route of administration on 19Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included psoriasis, high blood pressure, thyroid removal. The patient had no Known allergies. The patient other concomitant medications in two weeks included guselkumab (TREMFYA), levothyroxine sodium (SYNTHROID), aspirin (acetylsalicylic acid), bupropion hydrochloride (WELLBUTRIN), nebivolol hydrochloride (BYSTOLIC). Prior vaccination, the patient had not had COVID, not tested post vaccination. No other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 19Dec2020 at 12:00 PM at single dose in right arm for COVID-19 immunization. The patient experienced charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweats on 20Jan2021 07:00. The patient did not received treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jan2021. The outcome of the events charlie horses in legs, multiple cold sores on lip, chills, fatigue, headache, cold sweat was recovered in Jan2021. Information on the Lot/Batch number has been requested.
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| 59 | 2021-02-10 | feeling cold, tenderness |
first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus...
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first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus shot. swelling, pain to touch and pain with movement or when positioned onto that side. decreased over 36-48 hours second injection 02/09/2020 306 pm received injection left deltoid. Awakened at 1237 am 02/10/2020 with chills, inability to get warm, headache, lightheadedness, sensation of heart pounding, nausea and moderate site tenderness. up most of the night. Nausea resolved about 10 hours after the symptoms resolved, remained without appetite. Fatigue, overall just tired, just not feeling well. temp max about 20 hours after onset of symptoms 101.5 temp broke when awakened from sleep in sweat at 327am 02/11/2020. on /2/11/2020 7am mild- moderate intermittent headache persists. Easy fatigue-as an example- fed cat took dog out and was tired and went back to bed.. Appetite better. felt better than I had on 02/10/2020, but not normal. Noted upon awakening is left axillary lymphadenopathy moderate and mild on the right- unable to press arms down to side as increased pain. also supraclavicular tenderness.
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| 59 | 2021-02-10 | feeling cold, tremor, pain in extremity, hypersensitivity of all senses, weakness |
7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks throug...
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7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks through left arm down to fingertips... 8:30- shooting shocks through left arm and starting to throb down through hand ... shooting up through next and base of head 9:00am- random shocks throughout my whole body. shoulder pain. 10:30- shocks stopped somewhat, shoulder and arm still achy, extreme fatigue/weakness, fogginess, blurry vision 11:30- extreme fatigue/weakness, fogginess, kind of blurry vision, severe shaking rt hand, had to sit down. Needed to hang on to things to walk. 12:00pm- continued severe fatigue and brain fogginess & still minor blurry vision, and a few shooting shocks in arm, shoulder , neck, 1:00pm? still great fatigue/weak, body aches-more like shocks than aches Neck is especially sore? back of neck up through head 1:10pm- severe fatigue, eyes hurt, foggy vision and cannot focus? off and on? chest pain for a period of time 1:40pm- twinges through body, still extreme fatigue? fogginess, back of neck is super sore.. Shoulder is slightly sore? 2:00pm- shoulder sore, severe fatigue but other symptoms seem to be getting less?. 2:45pm- shocks in left arm? 4:00pm- went home from work? hard to drive and focus.. severe fogginess, disorientation, 4:20- laid on the couch? slept in between nausea, buzzing in my head, severe arm pain going down into my hand, random shocks throughout my body, could not focus, brain was fuzzy, random severe itching, neck pain, eye pain, extremely irritable, extremely thirsty, bad taste in my mouth, extremely cold, no fever, super sensitive to sound & touch, no appetite, trouble peeing, felt extremely dehydrated. Needed to hang on to things to walk. Fri, Feb 5 6:00am- next day? better, but still buzzing, ringing in my head, extremely exhausted & weak, arm pain radiating to hand, hard to focus, coughing, chest heaviness like an elephant sitting on it, sore, scratchy throat, drainage out of head but not stuffed up?, eyes hurt. Severe nausea & bloating, rt hand shaking badly, no appetite 9:30am- everything is a bit better, coughing & chest discomfort gone, still bad taste in my mouth, slight nausea, bloated, eyes hurt, extremely tired, entire arm sore, buzzing in my head?random twinges or jolts in my limbs? 11:00am- still super tired, still not peeing?... weird for me who pees every 2 hrs or so? Still really bloated? still buzzing in my head, 1:30pm- feeling better, no buzzing, no zinging, super tired and drinking a lot but not much peeing? 4:00pm- home and bed.. hard to sleep because of jolts though my body.. Sat, Feb 6 Normal body aches.. finally able to pee decently, arm and hand on shot side sore (this is my good hand side), shooting pain, and hand aching. Fatigue, This has continued into Monday.. arm and hand pain are off and on. Everything is getting better?
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| 59 | 2021-02-10 | flushing |
Developed flushing of the cheeks and was a little lightheaded. She was brought to an observation roo...
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Developed flushing of the cheeks and was a little lightheaded. She was brought to an observation room from 5:15 PM to 6:15 PM and provided with water and snacks. The lightheadedness resolved with water and food. She was monitored closely for respiratory distress, stridor, tachypnea, and accessory muscle use which were not noticed or appreciated during this time period. Denied difficulty swallowing, shortness of breath, tongue swelling, redness, or any other systemic symptoms. By 6:15 PM, the flushing had greatly subsided. If the flushing remained when she arrived home, recommended taking benadryl prior to going to sleep. Advised to go to the ED should she develop shortness of breath, respiratory distress, tongue swelling, hives, and/or increasing redness to other parts of the body. She expressed understanding.
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| 59 | 2021-02-10 | tremor |
12/16 vaccination 12/28 symptoms started to include; low blood sugar, shakiness, severe chills, hear...
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12/16 vaccination 12/28 symptoms started to include; low blood sugar, shakiness, severe chills, heart palpitations, low potassium. 2-3 hours symptoms lasted. Went to the ER; Oral potassium, juice to bring blood sugar up.
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| 59 | 2021-02-10 | tremor |
1/5 vaccination later that evening; shakiness, heart palpitations, chills. Lasted for approximately ...
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1/5 vaccination later that evening; shakiness, heart palpitations, chills. Lasted for approximately an hour and then subsided.
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| 59 | 2021-02-11 | tingling, pain in extremity |
Excruciating pain in left arm starting at shoulder - no movement or feeling - weakness - numbness - ...
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Excruciating pain in left arm starting at shoulder - no movement or feeling - weakness - numbness - tingling
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| 59 | 2021-02-14 | pain in extremity |
Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting co...
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Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting commencing the following day and continuing for 24 hours; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 16:30 at single dose in Right arm for covid-19 immunisation. Patient was not pregnant.Medical history included allergies to cefalexin (KEFLEX), codeine and sulfa.Concomitant medication included escitalopram oxalate and omeprazole (PRILOSEC) . Patient experienced naseau and vomiting commencing on 28Jan2021 at 10:00 and continuing for 24 hours. On 28Jan2021 at 10:00 patient also had redness and swelling and acute pain at site of injection, aches and pains in arm radiating in back and shoulder.No treatment given. Final outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 59 | 2021-02-14 | tremor | Fever for 2 to 3 weeks 103, tremors, chills, sweats, headaches, bladder infection |
| 59 | 2021-02-15 | difficulty speaking |
Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing ...
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Four hours after receiving the vaccine noticed that voice was lower and had a wet cough, "breathing was noisy. and noticeable" States breathing was not difficult but it felt like, "my chest was not right." About 12 hours later back to breathing normally. Tongue looks like all taste buds are gone on one section of tongue. Color is different than rest of tongue. Noticed metal taste on tongue on 02/11/2021 two days after vaccine. Food does not taste the same. Continues to have these concerns. 02/15/2021 chest was "pinkish, lacy redness." This was gone by 02/15/2021
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| 59 | 2021-02-15 | migraine |
After first dose, some discomfort in arm and low grade fever about 24 hours after administration. Af...
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After first dose, some discomfort in arm and low grade fever about 24 hours after administration. After second dose, approximately 12 -18 hours after, severe body aches, migraine headache which lasted for about 24 hours.
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| 59 | 2021-02-16 | weakness |
Weakness, fatigue, injection site sore, clouded thought process. Slept for 10 hours. Woke up to n...
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Weakness, fatigue, injection site sore, clouded thought process. Slept for 10 hours. Woke up to no other symptoms except sore arm.
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| 59 | 2021-02-17 | facial paralysis, nerve pain |
Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blu...
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Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
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| 59 | 2021-02-18 | burning sensation, tingling |
reaction to that of shingles. headache, nausea, burning/tingling sensation one side of body with sma...
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reaction to that of shingles. headache, nausea, burning/tingling sensation one side of body with small breakout and pain in breakout area. this began approx. 2 weeks after last covid 19 dose.
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| 59 | 2021-02-18 | migraine |
7 hours after injection body aches progressed over 3 hours to pain in all joints. Shivering, rigors,...
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7 hours after injection body aches progressed over 3 hours to pain in all joints. Shivering, rigors, fever 101.3. Then 12 hours after injection sever migraine and nausea lasting 12 hours. 48 hours later diarrhea for 8 hours.
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| 59 | 2021-02-18 | throat numbness |
Pfizer-BioNTech COVID-19 Vaccine EUA. Approximately 30 minutes after shot, got a very bad taste in t...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Approximately 30 minutes after shot, got a very bad taste in the mouth, then throat became numb and I could not swallow unless I really forced it. I had to drink to be able to swallow. Again had to really try before I could. Then roof of mouth, back of throat and back of tongue felt number as if I had novocaine. The lack of swallow lasted about 10 minutes of forced swallowing. The numbness continued for about 2 hours but I was able to do everything. The numbness was more of an annoyance.
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| 59 | 2021-02-22 | pain in extremity |
With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very dee...
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With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very deep sleep for 48 hours. I woke to drink water and use restroom only. On Monday morning I woke up soaked in sweat that smelled like vinegar and the fever was gone. My first shot I had a little soreness in my arm only.
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| 59 | 2021-02-23 | difficulty speaking | nausea, vomiting, hoarse throat, diaphoresis |
| 59 | 2021-02-23 | flushing |
small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushe...
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small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.
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| 59 | 2021-02-23 | pain in extremity |
soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest l...
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soreness in arm; achiness; Covid testing was positive/diagnosed with Covid-19; pulse ox 92 (lowest level); tightness in chest (no productive cough); This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 10Jan2021 09:00 (lot number EJ1686 and expiry date unknown) at single dose for Covid-19 immunization in a hospital and not in a military facility. Medical history included asthma. Concomitant medications included albuterol [salbutamol] from unspecified date for unspecified indication. Historical vaccine included flu shot in Oct2020 for immunization and experienced some soreness in arm and achy. The patient was not given other vaccines given the same day or 4 weeks prior. In Jan2021, the patient had some soreness in arm and achiness (Jan2021) after the Pfizer BioNTech Covid-19 vaccine it didn't last long and she went to work afterwards. The patient was scheduled for work the next day and could tell something was not right. The patient was flushed and thought it was from the Albuterol since it can cause a racing heart beat and checked for a fever and didn't' have one. The patient checked temperature before bed and it was 100.5 degrees and she went straight to (redacted). The patient informed that she went for Covid testing; she went to physician office for Covid testing. The patient was praying for the flu so she could take Tamiflu and the flu test was negative (21Jan2021) and the Covid testing was positive (21Jan2021). The patient was tested positive after first Covid vaccine and ran fever 8 to 9 days and highest temperature was 101 degrees, had a little bit of asthma and kept a close watch, congestion, pulse ox 92 (lowest level), tightness in chest (no productive cough), felt beat up, fatigued and tiredness. The patient was diagnosed with Covid-19. She was told as well not to take pain relievers (ibuprofen, Advil and Aleve) and was advised to take Tylenol instead. The patient informed that she was to get her second dose tomorrow. The patient wanted to know if she can get the second dose if she was tested positive. The patient was supposedly scheduled to have the second dose on 27Jan2021 however it was moved to 04Feb2021 due to tested positive of Covid and was put on quarantined. The outcome of the events was recovering. The patient was unable to provide seriousness criteria when queried and said that this was her luck of the draw. The patient thought the shot actually helped.
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| 59 | 2021-02-23 | tingling, weakness | Tingling in face, lightheaded, tired, feels "drunk", weak |
| 59 | 2021-02-24 | weakness |
Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen...
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Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
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| 59 | 2021-02-24 | numbness, tingling |
injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swe...
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injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, nausea, feeling unwell, numbness and tingling in left hand thumb and pointer finger
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| 59 | 2021-02-24 | tingling |
Tingling in L arm that radiated to fingertips. Patient felt like it was anxiety related, refused to ...
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Tingling in L arm that radiated to fingertips. Patient felt like it was anxiety related, refused to be seen by EMS
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| 59 | 2021-02-25 | tingling |
Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes af...
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Patient began to deeply sweat, was lightheaded, dizzy, and was blacking out. It started 3 minutes after she received the vaccine and also started with a weird iron taste in her mouth, and tingling in her hands. She felt like she was going to pass out but got better after 20 minutes. The tingling in her hands continued though and would start and stop periodically.
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| 59 | 2021-02-28 | pain in extremity |
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest o...
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nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
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| 59 | 2021-02-28 | pain in extremity |
Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from...
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Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from a non-contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 22Jan2021 (12:45) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium, magnesium, vitamin d nos (CAL MAG), calcium carbonate;colecalciferol;phytomenadione (VIT D+K) and fish oil (OMEGA 3). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) on 30Dec2020 (when the patient was 59 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021, the patient had sore arm; insomnia; and chills in the evening ("eve"). On 23Jan2021, the patient had body ache, headache and tiredness. The patient did not receive any treatment for the events. The outcome of the events, 'sore arm', 'insomnia', 'chills', 'body ache', 'headache' and 'tiredness', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-03-01 | weakness |
racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break;...
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racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies. The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 59 | 2021-03-01 | migraine | lightheadedness, migraine started. Waited extra 15 mins- Evaluated by EMS- Cleared |
| 59 | 2021-03-02 | weakness | Weakness. Evaluated by EMS- Cleared |
| 59 | 2021-03-02 | discomfort | Lightheaded, facial pressure, "feeling like something stuck in throat" - Evaluated by EMS-Cleared |
| 59 | 2021-03-02 | flushing, feeling hot |
20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Pat...
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20min post vaccination patient complained of numbness of tongue, flushing, with hives on chest. Patient was given 50mg of PO diphenhydramine and was monitored for 60 min. Refused call to 911. Flushing and warmth had abated and left clinic under own volition.
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| 59 | 2021-03-03 | numbness, tingling |
mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ t...
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mitral valve flare up; Heart palpatation; face numbness/ Numbness in right cheek; tingling finger/ tingling in right fingers; This is a spontaneous report from a contactable healthcare professional. A 59 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6201), via an unspecified route of administration (on left arm) on 18Feb2021 12:00 (at the age of 59-years-old), single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included levothyroxine, propranolol, omeprazole (PROTONIX), linaclotide (LINZESS). The patient previously took codeine, prednisone, dtap, had known allergies: Codeine prednisone and dtap. The patient experienced heart palpitation, face numbness, tingling finger, all on 18Feb2021 1500. Numbness in right cheek and tingling in right fingers and motto valve flare up, all on 19Feb2021, the events resulted in Emergency room/department or urgent care.No treatment given for adverse events. The outcome of the events were recovering. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination.; Sender's Comments: Based on available information, the Company considered all reported serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-03-03 | numbness |
I had normal vaccine reactions that lasted for two days including significant body aches, unable to ...
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I had normal vaccine reactions that lasted for two days including significant body aches, unable to lift left arm without significant pain, and chills. The very unusual symptom was all TEN fingers (i.e. both hands) from the last joint to the finger tip went numb for 2 hours from 11:50 am to 1:50 pm. And then the numbness was gone. The numbness felt like the kind you get if you were outside on a below freezing day and let your finger tips go numb in the cold. However, I tried many techniques to try and get my fingers to stop being numb and nothing worked. The numbness resolved on its own after 2 hours.
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| 59 | 2021-03-03 | tremor | shaky, nervous, palpitations. Evaluated by EMS-Cleared |
| 59 | 2021-03-04 | pain in extremity | Severe pain in arm hard to control with ibuprofen, extreme chills, mild fever |
| 59 | 2021-03-04 | tingling, muscle spasms | Tingling in Hands and Feet Blood Pressure Spike Nausea Cramping Dizziness / Lightheaded |
| 59 | 2021-03-06 | weakness, tremor |
Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, acros...
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Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, across back shoulders, and down right are above elbow from 3/4/2021 at 6:00 pm through current time (3/7/2021 at 10:30 am.). 3/5/2021 at 10:00 am to current time (3/7/2021 at 10:30 am.) Burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones. Overall weakness and tiredness throughout body. Slight headache begins and feeling unwell at 3/5/2021 at 10:00 am. 3/6/2021 at 8:00 a.m. through 3/7/2021 at 8:00 a.m. Dizziness and weakness, tiredness, severe/excursiating headache/ muscle pain/chilles/fever/feeling unwell/severe ringing in ears/unable to get out of bed. No relief from advil pain reliever. 3/6/2021 at 5:00 pm nausea added to all symptoms above last 2 hours. 3/7/2021 at 8:00 am to current time (3/7/2021) Able to get out of bed. Headache managable, dizziness presists, weakness/shakey/, minimal energy/burning underskin is still occurring but reduced in level somewhat. Muscle pain in arms/shoulders/back torso and chills is occurring but at a reduced level.
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| 59 | 2021-03-06 | weakness |
Elevated HR, throat tightening, rash on chest and neck, dizziness and weak. Evaluated by EMS, transp...
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Elevated HR, throat tightening, rash on chest and neck, dizziness and weak. Evaluated by EMS, transported to nearest ER.
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| 59 | 2021-03-06 | tingling | Tingling in upper lip, nose, hairline and right arm. Evaluated by medics-cleared |
| 59 | 2021-03-06 | tremor | SOB, shaky, pale, cleared by medics. |
| 59 | 2021-03-07 | weakness |
Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest ...
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Anaphylactic shock - throat restricting, tongue swelling, racing heart, rash predominantly on chest and neck. PB was elevated, dizzy, weak. Symptoms escalated quickly. Immediately flagged help from nearby medic.
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| 59 | 2021-03-07 | pain in extremity | Pain and soreness in left arm as if punched hard. |
| 59 | 2021-03-07 | pain in extremity |
Within 2 minutes I immediately broke out in hives on inside right forearm. I started with one and h...
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Within 2 minutes I immediately broke out in hives on inside right forearm. I started with one and had about 5 total (unsure of exact number but those I could physically see) on both left and right arms. Went away within one hour and also within the hour took 12.5 mg. antihistamine. However 24 hours after had pain (felt like bruising) on site of first hive which has continued since then.
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| 59 | 2021-03-07 | pain in extremity | Swelling under are, size of 1/2 baseball. Sore and painful. Resolving |
| 59 | 2021-03-07 | tingling, flushing | flushing, tingling both arms, HA. Evaluated by EMS-Cleared |
| 59 | 2021-03-08 | weakness |
Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head w...
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Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head was spinning so fast I would pass out. When I would wake up, I was so nauseated that I tried to throw up but hadn't eaten anything, so I had dry heaves. I would wake up and repeat this process over and over. After about 6 hours the dizziness got better but I could not walk by myself as I was so wobbly and weak. My husband tried to get me to the car to take me to the ER but I couldn't stand up. I felt a little better the next day (Sunday) but was unable to keep anything down. I slept a lot as I felt exhausted. I was unable to work on Monday or Tuesday as I was still very disoriented. I would periodically had dizzy spells where I thought I was going to pass out, so when I went back to work on Wednesday, my husband drove me to work and picked me up. At work, when walking I still was very unsteady on my feet and kind of had to hold onto the wall to keep my balance. This stayed with me thru the next week. I felt better the following week and have not had any other issues.
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| 59 | 2021-03-08 | weakness |
Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021...
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Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021), on a ventilator by Wednesday (2/10/2021) and died the following Monday, (2/15/2021) She was treated for HLH (hemophagocyticlymphoistiocytosis)
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| 59 | 2021-03-08 | night sweats | Vomiting, Diarrhea, night sweats, chills, low grade fever, fatigue, nightmares |
| 59 | 2021-03-09 | numbness |
having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; ...
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having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
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| 59 | 2021-03-10 | breast pain |
I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and ...
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I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and tissue expanders are still in place. I reached a fever of 103.6 and had pain and extreme redness in my right tissue expander. I also had all axillary lymph nodes removed from that side in December 2020. On Friday I was still feeling ill and noticed redness, so I immediately contacted my doctor and was instructed to meet him at the hospital. I was admitted and placed on antibiotics and had my tissue expander removed The next morning after no improvement from antibiotic infusion. I had a wound vac placed and stayed in the hospital for one week and had my expander replaced on that following Saturday. I am not planning on taking the second shot.
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| 59 | 2021-03-10 | flushing |
Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pre...
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Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pressure/pressing/swelling. I kept swallowing and it didn't feel like my throat, more like between the outside of my throat/esophagus and skin...in the position where a man's Adam's apple would be, or possibly where my thyroid is. I got flushed, but I could breath ok. I felt odd, but I think I may have been panicking, I don't know. I drove home and saw that my face, neck, chest, even my thighs, were slightly flushed. I took my temperature throughout the evening. I am normally a low temperature of 97.6. It went up to 99.9. The second day my temperature was in the low 98s. However, by second day the roof of my mouth where it meets the throat felt odd, like if you burned it by eating something hot. Third day, today, I woke up and my temperature was only 95.2. I kept taking it, and then used my daughter's thermometer as well. It stayed low for several hours. I also had several bouts of diarreah this morning. Temperature came up into the 98s again. None of this is life threatening, but I still feel the weirdness in the front of my neck. I've never heard of that side effect so it upset me and scared me. I can handle the fever also, but the low temperature also scared me.
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| 59 | 2021-03-10 | migraine |
Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with severe pain in my joints, very tired, all over bod...
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Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with severe pain in my joints, very tired, all over body aches, migraine and the chills for 2 days and sore/red/hard/hot/raised injection site. On third day the chills went away and I was feverish, but still had all the other symptoms. This lasted one more day. I still have the sore/red/hard/raised injection site, but the other symptoms finally went away.
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| 59 | 2021-03-10 | pain in extremity |
I woke up early the next day 3/10/21 nauseous and with diarrhea. I was tired and had a mild headach...
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I woke up early the next day 3/10/21 nauseous and with diarrhea. I was tired and had a mild headache. My arm hurt moderately where the injection site was, but also on the inside of my upper arm. I felt lethargic and nauseous the rest of the day. I did not sleep well. Then 3/11/21 I woke with a mild headache and some nausea, but also severe pain on the inside of my upper arm. It was very sensitive all up to my shoulder on the underarm area and somewhat on the side of my ribcage, but then also radiating down to my wrist. This pain persisted until I am writing this form, approx. 2pm 3/11/21. It has not subsided at this point.
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| 59 | 2021-03-10 | pain in extremity |
I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body ...
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I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body aches, joint aches, headache, fatigue, and nausea. The next night I started vomiting. I felt like I had the flu. These symptoms persisted 3-4 days. The sore throat lasted maybe a week or more. No fever at any time. Had the usual arm soreness start the evening of the vaccine, much more than any other vaccine I've received. The arm soreness awakened me at night if I rolled over. FYI: I received the 2nd vaccine 2/4/2021 and only had a sore throat and sore arm.
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| 59 | 2021-03-10 | tingling |
Distal tingling x 4 extremities, swelling, erythema of posterior pharynx, able to swallow saliva, no...
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Distal tingling x 4 extremities, swelling, erythema of posterior pharynx, able to swallow saliva, no tongue, lip or facial swelling, heart rate 90, respirations 16, lungs clear, 50 mg of Benadryl administered IM right deltoid at 11:33 AM with good effect, transported to the Medical Center via ambulance with advanced life support capability at 11:52 AM.
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| 59 | 2021-03-10 | tremor, muscle spasms | Having uncontrolled shaking and spasms of the legs |
| 59 | 2021-03-12 | facial paralysis |
30 minutes after injection temporary paralysis of face lips and tongue. Partially resolved after 5 m...
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30 minutes after injection temporary paralysis of face lips and tongue. Partially resolved after 5 minutes fully resolved after 3 hours
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| 59 | 2021-03-12 | pain in extremity |
initially sore arm that went away; few days later headache, rash on face which developed gradually. ...
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initially sore arm that went away; few days later headache, rash on face which developed gradually. could be reaction to mask or vaccine not sure. been very noticeable the last 2 days. bright red by nose and mouth not really on forehead or anywhere else, does not itch
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| 59 | 2021-03-13 | discomfort |
6 hrs- whole left arm heavy, sore deltoid, fatigue 18 hrs- Day 2 moderately severe headache, stiff n...
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6 hrs- whole left arm heavy, sore deltoid, fatigue 18 hrs- Day 2 moderately severe headache, stiff neck, heavy appendages x 4 as if concrete, elbows, wrists and knees ache, but low back pain worse, shivers, cold/hot feeling off and on, sleepy Day 3- headache 50% better, neck quite stiff still, low back pain but joints better. Still fatigue, anorexia.
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| 59 | 2021-03-13 | nerve pain, pain in extremity, numbness |
Pfizer-bioNTech COVID-19 vaccine EUA Numbness/pain (nerve pain) in left ring finger then pinky. Ner...
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Pfizer-bioNTech COVID-19 vaccine EUA Numbness/pain (nerve pain) in left ring finger then pinky. Nerve Pain on top of left wrist. Jaw stiffness, burn and scratching in throat.
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| 59 | 2021-03-13 | pain in extremity | Fever, chills, headache, sore arm, achey body |
| 59 | 2021-03-14 | burning sensation, tingling |
I have allergies and it feels like allergic hypersensitivity, which I had before when my allergy sho...
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I have allergies and it feels like allergic hypersensitivity, which I had before when my allergy shots were missed a year or so ago. Burning and tingling feeling in legs, torso, neck basically where clothes touches or rubs. Some tingling sensation on tongue as well. I stayed after 20 minutes after the vaccine because of I have allergies. After I left and got into my car to drive away I started having the burning feeling in my legs, torso and tingling in lips and tongue. I work for the ED group, so I drove over and stayed by the entrance until I felt like it was not getting any worse. I waited for about an hour. I though the burning sensation would go away, but it has not. I called my allergist and he advised I should contact you and report via this source.
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| 59 | 2021-03-14 | feeling hot, tremor, pain in extremity, cold sweat |
Day of vaccine my arm was sore and I had a slight headache and my heart rate felt fast but I think ...
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Day of vaccine my arm was sore and I had a slight headache and my heart rate felt fast but I think my heart rate was due to anxiety about the vaccine . That was until Friday morning. I woke up on the 5th at around 1 am shaking . Then got the cold sweats and chills and then burning up and body aching. Then I started throwing up. I started taking some IBProfen which helped with the fever and shakes. Stayed in bed all day and drank water. My heart rate was up to 122 bpm while I was laying on the couch. I was tracking it with my Apple Watch. I stayed on the couch for the next 2 days and Sunday I started feeling better. Each day I was feeling better but now almost two weeks out I still get slight headaches off and on, I have no energy and get the chills and my chest has a heavy feeling. But I don?t feel short of breath. I took a rapid covid test today 3/15/21 and the results were negative for covid and the flu. I am going to see a doctor on wed. as I am not sure I should get the second dose.
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| 59 | 2021-03-14 | pain in extremity |
03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever...
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03/04/21 - pain, swelling, redness , left arm 03/05/21 - pain, swelling, redness , left arm, fever 101 03/06/21 - pain, swelling, redness , left arm, fever 100 - 101, fever varied 03/07/21-03/14/21 - itchy left arm , pain left arm, fatigue, loss of appetite, dizziness 03/15/21 - fatigue, dizziness, general body aches
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| 59 | 2021-03-15 | feeling hot |
Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation ar...
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Patient received the first dose of the Pfizer COVID-19 vaccine and was waiting in the observation area when she started to experience a racing heart-rate and warmth. The patient was brought water, juice, and tried to relax. Patient was stable but after drinking juice started to feel swelling of the tongue and itching around the neck. Patient was given more water and a diphenhydramine capsule. Tongue swelling and itchiness decreased and the patient went home with her husband after improving. Total course of observed reaction was around 1 hour.
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| 59 | 2021-03-15 | pain in extremity | Feeling of "unsettled " "anxious " feeling of doom " "depressed". Sore arm |
| 59 | 2021-03-15 | pain in extremity |
5 days later got sore arm and some redness around injection site (like a small rash) no itching, I p...
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5 days later got sore arm and some redness around injection site (like a small rash) no itching, I put ice on it and took Aleve
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| 59 | 2021-03-15 | pain in extremity |
I had my first shot of the COVID vaccine last Friday, March 12. On Saturday I realized my vertigo wa...
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I had my first shot of the COVID vaccine last Friday, March 12. On Saturday I realized my vertigo was back more intensely than I have had it before. A few people I talked to said they had light-headedness or some dizziness as a side effect. Didn't think too much about it as I have had vertigo symptons on and off for at least 10 years. I figured it had to do with my ears and the constant ringing I hear in my ears. Sometimes when I roll over in bed the room will spin for a few seconds. After this Friday, the room spins a lot longer and faster. I have to make sure I am balanced when I stand up and just tilting my head can cause me to feel unbalanced. I am being careful and it is not stopping me from functioning. Just thought I should report it to someone. I am hopeful that it will go away as it usually does. Other than a sore arm the first night...this was the only side effect I have noticed. If you have any suggestions to help please let me know. Otherwise just letting you know.
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| 59 | 2021-03-15 | tingling |
Small area (6? round) of itchy rash on stomach which resolved after a few hours. Tingling of itchin...
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Small area (6? round) of itchy rash on stomach which resolved after a few hours. Tingling of itchiness on various locations of body.
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| 59 | 2021-03-15 | throat numbness |
Patient states my throat feels numb, rashes noted around neck and chest. Patient evaluated by parame...
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Patient states my throat feels numb, rashes noted around neck and chest. Patient evaluated by paramedics on site. Monitored patient for 30 minutes. Patient referred to ER due to elevated BP. Patient refused and signed AMA. Patient A&O x3, accompanied by husband.
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| 59 | 2021-03-16 | weakness | Persistent weakness/lethargy post vaccination observation period; transported to ED |
| 59 | 2021-03-16 | numbness, tingling, night sweats, feeling cold |
I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting t...
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I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting the vaccine both my right hand and right leg started tingling and I had pins and needles sensation. I also woke up in the middle of the night with immense night sweating. My arm started becoming numb and cold. I talked to a doctor and she suggested I go to the ER right away as this could be indicative of a minor stroke. I was admitted in the hospital as they needed to run several tests. I spoke with other doctors who suggested not taking the 2nd shot as it could make matters worse. So I opted out of taking the 2nd jab. I wonder if there is any study about adverse reaction for former Covid positive people and if they are better of only taking the 1st jab. Another Covid positive friend also had a similar reaction after the 1st jab. His right side of face became numb. I am worried about lasting damage if any. Could somebody please get back with me on this.
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| 59 | 2021-03-16 | numbness |
Per staff member, HCP, that attended to patient in observation area: " post covid vaccine note. Pt ...
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Per staff member, HCP, that attended to patient in observation area: " post covid vaccine note. Pt received vaccine at 1120am, 1125 while in chairs pt felt dizzy with left arm and leg numbness. Pt alert, skin warm and dry. Placed on stretcher and brought to obs area. 120/77 99% on 2 liters 76 16. Remains alert, dizziness and left extremity numbness persist along with facial numbness, bilat. No facial droop, PERL midline grasps equal. 911 called. 124/71 76 16. EMS arrived, assessed pt and decided to trans to hospital. Pt and husband agree and understood plan. Pt anxious at this time but remains alert but unable to raise left leg, speech slightly slurred. Pt left clinic via ambulance about 1155am with belongings"
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| 59 | 2021-03-16 | pain in extremity |
Received first vaccine on Saturday at 11:00 am. Sunday had a sore arm. Took 1000mg Tylenol and felt ...
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Received first vaccine on Saturday at 11:00 am. Sunday had a sore arm. Took 1000mg Tylenol and felt better. Woke up Monday morning to a slight rash/hives on back of neck. Tuesday it seemed to be getting worse so I went to my primary Dr. He prescribed Clobetasol cream 0.5%. He also said to take 25mg benadryl every 6 hours. Wednesday morning rash spread to shoulders and both arms. Called Dr and he prescribed a taper of prednisone.
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| 59 | 2021-03-17 | weakness |
headache; not feeling well; nausea; had a temperature of 100.4 and 100.2; weak and tired; weak and t...
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headache; not feeling well; nausea; had a temperature of 100.4 and 100.2; weak and tired; weak and tired; sinuses became very dry; This is a spontaneous report from a Pfizer-sponsored program, COVAX Support. A contactable consumer (patient) reported that a 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EM9809, expiry: 30Jun2021), via an unspecified route of administration on the left arm on 08Feb2021 at 16:45 (at the age of 59years) at 0.3 mL, single because she didn't want to get the virus and wants to get the world back to normal. Medical history included obese, prophylaxis (reported as she takes as extra precaution during winter) and abdominal discomfort (reported as stomach). Concomitant medications included cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, sodium ascorbate, thiamine mononitrate (ONE A DAY), montelukast sodium (SINGULAIR), lansoprazole for stomach, sucralfate, piroxicam (ZICAM) for she takes as extra precaution during winter, calcium and bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). Historical vaccine included flu shot and experienced arm sore and bed for the weekend (first time she got the flu shot she was in bed. It was kind of the same thing. Everyone said with the first vaccine it would make her arm sore. She was in bed for the weekend. She has had the flu shot five times in her lifetime. Subsequent flu shots she has been fine with. She doesn't have NDC, lot, and expiry for flu shot as it was at least 27 or 28 years ago). She received Pfizer COVID19 vaccine on Monday 08Feb2021 and her "sinuses became very dry" (in Feb2021). The patient experienced not feeling well, headache, nausea, temperature of 100.4 and 100.2 on 09Feb2021. During the night probably early on the ninth (09Feb2021) she got a headache, was not feeling well, and had nausea. When she got out of bed she had a temperature of 100.4 and 100.2. She thought that was a regular reaction to the vaccine. She didn't go to work. She felt weak and tired. She was told that was not usual for first but was for the second. She had slight headache the next day. She had a light headache for a few days. On Tuesday when she had the fever, she took paracetamol (TYLENOL, extra strength) and it wasn't getting rid of the headache. The fever came down a little. She wouldn't call what she had a big fever. She took ibuprofen (ADVIL, regular strength) later in the day. She normally doesn't take ibuprofen, but she did because she needed relief and paracetamol wasn't doing it. Since Wednesday, she might have taken one or two paracetamol a day. Once her sinuses started to dry out she started taking paracetamol. On Friday night her sinuses felt very dry and she was thinking it was all from the vaccine. She had a three day weekend. On Monday, she couldn't go back to work because she was nasally. Her symptoms began on 11Feb2021 and the health department had her quarantining for 10 days. The doctor said she should get tested and she was she then tested positive for COVID-19 on 12Feb2021. Apparently she picked it up coincidently. She couldn't figure where she picked up COVID. She tested positive. There was nothing concrete on when she can go back to get second COVID vaccine. She knows she couldn't be sick and symptomatic. She has to follow quarantine. The second appointment was on 01Mar. The patient asked if there was any guidance regarding when could she get the next dose and if she could return to work on 23Feb2021. Also asked if how long she could go without losing the efficacy of the first dose. She felt better today. She took the COVID test on Monday 15Feb2021. It was the PCR test. The results came in an email at 05:00 on 16Feb2021. The patient has been isolating in her bedroom. Her daughter was home. Her husband's company paid for him to stay in a hotel. She has felt good today and got on the treadmill. Usually she was a very active person. The facility was a state-run vaccine site. The patient had no previous immunization with the Pfizer vaccine, no additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. The outcome of the events was unknown.
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| 59 | 2021-03-17 | pain in extremity |
No symptoms immediately after first shot except after 13 days later woke up with pain in arm (same a...
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No symptoms immediately after first shot except after 13 days later woke up with pain in arm (same arm as injection). Pain is still present after 3 days. Taking ibuprofen, ben-gay, and heating pad with essentially no effect. If I keep arm elevated the pain is slightly less. Not able to sleep due to discomfort on Day 2 and was able to sleep on Day 3 although woke up at 2am and put on ben-gay and heating pad. Constant pain limiting mobility in arm.
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| 59 | 2021-03-17 | tingling |
Tingling along arms, back, sometimes legs that seems to occur shortly after eating. It subsides aft...
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Tingling along arms, back, sometimes legs that seems to occur shortly after eating. It subsides after a couple of hours
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| 59 | 2021-03-17 | throat numbness, tingling |
Tongue, gums and throat numb for 45 minutes, waves of of tingling numbness from my knees to my throa...
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Tongue, gums and throat numb for 45 minutes, waves of of tingling numbness from my knees to my throat every 10 minutes for about 45 minutes.
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| 59 | 2021-03-17 | tremor, tingling |
swollen lips, blurry vision, shaky, tingling. Evaluated by EMS- Transported to Emergency room/depart...
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swollen lips, blurry vision, shaky, tingling. Evaluated by EMS- Transported to Emergency room/department or urgent care.
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| 59 | 2021-03-18 | weakness |
Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on e...
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Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on energy for an hour or so; and then all of a sudden I can't even hold my head up; Eyes were swollen; Back to my head very weak; My whole body feels like it is bruised; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9262/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 17:30 (at the age of 59 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included rheumatoid arthritis. Concomitant medication included methotrexate 2.5 mg (8 tablets, once weekly), hydroxychloroquine 200 mg, 2x/day and folic acid UNK, 1x/day(1 tablet). On 12Feb2021 (Friday night), the patient reported that she "don't still feel good". The clinical course was as follows: On 12Feb2021, an hour after the receiving the vaccination, the patient reported "it started with pain in side in my head and within minutes it was like I was jelly. I was felt like fall on to the floor. I slowed down and I was extremely tired. I even left work early. I was off Saturday and Sunday. Today I could not even get work. It is like I have a burst on energy for an hour or so. And then all of a sudden, I can't even hold my head up. My eyes were swollen and back to my head very weak. My whole body feels like it is bruised. Treatment received for the events included ibuprofen. The consumer stated, "I took 4 on Saturday and later on like midday about 4 or 5 O'Clock. That was 200 mg each. It was total of 800mg." The outcome of the events was unknown.
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| 59 | 2021-03-18 | weakness |
(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up ar...
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(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up around 12 hours after having the vaccine and felt a strange sensation in my head, almost like a helmet of fog over my head, sort of a numb feeling, and I noticed that also my eyes and lips felt numb. I ate a grapefruit as I usually do (not sectioned by myself). I felt extremely lethargic, had joint pain and a weakness. I usually have tea and toast in the morning and as I was at the table buttering my toast, I had an overwhelming nausea come on. I then woke up on the floor. My companion told me I went unconscious and slipped off the chair. Perhaps the whole episode was a maximum of 20 seconds. My first words were "Where am I?" and my companion told me. I rest on the floor, directed my companion to read on the internet about stroke and we ascertained I was okay, so I was thinking completely clearly. In any case, I had the fog in my head the entire day, and also today, but I feel a little better and was able to eat after 4 hours of rest. I wasn't able to fall asleep but I rested the entire day and slept a couple of hours during the night, which is not like me. I usually don't have any problem sleeping.
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| 59 | 2021-03-18 | electric shock sensation |
About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my...
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About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine). The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
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| 59 | 2021-03-18 | numbness, tingling |
Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. i...
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Face numbing, mainly in cheek and eye area, eye twitching, eyes very dry, part of lip and chin. it started off as becoming very tight, then the tingling. it has been over 24 hours and still sum tingling in the check bone and chin area.
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| 59 | 2021-03-18 | numbness |
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l...
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Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
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| 59 | 2021-03-18 | night sweats |
Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and un...
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Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and under arm on the side where got the shot swelled up; hurt quite badly; huge swollen lymph nodes; Body ache; Could barely walk; could walk to shuffle my feet; joints stiff; Horrible headaches; Diarrhea; I was dizzy and foggy; Night I break out into a horrible sweat in night like I have to change my pajamas twice; I am like wet; Arm sore/My arm was just little bit sore; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EN6202) (at the age of 59) as a single dose, for covid-19 immunisation. Medical history included an unspecified heart condition and a flu shot un an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE). The patient stated, "I am calling about the side effects I had from my Covid shot vaccine. I am concerned about getting the second one because my reaction was so big. I got it on Saturday, this past Saturday about 12:45 I think 12:30 and I did fine, the shot didn't hurt at all. That night I was a little bit tired but that's it. My arm was just little bit sore. The next day I got up, I still felt good I went to work for 2 hours and then about 12 o'clock it hit me all at once. This Sunday I ran anywhere from a 103 to 104.6 fever and that was me taking Tylenol and I took Tylenol every 4 hour because my fever was still high. The glands in my neck and the glands under my arm on the side where I got the shot swelled up, they are still swollen. My whole body ached. I had Covid fairly bad I got pneumonia with it all for "two weeks" (not clarified) but my fever was not as high as got with the shot, the vaccine like I could barely walk after the vaccine because my joints were so stiff only way I could walk was to shuffle my feet, it was horrible. I had a fever yesterday all day but it was only in the 102.3 and 4, it never went back to 103. Glands in my arm and my neck hurt quite badly. My arm where I got it, it wasn't swollen but I get the same reaction when I get a Flu shot (unspecified shot) so that's not a big deal. I got horrible headaches. I had diarrhea all day Sunday and yesterday and so this morning my fever is only right around 101 like 101.1, 101.2, I am still super tired and also yesterday and day before I was dizzy and foggy. I still have a slight fever today. My lymph nodes are still swollen, my neck and under my arm, my arm where I got the shot is still swollen and sore but I can tolerate that. My joints are stiff a little bit but not nearly as bad as they were, so I don't know if I should get the second shot, everyone says the second shot is worst like all those heart palpitations start with it as well." One of my other symptom is at night I break out into a horrible sweat like I have to change my pajamas twice. It was last night and the night before. I am like really wet." The outcome of the events was not reported.
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| 59 | 2021-03-18 | pain in extremity, muscle spasms |
She was tested on 13Jan2021 and it came back positive the next day 14Jan2021; she was getting a cold...
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She was tested on 13Jan2021 and it came back positive the next day 14Jan2021; she was getting a cold; She also had a fever of 99.5; chills; sweats; she had lost smell and taste; she had lost smell and taste; That night she could not lift her arm. It was sore at first; That night she could not lift her arm. It was sore at first/Then she could not lift her arm; tired/she felt extremely tired; terrible left leg pain; leg cramps/more so in the left leg and then it turned into both legs/sporadic leg cramps; full body achiness; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported for herself that a 59-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Jan2021 (at the age of 59-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing prophylactic health. Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81mg; calcium/colecalciferol (CALCIUM +D3) at 600mg; ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+); colecalciferol (D3) at 200 units and elderberry gummies with vitamin c and zinc. All are ongoing and taken for prophylactic health. The patient had her first COVID Vaccine dose on 09Jan2021. She thought she was getting a reaction but ended up testing positive for COVID. She was tested on 13Jan2021 and it came back positive the next day 14Jan2021. She had questions about when and if she should get the second dose. She was referred to speak with her doctor and Pfizer does not have information for that. She got her first dose on 09Jan2021. That afternoon (09Jan2021) her daughter came home, and she had lost smell and taste. That night she could not lift her arm. It was sore at first. She was laying down and her husband asked if she needed anything, and she said no. Then she could not lift her arm. She was sure that was from the vaccine. That lasted until 10Jan2021 and then she was fine and has recovered completely. That same day on 09Jan2021, she felt extremely tired. That lasted about two weeks from the COVID. On 11Jan2021 that Monday, she had also felt like she was getting a cold, but she was not even really stuffy. She also had a fever of 99.5. The chills were setting in even without a fever. She was got, had chills and sweats. That night she went to bed and woke up about an hour later and had terrible left leg pain. Her doctor wanted her to get tested in case it was COVID. She had called him that Monday she thinks, 11Jan2021. He wanted her to go to the ER, not somewhere private, in case she did have COVID, but she did not want to go. She had the leg cramps for 3 days, more so in the left leg and then it turned into both legs. She also had her legs checked out and was negative for any DVTs. It was 3 days of sporadic leg cramps. They were so bad and mainly on her left side. It then turned into full body achiness after that. Caller says overall she was fine. The outcome of the events smell loss, taste loss, pain in arm, mobility decreased recovered on 10Jan2021, all other events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.
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| 59 | 2021-03-19 | weakness |
about 23 hours after the short I fell tired, weak, I got chills and a fever. That night while sleepi...
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about 23 hours after the short I fell tired, weak, I got chills and a fever. That night while sleeping I woke up to a pain under my arm (armpit) on the same arm as the injection. Later the next morning I had a red splotch on my arm (same as injection but not the same spot). The splotch is warm to the touch, and has a bump or hardening under the skin, it is also a little painful.
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| 59 | 2021-03-19 | weakness |
Extreme weakness. Walking was at a shuffle (24 hours) Sleeplessness. Hyper but couldn?t sleep for 3...
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Extreme weakness. Walking was at a shuffle (24 hours) Sleeplessness. Hyper but couldn?t sleep for 3 days. All resolved with no lasting effect. Please note - this was 2d dose. First was 6 weeks prior.
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| 59 | 2021-03-19 | weakness | sever loss of energy. bloodshot eyes |
| 59 | 2021-03-19 | hot flush |
Heart Palpatations Chest Tightness Coughing Chills Body Aches Hot Flashes Shortness of Breath Conges...
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Heart Palpatations Chest Tightness Coughing Chills Body Aches Hot Flashes Shortness of Breath Congestion Muscle/Joint Pain
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| 59 | 2021-03-19 | pain in extremity | Sore arm Severe headache Nausea |
| 59 | 2021-03-20 | pain in extremity |
Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg b...
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Left leg swollen,veins in leg very pronounced,leg aching,bruising to arms and legs,right lower leg bright red spots appeared ,headache very bad,back of head hurting like a baseball bat had whacked it,
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| 59 | 2021-03-20 | cold extremities |
Ringing in my ears since a day after I got the shot , Have had the condition previously but this has...
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Ringing in my ears since a day after I got the shot , Have had the condition previously but this has been exacerbated significantly since the vaccine. Sensation in tip of my tongue. Left eye feels like it is a bit burry . Hands and feet very cold . Has gotten better after the 5th day. Was tired for 5 days after vaccine.
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| 59 | 2021-03-21 | feeling hot, flushing |
patient was feeling warm and flushed, she noticed her skin on her arms and chest were turning pink/r...
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patient was feeling warm and flushed, she noticed her skin on her arms and chest were turning pink/red. She reported that she has a sulfa allergy and had experienced something similar. Benadryl was given when she had taken the antibiotics and the physician said that was the only thing that "saved her bacon". Patient prefers to sit vs lay down. Felt, slightly nauseated and light headed. Gave alcohol prep to help with the nausea. IM Benadryl given per standing order. 50mg IM to Rt deltoid. Patient responded well to this and started to get normal coloring back and felt good enough to go home; declined evaluation offered by paramedics to hospital.
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| 59 | 2021-03-21 | numbness |
AT 0900, patient complained of left hand and finger numbness. Patient stated this has happened befor...
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AT 0900, patient complained of left hand and finger numbness. Patient stated this has happened before. Staff continued and to watch for additional 5 minutes. Patient went home after additional 5 minutes and told to go to the emergency room if any symptoms returned.
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| 59 | 2021-03-21 | pain in extremity |
Severe body aches, joint pain, muscle pain, fever (99.7), headache, extreme fatigue, sore arm (this ...
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Severe body aches, joint pain, muscle pain, fever (99.7), headache, extreme fatigue, sore arm (this began about Saturday morning 2:00 a.m.) fever was gone by 8:00 a.m. I had mild joint and muscle pain when I went to sleep Saturday evening, but when I woke up Sunday morning, all symptoms were gone. On Sunday evening, I began to get a throbbing headache that pulsed in my head all night. I was briefly nauseated when I got up Monday morning because of the headache. By 10 a.m. the headache was gone. I developed a slight rash and warmth at the injection site on Monday morning. As of 5:00 p.m. the rash is still there but the pain is lessening as is the warmth.
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| 59 | 2021-03-21 | pain in extremity |
Patient presents to urgent care 4 days afer 1st covid vaccine with chest discomfort, SOB, body aches...
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Patient presents to urgent care 4 days afer 1st covid vaccine with chest discomfort, SOB, body aches, arm pain. Mild vaccine reaction, follow up with PCP.
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| 59 | 2021-03-21 | tenderness |
Upper shoulder pain, pain running up from shoulder to the left side of neck towards the ear, no pain...
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Upper shoulder pain, pain running up from shoulder to the left side of neck towards the ear, no pain in the actual ear just in the neck. Underarm pain expanding into the left side of left breast. All pain was an aching pain with tenderness if touched. Took Tylenol for some relief. There was no redness or rash. Lasted about 2 days with heavy pain on day one and lighter pain on day two.
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| 59 | 2021-03-22 | weakness | ?Fainting, ?body chills, ?fever, ?loss of appetite, ?weakness, ?sleepiness, ?headaches |
| 59 | 2021-03-22 | bell's palsy |
15 minutes after vaccine was getting lightheaded and little dizzy. Then 30 minutes after ( now 45 mi...
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15 minutes after vaccine was getting lightheaded and little dizzy. Then 30 minutes after ( now 45 minutes after vaccine) started getting nerve problems behind left eye that was bothering me. Then my face got nerve problems too. Then all my teeth on top and bottom row were hurting. my lips and tongue got numb with nerve problems like I had too much Novocain. Then my throat felt like it was swelling up. I called hot Line of vaccine to report side effects. They transferred me to a Covid 19 nurse that said go to emergency room right away sounds like yiur getting Bell?s palsy. FYI my brother who lives in another state did not report his side effects. In February he got the second dose of Pfizer and he said four hours after he got nerve problems in his face and his right side of eye and mouth drooped and he was talking strange like someone with paralysis of mouth . Still has it but never went to doctor and won?t fill out info to report
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| 59 | 2021-03-22 | pain in extremity |
Brand and lot of vaccine: EL9267 Pfizer 2nd dose, CN6200 Pfizer 1st dose given 2/26 @1400 at stadium...
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Brand and lot of vaccine: EL9267 Pfizer 2nd dose, CN6200 Pfizer 1st dose given 2/26 @1400 at stadium Date and time adverse event started: 3/19/2021 @1400 Did the adverse event start after the first or second vaccination? arm started getting sore in the evening, then legs feels achy, lower back pain, 99.6F, pain in armpit in injection arm left arm, itching to back then dizzy
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| 59 | 2021-03-23 | cold sweat, feeling cold |
16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. ...
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16 min after injection i feltmlike i needed fresh air as it felt like i couldn't get a good breath. I asked to go outside and was told no. I moved from back to the front as i felt cold and was swearing. It was sift chsnge and the staff was huddled in a corner and i called for help.2x before taking off my mask amd callinf a thried time. By this point i felt like vomiting and nedded immediate water. The thirst was intrnse. The University of Arizona didn't have anything for me to throw-up into except a half full used large janitorial garbage can. I was given water and that really helped the thirst and nausea. The nurse came and put a monitor on my finger and immediately took me to a back area where rhe cold sweat and chills now covered my whole body and the thirst returned. Tje nurse took my vitals and i remember my heartbeat reading in the 30s and had a very low blood pressure. No one ever experienced what was happening and i asked if i was going to die. The only thing they had to lie down on was an army cot 6" off rhe ground. I wanted to lie down so badly buy it had no sheets, pillow or anything. With all the money they get from the feds they should be able to afford a gurney. I was never told the truth about what had happened to me. I was let go with a very low heart rate of 51. My normal is 68 to 78. No follow up instructions.
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| 59 | 2021-03-23 | cold sweat, flushing | feeling flush, dizziness and cold sweat |
| 59 | 2021-03-23 | feeling jittery, numbness, tingling |
I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing...
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I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing tingling sensation on the right side of my face and tongue and top of my head. I also felt very jittery or crawling sensation like I had to much coffee. I called the guards to my car twice and was told it was my nerves. I was released even though I wasn't feeling right and felt like was drunk driving on the way home, the worst of it passed within a hour but the fuzzy feeling lingered with numb spots on my face lasted for a few days. Now I'm afraid to get my second shot due April 3rd.
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| 59 | 2021-03-23 | pain in extremity | Bad stomach ache, sore left arm |
| 59 | 2021-03-24 | weakness, muscle spasms, migraine |
Upper abdominal pain (previously reported) - still sporadic; relieved by Alka Seltzer and/or food 03...
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Upper abdominal pain (previously reported) - still sporadic; relieved by Alka Seltzer and/or food 03/20 0200 - severe chills with muscle spasms leading to painful tonic spasms; treated with Disatat 10 mg x 2 03/20 -continuing - fever (<100) treated with acetamenophen/ibuprophen PRN; 03/35 - fever 102 treated with acetamenophen 03/20 continuing - joint pain; increased weakness in L shoulder 03/20 continuing - malaise/fatigue 03/20 0900 - migraine relieved by Relpax
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| 59 | 2021-03-24 | burning sensation |
Itching and rash NOT at injection site: head, neck, arms, chest, stomach, legs Rash is fairly fine,...
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Itching and rash NOT at injection site: head, neck, arms, chest, stomach, legs Rash is fairly fine, NOT hives. Pops up on various parts of body, itchy and mild burning. This is NOT a terrible side effect, but I thought it best to report. It is not yet getting better or subsiding (got injection 5 days ago).
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| 59 | 2021-03-24 | feeling of body temperature change |
Date and time adverse event started: 3/22/2021 less than 12 hours after 1st dose Adverse events expe...
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Date and time adverse event started: 3/22/2021 less than 12 hours after 1st dose Adverse events experienced and are they still occurring now: started with headache and muscle pain less than 12 hours of receiving first dose. On 3/23/21 experiencing body ache, joint pain, hot/cold feeling, upset stomach (no diarrhea). Feeling much better, symptoms resolved except for fatigue.
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| 59 | 2021-03-24 | flushing |
10 minutes after shot had Pain in neck Then headache Then flushing (wave of heat from head down arm...
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10 minutes after shot had Pain in neck Then headache Then flushing (wave of heat from head down arms and hands. Skin mottled and red) Then Blood pressure observed to be was high Then hives and itching developed Then Dizziness occurred Then nurses took me from shot clinic to the ER All above symptoms within 30 minutes of shot About 9 pm experienced swollen and painful veins in left arm (shot was in right arm) as of 7pm next day still painful veins in left arm.
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| 59 | 2021-03-24 | muscle spasms |
I started having several symptoms of COVID-19. I had fever (went up to 102.8), chills, high pulse, ...
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I started having several symptoms of COVID-19. I had fever (went up to 102.8), chills, high pulse, diarrhea and cramping, and slight headache for about 3 or 4 days. Then, I was having sharp, severe shooting pains in my ring finger and elbow. I talked to my primary care doctor's office 3 times. I went to the emergency room on Thursday, March 18th. The hosptial did a CT scan of my chest and abdominal area, a urine test, some blood work, etc. I also had a COVID-19 test on both March 18th and March 21st. They were both negative.
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| 59 | 2021-03-24 | pain in extremity | Arm pain Left chest pain Difficulty breathing |
| 59 | 2021-03-24 | pain in extremity |
First dose 2/28 - was fine Second dose 3/21- that evening headache dizziness took ibuprofen around ...
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First dose 2/28 - was fine Second dose 3/21- that evening headache dizziness took ibuprofen around 8-9pm. 3/22 - soreness in arm, headache. 3/23 - swelling on shot area leading around to underarm, hard lump side of underarm area very sore. Took ibuprofen Add ice.pack
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| 59 | 2021-03-24 | pain in extremity | Pain in the arm Body aches Headache Chills |
| 59 | 2021-03-24 | tremor, pain in extremity, depressed level of consciousness, hot flush |
?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, ...
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?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, possible seizure, tinnitis, pressure in frontal cortex, brain fog, inability to urinate for 1 day, headache, exhaustion-constant sleeping, rapid heart rate, problems speaking-slow and deliberate, dehydration, motor skills slower, sinus's and whole brain feels dry, time going by really fast, ears hurt, teeth hurt, right and left neck hurt, left arm hurt, right shoulder hurt, hot flashes day and night. MEMORY ISSUES SUBSIDED TODAY, still brain fog, still RAPID HEARTBEAT and shaky. If all of this brain fog/rapid heartbeat doesn't subside by Monday March 29, 2021, an EEG will be ordered to look at the brain. I'm on my 2nd weeks bedrest with no exercise and Tylenol every 6 hours, the tylenol every 6 hours seems to help with some of the brain fog and the rapid heart beat, if I forget to take it I am soon reminded as my heart races and the brain fog reappears.
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| 59 | 2021-03-25 | numbness |
1100: patient with c/o numbness and tingling of right side of tongue. Physician on duty ordered 25m...
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1100: patient with c/o numbness and tingling of right side of tongue. Physician on duty ordered 25mg Po Benadryl to be given. Patient took Benadryl and refused water. 1110: Patient checked on by EMS on Duty with no changes. 1120: No changes to mouth noted still for patient. 1130: Still no changes, EMS on duty cleared patient for discharge home after 30 minutes of observation. Informed patient to seek immediate medical attention if symptoms should worsen. Patient communicated understanding.
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| 59 | 2021-03-25 | tingling |
Patient had tingling sensation that started on her body immediately after injection. Her face became...
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Patient had tingling sensation that started on her body immediately after injection. Her face became red and she was moved into the EMS room for observation. The MD on call ordered zyrtec 10mg by mouth to be given x1 now and patient tolerated well at 1545. Apple juice was supplied to the patient at 1550. 1600 patient reported tingling sensation had decreased, denied any shortness of breath, chest pain or nausea. 1605 patient was discharged from clinic in no distress.
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| 59 | 2021-03-26 | weakness, tremor |
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Dif...
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Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
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| 59 | 2021-03-26 | migraine, numbness |
3/25/21 6:00 pm chills, shivering, muscle aches, numbness in left arm hand and left leg. 8:00 pm mi...
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3/25/21 6:00 pm chills, shivering, muscle aches, numbness in left arm hand and left leg. 8:00 pm migraine headache, nausea & vertigo.
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| 59 | 2021-03-26 | pain in extremity, flushing |
On day of vaccine I became a little flush 30 minutes after vaccination. Next day, arm hurt. Otherwis...
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On day of vaccine I became a little flush 30 minutes after vaccination. Next day, arm hurt. Otherwise I felt fine. 5 days after receiving the vaccination I noticed I was dizzy when standing up in the AM. Late AM I developed a headache which got more severe in the afternoon through the evening and was accompanied by nausea, chills, briefly high heart rate (199), fatigue, and the dizziness. Took 2 Tylenol in the evening . 2 hrs later symptoms improved dramatically. Felt a little unsteady today.
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| 59 | 2021-03-27 | bell's palsy | Developed Bells Palsy |
| 59 | 2021-03-27 | pain in extremity |
Received the shot around 4pm started to have extreme discomfort in my left wrist, hand area Woke up ...
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Received the shot around 4pm started to have extreme discomfort in my left wrist, hand area Woke up this morning unable to move the hand without extreme pain. I have been taken 400mg of Advil every 4 hours and the pain has lessened somewhat.
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| 59 | 2021-03-27 | tingling | SWOLLEN TONGUE AND THROAT, HIGH BLOOD PRESSURE, FAST HEART RATE, TINGLING IN FACE |
| 59 | 2021-03-27 | tremor |
uncontrollable body shakes for 4 hours from midnight to 4 am; muscle aches, fuzzy head, low grade fe...
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uncontrollable body shakes for 4 hours from midnight to 4 am; muscle aches, fuzzy head, low grade fever, extreme fatigue
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| 59 | 2021-03-28 | weakness |
Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated wit...
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Covid exposure on 3/3/2021. 3/9/2021 received first Pfizer vac. Within an hour was nauseated with pressure pain across the top of her stomach "under her ribs" and nausea. 3/10/2021 dev fever, weakness, and cough. Covid test 3/12/2021 neg. Eval in walk in clinic. Diag allergies. Rx oral steroid and Amoxicillin. A couple of days later, symptoms still continued. Eval in her physician's office 3/18/2021. Given steroid injection and antibiotic changed to Azithromycin. 3/19/2021 felt worse with pain/pressure under ribs and upper abd. eval in ER. O2 sat 87 improved to 93 with oxygen. Labs, chest xray, and CT scan obtained. Covid test neg. Admitted to hosp with diag of bilat pneumonia. Discharged on 3/22/2921 with steroids to take over next 5 days. She continues to have mild cough and pressure under her lower ribs. F/u appt scheduled with her physician. Was advised by her physician her pneumonia might be a reaction to the vaccine.
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| 59 | 2021-03-28 | feeling hot, numbness |
Heat through body, Nausea, numbness in left hand, pressure in head, cognitive problems, pressure in ...
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Heat through body, Nausea, numbness in left hand, pressure in head, cognitive problems, pressure in head, memory problems, joint pain, right eye not focusing Have seen my primary, rheumatologist- received injection of steroid and put on oral steroids, chiropractor nerve stimulation, adjustment. Waiting to see a neurologist
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| 59 | 2021-03-28 | pain in extremity | After going to sleep on my legs started hurting really bad and better next morning. |
| 59 | 2021-03-29 | feeling hot, tingling, numbness |
immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1...
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immediately following my left arm got a hot sensation, my hand went numb, and my fingers tingled. 1 hour later I was nauseated and I had flu like symptoms, body aches, chills and a horrific headache. By 4th hour I needed to go to bed.
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| 59 | 2021-03-30 | weakness |
When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen;...
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When she passed out; feeling real dizzy; since her leg and knee feel bruised; right eye was swollen; felt unwell; weak; This is a spontaneous report from a contactable consumer (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 as a single dose (at the age of 59-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer-BioNTech COVID-19 Vaccine first dose on Saturday, 13Mar2021, and was fine after the shot but had a reaction on Sunday, 14Mar2021. On 14Mar2021, she got up to make breakfast and started feeling real dizzy and the next thing she knew, she was on the floor; this happened twice. When she passed out, she must have hit something on her right side, since her leg and knee feel bruised and right eye was swollen. She felt unwell, dizzy and weak; no dizziness today (15Mar2021). She planned to discuss further with her physician. The outcome of the event dizziness was recovered on 15Mar2021 and unknown for the rest of the events. Information on the lot/batch number has been requested.
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| 59 | 2021-04-01 | weakness |
Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneo...
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Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 19Mar2021 at 21:00 as a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date to an unknown date, prior to vaccination. The patient had a nasal swab test for COVID on 18Mar2021 with a result of negative. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines in four weeks prior to the COVID vaccine. The patient experienced body chills, fever, body aches, loss of appetite, weakness, sleepiness and fainted on 20Mar2021 at 01:00. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on batch/lot number was requested.
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| 59 | 2021-04-01 | breast pain |
Severe pain under right breast around into upper right back. Was hospitalized 12Mar2020 for two day...
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Severe pain under right breast around into upper right back. Was hospitalized 12Mar2020 for two days. Pain is still very intense; Severe pain under right breast around into upper right back. Was hospitalized 12Mar2020 for two days. Pain is still very intense.; This is a spontaneous report from a contactable other health professional (HCP). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right arm on 11Feb2021 at 13:00 (Batch/Lot number was not reported) as single dose, then second dose via an unspecified route of administration, administered in right arm on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Congestive heart failure (CHF), kidney stones, diabetes, penicillin allergy, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), both for unspecified indication. The patient previously took statin [nystatin] for unspecified indication. On 05Mar2021 at 04:00, the patient experienced severe pain under right breast around into upper right back. The patient was hospitalized on 12Mar2020 for two days. Pain is still very intense. The patient underwent lab tests and procedures which included nasal swab: negative on 18Mar2021. The patient had bloodwork, x-ray, MRI and EKG as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: The causal association cannot be excluded between the reported events of breast pain and back pain with BNT162B2 vaccine use due to strong temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 59 | 2021-04-03 | speech disorder |
eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; li...
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eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-04-04 | pain in extremity |
Telephone call received from client who reports she received vaccine yesterday and is now having a ...
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Telephone call received from client who reports she received vaccine yesterday and is now having a sore arm and pressure in her ears. Also stated she had sinus infection for a month. Having buzzing in her ears but not sure if buzzing or "shot:. Stated at work at time of this report and just wanted to report.
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| 59 | 2021-04-06 | weakness |
O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the low...
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O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the lower lungs that was rubbing on her diaphragm; Pneumonia; Cough/bad cough/dry cough; Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage; gastroenteritis; short of breath; she wasn't breathing deep; feels like she doesn't have any energy; feeling bad; nauseated/felt sick to stomach; ate about half of her breakfast, this lasted for several days, she wouldn't eat much; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer. This consumer reported similar event for two patients. This is the first of two reports. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206, expiry date: unknown), via an unspecified route of administration, on 09Mar2021, as single dose, for COVID-19 immunisation. Medical history included exposure to SARS-COV-2 on 02Mar2021 (reported as "daughter tested positive for COVID on 02Mar2021, patient had been around their daughter and their daughter's husband, they went out to eat with them on the night of 02Mar2021"). Concomitant medication included esomeprazole sodium (NEXIUM) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021, the patient received her first shot. About 20 minutes after she took the shot, she started feeling bad and became nauseated/felt sick to stomach. On 09Mar2021, the top part of her stomach would hurt, and she started developing a cough. On 11Mar2021, the patient felt like she doesn't have any energy. The coughing went pretty bad so on 12Mar2021, the patient took a COVID-19 PCR test and it came back negative. The patient kept having a bad cough so then they went to the doctor where they put the patient on prednisone 20 mg and amoxicillin 875 mg on 12Mar2021. On 16Mar2021, the patient went to the family doctor and the doctor put the patient on azithromycin and gave her a steroid shot. Then the patient kept coughing and her stomach was hurting right at the bottom of her rib cage. The patient was never getting better or anything. So, on 18Mar2021, the patient had COVID-19 Virus test where they swabbed her nose and the test came back negative. The patient was taken to the hospital on 19Mar2021 at 11:30 where they did an x-ray of the patient's lungs and her O2 level was 82-86 sitting in the bed (also reported as 84-86 so she was put on oxygen), performed CT scan of her lungs and it looked like there was inflammation in the lower lungs that was rubbing on her diaphragm, and performed Chest CT which determined pneumonia. That night they did another COVID-19 virus test where they went really deep and it came back negative. The patient was admitted to the hospital on the night of 19Mar2021. The patient was given IV ceftriaxone, IV azithromycin, azithromycin (also reported as Zythromax), one breathing treatment, and they said they may have to send the patient home with some oxygen. It was also reported that on 19Mar2021, the patient did really good with coughing, she didn't cough that much. The patient had a dry cough that wasn't productive at all. The patient acted kind of short of breath because she wasn't breathing deep because of the pain in the top part of her stomach, but the reporter doesn't believe it was true shortness of breath. When the patient got out of the hospital on 22Mar2021, she didn't need to come home with the oxygen. The patient's oxygen level is running pretty good at the time of the report, in the lower 90s (Mar2021). The patient was on Decadron 6 mg for 5 days and she's doing pretty good, she still has a little bit of a cough. It was also reported that in Mar2021, the patient only ate about half of her breakfast, this lasted for several days, she wouldn't eat much. The patient pretty much recovered from the nausea. When she ate, it felt like everything would make it to her stomach and just sit there. The emergency room doctor said it could be from gastroenteritis, also they gave the patient several rounds of Protonix. The patient usually takes Nexium every night. The doctor felt that this event could very well be from the vaccine. The reporter asked if the patient could get the second shot on 30Mar2021. The patient was recovering from "Cough/bad cough/dry cough", "Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage", and "O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen"; has recovered from "nauseated/felt sick to stomach" on an unspecified date. The outcome of the events "inflammation in the lower lungs that was rubbing on her diaphragm", pneumonia, "feeling bad", "ate about half of her breakfast, this lasted for several days, she wouldn't eat much", "feels like she doesn't have any energy", "gastroenteritis", "short of breath" and "she wasn't breathing deep" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329963 Same reporter, drug and event; different patient
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| 59 | 2021-04-06 | numbness |
head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then fe...
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head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing. The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
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| 59 | 2021-04-10 | bell's palsy |
nerve problems behind left eye; nerve problems in face; lips had nerve problems; tongue was numb; th...
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nerve problems behind left eye; nerve problems in face; lips had nerve problems; tongue was numb; throat felt swollen; Bell's palsy; lightheaded and dizzy; This is a spontaneous report received from a contactable consumer (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via an unspecified route of administration in the left arm, on 11Mar2021 15:30, as single dose, for covid-19 immunisation. Medical history included known allergies to antihistamine (unspecified) and sulfur drugs. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior the vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); omeprazole; and anastrozole, all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) received at age 59 years, via an unspecified route of administration in the left arm, on 18Feb2021 15:45, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 11Mar2021 at 15:45, 15 minutes after the second dose, the patient got lightheaded and dizzy. On the same day at 16:15, 45 minutes after the second dose, the patient experienced nerve problems behind left eye, then nerve problems in face, then lips had nerve problems, then tongue was numb, and throat felt swollen. The patient reported the side effects on the hotline, and she was transferred to a nurse who told her to go to the emergency room immediately as she could be getting Bell's palsy from the vaccine. The events resulted to emergency room visit and hospitalization (unspecified date in Mar2021). Treatment for the events included unspecified IV. The patient was hooked up to an EKG and her blood was drawn for checking in Mar2021 (results were unknown). The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.
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| 59 | 2021-04-11 | weakness |
Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had ...
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Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had severe weakness of the right arm starting the day after the immunization, headaches across the whole head, severe fatigue, confusion (brain fog), worsening depression, body aches, and these all progressed and got worse for at least 14 days. She was unable to work any of those days due to weakness, confusion, and body aches. She saw me in the clinic on March 2 as she was still feeling weak, tired, confused. The clinic notes that day record: "On the next day, the 26th, she had severe pain and couldn't do much. Then she got super depressed and could not get out of bed for 2 weeks, had a lot of fatigue, body aches, and felt down. She tried going to the store one day and by the time she got done she could not get into her truck because she was in so much pain. That would have been about 2 weeks ago. She went back to work last week and was at work the whole week. She was told she does have leave time and that it did not cover the absence of work. She now needs new leave time forms completed. Currently she is in a lot of pain. She has her endocrine appointment on March 15th. The pain is getting worse. The cold is really hard on her. She is barely able to move her right arm at the end of the day, and that is the arm where she had the COVID shot. She is having a lot more weakness. She can not even take one flight of stairs now because everything hurts her. This is a huge difference than before. She used to be able to do several flights, and she can't do that anymore. She has also had vision changes. She has floaters but she is having a harder time focusing. She feels like no one would believe her, but she feels like this is all part of the reaction to COVID. She has a hard time focusing. She feels like she is going insane."
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| 59 | 2021-04-13 | tenderness |
Headaches started slowly along with dizziness feelings of floating or being on a drug and then got ...
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Headaches started slowly along with dizziness feelings of floating or being on a drug and then got more intense after second shot and continued after for weeks until I was told I may have Giant cell Aritise. I had biopsy and was put on high does steroids. That was negative. I still get headaches and have headaches sensitive to the touch.
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| 59 | 2021-04-15 | pain in extremity |
sore right arm, fever, fatigue, nausea lasted 4 days, unable to get out of bed or eat due to nausea,...
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sore right arm, fever, fatigue, nausea lasted 4 days, unable to get out of bed or eat due to nausea, which led to dehydration.
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| 59 | 2021-04-17 | pain in extremity |
Congestive heart failure; Chronic obstructive pulmonary disease; congestive heart failure and chroni...
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Congestive heart failure; Chronic obstructive pulmonary disease; congestive heart failure and chronic obstructive pulmonary disease; Arm was killing her all the way down/her arm hurt so bad/ left leg hurts from her knee to her hip; Chills; Headache; Left leg hurts from her knee to her hip; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Lot Number: ENB207), via an unspecified route of administration, administered in right arm on 19Mar2021 08:00 AM (at the age of 59-year-old) as single dose for COVID-19 immunization. Medical history included asthma since 1990, obese since 1990, Congestive heart failure about 4 years ago in 2017, Chronic obstructive pulmonary disease since 1989; all were ongoing. She had a chemical exposure in a small town that started the COPD since about 1989. Concomitant medications were not reported. The patient previously received fluzone on unspecified date for flu vaccine and caused COPD exacerbation, she was given doxycycline and prednisone with that. The patient is calling about the Pfizer Covid 19, her first dose she received on 19Mar2021. She isn't going to take the second Covid 19 vaccine. On 19Mar2021 at 7:00PM on the day she received her Covid 19 vaccine her arm was killing her all the way down/ arm hurt so bad she wanted to cut it off. That lasted the whole next day and she took 2 Tylenol arthritis pills. Her arm was real sore the next day but it wasn't paining her like it was that first day. It was still a little sore but not like it was. The pain was down the whole arm. Last week (on unspecified date in Mar2021), she started getting headaches and chills. She'll get a chill and the chill will go away. Then a couple hours later the chills will come back. Her headache comes and goes. She checked her blood pressure and her blood pressure is normally low, she checked it and it was 117/76 in 2021. She knew her blood pressure wasn't causing her headaches. And she checked her oxygen level on unspecified date in 2021 and it was good. She normally does not have headaches. She's on 4L of oxygen because of congestive heart failure and chronic obstructive pulmonary disease. Her breathing has been, she can't describe it. Her doctor prescribed some steroids yesterday, 30Mar2021. She is asking if this is normal after 2 weeks. When asking her about her breathing she reports it's like her chest is tighter and she has shortness of breath. If she moves, her oxygen level on unspecified date in 2021 drops with the slightest little movement. Her oxygen has been dropping into the 70s and she has to do the pursed lips breathing to recover. It's taking a while to recover. She has to really work to get her oxygen back into the 90s. That started last week some time. She did call her doctor and her doctor prescribed prednisone and doxycycline (Prednisone 4, 10 mg tablets for 3 days, then 3 tablets for 3 days, then 2 tablets for 3 days, then 1 tablet for 3 days and Doxycline Hyclate 100mg 1 capsule twice daily for 7 days). She forgot to mention that her left leg hurts from her knee to her hip on unspecified date in 2021. That started a couple days ago. She didn't have any problems with her hip before. She's scared because the second vaccine is more potent, it's worse. She doesn't know if she's going to get that second Covid 19 vaccine. The outcome of the events was not recovered.
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| 59 | 2021-04-18 | pain in extremity |
Gillion bar syndrome, spinal tap confirmed on April 17, 2021 Pain started in her back in April 10th...
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Gillion bar syndrome, spinal tap confirmed on April 17, 2021 Pain started in her back in April 10th 36 hours after shot went down her back to but and legs. Friday April 16,2021 she could not walk. Hospital on the 16th by the 17th her arms and hands were affected. Still in the hospital to current date receiving IVIG to see if that will work for her.
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| 59 | 2021-04-24 | tremor |
Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got...
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Got violent shakes and chills; Got violent shakes and chills; Stomach pain; temperature suddenly got to 103.5; Blood Pressure was very high; flu like; 1st dose :20Mar2021; 2nd dose: 04Apr2021; 1st dose :20Mar2021; 2nd dose: 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Apr2021 11:00 (Lot Number: EW0150) as single dose (at the age of 59-years-old) for covid-19 immunisation. Medical history included breast cancer, anxiety, depression, irritable bowel syndrome (IBS), Low Thyroid, arthritis. Patient had no known allergies. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration, administered in Arm Left (Lot number: ER2613) on 20Mar2021 12:00 PM (at the age of 59-years-old) for COVID-19 immunization. It was reported that patient received first dose on 20Mar2021 and second dose on 04Apr2021 (Inappropriate schedule). Patient stated that she had her second (2 nd) shot on 04Apr2021 (Sunday), was fine until 07Apr2021 (Wednesday). On 07Apr2021 at 15:00 she got violent shakes and chills, stomach pain, temperature suddenly got to 103.5. Patient went to Emergency room. Blood Pressure was very high. She was released and better on Friday but still flu like. They could find no reason for this and three doctors (Dr's) thought it was a reaction to the vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 3 days. She was treated with intravenous (IV's), Antibiotics, cat scan and X-ray, results unknown. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 07Apr2021. She was recovering from the events, at the time of the report.
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| 59 | 2021-04-26 | migraine, weakness, tremor |
to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular p...
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to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular premature beat); Large black bruise on left breast; 40 hrs fever; throwing up/vomiting; nausea 36 hours; intermittent breathing issues/sporadic breathing issues/difficulty breathing and hard to get a breath; She was weak; severe migraine; Headache; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number ER8727, expiration date: 31Jul2021), via an unspecified route of administration in arm left on 07Apr2021 12:00 as single dose for Covid-19 immunisation. Medical history included allergy ( macro Danton, sulfa). Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included Nerontin. The patient reviously received flu vaccine and had normal things, previously received first dose of bnt162b2 (Lot Number: EN5318; Expiration Date: 31May2021) in arm left on 17Mar2021 16:00 and experienced acute lymphatic response, brain fog and arm started to hurt. The pateint was calling because her doctor, who she saw yesterday 14Apr2021, told her she should let Pfizer know what was going on. She had a reaction to the Pfizer Covid19 Vaccine. she was now having PVCs. The patient added that all of the events started with a fever, and throwing up. She had a fever and threw up for 36 hours. She had to contact her physician to get medication and to stop vomiting and the nausea and everything. During that time, she was sick. She was having intermittent breathing issues which she did not think she felt too much of until after the other sickness was over. She was weak, like people get after they are sick, and had bizarre shaking legs and arms which was strange. She added that she had breathing issues and difficulty breathing and hard to get a breath. That was what she was dealing with. Treatment: caller took Pedialyte and all the proper things to get back into better shape. The breathing issue still remained. The doctor called in a rescue inhaler. She kept going downhill so he called in a rescue inhaler. Large black bruise on left breast after second vaccine: Caller added that this one will not be believed but on Monday, she woke up and got dressed again and was just weak and had breathing issues but was just doing work on the laptop. She did not fall, she did not run into anything. In the evening, she went to take a bath and saw that when she took her clothes off there was a large black bruise on her left breast, it was probably 2 inches in diameter. It is very large, but does not hurt like a bruise. She checked the rest of her body for blood issues and only saw a couple normal looking bruises. She contacted her doctor, and they questioned her thoroughly on her bruising and activity. This was on Monday. Tuesday, she still felt the same headache, weak, and breathing issues. PVCs (Ventricular premature beat) after second vaccine: Yesterday, 14Apr2021, she started declining and the doctor wanted to see her. Caller stated the doctor heard PVCs in her heart. Caller asked clarification of PVC abbreviation and does not provide. She never had heart issues ever. The doctor did blood work and a chest x-ray, and saw the bruise and was worried about her blood. Caller added that even though these are not listed as side effects of the vaccine, she was worried. Her doctor sent her to a facility for chest x-rays to make sure there is no pulmonary embolism. Caller confirmed this was on 14Apr2021. She has not yet heard back. PVCs after second vaccine: Caller added the doctor said her lungs sounded good but wanted to see what was going on to see how her breathing was because there was difficulty. The doctor wanted to cover bases and check. Today, caller can tell her heart is still not in correct rhythm and that it is in continued PVCs. She still had the same breathing issues, limbs were weak, she was shaky, and she is lightheaded. She was hoping to wake up today and feel better. Fever after second vaccine: started 3am 08Apr2021. She had a fever and was throwing up at this time. Throwing up and nausea after second vaccine: caller add that throwing up and vomiting with nausea occurred at 3 am, all of this occurred 08APR2021. The vomiting lasted 36 hours, and it ended when she took medication. The fever lasted 40 hours. Even after the medication worked for her fever, she had nausea. Around Friday was when it went away. Intermittent breathing issues after second vaccine: caller adds it started with throwing up and fever, but she did not think a lot about this or know when it started because she was dealing with the fever and vomiting. It continued, and it has not subsided or ended. As a matter of fact, there are 2 or 3 times it has gotten bad which is why she was given an inhaler. Treatments: caller took a Phenergan suppository, which she adds is the best medicine in the World for nausea and beats Zofran. She had used two or three doses and it did work. She used a rescue inhaler, Albuterol Sulfate HFA. She took Tylenol for fever. She is also now taking an aspirin daily because of the blood issues. No additional information regarding the products. Weak after second vaccine: caller adds that this started at the same time, she was over the nausea and noticed this. It felt different than what it feels like with the flu. This is still going on, she did not think too much about it but it has persisted. Sometimes there is a little bit of shaking but that is intermittent. Caller states she can not put it into words. Bizarre shaking legs and arms after second vaccine: this goes with the weakness, she is continually weak but she has a shaky feeling that will come every now and then and is random. Large black bruise on left breast after second vaccine: Monday this started, 12APR2021 and it is still there but it is the same. It has not been sore like a bruise but it is black and large. The physician has seen it now and it is bizarre and scary. It is the left breast on the outside. Headache after second vaccine: started probably an hour after the vaccine, pretty quick. There were degrees to this headache because it was an actual migraine for a good 48 hours and even after the fever was gone it was terrible. It started out just a mild headache and then was very severe for a couple of days. Then, after that it was just there but not as severe. PVCs after second vaccine: caller adds that she went to the doctor yesterday 14APR2021 and she can tell every now and again that she is having these but there is nothing she can do about it. Caller adds this is everything new she can think of, but some of it is foggy, she thinks this is the main information. Brain fog after first and second vaccine: Caller then states, by the way, after both vaccines within 2 or 3 minutes of having them her head started feeling foggy and weird. Investigations: caller has not received any results yet. She did get an EKG, Chest XRAY, blood work, and the doctor also rattled off a bunch of things the doctor was going to check. These all were on 14Apr2021 and she is waiting on results. Caller confirms the physician told her she had PVCs while listening to caller's heart. Did any AE require a visit to: Physician office? 15Apr2021 she was in contact with her physician, and the whole week they were on the phone. Yesterday 14Apr2021 the physician wanted to see her. The doctor figured out something was going on with her heart so thankfully the doctor wanted to see her. It was discussed if caller should go to the ER but caller did everything she could not to go because that is the last place she wants to go. Emergency Room: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of fever, vomiting, nausea was recovered, intermittent breathing issues, shaking legs and arms, weak, severe migraine, headache was not recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-04-26 | pain in extremity |
Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low ...
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Blood pressure was high, pain in left arm, lump and pain on my left shoulder blade, chills and low grade fever. I took Tylenol and the chills and fever went away Friday night, The pain in my arm went away by Sunday, 4/25. My blood pressure went down after drinking more water. I can still feel the lump but its not as painful.
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| 59 | 2021-04-28 | breast pain, pain in extremity |
blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye undern...
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blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye underneath; feeling crummy; she was down; headaches; couldn't move; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; got very sick; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:30 (at the age of 59years) as single dose for Covid-19 immunization. Medical history included ongoing rheumatoid arthritis and osteoarthritis (not bad enough that she takes treatment, but she is diagnosed; she was diagnosed way back in 2006). Concomitant products: patient stated she takes some medications (not further specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had her first dose of the Pfizer Covid-19 vaccine on 05Apr2021 and got very sick. She was down for two days and after day 10 (as reported) she has a blood clot under her eye. She would like to know what would happen if does not get a second dose. She consulted if there is any talk on whether or not people should receive an additional dose of the Pfizer Covid-19 vaccine next year. The patient further reported that on 06Apr2021 she woke up feeling crummy right away and a couple of hours into that day she couldn't lift her arm, literally couldn't lift arm for 6 inches and stated it went on for 2 days. She further stated that her arm hurt all the way below her arm pit into her breast. She stated that it all ended on 08Apr2021 and she went back to work on 08Apr2021. The patient added that she was down for two days, had headaches, and stated she never knew what people meant when they said they got hit by train. She doesn't believe she had a fever and couldn't move. The patient further stated that she got pretty darn sick and this morning 14Apr2021, she woke up with a blood clot under her eye. She is an esthetician and is pretty good with skin. She stated that she doesn't know how she could get this overnight unless she injured herself in her sleep, but she is a light sleeper. She does not know if it is a clot. She also stated that she called a medical esthetician who told her to take a baby aspirin and cold compress. The patient clarified that she didn't feel so good and today she feels better. She doesn't know that it is a blood clot, it is not raised and not hard, it looks like she has a bright red bruise in the corner of the eye to the middle of the eye underneath, not in the eye. She wants to make it clear she doesn't know if it is a blood clot. She feels like if she hurt herself, that would be the reason, but it would be painful, and it is not. She added that the bruise is about the same. Therapeutic measures were taken as a result of the events (except for feeling down and couldn't move). The outcome of events thrombosis and contusion was not recovered; the outcome of other events was recovered on 08Apr2021.
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| 59 | 2021-04-28 | tremor, seizure |
Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side;...
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Lost consciousness; dizzy like she was about to faint; twitching and shaking; eyes went to one side; she was about to faint; seizure; Diarrhea; chills; head hurting; eyes hurting; Muscle soreness; joint pain; Nausea; temperature of 99.3; This is a spontaneous report from a contactable consumer (daughter of patient) and another consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:21 (Lot Number: EW0164; Expiration Date: Aug2021) at vaccination age of 59 years old as single dose for covid-19 immunisation. Medical history included vertigo, antacid therapy. Concomitant medication included esomeprazole magnesium (NEXIUM 24HR) taken for antacid therapy from an unspecified start date and ongoing. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EP7533), on 23Mar2021 at 17:38 PM at age of 59 years old in the right arm as single dose for covid-19 immunisation and only had a little bit of muscle soreness on her right arm on 23Mar2021 after the first dose and it went away the day after (24Mar2021). The patient took Tetanus shot about two weeks before the first dose of the Pfizer COVID 19 vaccine. Then received the second dose on 13Apr2021 16:21PM in the left arm. After the second dose she had chills; her head was hurting; her eyes were hurting; she had muscle soreness; she had joint pain all yesterday 14Apr2021. Then this morning 15Apr2021, after taking a Tylenol and getting a shower she felt dizzy like she was about to faint. Her mother had vertigo but this was not like her usual vertigo. Her mother sat on the bed and started to have what looked like a seizure with twitching and shaking; then she lost consciousness. Her mother's eyes were open and they saw her mother's eyes twisted, went to one side, and she fell back on the bed. They called at 05:30 AM and the ambulance arrived quickly but by the time they arrived she had regained consciousness. They recommended she follow up with HCP. They called the doctor who advised her to rest, and make an appointment to see the doctor tomorrow. Reporter clarified her mother had the chills from 10:00 AM today (15Apr2021) and had them day with a lot of headache, eyes hurting goes along with the headache, and she had a temperature of 99.3. The chills and temperature resolved last night then the eyes hurting ended this morning (15Apr2021) with the headache. All of the other symptoms resolved yesterday (14Apr2021). She also had nausea that started yesterday (14Apr2021) and she started to have diarrhea once today (15Apr2021)and felt like it had stopped. The nausea was coming and going from time to time. The events did not require a visit to emergency room or physician office. The outcome of events chills, muscle soreness, joint pain, temperature of 99.3 was recovered on 14Apr2021. The outcome of events Lost consciousness, head hurting, eyes hurting, felt dizzy, twitching and shaking, eyes went to one side, Diarrhea was recovered on 15Apr2021. The outcome of event seizure, she was about to faint was unknown. The outcome of event nausea was recovering.
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| 59 | 2021-04-28 | tremor |
Slight fever, severe chills and shaking to the bone where whole body tightens. Took 2 alka-seltzer p...
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Slight fever, severe chills and shaking to the bone where whole body tightens. Took 2 alka-seltzer plus cold and flu evervescent tablets. Waiting to see if works.
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| 59 | 2021-04-28 | tremor |
Slight fever, severe chills with shakes That tighten the whole body. Talk 2 alka-sheltzer plus cold ...
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Slight fever, severe chills with shakes That tighten the whole body. Talk 2 alka-sheltzer plus cold and flu effervescent tablets. Waiting on results.
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| 59 | 2021-04-30 | pain in extremity |
acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cy...
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acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cysts except both sides were hurting; had trouble catching breath with the pain; arm pain; brain fog/head started feeling foggy and weird; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 16:00 (Lot Number: EN5318, Expiry date: 31May2021) on left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Historical Vaccine included flu shots. The patient stated her physician told her she had an acute lymphatic response. She added there was something about 3 am (18Mar2021) because she woke up at 3 am and had severe pain in some of her lymph nodes. In particular, the ones around her ovaries. She added that she was old and her ovaries had not worked in a long time. She had severe pain like cysts except both sides were hurting. She also had trouble catching breath with the pain. This lasted 45 minutes and subsided. The next morning 18Mar2021, when she got up some of her lymph nodes were very panful and there was one even that was a node visible down her throat almost at the base of her neck in the center. She could see it sticking out, it was crazy. It went down in about three days. The pain and the weirdness in all of her other lymph's was about 3 or 4 days. It was an odd response and people told her it was just her body acting like a young person and was going to work. This was the first issue she had with the vaccines. The patient also experienced brain fog after first vaccine on 17Mar2021: within 2 or 3 minutes of having them her head started feeling foggy and weird. It was after the first vaccine, she thought it was psychological but it did not go away and it was not psychological. It was like a weird foggy and like taking sinus medication, no additional details. When it happened with the first vaccine, it did not concern her as much as the first one. It went away after the first vaccine probably late that evening (17Mar2021), around 10:30 pm right when her arm started to hurt. She did not have arm pain that was severe. She added maybe it lasted a day. The next day it hurt but it was not anything bad, it just hurt to touch it and to lift it hurt for a day. Maybe this was for 36-40 hours before the pain went out. The outcome of event "trouble catching breath with the pain" was resolved on 18Mar2021 03:45, outcome of event "brain fog/head started feeling foggy and weird" was resolved on 17Mar2021, outcome of other events were resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-04-30 | pain in extremity |
they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving he...
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they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved. Information on the lot/batch number has been requested.
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| 59 | 2021-04-30 | pain in extremity |
Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure;...
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Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation (Age at vaccination: 59 years) . Medical history included liver disorder , hypersensitivity, hepatitis C from , osteopetrosis , arthropod sting allergy , drug hypersensitivity , gluten sensitivity (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient experienced high bp/pressure in head and high blood pressure on 05Apr2021 with outcome of unknown , fatigue on an unspecified date with outcome of unknown , severe chills on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders on 05Apr2021 with outcome of recovered , arm hurt after shot on 05Apr2021 with outcome of unknown , pressure in head on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea on 05Apr2021 with outcome of unknown , brain fog on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious. The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97 on unknown date , blood pressure measurement: 152/87 on 06Apr2021 , body temperature decreased: low No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-05-02 | weakness |
Severe flu like symptoms, including low grade fever lasting 3 days. Severe headache, dizzy, weak, un...
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Severe flu like symptoms, including low grade fever lasting 3 days. Severe headache, dizzy, weak, unable to eat for 36 hours.
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| 59 | 2021-05-07 | feeling cold, feeling hot |
little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a...
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little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a ghost; felt cold; Dizzy; bruised her tailbone; Passed out; from when she fell she has a knot on the back of her head, and her back has a kink; from when she fell she has a knot on the back of her head, and her back has a kink; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Apr2021 17:36 (Lot Number: EW0161) (at age 59 years old) as single dose for covid-19 immunisation. Medical history included diabetic from an unknown date and unknown if ongoing diagnosed in 2001-2002. The patient's concomitant medications were not reported. She did not get any other vaccinations yesterday or in the last four weeks. She says she has started no other new meds recently. The patient stated she got her first dose on 22Apr2021 and was perfectly fine, she didn't feel anything. She says when she went to bed a few hours later, she felt really really warm like she was sunburnt or something. She says she slept, then woke up around midnight and got up and thought maybe she had to go to the bathroom. She says she felt nauseous and thought she was going to be sick so she went back to the bathroom and she was white as a ghost, and felt cold and dizzy. She says she was feeling like she was gonna pass out, so she thought her sugar levels had dropped really low, so she went downstairs to check them then woke up on the floor, she had passed out. She says she came to, and checked her sugar and it was normal, 110, so she is assuming she passed out due to the shot. She says her first dose was injected around 17:36, and it was a few hours later when she went to bed around 09:00-9:30PM and got into bed when she kind of felt like she was on fire. She says she did no treatment; she went to sleep. She says from when she fell she has a knot on the back of her head, and her back has a kink in it. She says she is sure she has also bruised her tailbone. As of 23Apr2021, she doesn't feel warm or anything now, she just has little heart palpitations that is all, and those have stayed about the same. Outcome of the events was unknown.
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| 59 | 2021-05-07 | pain in extremity |
Tiredness; brain fog; headache; Day 1 Sore arm; This is a spontaneous report from a non-contactable ...
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Tiredness; brain fog; headache; Day 1 Sore arm; This is a spontaneous report from a non-contactable Other Health Professional, the patient. A 59-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EK5730), via an unspecified route of administration as a single dose on 30Dec2020 for COVID-19 immunisation. The patient medical history was not reported. No allergies to medications, food, or other products reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium/magnesium/ vitamin d nos (CAL MAG), calcium carbonate/colecalciferol/phytomenadione (Vit D+K), fish oil (OMEGA 3) and multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, the patient experienced sore arm on day 1 of vaccination and on 31Dec2020 experienced tiredness, brain fog and headache. No treatment was received for the events. The outcome of the events were recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-05-07 | tension headache |
Passed out; Pressure in her head; Major headache; Fatigue/ tiredness; Stress/fatigue headache; This ...
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Passed out; Pressure in her head; Major headache; Fatigue/ tiredness; Stress/fatigue headache; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in left arm on 12Apr2021 at 09:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation and asthmatic. The patient's medical history included rheumatoid arthritis (diagnosed three months ago), sleep disorder, blood pressure, blood pressure increased, PTSD (post-traumatic stress disorder). Patient's medical history (including any illness at time of vaccination) was none. Concomitant medications included trazodone (Strength: 25 mg) orally taking for years at 25 mg, once a day for sleep disorder, losartan (Strength: 25 mg) orally taking for 4 years at 25 mg, once a day for blood pressure, acetylsalicylic acid (ASPIRIN) orally taking for 4 years 81 mg, once a day for blood pressure increased, hydroxychloroquine (Strength: 200mg) orally taking for two months at 200 mg, once a day for rheumatoid arthritis, leflunomide (Strength: 10 mg) orally taking for two months at 10 mg, once a day, sertraline orally taking for 4 years at 50 mg, once a day for PTSD (post-traumatic stress disorder); All ongoing. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206, NDC number: Unknown, Expiration date: Unknown), on 22Mar2021 at 15:30 as a single dose in left arm for COVID-19 Immunization and asthmatic. Family history was none. Prior vaccinations (within 4 weeks) was none. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 she reports developing a headache that has been ongoing since then, 14-16 days total. She also reports fatigue. She has been seen by doctors and had CT scans and bloodwork, the doctors think it was a stress/fatigue headache. Caller indicated she didn't think the symptoms were vaccine related but wants to rule everything out. Enquired what information do we have for duration of headache after vaccination. Caller indicated she had already spoken to a nurse with safety. Caller was a 59-year-old female reporting a headache that started 2 days after her second dose of the Pfizer COVID-19 vaccine, with symptoms that have been ongoing for 14-16 days. Response: Provided information from fact sheet that 55.1% of patients reported headache in the clinical trials, and that data was coming from the 7 days after either dose. Enquired how long side effects last. Which states adverse events typically start 1-2 days after vaccination and resolve shortly thereafter; Also spoke from CDC data which indicates adverse events might be more intense after the second dose. Referred back to healthcare professional for additional assessment and treatment. Consumer calling regarding the Pfizer COVID-19 vaccine. Reports she got the second shot 12Apr2021 and a couple of days later she got pressure in her head that has turned into a major headache. States and it has been a major headache. Reports she has been to the emergency room and her primary care doctor. Adds she had a CT scan, and bloodwork till she looks like a pin cushion, and everything was coming back fine. Adds she was tired all the time and could not get rid of the headache. Her question; Mentions she was looking at the side effects and saw tiredness and headaches a couple of days after; but enquired have we had any complaints about them lasting so long. Clarified she received the second dose of the Pfizer COVID-19 vaccine on 12Apr2021 at 09:30 AM in the left arm. A couple of day later the headache started; and the tiredness started at the same time. Tiredness was reported as worsened. She got the shot at PRIVACY. Adds she has missed two weeks of work and she could sleep 24 hours a day if the headache would let her. Adds she was 60 years old and takes a lot of medication; she tries not. Primary/prescriber: States the rank was major; she thinks her doctor was on maternity leave; Product: Pfizer COVID-19 vaccine; treatment first dose of the vaccine 22Mar2021 at 15:30 PM in the left arm. Lot EN6206; provides lot number for both doses from vaccination card but does not see NDC, expiration date or dose. This past Sunday the headache got so bad that she passed out in her living room and her 72-year-old husband called 911. She was taken to the (PRIVACY) Hospital and they did the CT scan and the blood work that was normal. She went home and tried to go to work on Monday and that only lasted 3 hours. No investigation assessment. No relevant test. The adverse events require a visit to emergency room but not admitted to the hospital and visit to physician office as she saw a doctor at the base on Monday, she had doctor's excuse to be off on Monday and Tuesday, so she called and got a walk-in appointment for Thursday. They did more blood work, and it came out great. The patient underwent lab test and procedure which included blood work: Normal, CT scan: Normal on an unspecified date. The outcome of the event passed out was recovered on an unspecified date in 2021, unknown for the event pressure in her head and not recovered for the other events. No follow-up attempts are needed. No further information is expected. Lot number obtained.
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| 59 | 2021-05-09 | burning sensation |
Day of shot within 1 hour Felt like my arm was dislocated for several days. Still feeling discomfort...
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Day of shot within 1 hour Felt like my arm was dislocated for several days. Still feeling discomfort. Day 3 Extreme burning in lower jaw with pain also similar to toothache and all teeth and lower jaw. Eventually extended throughout my neck and lower part of my head. Inhaling felt like stabbing in lower neck and a three and four.
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| 59 | 2021-05-09 | pain in extremity |
I was hospitalized for bilateral pulmonary embolism 4/18/2021 at hospital. I think I had symptoms fo...
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I was hospitalized for bilateral pulmonary embolism 4/18/2021 at hospital. I think I had symptoms for over 3 weeks prior to hospitalization. I was rapid COVID tested on 3/26/2021 the nurse at CVS asked why my blood oxygen was low. I did not know but had me pant and move my fingers and it went up to 96. I also remember severe leg pain on a drive 3/25/21. I noticed shortness of breath 4/5/21 and fast pulse but didnot go to hospital until 4/18/21. I previously had a PE 7/2009 and also had it for ~2 weeks before going to hospital. I was not on blood thinner since 2015. The doctors at the hospital and primary care doctor did not seem to think the PE was vaccine related but they also do not believe I had symptoms for over 3 weeks.
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| 59 | 2021-05-10 | bell's palsy |
facial symptoms; Bell's Palsy.; headache; This is a spontaneous report from a contactable consumer (...
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facial symptoms; Bell's Palsy.; headache; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 25Mar2021 10:30 AM (Lot Number: ER8733) at the same age as single dose for COVID-19 immunisation. Medical history included Herpes (although no symptoms or outbreaks for 20+ years). Concomitant medications included estradiol (ESTROGEN) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 04Mar2021 11.30am (Lot Number: EN6206) as single dose for COVID-19 immunisation. The patient experienced Bell's Palsy and first had headache on 12Apr2021, first facial symptoms appeared on 16Apr2021. The adverse event result in: Doctor or other healthcare professional office/clinic visit. Treatment was received for the events including Prednisone and anti-viral. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant. Outcome of the events was recovering.
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| 59 | 2021-05-10 | pain in extremity |
Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they wer...
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Mouth broke out; zit that broke out on the top of her eyebrow. There are hard little bumps; they were red and hard; Arm was sore; puffy/swollen; She had a breakout on her face, a couple of lesions, and her mouth broke out.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included allergic to Penicillin, crustaceans, shellfish, and mushrooms. Those were what she usually had a breakout for. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug allergy and second degree burns. Her reaction to amoxicillin was probably 15 years before. The patient had a reaction to her first Covid-19 shot. She took the first shot last Tuesday. She had a breakout on her face, a couple of lesions, and her mouth broke out. It looked like a reaction. She took a couple of diphenhydramine hydrochloride (BENADRYL), and it was going away. Her second shot was scheduled for next Tuesday 11May2021. She needed to know if there was anything in the shot that would cause this. She was leery of taking it. She was okay with it, and the diphenhydramine hydrochloride was fine. She did contact her doctor. That was it, she had nothing else just the breakout. She thought it was maybe Thursday 22Apr2021 or Friday 23Apr2021 that she noticed the breakout on her face. She started trying to take some diphenhydramine hydrochloride. It was rapid when it happened, not slow. She saw these as almost like a reaction. She had welting on the skin similar to a reaction to dust mites. There was this thing she thought was just a zit that broke out on the top of her eyebrow. There were hard little bumps. One had gone away, and the other was still there. It was almost like when she had a breakout of zits was kind of what she would say. It was dissipating. She started taking rounds of diphenhydramine hydrochloride to stop the reaction, and it was working. She was concerned about the second shot. She didn't know if it was an allergic reaction to amoxicillin or any other type of medicine if it was in there. That was what she was concerned about. Before she got the second shot she needed an idea of what might have happened. The lesions came a day or so after the breakout on her face. She would say Sunday 25Apr2021 was when she saw the lesions above her eyebrows. It was right at the beginning of her eyebrow. It was really hard at first. It was not itching, just like zits. Similarly, they were red and hard. Once again she started the diphenhydramine hydrochloride and saw a little bit of difference, but had to keep putting on topical Aquaphor and cocoa butter. She had to keep putting it on there, it was just swollen. The lesions were puffy and red. There was just one left, it was going down. Her mouth was the number one thing. She thought it was from wearing a mask. She had never had a breakout with a mask before. She took the shot on Tuesday, and her arm was sore just for 24 hours. She noticed her mouth broke out Thursday or Friday for sure when she woke up. At first she just kind of forgot about the shot and didn't put two and two together. She took diphenhydramine hydrochloride. It was the same type of reaction she would have if it was amoxicillin. She really needed to know if she should anticipate something with the second shot. Outcome of event a breakout on her face, a couple of lesions, and her mouth broke out was resolving, and of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 59 | 2021-05-11 | bell's palsy |
Diagnosis of Bells Palsy on 14Apr2021; This is a spontaneous report from a contactable consumer. A...
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Diagnosis of Bells Palsy on 14Apr2021; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in the left arm on 26Mar2021, at 11:00 as single dose for covid-19 immunization. Medical history included hypertension from an unknown date . No known allergies were noted. There were no concomitant medications. The patient had diagnosis of Bells palsy on 14apr2021 on 14Apr2021, at 06:00. The event resulted in Emergency room/department or urgent care visit. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of diagnosis of bells palsy on 14apr2021, and included treatment with predisone (x 5 days) and anti-viral (x 10 days). The outcome of diagnosis of Bells palsy on 14apr2021 was not recovered.
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